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New injectable gel can deliver immune cells directly to cancer tumors
A simple, two-ingredient gel may boost the fighting power of a groundbreaking cancer treatment, say Stanford University engineers.
The gel – made from water and a plant-based polymer – delivers targeted T cells adjacent to a cancer growth, taking aim at solid tumors.
It’s the latest development in CAR T-cell therapy, a type of immunotherapy that involves collecting the patient’s T cells, reengineering them to be stronger, and returning them to the patient’s body.
Results have been promising in blood cancers, such as leukemia and lymphoma, but less so in solid tumors, such as brain, breast, or kidney cancer, according to the National Cancer Institute.
The gel “is a really exciting step forward,” says Abigail Grosskopf, a PhD candidate at Stanford (Calif.) University, who is the lead study author, “because it can change the delivery of these cells and expand this kind of treatment to other cancers.”
CAR T-cell therapy: Limits in solid tumors
Currently available CAR T-cell therapies are administered by intravenous infusion. But that doesn’t do much against tumors in specific locations because the cells enter the bloodstream and flow throughout the body. The cancer-fighting effort exhausts the T cells, weakening their ability to infiltrate dense tumors.
CAR T cells need cytokines to tell them when to attack, Ms. Grosskopf explains. If delivered through an IV drip, the number of cytokines required to destroy a solid tumor would be toxic to other, healthy parts of the body.
So
In their study, which was published in Science Advances, the injections wiped out mouse tumors in 12 days. The gel degraded harmlessly a few weeks later.
A “leaky pen” that fights cancer
The reason a gel works better than a liquid is because of its staying power, says Ms. Grosskopf, who compares the method to a leaky pen.
The gel acts as the “pen,” releasing activated CAR T cells at regular intervals to attack the cancerous growth. Whereas liquid dissipates quickly, the gel’s structure is strong enough to stay in place for weeks, Ms. Grosskopf says. Plus, it’s biocompatible and harmless within the body, she adds.
More preclinical studies are needed before human clinical trials can occur, Ms. Grosskopf says.
“Not only could this be a way to deliver T cells and cytokines,” Ms. Grosskopf says, “but it may be used for other targeted therapy cancer drugs that are in development. So we see this as running parallel to those efforts.”
Taking an even broader view, the gel could have applications across medical specialties, such as slow-release delivery of vaccines.
A version of this article first appeared on Medscape.com.
A simple, two-ingredient gel may boost the fighting power of a groundbreaking cancer treatment, say Stanford University engineers.
The gel – made from water and a plant-based polymer – delivers targeted T cells adjacent to a cancer growth, taking aim at solid tumors.
It’s the latest development in CAR T-cell therapy, a type of immunotherapy that involves collecting the patient’s T cells, reengineering them to be stronger, and returning them to the patient’s body.
Results have been promising in blood cancers, such as leukemia and lymphoma, but less so in solid tumors, such as brain, breast, or kidney cancer, according to the National Cancer Institute.
The gel “is a really exciting step forward,” says Abigail Grosskopf, a PhD candidate at Stanford (Calif.) University, who is the lead study author, “because it can change the delivery of these cells and expand this kind of treatment to other cancers.”
CAR T-cell therapy: Limits in solid tumors
Currently available CAR T-cell therapies are administered by intravenous infusion. But that doesn’t do much against tumors in specific locations because the cells enter the bloodstream and flow throughout the body. The cancer-fighting effort exhausts the T cells, weakening their ability to infiltrate dense tumors.
CAR T cells need cytokines to tell them when to attack, Ms. Grosskopf explains. If delivered through an IV drip, the number of cytokines required to destroy a solid tumor would be toxic to other, healthy parts of the body.
So
In their study, which was published in Science Advances, the injections wiped out mouse tumors in 12 days. The gel degraded harmlessly a few weeks later.
A “leaky pen” that fights cancer
The reason a gel works better than a liquid is because of its staying power, says Ms. Grosskopf, who compares the method to a leaky pen.
The gel acts as the “pen,” releasing activated CAR T cells at regular intervals to attack the cancerous growth. Whereas liquid dissipates quickly, the gel’s structure is strong enough to stay in place for weeks, Ms. Grosskopf says. Plus, it’s biocompatible and harmless within the body, she adds.
More preclinical studies are needed before human clinical trials can occur, Ms. Grosskopf says.
“Not only could this be a way to deliver T cells and cytokines,” Ms. Grosskopf says, “but it may be used for other targeted therapy cancer drugs that are in development. So we see this as running parallel to those efforts.”
Taking an even broader view, the gel could have applications across medical specialties, such as slow-release delivery of vaccines.
A version of this article first appeared on Medscape.com.
A simple, two-ingredient gel may boost the fighting power of a groundbreaking cancer treatment, say Stanford University engineers.
The gel – made from water and a plant-based polymer – delivers targeted T cells adjacent to a cancer growth, taking aim at solid tumors.
It’s the latest development in CAR T-cell therapy, a type of immunotherapy that involves collecting the patient’s T cells, reengineering them to be stronger, and returning them to the patient’s body.
Results have been promising in blood cancers, such as leukemia and lymphoma, but less so in solid tumors, such as brain, breast, or kidney cancer, according to the National Cancer Institute.
The gel “is a really exciting step forward,” says Abigail Grosskopf, a PhD candidate at Stanford (Calif.) University, who is the lead study author, “because it can change the delivery of these cells and expand this kind of treatment to other cancers.”
CAR T-cell therapy: Limits in solid tumors
Currently available CAR T-cell therapies are administered by intravenous infusion. But that doesn’t do much against tumors in specific locations because the cells enter the bloodstream and flow throughout the body. The cancer-fighting effort exhausts the T cells, weakening their ability to infiltrate dense tumors.
CAR T cells need cytokines to tell them when to attack, Ms. Grosskopf explains. If delivered through an IV drip, the number of cytokines required to destroy a solid tumor would be toxic to other, healthy parts of the body.
So
In their study, which was published in Science Advances, the injections wiped out mouse tumors in 12 days. The gel degraded harmlessly a few weeks later.
A “leaky pen” that fights cancer
The reason a gel works better than a liquid is because of its staying power, says Ms. Grosskopf, who compares the method to a leaky pen.
The gel acts as the “pen,” releasing activated CAR T cells at regular intervals to attack the cancerous growth. Whereas liquid dissipates quickly, the gel’s structure is strong enough to stay in place for weeks, Ms. Grosskopf says. Plus, it’s biocompatible and harmless within the body, she adds.
More preclinical studies are needed before human clinical trials can occur, Ms. Grosskopf says.
“Not only could this be a way to deliver T cells and cytokines,” Ms. Grosskopf says, “but it may be used for other targeted therapy cancer drugs that are in development. So we see this as running parallel to those efforts.”
Taking an even broader view, the gel could have applications across medical specialties, such as slow-release delivery of vaccines.
A version of this article first appeared on Medscape.com.
FROM SCIENCE ADVANCES
Ways to lessen toxic effects of chemo in older adults
Age-related changes that potentiate adverse drug reactions include alterations in absorption, distribution, metabolism, and excretion. As such, older patients often require adjustments in medications to optimize safety and use. Medication adjustment is especially important for older patients on complex medication regimens for multiple conditions, such as those undergoing cancer treatment. Three recent high-quality randomized trials evaluated the use of geriatric assessment (GA) in older adults with cancer.1-3
Interdisciplinary GA can identify aging-related conditions associated with poor outcomes in older patients with cancer (e.g., toxic effects of chemotherapy) and provide recommendations aimed at improving health outcomes. The results of these trials suggest that interdisciplinary GA can improve care outcomes and oncologists’ communication for older adults with cancer, and should be considered an emerging standard of care.
Geriatric assessment and chemotherapy-related toxic effects
A cluster randomized trial1 at City of Hope National Medical Center conducted between August 2015 and February 2019 enrolled 613 participants and randomly assigned them to receive a GA-guided intervention or usual standard of care in a 2-to-1 ratio. Participants were eligible for the study if they were aged ≥65 years; had a diagnosis of solid malignant neoplasm of any stage; were starting a new chemotherapy regimen; and were fluent in English, Spanish, or Chinese.
The intervention included a GA at baseline followed by assessments focused on six common areas: sleep problems, problems with eating and feeding, incontinence, confusion, evidence of falls, and skin breakdown. An interdisciplinary team (oncologist, nurse practitioner, pharmacist, physical therapist, occupational therapist, social worker, and nutritionist) performed the assessment and developed a plan of care. Interventions were multifactorial and could include referral to specialists; recommendations for medication changes; symptom management; nutritional intervention with diet recommendations and supplementation; and interventions targeting social, spiritual, and functional well-being. Follow-up by a nurse practitioner continued until completion of chemotherapy or 6 months after starting chemotherapy, whichever was earlier.
The primary outcome was grade 3 or higher chemotherapy-related toxic effects using National Cancer Institute criteria, and secondary outcomes were advance directive completion, emergency room visits and unplanned hospitalizations, and survival up to 12 months. Results showed a 10% absolute reduction in the incidence of grade 3 or higher toxic effects (P = .02), with a number needed to treat of 10. Advance directive completion also increased by 15%, but no differences were observed for other outcomes. This study offers high-quality evidence that a GA-based intervention can reduce toxic effects of chemotherapy regimens for older adults with cancer.
Geriatric assessment in community oncology practices
A recent study by Supriya G. Mohile, MD, and colleagues2 is the first nationwide multicenter clinical trial to demonstrate the effects of GA and GA-guided management. This study was conducted in 40 oncology practices from the University of Rochester National Cancer Institute Community Oncology Research Program network. Centers were randomly assigned to intervention or usual care (362 patients treated by 68 oncologists in the intervention group and 371 patients treated by 91 oncologists in the usual-care group). Eligibility criteria were age ≥70 years; impairment in at least one GA domain other than polypharmacy; incurable advanced solid tumor or lymphoma with a plan to start new cancer treatment with a high risk for toxic effects within 4 weeks; and English language fluency. Both study groups underwent a baseline GA that assessed patients’ physical performance, functional status, comorbidity, cognition, nutrition, social support, polypharmacy, and psychological status. For the intervention group, a summary and management recommendations were provided to the treating oncologists.
The primary outcome was grade 3 or higher toxic effects within 3 months of starting a new regimen; secondary outcomes included treatment intensity and survival and GA outcomes within 3 months. A smaller proportion of patients in the intervention group experienced toxicity (51% vs. 71%), with an absolute risk reduction of 20%. Patients in the intervention group also had fewer falls and a greater reduction in medications used; there were no other differences in secondary outcomes. This study offers very strong and generalizable evidence that incorporating GA in the care of older adults with cancer at risk for toxicity can reduce toxicity as well as improve other outcomes, such as falls and polypharmacy.
Geriatric assessment and oncologist-patient communication
A secondary analysis3 of data from Dr. Mohile and colleagues2 evaluated the effect of GA-guided recommendations on oncologist-patient communication regarding comorbidities. Patients (n = 541) included in this analysis were 76.6 years of age on average and had 3.2 (standard deviation, 1.9) comorbid conditions. All patients underwent GA, but only oncologists in the intervention arm received GA-based recommendations. Clinical encounters between oncologist and patient immediately following the GA were audio recorded and analyzed to examine communication between oncologists and participants as it relates to chronic comorbid conditions.
In the intervention arm, more discussions regarding comorbidities took place, and more participants’ concerns about comorbidities were acknowledged. More importantly, participants in the intervention group were 2.4 times more likely to have their concerns about comorbidities addressed through referral or education, compared with the usual-care group (P = .004). Moreover, 41% of oncologists in the intervention arm modified dosage or cancer treatment schedule because of concern about tolerability or comorbidities. This study demonstrates beneficial effects of GA in increasing communication and perhaps consideration of comorbidities of older adults when planning cancer treatment.
Dr. Hung is professor of geriatrics and palliative care at Mount Sinai Hospital, New York. He disclosed no relevant conflicts of interest.
References
1. Li D et al. JAMA Oncol. 2021;7:e214158.
2. Mohile SG et al. Lancet. 2021;398:1894-1904.
3. Kleckner AS et al. JCO Oncol Pract. 2022;18:e9-19.
A version of this article first appeared on Medscape.com.
Age-related changes that potentiate adverse drug reactions include alterations in absorption, distribution, metabolism, and excretion. As such, older patients often require adjustments in medications to optimize safety and use. Medication adjustment is especially important for older patients on complex medication regimens for multiple conditions, such as those undergoing cancer treatment. Three recent high-quality randomized trials evaluated the use of geriatric assessment (GA) in older adults with cancer.1-3
Interdisciplinary GA can identify aging-related conditions associated with poor outcomes in older patients with cancer (e.g., toxic effects of chemotherapy) and provide recommendations aimed at improving health outcomes. The results of these trials suggest that interdisciplinary GA can improve care outcomes and oncologists’ communication for older adults with cancer, and should be considered an emerging standard of care.
Geriatric assessment and chemotherapy-related toxic effects
A cluster randomized trial1 at City of Hope National Medical Center conducted between August 2015 and February 2019 enrolled 613 participants and randomly assigned them to receive a GA-guided intervention or usual standard of care in a 2-to-1 ratio. Participants were eligible for the study if they were aged ≥65 years; had a diagnosis of solid malignant neoplasm of any stage; were starting a new chemotherapy regimen; and were fluent in English, Spanish, or Chinese.
The intervention included a GA at baseline followed by assessments focused on six common areas: sleep problems, problems with eating and feeding, incontinence, confusion, evidence of falls, and skin breakdown. An interdisciplinary team (oncologist, nurse practitioner, pharmacist, physical therapist, occupational therapist, social worker, and nutritionist) performed the assessment and developed a plan of care. Interventions were multifactorial and could include referral to specialists; recommendations for medication changes; symptom management; nutritional intervention with diet recommendations and supplementation; and interventions targeting social, spiritual, and functional well-being. Follow-up by a nurse practitioner continued until completion of chemotherapy or 6 months after starting chemotherapy, whichever was earlier.
The primary outcome was grade 3 or higher chemotherapy-related toxic effects using National Cancer Institute criteria, and secondary outcomes were advance directive completion, emergency room visits and unplanned hospitalizations, and survival up to 12 months. Results showed a 10% absolute reduction in the incidence of grade 3 or higher toxic effects (P = .02), with a number needed to treat of 10. Advance directive completion also increased by 15%, but no differences were observed for other outcomes. This study offers high-quality evidence that a GA-based intervention can reduce toxic effects of chemotherapy regimens for older adults with cancer.
Geriatric assessment in community oncology practices
A recent study by Supriya G. Mohile, MD, and colleagues2 is the first nationwide multicenter clinical trial to demonstrate the effects of GA and GA-guided management. This study was conducted in 40 oncology practices from the University of Rochester National Cancer Institute Community Oncology Research Program network. Centers were randomly assigned to intervention or usual care (362 patients treated by 68 oncologists in the intervention group and 371 patients treated by 91 oncologists in the usual-care group). Eligibility criteria were age ≥70 years; impairment in at least one GA domain other than polypharmacy; incurable advanced solid tumor or lymphoma with a plan to start new cancer treatment with a high risk for toxic effects within 4 weeks; and English language fluency. Both study groups underwent a baseline GA that assessed patients’ physical performance, functional status, comorbidity, cognition, nutrition, social support, polypharmacy, and psychological status. For the intervention group, a summary and management recommendations were provided to the treating oncologists.
The primary outcome was grade 3 or higher toxic effects within 3 months of starting a new regimen; secondary outcomes included treatment intensity and survival and GA outcomes within 3 months. A smaller proportion of patients in the intervention group experienced toxicity (51% vs. 71%), with an absolute risk reduction of 20%. Patients in the intervention group also had fewer falls and a greater reduction in medications used; there were no other differences in secondary outcomes. This study offers very strong and generalizable evidence that incorporating GA in the care of older adults with cancer at risk for toxicity can reduce toxicity as well as improve other outcomes, such as falls and polypharmacy.
Geriatric assessment and oncologist-patient communication
A secondary analysis3 of data from Dr. Mohile and colleagues2 evaluated the effect of GA-guided recommendations on oncologist-patient communication regarding comorbidities. Patients (n = 541) included in this analysis were 76.6 years of age on average and had 3.2 (standard deviation, 1.9) comorbid conditions. All patients underwent GA, but only oncologists in the intervention arm received GA-based recommendations. Clinical encounters between oncologist and patient immediately following the GA were audio recorded and analyzed to examine communication between oncologists and participants as it relates to chronic comorbid conditions.
In the intervention arm, more discussions regarding comorbidities took place, and more participants’ concerns about comorbidities were acknowledged. More importantly, participants in the intervention group were 2.4 times more likely to have their concerns about comorbidities addressed through referral or education, compared with the usual-care group (P = .004). Moreover, 41% of oncologists in the intervention arm modified dosage or cancer treatment schedule because of concern about tolerability or comorbidities. This study demonstrates beneficial effects of GA in increasing communication and perhaps consideration of comorbidities of older adults when planning cancer treatment.
Dr. Hung is professor of geriatrics and palliative care at Mount Sinai Hospital, New York. He disclosed no relevant conflicts of interest.
References
1. Li D et al. JAMA Oncol. 2021;7:e214158.
2. Mohile SG et al. Lancet. 2021;398:1894-1904.
3. Kleckner AS et al. JCO Oncol Pract. 2022;18:e9-19.
A version of this article first appeared on Medscape.com.
Age-related changes that potentiate adverse drug reactions include alterations in absorption, distribution, metabolism, and excretion. As such, older patients often require adjustments in medications to optimize safety and use. Medication adjustment is especially important for older patients on complex medication regimens for multiple conditions, such as those undergoing cancer treatment. Three recent high-quality randomized trials evaluated the use of geriatric assessment (GA) in older adults with cancer.1-3
Interdisciplinary GA can identify aging-related conditions associated with poor outcomes in older patients with cancer (e.g., toxic effects of chemotherapy) and provide recommendations aimed at improving health outcomes. The results of these trials suggest that interdisciplinary GA can improve care outcomes and oncologists’ communication for older adults with cancer, and should be considered an emerging standard of care.
Geriatric assessment and chemotherapy-related toxic effects
A cluster randomized trial1 at City of Hope National Medical Center conducted between August 2015 and February 2019 enrolled 613 participants and randomly assigned them to receive a GA-guided intervention or usual standard of care in a 2-to-1 ratio. Participants were eligible for the study if they were aged ≥65 years; had a diagnosis of solid malignant neoplasm of any stage; were starting a new chemotherapy regimen; and were fluent in English, Spanish, or Chinese.
The intervention included a GA at baseline followed by assessments focused on six common areas: sleep problems, problems with eating and feeding, incontinence, confusion, evidence of falls, and skin breakdown. An interdisciplinary team (oncologist, nurse practitioner, pharmacist, physical therapist, occupational therapist, social worker, and nutritionist) performed the assessment and developed a plan of care. Interventions were multifactorial and could include referral to specialists; recommendations for medication changes; symptom management; nutritional intervention with diet recommendations and supplementation; and interventions targeting social, spiritual, and functional well-being. Follow-up by a nurse practitioner continued until completion of chemotherapy or 6 months after starting chemotherapy, whichever was earlier.
The primary outcome was grade 3 or higher chemotherapy-related toxic effects using National Cancer Institute criteria, and secondary outcomes were advance directive completion, emergency room visits and unplanned hospitalizations, and survival up to 12 months. Results showed a 10% absolute reduction in the incidence of grade 3 or higher toxic effects (P = .02), with a number needed to treat of 10. Advance directive completion also increased by 15%, but no differences were observed for other outcomes. This study offers high-quality evidence that a GA-based intervention can reduce toxic effects of chemotherapy regimens for older adults with cancer.
Geriatric assessment in community oncology practices
A recent study by Supriya G. Mohile, MD, and colleagues2 is the first nationwide multicenter clinical trial to demonstrate the effects of GA and GA-guided management. This study was conducted in 40 oncology practices from the University of Rochester National Cancer Institute Community Oncology Research Program network. Centers were randomly assigned to intervention or usual care (362 patients treated by 68 oncologists in the intervention group and 371 patients treated by 91 oncologists in the usual-care group). Eligibility criteria were age ≥70 years; impairment in at least one GA domain other than polypharmacy; incurable advanced solid tumor or lymphoma with a plan to start new cancer treatment with a high risk for toxic effects within 4 weeks; and English language fluency. Both study groups underwent a baseline GA that assessed patients’ physical performance, functional status, comorbidity, cognition, nutrition, social support, polypharmacy, and psychological status. For the intervention group, a summary and management recommendations were provided to the treating oncologists.
The primary outcome was grade 3 or higher toxic effects within 3 months of starting a new regimen; secondary outcomes included treatment intensity and survival and GA outcomes within 3 months. A smaller proportion of patients in the intervention group experienced toxicity (51% vs. 71%), with an absolute risk reduction of 20%. Patients in the intervention group also had fewer falls and a greater reduction in medications used; there were no other differences in secondary outcomes. This study offers very strong and generalizable evidence that incorporating GA in the care of older adults with cancer at risk for toxicity can reduce toxicity as well as improve other outcomes, such as falls and polypharmacy.
Geriatric assessment and oncologist-patient communication
A secondary analysis3 of data from Dr. Mohile and colleagues2 evaluated the effect of GA-guided recommendations on oncologist-patient communication regarding comorbidities. Patients (n = 541) included in this analysis were 76.6 years of age on average and had 3.2 (standard deviation, 1.9) comorbid conditions. All patients underwent GA, but only oncologists in the intervention arm received GA-based recommendations. Clinical encounters between oncologist and patient immediately following the GA were audio recorded and analyzed to examine communication between oncologists and participants as it relates to chronic comorbid conditions.
In the intervention arm, more discussions regarding comorbidities took place, and more participants’ concerns about comorbidities were acknowledged. More importantly, participants in the intervention group were 2.4 times more likely to have their concerns about comorbidities addressed through referral or education, compared with the usual-care group (P = .004). Moreover, 41% of oncologists in the intervention arm modified dosage or cancer treatment schedule because of concern about tolerability or comorbidities. This study demonstrates beneficial effects of GA in increasing communication and perhaps consideration of comorbidities of older adults when planning cancer treatment.
Dr. Hung is professor of geriatrics and palliative care at Mount Sinai Hospital, New York. He disclosed no relevant conflicts of interest.
References
1. Li D et al. JAMA Oncol. 2021;7:e214158.
2. Mohile SG et al. Lancet. 2021;398:1894-1904.
3. Kleckner AS et al. JCO Oncol Pract. 2022;18:e9-19.
A version of this article first appeared on Medscape.com.
Filling opioid prescriptions akin to a Sisyphean task
Pain management is a huge part of how we in palliative care help patients – and most of the time, I think we do it well, but in the regulatory environment of the opioid epidemic,
A patient – let’s call her Joan – calls me in distress. She is a 62-year-old woman with widespread metastatic breast cancer. Her pain is mainly due to bone metastases, but she also has discomfort due to the cancer’s invasion of the thin membranes that line her lungs and abdomen.
She was started on a combination opioid and acetaminophen tablet about 2 months ago by her oncologist, but is now requiring it around the clock, nearing the ceiling dose for this particular medication.
Given that her pain is escalating, Joan and I discuss starting a long-acting opioid to better manage the peak and trough effect of short-acting opioids, which can make a patient feel that the pain is relieved only for a few hours at a time, with sharp spikes throughout the day that mandate the next dose of short-acting opioid. This tethers the patient to the clock, having to take as many as six or eight doses of medication per day, and can be very disruptive to daily life.
I send an e-prescription for the same opioid Joan’s currently taking, but in a long-acting format that will slow-release over 8-10 hours, relieving her of the need to take a medication every 3-4 hours. I have learned over the years that nearly every long-acting opioid automatically generates a prior authorization request from the patient’s insurance company and so I immediately email our prior authorization team to submit to Joan’s insurance right away to avoid this extra delay.
Our prior authorization team is exceptionally responsive and submits these requests with urgency every time – they understand that cancer pain is a serious problem and we can’t wait 5 business days for answers. They are typically able to obtain an approved prior authorization for nearly every long-acting opioid I write within 24-48 hours.
But here’s where things go sideways.
First, the insurance company denies the prior authorization request, demanding that I revise the prescription from the long-acting version of the opioid she is currently taking to a cheaper, older opioid that she’s never tried before. In other words, they won’t cover the drug I requested without Joan first trying a completely different drug and failing it. This only makes sense for the insurance company’s bottom line – it makes no clinical sense at all. Why would I try a novel compound that Joan’s never had and one to which I have no idea how she’ll respond when I could keep her on the same compound knowing that she tolerates it just fine?
Past experience tells me insurance companies rarely budge on this, and appealing the decision would just introduce even more delay of care, so I begrudgingly change the prescription and send it again to the pharmacy. I message Joan to let her know that her insurance won’t cover my drug of choice and that we have to try this older one first.
A few hours later, Joan sends me a message: “My pharmacy says it’s going to take A WEEK to get the long-acting medicine!”
In the meantime, Joan has been using her short-acting opioid faster than anticipated because of her escalating pain – so she’s now running low on that as well.
I write for more of her short-acting opioid and e-script it to her pharmacy.
Within a few hours, we get another automatic response from her insurance that we’re going to need a prior authorization for additional short-acting opioid because she’s exceeded “quantity limitations,” which as far as I can tell is a completely arbitrary number not based on clinical evidence.
The prior auth team jumps on it and submits to override the quantity limit – successfully – and sends the override code to her pharmacy to reprocess the prescription.
But now the pharmacist tells Joan that they won’t fill the Rx anyway because it’s “too early.” They tell her that “state laws” prevent them from filling the scrip.
Is this true? I have no idea. I’m not an expert on California pharmacy law. All I know is that my patient is in pain and something needs to happen quickly.
I write for a second short-acting opioid – again a completely different compound. Ironically, this Rx goes through instantly without need for prior authorization. But now Joan has to switch to another new drug for no good medical reason.
If you’re still with me this far into the weeds, I’m grateful. In all it took a combined 4 hours of work (between myself and the prior auth team) to get two opioid Rx’s filled – and these were completely different medications than the ones I originally wrote for. I also had to move her prescriptions to the hospital’s pharmacy (another inconvenience for Joan and her family) so that she could get the medications in a timely manner. All this work to ensure that a single patient had adequate and timely pain relief and to prevent her from having to make an unnecessary visit to the emergency department for pain crisis.
This is just a regular day in outpatient palliative care in the era of the opioid epidemic.
The epidemic has caused tremendous pain and suffering for millions of people over the past 2 decades – namely those lost to opioid overdoses and their loved ones. And for the most part, tightening access to opioids for routine aches and pains among a relatively healthy population is not wrong, in my opinion, as long as those restrictions are based in good faith on robust evidence.
But the hidden cost of the Centers for Disease Control and Prevention’s 2016 opioid prescribing guidelines for nonmalignant pain, as well as the flurry of restrictive state laws they generated, is felt every day by patients with serious illness even though the guidelines were never meant to affect them. Patients with active cancer, receiving palliative care services, or at the end of life, were supposed to be exempted from these guidelines since good evidence supports the use of opioids in these populations.
Instead of preserving access to desperately needed pain medicine for those suffering with serious illness, states and insurers have aggressively sought to gatekeep opioids from everyone, resulting in stigma, delays, and needless suffering.
Several recent studies have revealed the effects of this gatekeeping on patients with cancer.
A qualitative study with 26 advanced cancer patients described the demoralization and stigma many patients felt when taking opioids, which they directly tied to media messaging around the opioid epidemic. Even when they reluctantly agreed to take opioids to treat cancer-related pain, there were systemic impediments to achieving adequate pain relief – similar to my experience with Joan – that were directly caused by insurance and pharmacy constraints.
Those of us who care for oncology patients also appear to be undertreating cancer-related pain. Another recent study that found the amount of opioid medications prescribed to an advanced cancer patient near the end of life dropped by 38% between 2007 and 2017. The authors suggest that a direct consequence of this decline in appropriate opioid prescribing is an observed 50% rise in emergency department visits over the same time period by cancer patients for pain-related reasons.
This makes sense – if patients aren’t routinely prescribed the opioids they need to manage their cancer-related pain; or, if the stigma against using opioids is so harsh that it causes patients to shun opioids; or, if there are so many system barriers in place to prevent patients from obtaining opioids in a timely manner – then patients’ pain will crescendo, leaving them with little alternative but to head to the emergency department.
This undertreatment is corroborated by another study that examined data from the Centers for Medicare & Medicaid Services Part D prescriber database between 2013 and 2017, finding that both oncologists and nononcologists prescribed about 21% fewer opioids to Medicare beneficiaries during that time, compared with the period prior to 2013.
Interestingly, the researchers also found that opioid prescribing by palliative care providers increased by 15% over the same period. On a positive note, this suggests the presence of a growing outpatient palliative care workforce. But it may also reflect growing unease among oncologists with the perceived liability for prescribing opioids and a desire to ask other specialists to take on this liability. At the same time, it may reflect the very real and ever-increasing administrative burden associated with prescribing opioids and the fact that busy oncologists may not have time to spend on this aspect of cancer care. Thus, as palliative care clinicians become more visible and numerous in the outpatient arena, oncologists may increasingly ask palliative care clinicians like myself to take this on.
The problem with this is that merely handing off the administrative burden to another clinician doesn’t address the underlying problem. Anecdotal evidence suggests (and my own experiences corroborate) this administrative burden can cause real harm. A survey of 1,000 physicians conducted by the American Medical Association in 2021 found that 93% of respondents reported a delay in patient care due to prior authorization burden and 34% of respondents reported that their patients had suffered a “serious adverse event” due to prior authorization requirements.
The CDC recently announced it will take steps to revise the 2016 opioid prescribing guidelines for chronic pain after hearing from members of the medical community as well as patients living with chronic pain about the harsh, unintended consequences of the guidelines. I can only hope that insurance companies will follow suit, revising their opioid prior authorization requirements to finally come into alignment with the rational, safe use of opioids in patients with advanced cancer. It’s too bad that any improvement in the future will be too late for the millions of patients who have suffered irreversible iatrogenic harms due to delays in achieving adequate pain relief.
Sarah F. D’Ambruoso, NP, is a palliative care nurse practitioner in Santa Monica, Calif.
Pain management is a huge part of how we in palliative care help patients – and most of the time, I think we do it well, but in the regulatory environment of the opioid epidemic,
A patient – let’s call her Joan – calls me in distress. She is a 62-year-old woman with widespread metastatic breast cancer. Her pain is mainly due to bone metastases, but she also has discomfort due to the cancer’s invasion of the thin membranes that line her lungs and abdomen.
She was started on a combination opioid and acetaminophen tablet about 2 months ago by her oncologist, but is now requiring it around the clock, nearing the ceiling dose for this particular medication.
Given that her pain is escalating, Joan and I discuss starting a long-acting opioid to better manage the peak and trough effect of short-acting opioids, which can make a patient feel that the pain is relieved only for a few hours at a time, with sharp spikes throughout the day that mandate the next dose of short-acting opioid. This tethers the patient to the clock, having to take as many as six or eight doses of medication per day, and can be very disruptive to daily life.
I send an e-prescription for the same opioid Joan’s currently taking, but in a long-acting format that will slow-release over 8-10 hours, relieving her of the need to take a medication every 3-4 hours. I have learned over the years that nearly every long-acting opioid automatically generates a prior authorization request from the patient’s insurance company and so I immediately email our prior authorization team to submit to Joan’s insurance right away to avoid this extra delay.
Our prior authorization team is exceptionally responsive and submits these requests with urgency every time – they understand that cancer pain is a serious problem and we can’t wait 5 business days for answers. They are typically able to obtain an approved prior authorization for nearly every long-acting opioid I write within 24-48 hours.
But here’s where things go sideways.
First, the insurance company denies the prior authorization request, demanding that I revise the prescription from the long-acting version of the opioid she is currently taking to a cheaper, older opioid that she’s never tried before. In other words, they won’t cover the drug I requested without Joan first trying a completely different drug and failing it. This only makes sense for the insurance company’s bottom line – it makes no clinical sense at all. Why would I try a novel compound that Joan’s never had and one to which I have no idea how she’ll respond when I could keep her on the same compound knowing that she tolerates it just fine?
Past experience tells me insurance companies rarely budge on this, and appealing the decision would just introduce even more delay of care, so I begrudgingly change the prescription and send it again to the pharmacy. I message Joan to let her know that her insurance won’t cover my drug of choice and that we have to try this older one first.
A few hours later, Joan sends me a message: “My pharmacy says it’s going to take A WEEK to get the long-acting medicine!”
In the meantime, Joan has been using her short-acting opioid faster than anticipated because of her escalating pain – so she’s now running low on that as well.
I write for more of her short-acting opioid and e-script it to her pharmacy.
Within a few hours, we get another automatic response from her insurance that we’re going to need a prior authorization for additional short-acting opioid because she’s exceeded “quantity limitations,” which as far as I can tell is a completely arbitrary number not based on clinical evidence.
The prior auth team jumps on it and submits to override the quantity limit – successfully – and sends the override code to her pharmacy to reprocess the prescription.
But now the pharmacist tells Joan that they won’t fill the Rx anyway because it’s “too early.” They tell her that “state laws” prevent them from filling the scrip.
Is this true? I have no idea. I’m not an expert on California pharmacy law. All I know is that my patient is in pain and something needs to happen quickly.
I write for a second short-acting opioid – again a completely different compound. Ironically, this Rx goes through instantly without need for prior authorization. But now Joan has to switch to another new drug for no good medical reason.
If you’re still with me this far into the weeds, I’m grateful. In all it took a combined 4 hours of work (between myself and the prior auth team) to get two opioid Rx’s filled – and these were completely different medications than the ones I originally wrote for. I also had to move her prescriptions to the hospital’s pharmacy (another inconvenience for Joan and her family) so that she could get the medications in a timely manner. All this work to ensure that a single patient had adequate and timely pain relief and to prevent her from having to make an unnecessary visit to the emergency department for pain crisis.
This is just a regular day in outpatient palliative care in the era of the opioid epidemic.
The epidemic has caused tremendous pain and suffering for millions of people over the past 2 decades – namely those lost to opioid overdoses and their loved ones. And for the most part, tightening access to opioids for routine aches and pains among a relatively healthy population is not wrong, in my opinion, as long as those restrictions are based in good faith on robust evidence.
But the hidden cost of the Centers for Disease Control and Prevention’s 2016 opioid prescribing guidelines for nonmalignant pain, as well as the flurry of restrictive state laws they generated, is felt every day by patients with serious illness even though the guidelines were never meant to affect them. Patients with active cancer, receiving palliative care services, or at the end of life, were supposed to be exempted from these guidelines since good evidence supports the use of opioids in these populations.
Instead of preserving access to desperately needed pain medicine for those suffering with serious illness, states and insurers have aggressively sought to gatekeep opioids from everyone, resulting in stigma, delays, and needless suffering.
Several recent studies have revealed the effects of this gatekeeping on patients with cancer.
A qualitative study with 26 advanced cancer patients described the demoralization and stigma many patients felt when taking opioids, which they directly tied to media messaging around the opioid epidemic. Even when they reluctantly agreed to take opioids to treat cancer-related pain, there were systemic impediments to achieving adequate pain relief – similar to my experience with Joan – that were directly caused by insurance and pharmacy constraints.
Those of us who care for oncology patients also appear to be undertreating cancer-related pain. Another recent study that found the amount of opioid medications prescribed to an advanced cancer patient near the end of life dropped by 38% between 2007 and 2017. The authors suggest that a direct consequence of this decline in appropriate opioid prescribing is an observed 50% rise in emergency department visits over the same time period by cancer patients for pain-related reasons.
This makes sense – if patients aren’t routinely prescribed the opioids they need to manage their cancer-related pain; or, if the stigma against using opioids is so harsh that it causes patients to shun opioids; or, if there are so many system barriers in place to prevent patients from obtaining opioids in a timely manner – then patients’ pain will crescendo, leaving them with little alternative but to head to the emergency department.
This undertreatment is corroborated by another study that examined data from the Centers for Medicare & Medicaid Services Part D prescriber database between 2013 and 2017, finding that both oncologists and nononcologists prescribed about 21% fewer opioids to Medicare beneficiaries during that time, compared with the period prior to 2013.
Interestingly, the researchers also found that opioid prescribing by palliative care providers increased by 15% over the same period. On a positive note, this suggests the presence of a growing outpatient palliative care workforce. But it may also reflect growing unease among oncologists with the perceived liability for prescribing opioids and a desire to ask other specialists to take on this liability. At the same time, it may reflect the very real and ever-increasing administrative burden associated with prescribing opioids and the fact that busy oncologists may not have time to spend on this aspect of cancer care. Thus, as palliative care clinicians become more visible and numerous in the outpatient arena, oncologists may increasingly ask palliative care clinicians like myself to take this on.
The problem with this is that merely handing off the administrative burden to another clinician doesn’t address the underlying problem. Anecdotal evidence suggests (and my own experiences corroborate) this administrative burden can cause real harm. A survey of 1,000 physicians conducted by the American Medical Association in 2021 found that 93% of respondents reported a delay in patient care due to prior authorization burden and 34% of respondents reported that their patients had suffered a “serious adverse event” due to prior authorization requirements.
The CDC recently announced it will take steps to revise the 2016 opioid prescribing guidelines for chronic pain after hearing from members of the medical community as well as patients living with chronic pain about the harsh, unintended consequences of the guidelines. I can only hope that insurance companies will follow suit, revising their opioid prior authorization requirements to finally come into alignment with the rational, safe use of opioids in patients with advanced cancer. It’s too bad that any improvement in the future will be too late for the millions of patients who have suffered irreversible iatrogenic harms due to delays in achieving adequate pain relief.
Sarah F. D’Ambruoso, NP, is a palliative care nurse practitioner in Santa Monica, Calif.
Pain management is a huge part of how we in palliative care help patients – and most of the time, I think we do it well, but in the regulatory environment of the opioid epidemic,
A patient – let’s call her Joan – calls me in distress. She is a 62-year-old woman with widespread metastatic breast cancer. Her pain is mainly due to bone metastases, but she also has discomfort due to the cancer’s invasion of the thin membranes that line her lungs and abdomen.
She was started on a combination opioid and acetaminophen tablet about 2 months ago by her oncologist, but is now requiring it around the clock, nearing the ceiling dose for this particular medication.
Given that her pain is escalating, Joan and I discuss starting a long-acting opioid to better manage the peak and trough effect of short-acting opioids, which can make a patient feel that the pain is relieved only for a few hours at a time, with sharp spikes throughout the day that mandate the next dose of short-acting opioid. This tethers the patient to the clock, having to take as many as six or eight doses of medication per day, and can be very disruptive to daily life.
I send an e-prescription for the same opioid Joan’s currently taking, but in a long-acting format that will slow-release over 8-10 hours, relieving her of the need to take a medication every 3-4 hours. I have learned over the years that nearly every long-acting opioid automatically generates a prior authorization request from the patient’s insurance company and so I immediately email our prior authorization team to submit to Joan’s insurance right away to avoid this extra delay.
Our prior authorization team is exceptionally responsive and submits these requests with urgency every time – they understand that cancer pain is a serious problem and we can’t wait 5 business days for answers. They are typically able to obtain an approved prior authorization for nearly every long-acting opioid I write within 24-48 hours.
But here’s where things go sideways.
First, the insurance company denies the prior authorization request, demanding that I revise the prescription from the long-acting version of the opioid she is currently taking to a cheaper, older opioid that she’s never tried before. In other words, they won’t cover the drug I requested without Joan first trying a completely different drug and failing it. This only makes sense for the insurance company’s bottom line – it makes no clinical sense at all. Why would I try a novel compound that Joan’s never had and one to which I have no idea how she’ll respond when I could keep her on the same compound knowing that she tolerates it just fine?
Past experience tells me insurance companies rarely budge on this, and appealing the decision would just introduce even more delay of care, so I begrudgingly change the prescription and send it again to the pharmacy. I message Joan to let her know that her insurance won’t cover my drug of choice and that we have to try this older one first.
A few hours later, Joan sends me a message: “My pharmacy says it’s going to take A WEEK to get the long-acting medicine!”
In the meantime, Joan has been using her short-acting opioid faster than anticipated because of her escalating pain – so she’s now running low on that as well.
I write for more of her short-acting opioid and e-script it to her pharmacy.
Within a few hours, we get another automatic response from her insurance that we’re going to need a prior authorization for additional short-acting opioid because she’s exceeded “quantity limitations,” which as far as I can tell is a completely arbitrary number not based on clinical evidence.
The prior auth team jumps on it and submits to override the quantity limit – successfully – and sends the override code to her pharmacy to reprocess the prescription.
But now the pharmacist tells Joan that they won’t fill the Rx anyway because it’s “too early.” They tell her that “state laws” prevent them from filling the scrip.
Is this true? I have no idea. I’m not an expert on California pharmacy law. All I know is that my patient is in pain and something needs to happen quickly.
I write for a second short-acting opioid – again a completely different compound. Ironically, this Rx goes through instantly without need for prior authorization. But now Joan has to switch to another new drug for no good medical reason.
If you’re still with me this far into the weeds, I’m grateful. In all it took a combined 4 hours of work (between myself and the prior auth team) to get two opioid Rx’s filled – and these were completely different medications than the ones I originally wrote for. I also had to move her prescriptions to the hospital’s pharmacy (another inconvenience for Joan and her family) so that she could get the medications in a timely manner. All this work to ensure that a single patient had adequate and timely pain relief and to prevent her from having to make an unnecessary visit to the emergency department for pain crisis.
This is just a regular day in outpatient palliative care in the era of the opioid epidemic.
The epidemic has caused tremendous pain and suffering for millions of people over the past 2 decades – namely those lost to opioid overdoses and their loved ones. And for the most part, tightening access to opioids for routine aches and pains among a relatively healthy population is not wrong, in my opinion, as long as those restrictions are based in good faith on robust evidence.
But the hidden cost of the Centers for Disease Control and Prevention’s 2016 opioid prescribing guidelines for nonmalignant pain, as well as the flurry of restrictive state laws they generated, is felt every day by patients with serious illness even though the guidelines were never meant to affect them. Patients with active cancer, receiving palliative care services, or at the end of life, were supposed to be exempted from these guidelines since good evidence supports the use of opioids in these populations.
Instead of preserving access to desperately needed pain medicine for those suffering with serious illness, states and insurers have aggressively sought to gatekeep opioids from everyone, resulting in stigma, delays, and needless suffering.
Several recent studies have revealed the effects of this gatekeeping on patients with cancer.
A qualitative study with 26 advanced cancer patients described the demoralization and stigma many patients felt when taking opioids, which they directly tied to media messaging around the opioid epidemic. Even when they reluctantly agreed to take opioids to treat cancer-related pain, there were systemic impediments to achieving adequate pain relief – similar to my experience with Joan – that were directly caused by insurance and pharmacy constraints.
Those of us who care for oncology patients also appear to be undertreating cancer-related pain. Another recent study that found the amount of opioid medications prescribed to an advanced cancer patient near the end of life dropped by 38% between 2007 and 2017. The authors suggest that a direct consequence of this decline in appropriate opioid prescribing is an observed 50% rise in emergency department visits over the same time period by cancer patients for pain-related reasons.
This makes sense – if patients aren’t routinely prescribed the opioids they need to manage their cancer-related pain; or, if the stigma against using opioids is so harsh that it causes patients to shun opioids; or, if there are so many system barriers in place to prevent patients from obtaining opioids in a timely manner – then patients’ pain will crescendo, leaving them with little alternative but to head to the emergency department.
This undertreatment is corroborated by another study that examined data from the Centers for Medicare & Medicaid Services Part D prescriber database between 2013 and 2017, finding that both oncologists and nononcologists prescribed about 21% fewer opioids to Medicare beneficiaries during that time, compared with the period prior to 2013.
Interestingly, the researchers also found that opioid prescribing by palliative care providers increased by 15% over the same period. On a positive note, this suggests the presence of a growing outpatient palliative care workforce. But it may also reflect growing unease among oncologists with the perceived liability for prescribing opioids and a desire to ask other specialists to take on this liability. At the same time, it may reflect the very real and ever-increasing administrative burden associated with prescribing opioids and the fact that busy oncologists may not have time to spend on this aspect of cancer care. Thus, as palliative care clinicians become more visible and numerous in the outpatient arena, oncologists may increasingly ask palliative care clinicians like myself to take this on.
The problem with this is that merely handing off the administrative burden to another clinician doesn’t address the underlying problem. Anecdotal evidence suggests (and my own experiences corroborate) this administrative burden can cause real harm. A survey of 1,000 physicians conducted by the American Medical Association in 2021 found that 93% of respondents reported a delay in patient care due to prior authorization burden and 34% of respondents reported that their patients had suffered a “serious adverse event” due to prior authorization requirements.
The CDC recently announced it will take steps to revise the 2016 opioid prescribing guidelines for chronic pain after hearing from members of the medical community as well as patients living with chronic pain about the harsh, unintended consequences of the guidelines. I can only hope that insurance companies will follow suit, revising their opioid prior authorization requirements to finally come into alignment with the rational, safe use of opioids in patients with advanced cancer. It’s too bad that any improvement in the future will be too late for the millions of patients who have suffered irreversible iatrogenic harms due to delays in achieving adequate pain relief.
Sarah F. D’Ambruoso, NP, is a palliative care nurse practitioner in Santa Monica, Calif.
“I didn’t want to meet you.” Dispelling myths about palliative care
The names of health care professionals and patients cited within the dialogue text have been changed to protect their privacy.
but over the years I have come to realize that she was right – most people, including many within health care, don’t have a good appreciation of what palliative care is or how it can help patients and health care teams.
A recent national survey about cancer-related health information found that of more than 1,000 surveyed Americans, less than 30% professed any knowledge of palliative care. Of those who had some knowledge of palliative care, around 30% believed palliative care was synonymous with hospice.1 Another 15% believed that a patient would have to give up cancer-directed treatments to receive palliative care.1
It’s not giving up
This persistent belief that palliative care is equivalent to hospice, or is tantamount to “giving up,” is one of the most commonly held myths I encounter in everyday practice.
I knock on the exam door and walk in.
A small, trim woman in her late 50s is sitting in a chair, arms folded across her chest, face drawn in.
“Hi,” I start. “I’m Sarah, the palliative care nurse practitioner who works in this clinic. I work closely with Dr. Smith.”
Dr. Smith is the patient’s oncologist.
“I really didn’t want to meet you,” she says in a quiet voice, her eyes large with concern.
I don’t take it personally. Few patients really want to be in the position of needing to meet the palliative care team.
“I looked up palliative care on Google and saw the word hospice.”
“Yeah,” I say. “I hear that a lot. Well, I can reassure you that this isn’t hospice.
In this clinic, our focus is on your cancer symptoms, your treatment side effects, and your quality of life.”
She looks visibly relieved. “Quality of life,” she echoes. “I need more of that.”
“OK,” I say. “So, tell me what you’re struggling with the most right now.”
That’s how many palliative care visits start. I actually prefer if patients haven’t heard of palliative care because it allows me to frame it for them, rather than having to start by addressing a myth or a prior negative experience. Even when patients haven’t had a negative experience with palliative care per se, typically, if they’ve interacted with palliative care in the past, it’s usually because someone they loved died in a hospital setting and it is the memory of that terrible loss that becomes synonymous with their recollection of palliative care.
Many patients I meet have never seen another outpatient palliative care practitioner – and this makes sense – we are still too few and far between. Most established palliative care teams are hospital based and many patients seen in the community do not have easy access to palliative care teams where they receive oncologic care.2 As an embedded practitioner, I see patients in the same exam rooms and infusion centers where they receive their cancer therapies, so I’m effectively woven into the fabric of their oncology experience. Just being there in the cancer center allows me to be in the right place at the right time for the right patients and their care teams.
More than pain management
Another myth I tend to dispel a lot is that palliative care is just a euphemism for “pain management.” I have seen this less lately, but still occasionally in the chart I’ll see documented in a note, “patient is seeing palliative/pain management,” when a patient is seeing me or one of my colleagues. Unfortunately, when providers have limited or outdated views of what palliative care is or the value it brings to patient-centered cancer care, referrals to palliative care tend to be delayed.3
“I really think Ms. Lopez could benefit from seeing palliative care,” an oncology nurse practitioner says to an oncologist.
I’m standing nearby, about to see another patient in one of the exam rooms in our clinic.
“But I don’t think she’s ready. And besides, she doesn’t have any pain,” he says.
He turns to me quizzically. “What do you think?”
“Tell me about the patient,” I ask, taking a few steps in their direction.
“Well, she’s a 64-year-old woman with metastatic cancer.
She has a really poor appetite and is losing some weight.
Seems a bit down, kind of pessimistic about things.
Her scan showed some new growth, so guess I’m not surprised by that.”
“I might be able to help her with the appetite and the mood changes.
I can at least talk with her and see where she’s at,” I offer.
“Alright,” he says. “We’ll put the palliative referral in.”
He hesitates. “But are you sure you want to see her?
She doesn’t have any pain.” He sounds skeptical.
“Yeah, I mean, it sounds like she has symptoms that are bothering her, so I’d be happy to see her. She sounds completely appropriate for palliative care.”
I hear this assumption a lot – that palliative care is somehow equivalent to pain management and that unless a patient’s pain is severe, it’s not worth referring the patient to palliative care. Don’t get me wrong – we do a lot of pain management, but at its heart, palliative care is an interdisciplinary specialty focused on improving or maintaining quality of life for people with serious illness. Because the goal is so broad, care can take many shapes.4
In addition to pain, palliative care clinicians commonly treat nausea, shortness of breath, constipation or diarrhea, poor appetite, fatigue, anxiety, depression, and insomnia.
Palliative care is more than medical or nursing care
A related misconception about palliative care held by many lay people and health care workers alike is that palliative care is primarily medical or nursing care focused mostly on alleviating physical symptoms such as pain or nausea. This couldn’t be further from the truth.
We’ve been talking for a while.
Ms. Lopez tells me about her struggles to maintain her weight while undergoing chemotherapy. She has low-grade nausea that is impacting her ability and desire to eat more and didn’t think that her weight loss was severe enough to warrant taking medication.
We talk about how she may be able to use antinausea medication sparingly to alleviate nausea while also limiting side effects from the medications—which was a big concern for her.
I ask her what else is bothering her.
She tells me that she has always been a strong Catholic and even when life has gotten tough, her faith was never shaken – until now.
She is struggling to understand why she ended up with metastatic cancer at such a relatively young age—why would God do this to her?
She had plans for retirement that have since evaporated in the face of a foreshortened life.
Why did this happen to her of all people? She was completely healthy until her diagnosis.
Her face is wet with tears.
We talk a little about how a diagnosis like this can change so much of a person’s life and identity. I try to validate her experience. She’s clearly suffering from a sense that her life is not what she expected, and she is struggling to integrate how her future looks at this point.
I ask her what conversations with her priest have been like.
At this point you may be wondering where this conversation is going. Why are we talking about Ms. Lopez’s religion? Palliative care is best delivered through high functioning interdisciplinary teams that can include other supportive people in a patient’s life. We work in concert to try to bring comfort to a patient and their family.4 That support network can include nurses, physicians, social workers, and chaplains. In this case, Ms. Lopez had not yet reached out to her priest. She hasn’t had the time or energy to contact her priest given her symptoms.
“Can I contact your priest for you?
Maybe he can visit or call and chat with you?”
She nods and wipes tears away.
“That would be really nice,” she says. “I’d love it if he could pray with me.”
A few hours after the visit, I call Ms. Lopez’s priest.
I ask him to reach out to her and about her request for prayer.
He says he’s been thinking about her and that her presence has been missed at weekly Mass. He thanks me for the call and says he’ll call her tomorrow.
I say my own small prayer for Ms. Lopez and head home, the day’s work completed.
Sarah D'Ambruoso was born and raised in Maine. She completed her undergraduate and graduate nursing education at New York University and UCLA, respectively, and currently works as a palliative care nurse practitioner in an oncology clinic in Los Angeles.
References
1. Cheng BT et al. Patterns of palliative care beliefs among adults in the U.S.: Analysis of a National Cancer Database. J Pain Symptom Manage. 2019 Aug 10. doi: 10.1016/j.jpainsymman.2019.07.030.
2. Finlay E et al. Filling the gap: Creating an outpatient palliative care program in your institution. Am Soc Clin Oncol Educ Book. 2018 May 23. doi: 10.1200/EDBK_200775.
3. Von Roenn JH et al. Barriers and approaches to the successful integration of palliative care and oncology practice. J Natl Compr Canc Netw. 2013 Mar. doi: 10.6004/jnccn.2013.0209.
4. Ferrell BR et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2016.70.1474.
The names of health care professionals and patients cited within the dialogue text have been changed to protect their privacy.
but over the years I have come to realize that she was right – most people, including many within health care, don’t have a good appreciation of what palliative care is or how it can help patients and health care teams.
A recent national survey about cancer-related health information found that of more than 1,000 surveyed Americans, less than 30% professed any knowledge of palliative care. Of those who had some knowledge of palliative care, around 30% believed palliative care was synonymous with hospice.1 Another 15% believed that a patient would have to give up cancer-directed treatments to receive palliative care.1
It’s not giving up
This persistent belief that palliative care is equivalent to hospice, or is tantamount to “giving up,” is one of the most commonly held myths I encounter in everyday practice.
I knock on the exam door and walk in.
A small, trim woman in her late 50s is sitting in a chair, arms folded across her chest, face drawn in.
“Hi,” I start. “I’m Sarah, the palliative care nurse practitioner who works in this clinic. I work closely with Dr. Smith.”
Dr. Smith is the patient’s oncologist.
“I really didn’t want to meet you,” she says in a quiet voice, her eyes large with concern.
I don’t take it personally. Few patients really want to be in the position of needing to meet the palliative care team.
“I looked up palliative care on Google and saw the word hospice.”
“Yeah,” I say. “I hear that a lot. Well, I can reassure you that this isn’t hospice.
In this clinic, our focus is on your cancer symptoms, your treatment side effects, and your quality of life.”
She looks visibly relieved. “Quality of life,” she echoes. “I need more of that.”
“OK,” I say. “So, tell me what you’re struggling with the most right now.”
That’s how many palliative care visits start. I actually prefer if patients haven’t heard of palliative care because it allows me to frame it for them, rather than having to start by addressing a myth or a prior negative experience. Even when patients haven’t had a negative experience with palliative care per se, typically, if they’ve interacted with palliative care in the past, it’s usually because someone they loved died in a hospital setting and it is the memory of that terrible loss that becomes synonymous with their recollection of palliative care.
Many patients I meet have never seen another outpatient palliative care practitioner – and this makes sense – we are still too few and far between. Most established palliative care teams are hospital based and many patients seen in the community do not have easy access to palliative care teams where they receive oncologic care.2 As an embedded practitioner, I see patients in the same exam rooms and infusion centers where they receive their cancer therapies, so I’m effectively woven into the fabric of their oncology experience. Just being there in the cancer center allows me to be in the right place at the right time for the right patients and their care teams.
More than pain management
Another myth I tend to dispel a lot is that palliative care is just a euphemism for “pain management.” I have seen this less lately, but still occasionally in the chart I’ll see documented in a note, “patient is seeing palliative/pain management,” when a patient is seeing me or one of my colleagues. Unfortunately, when providers have limited or outdated views of what palliative care is or the value it brings to patient-centered cancer care, referrals to palliative care tend to be delayed.3
“I really think Ms. Lopez could benefit from seeing palliative care,” an oncology nurse practitioner says to an oncologist.
I’m standing nearby, about to see another patient in one of the exam rooms in our clinic.
“But I don’t think she’s ready. And besides, she doesn’t have any pain,” he says.
He turns to me quizzically. “What do you think?”
“Tell me about the patient,” I ask, taking a few steps in their direction.
“Well, she’s a 64-year-old woman with metastatic cancer.
She has a really poor appetite and is losing some weight.
Seems a bit down, kind of pessimistic about things.
Her scan showed some new growth, so guess I’m not surprised by that.”
“I might be able to help her with the appetite and the mood changes.
I can at least talk with her and see where she’s at,” I offer.
“Alright,” he says. “We’ll put the palliative referral in.”
He hesitates. “But are you sure you want to see her?
She doesn’t have any pain.” He sounds skeptical.
“Yeah, I mean, it sounds like she has symptoms that are bothering her, so I’d be happy to see her. She sounds completely appropriate for palliative care.”
I hear this assumption a lot – that palliative care is somehow equivalent to pain management and that unless a patient’s pain is severe, it’s not worth referring the patient to palliative care. Don’t get me wrong – we do a lot of pain management, but at its heart, palliative care is an interdisciplinary specialty focused on improving or maintaining quality of life for people with serious illness. Because the goal is so broad, care can take many shapes.4
In addition to pain, palliative care clinicians commonly treat nausea, shortness of breath, constipation or diarrhea, poor appetite, fatigue, anxiety, depression, and insomnia.
Palliative care is more than medical or nursing care
A related misconception about palliative care held by many lay people and health care workers alike is that palliative care is primarily medical or nursing care focused mostly on alleviating physical symptoms such as pain or nausea. This couldn’t be further from the truth.
We’ve been talking for a while.
Ms. Lopez tells me about her struggles to maintain her weight while undergoing chemotherapy. She has low-grade nausea that is impacting her ability and desire to eat more and didn’t think that her weight loss was severe enough to warrant taking medication.
We talk about how she may be able to use antinausea medication sparingly to alleviate nausea while also limiting side effects from the medications—which was a big concern for her.
I ask her what else is bothering her.
She tells me that she has always been a strong Catholic and even when life has gotten tough, her faith was never shaken – until now.
She is struggling to understand why she ended up with metastatic cancer at such a relatively young age—why would God do this to her?
She had plans for retirement that have since evaporated in the face of a foreshortened life.
Why did this happen to her of all people? She was completely healthy until her diagnosis.
Her face is wet with tears.
We talk a little about how a diagnosis like this can change so much of a person’s life and identity. I try to validate her experience. She’s clearly suffering from a sense that her life is not what she expected, and she is struggling to integrate how her future looks at this point.
I ask her what conversations with her priest have been like.
At this point you may be wondering where this conversation is going. Why are we talking about Ms. Lopez’s religion? Palliative care is best delivered through high functioning interdisciplinary teams that can include other supportive people in a patient’s life. We work in concert to try to bring comfort to a patient and their family.4 That support network can include nurses, physicians, social workers, and chaplains. In this case, Ms. Lopez had not yet reached out to her priest. She hasn’t had the time or energy to contact her priest given her symptoms.
“Can I contact your priest for you?
Maybe he can visit or call and chat with you?”
She nods and wipes tears away.
“That would be really nice,” she says. “I’d love it if he could pray with me.”
A few hours after the visit, I call Ms. Lopez’s priest.
I ask him to reach out to her and about her request for prayer.
He says he’s been thinking about her and that her presence has been missed at weekly Mass. He thanks me for the call and says he’ll call her tomorrow.
I say my own small prayer for Ms. Lopez and head home, the day’s work completed.
Sarah D'Ambruoso was born and raised in Maine. She completed her undergraduate and graduate nursing education at New York University and UCLA, respectively, and currently works as a palliative care nurse practitioner in an oncology clinic in Los Angeles.
References
1. Cheng BT et al. Patterns of palliative care beliefs among adults in the U.S.: Analysis of a National Cancer Database. J Pain Symptom Manage. 2019 Aug 10. doi: 10.1016/j.jpainsymman.2019.07.030.
2. Finlay E et al. Filling the gap: Creating an outpatient palliative care program in your institution. Am Soc Clin Oncol Educ Book. 2018 May 23. doi: 10.1200/EDBK_200775.
3. Von Roenn JH et al. Barriers and approaches to the successful integration of palliative care and oncology practice. J Natl Compr Canc Netw. 2013 Mar. doi: 10.6004/jnccn.2013.0209.
4. Ferrell BR et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2016.70.1474.
The names of health care professionals and patients cited within the dialogue text have been changed to protect their privacy.
but over the years I have come to realize that she was right – most people, including many within health care, don’t have a good appreciation of what palliative care is or how it can help patients and health care teams.
A recent national survey about cancer-related health information found that of more than 1,000 surveyed Americans, less than 30% professed any knowledge of palliative care. Of those who had some knowledge of palliative care, around 30% believed palliative care was synonymous with hospice.1 Another 15% believed that a patient would have to give up cancer-directed treatments to receive palliative care.1
It’s not giving up
This persistent belief that palliative care is equivalent to hospice, or is tantamount to “giving up,” is one of the most commonly held myths I encounter in everyday practice.
I knock on the exam door and walk in.
A small, trim woman in her late 50s is sitting in a chair, arms folded across her chest, face drawn in.
“Hi,” I start. “I’m Sarah, the palliative care nurse practitioner who works in this clinic. I work closely with Dr. Smith.”
Dr. Smith is the patient’s oncologist.
“I really didn’t want to meet you,” she says in a quiet voice, her eyes large with concern.
I don’t take it personally. Few patients really want to be in the position of needing to meet the palliative care team.
“I looked up palliative care on Google and saw the word hospice.”
“Yeah,” I say. “I hear that a lot. Well, I can reassure you that this isn’t hospice.
In this clinic, our focus is on your cancer symptoms, your treatment side effects, and your quality of life.”
She looks visibly relieved. “Quality of life,” she echoes. “I need more of that.”
“OK,” I say. “So, tell me what you’re struggling with the most right now.”
That’s how many palliative care visits start. I actually prefer if patients haven’t heard of palliative care because it allows me to frame it for them, rather than having to start by addressing a myth or a prior negative experience. Even when patients haven’t had a negative experience with palliative care per se, typically, if they’ve interacted with palliative care in the past, it’s usually because someone they loved died in a hospital setting and it is the memory of that terrible loss that becomes synonymous with their recollection of palliative care.
Many patients I meet have never seen another outpatient palliative care practitioner – and this makes sense – we are still too few and far between. Most established palliative care teams are hospital based and many patients seen in the community do not have easy access to palliative care teams where they receive oncologic care.2 As an embedded practitioner, I see patients in the same exam rooms and infusion centers where they receive their cancer therapies, so I’m effectively woven into the fabric of their oncology experience. Just being there in the cancer center allows me to be in the right place at the right time for the right patients and their care teams.
More than pain management
Another myth I tend to dispel a lot is that palliative care is just a euphemism for “pain management.” I have seen this less lately, but still occasionally in the chart I’ll see documented in a note, “patient is seeing palliative/pain management,” when a patient is seeing me or one of my colleagues. Unfortunately, when providers have limited or outdated views of what palliative care is or the value it brings to patient-centered cancer care, referrals to palliative care tend to be delayed.3
“I really think Ms. Lopez could benefit from seeing palliative care,” an oncology nurse practitioner says to an oncologist.
I’m standing nearby, about to see another patient in one of the exam rooms in our clinic.
“But I don’t think she’s ready. And besides, she doesn’t have any pain,” he says.
He turns to me quizzically. “What do you think?”
“Tell me about the patient,” I ask, taking a few steps in their direction.
“Well, she’s a 64-year-old woman with metastatic cancer.
She has a really poor appetite and is losing some weight.
Seems a bit down, kind of pessimistic about things.
Her scan showed some new growth, so guess I’m not surprised by that.”
“I might be able to help her with the appetite and the mood changes.
I can at least talk with her and see where she’s at,” I offer.
“Alright,” he says. “We’ll put the palliative referral in.”
He hesitates. “But are you sure you want to see her?
She doesn’t have any pain.” He sounds skeptical.
“Yeah, I mean, it sounds like she has symptoms that are bothering her, so I’d be happy to see her. She sounds completely appropriate for palliative care.”
I hear this assumption a lot – that palliative care is somehow equivalent to pain management and that unless a patient’s pain is severe, it’s not worth referring the patient to palliative care. Don’t get me wrong – we do a lot of pain management, but at its heart, palliative care is an interdisciplinary specialty focused on improving or maintaining quality of life for people with serious illness. Because the goal is so broad, care can take many shapes.4
In addition to pain, palliative care clinicians commonly treat nausea, shortness of breath, constipation or diarrhea, poor appetite, fatigue, anxiety, depression, and insomnia.
Palliative care is more than medical or nursing care
A related misconception about palliative care held by many lay people and health care workers alike is that palliative care is primarily medical or nursing care focused mostly on alleviating physical symptoms such as pain or nausea. This couldn’t be further from the truth.
We’ve been talking for a while.
Ms. Lopez tells me about her struggles to maintain her weight while undergoing chemotherapy. She has low-grade nausea that is impacting her ability and desire to eat more and didn’t think that her weight loss was severe enough to warrant taking medication.
We talk about how she may be able to use antinausea medication sparingly to alleviate nausea while also limiting side effects from the medications—which was a big concern for her.
I ask her what else is bothering her.
She tells me that she has always been a strong Catholic and even when life has gotten tough, her faith was never shaken – until now.
She is struggling to understand why she ended up with metastatic cancer at such a relatively young age—why would God do this to her?
She had plans for retirement that have since evaporated in the face of a foreshortened life.
Why did this happen to her of all people? She was completely healthy until her diagnosis.
Her face is wet with tears.
We talk a little about how a diagnosis like this can change so much of a person’s life and identity. I try to validate her experience. She’s clearly suffering from a sense that her life is not what she expected, and she is struggling to integrate how her future looks at this point.
I ask her what conversations with her priest have been like.
At this point you may be wondering where this conversation is going. Why are we talking about Ms. Lopez’s religion? Palliative care is best delivered through high functioning interdisciplinary teams that can include other supportive people in a patient’s life. We work in concert to try to bring comfort to a patient and their family.4 That support network can include nurses, physicians, social workers, and chaplains. In this case, Ms. Lopez had not yet reached out to her priest. She hasn’t had the time or energy to contact her priest given her symptoms.
“Can I contact your priest for you?
Maybe he can visit or call and chat with you?”
She nods and wipes tears away.
“That would be really nice,” she says. “I’d love it if he could pray with me.”
A few hours after the visit, I call Ms. Lopez’s priest.
I ask him to reach out to her and about her request for prayer.
He says he’s been thinking about her and that her presence has been missed at weekly Mass. He thanks me for the call and says he’ll call her tomorrow.
I say my own small prayer for Ms. Lopez and head home, the day’s work completed.
Sarah D'Ambruoso was born and raised in Maine. She completed her undergraduate and graduate nursing education at New York University and UCLA, respectively, and currently works as a palliative care nurse practitioner in an oncology clinic in Los Angeles.
References
1. Cheng BT et al. Patterns of palliative care beliefs among adults in the U.S.: Analysis of a National Cancer Database. J Pain Symptom Manage. 2019 Aug 10. doi: 10.1016/j.jpainsymman.2019.07.030.
2. Finlay E et al. Filling the gap: Creating an outpatient palliative care program in your institution. Am Soc Clin Oncol Educ Book. 2018 May 23. doi: 10.1200/EDBK_200775.
3. Von Roenn JH et al. Barriers and approaches to the successful integration of palliative care and oncology practice. J Natl Compr Canc Netw. 2013 Mar. doi: 10.6004/jnccn.2013.0209.
4. Ferrell BR et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2016.70.1474.
Physicians may be overprescribing immunotherapy for unfit cancer patients
.
The study, by Ravi B. Parikh, MD, an assistant professor of medical ethics and health policy and medicine at the University of Pennsylvania, Philadelphia, is an analysis of patient data from 280 U.S.-based community oncology practices. It included 34,131 patients who received first-line systemic therapy with immune checkpoint inhibitors (ICIs), or other treatment, between January 2014 and December 2019 for newly diagnosed metastatic or recurrent non–small cell lung cancer (NSCLC), urothelial cell cancer (UCC), renal cell cancer (RCC), or hepatocellular carcinoma (HCC). Researchers examined survival outcomes between patients who were eligible to participate in clinical trials with those who were deemed ineligible but may have still received ICIs.
For patients with poor performance status or organ dysfunction, participating in randomized clinical trials for immune checkpoint inhibitors is largely out of reach because of advanced disease, but it is not unusual for these patients to be accepted into clinical trials, a decision sometimes referred to as “desperation oncology,” the authors wrote.
In this study of 34,131 patients, 9,318 were considered ineligible to participate in ICI clinical trials because of advanced disease or organ dysfunction, yet up to 30% of these patients were treated with ICIs by their physician outside of a clinical trial. Dr. Parikh and colleagues found no overall survival differences between patients deemed ineligible for clinical trials, but were ultimately treated with ICI monotherapy, ICI combination therapy, or other treatments at 12 and 36 months. In fact, ICI monotherapy appeared to be harmful within 6 months of starting treatment.
“Clinicians who care for patients with poor performance status or organ dysfunction should be cautious about ICI use and carefully weigh expected survival gains against the potential for early mortality and adverse effects,” the authors wrote. They found the efficacy of ICI treatment alone, or in combination with other treatment, can be worse among trial-ineligible patients than patients who met the criteria for clinical trials.
No survival benefit was found for trial-ineligible patients who were treated with ICI monotherapy or combination therapy. Overall survival rates were similar at 12 and 36 months for both treatment groups. The overall median survival was less than 10 months, but 40% of trial ineligible patients treated with ICIs died within 6 months.
The use of ICIs for patients with poor performance status was found to be associated with lower hospice enrollment, more inpatient deaths, and more treatment during the last month of life. “It is critical to ensure that vulnerable, trial-ineligible patients are not exposed to non–evidence-based therapies that could cause harm and contradict patient goals,” the authors wrote.
The harms of treating unfit patients
The use of immune checkpoint inhibitor monotherapy in trial-ineligible patients is concerning, the authors said, because for patients with UCC and NSCLC, the standard of care is platinum-based chemotherapy. For patients with HCC and RCC, the standard of care is oral anti–vascular endothelial growth factor therapy. Immune checkpoint inhibitors may be prescribed in these cases to avoid side effects associated with other therapies, despite the lack of evidence showing that ICIs are effective in these cases.
“Individuals with poor performance status and/or organ dysfunction are vulnerable to receiving treatments that may not benefit them or cause disproportionately high side effects,” Dr. Parikh said in an interview. “Immunotherapy causes fewer side effects overall and is an attractive option, but there is no good phase 3 evidence that immunotherapy has benefits in this population.
“Physicians are preferentially using immunotherapy for unfit patients despite the fact that these individuals are usually excluded from clinical trials. Trial-ineligible patients – despite making up 30% of the cancer population – are different from patients studied in clinical trials. They are generally sicker, older and more prone to treatment adverse effects (including death), However, excluding these groups means that we don’t have good data on what treatments could benefit this vulnerable group. Thus, we are usually left to extrapolating results from healthier patients to unhealthy patients which risks giving them the wrong treatment,” he said.
A review that looked at immunotherapy in older adults suggested that, while those aged 65 or older represent most cancer patients, they are under-represented in clinical trials, including studies that led to approval of immunotherapy agents. A 2019 report suggested that, while 11 pivotal phase 3, randomized clinical trials have estimated the activity of ICIs in locally advanced and advanced NSCLC, each trial excluded patients with poor performance status.
Phase 3 trials needed for patients with poor performance
This retrospective study included 34,131 patients (median age, 70 years; 42% women) of which 27.3% had poor performance status and/or organ dysfunction and were classed as trial ineligible. The researchers assessed the use and overall survival outcomes following first-line ICI and non-ICI therapy that was initiated from January 2014 through December 2019.
Over the course of the study, the proportion of patients receiving ICI monotherapy increased from 0%-30.2% among trial-ineligible patients and from 0.1%-19.4% among eligible patients. However, among trial-ineligible patients, there were no overall survival differences between treatment with ICI monotherapy, ICI combination therapy and non-ICI therapy at 12 and 36 months.
Among trial-ineligible patients, ICI use was linked to a 14%-19% greater risk of death during the first 6 months after ICI initiation, but a 20% lower risk of death among those who survived 6 months after ICI initiation. Further, ICI combination therapy was associated with potential early harm among trial-ineligible patients.
“Phase 3 trials are sorely needed in patients with poor performance status or organ dysfunction so that we can adequately counsel patients who are unfit about expectations with novel cancer therapies,” Dr. Parikh said.
The cohort only included patients who received systemic therapy, which is a limitation of the study, so conclusions cannot be made about the efficacy of systemic therapy versus no systemic therapy in trial-ineligible patients.
Dr. Parikh reported nonfinancial support from Flatiron Health, grants from Humana, personal fees and equity from GNS Healthcare and Onc.AI, along with personal fees from the Cancer Study Group and Nanology outside the submitted work.
.
The study, by Ravi B. Parikh, MD, an assistant professor of medical ethics and health policy and medicine at the University of Pennsylvania, Philadelphia, is an analysis of patient data from 280 U.S.-based community oncology practices. It included 34,131 patients who received first-line systemic therapy with immune checkpoint inhibitors (ICIs), or other treatment, between January 2014 and December 2019 for newly diagnosed metastatic or recurrent non–small cell lung cancer (NSCLC), urothelial cell cancer (UCC), renal cell cancer (RCC), or hepatocellular carcinoma (HCC). Researchers examined survival outcomes between patients who were eligible to participate in clinical trials with those who were deemed ineligible but may have still received ICIs.
For patients with poor performance status or organ dysfunction, participating in randomized clinical trials for immune checkpoint inhibitors is largely out of reach because of advanced disease, but it is not unusual for these patients to be accepted into clinical trials, a decision sometimes referred to as “desperation oncology,” the authors wrote.
In this study of 34,131 patients, 9,318 were considered ineligible to participate in ICI clinical trials because of advanced disease or organ dysfunction, yet up to 30% of these patients were treated with ICIs by their physician outside of a clinical trial. Dr. Parikh and colleagues found no overall survival differences between patients deemed ineligible for clinical trials, but were ultimately treated with ICI monotherapy, ICI combination therapy, or other treatments at 12 and 36 months. In fact, ICI monotherapy appeared to be harmful within 6 months of starting treatment.
“Clinicians who care for patients with poor performance status or organ dysfunction should be cautious about ICI use and carefully weigh expected survival gains against the potential for early mortality and adverse effects,” the authors wrote. They found the efficacy of ICI treatment alone, or in combination with other treatment, can be worse among trial-ineligible patients than patients who met the criteria for clinical trials.
No survival benefit was found for trial-ineligible patients who were treated with ICI monotherapy or combination therapy. Overall survival rates were similar at 12 and 36 months for both treatment groups. The overall median survival was less than 10 months, but 40% of trial ineligible patients treated with ICIs died within 6 months.
The use of ICIs for patients with poor performance status was found to be associated with lower hospice enrollment, more inpatient deaths, and more treatment during the last month of life. “It is critical to ensure that vulnerable, trial-ineligible patients are not exposed to non–evidence-based therapies that could cause harm and contradict patient goals,” the authors wrote.
The harms of treating unfit patients
The use of immune checkpoint inhibitor monotherapy in trial-ineligible patients is concerning, the authors said, because for patients with UCC and NSCLC, the standard of care is platinum-based chemotherapy. For patients with HCC and RCC, the standard of care is oral anti–vascular endothelial growth factor therapy. Immune checkpoint inhibitors may be prescribed in these cases to avoid side effects associated with other therapies, despite the lack of evidence showing that ICIs are effective in these cases.
“Individuals with poor performance status and/or organ dysfunction are vulnerable to receiving treatments that may not benefit them or cause disproportionately high side effects,” Dr. Parikh said in an interview. “Immunotherapy causes fewer side effects overall and is an attractive option, but there is no good phase 3 evidence that immunotherapy has benefits in this population.
“Physicians are preferentially using immunotherapy for unfit patients despite the fact that these individuals are usually excluded from clinical trials. Trial-ineligible patients – despite making up 30% of the cancer population – are different from patients studied in clinical trials. They are generally sicker, older and more prone to treatment adverse effects (including death), However, excluding these groups means that we don’t have good data on what treatments could benefit this vulnerable group. Thus, we are usually left to extrapolating results from healthier patients to unhealthy patients which risks giving them the wrong treatment,” he said.
A review that looked at immunotherapy in older adults suggested that, while those aged 65 or older represent most cancer patients, they are under-represented in clinical trials, including studies that led to approval of immunotherapy agents. A 2019 report suggested that, while 11 pivotal phase 3, randomized clinical trials have estimated the activity of ICIs in locally advanced and advanced NSCLC, each trial excluded patients with poor performance status.
Phase 3 trials needed for patients with poor performance
This retrospective study included 34,131 patients (median age, 70 years; 42% women) of which 27.3% had poor performance status and/or organ dysfunction and were classed as trial ineligible. The researchers assessed the use and overall survival outcomes following first-line ICI and non-ICI therapy that was initiated from January 2014 through December 2019.
Over the course of the study, the proportion of patients receiving ICI monotherapy increased from 0%-30.2% among trial-ineligible patients and from 0.1%-19.4% among eligible patients. However, among trial-ineligible patients, there were no overall survival differences between treatment with ICI monotherapy, ICI combination therapy and non-ICI therapy at 12 and 36 months.
Among trial-ineligible patients, ICI use was linked to a 14%-19% greater risk of death during the first 6 months after ICI initiation, but a 20% lower risk of death among those who survived 6 months after ICI initiation. Further, ICI combination therapy was associated with potential early harm among trial-ineligible patients.
“Phase 3 trials are sorely needed in patients with poor performance status or organ dysfunction so that we can adequately counsel patients who are unfit about expectations with novel cancer therapies,” Dr. Parikh said.
The cohort only included patients who received systemic therapy, which is a limitation of the study, so conclusions cannot be made about the efficacy of systemic therapy versus no systemic therapy in trial-ineligible patients.
Dr. Parikh reported nonfinancial support from Flatiron Health, grants from Humana, personal fees and equity from GNS Healthcare and Onc.AI, along with personal fees from the Cancer Study Group and Nanology outside the submitted work.
.
The study, by Ravi B. Parikh, MD, an assistant professor of medical ethics and health policy and medicine at the University of Pennsylvania, Philadelphia, is an analysis of patient data from 280 U.S.-based community oncology practices. It included 34,131 patients who received first-line systemic therapy with immune checkpoint inhibitors (ICIs), or other treatment, between January 2014 and December 2019 for newly diagnosed metastatic or recurrent non–small cell lung cancer (NSCLC), urothelial cell cancer (UCC), renal cell cancer (RCC), or hepatocellular carcinoma (HCC). Researchers examined survival outcomes between patients who were eligible to participate in clinical trials with those who were deemed ineligible but may have still received ICIs.
For patients with poor performance status or organ dysfunction, participating in randomized clinical trials for immune checkpoint inhibitors is largely out of reach because of advanced disease, but it is not unusual for these patients to be accepted into clinical trials, a decision sometimes referred to as “desperation oncology,” the authors wrote.
In this study of 34,131 patients, 9,318 were considered ineligible to participate in ICI clinical trials because of advanced disease or organ dysfunction, yet up to 30% of these patients were treated with ICIs by their physician outside of a clinical trial. Dr. Parikh and colleagues found no overall survival differences between patients deemed ineligible for clinical trials, but were ultimately treated with ICI monotherapy, ICI combination therapy, or other treatments at 12 and 36 months. In fact, ICI monotherapy appeared to be harmful within 6 months of starting treatment.
“Clinicians who care for patients with poor performance status or organ dysfunction should be cautious about ICI use and carefully weigh expected survival gains against the potential for early mortality and adverse effects,” the authors wrote. They found the efficacy of ICI treatment alone, or in combination with other treatment, can be worse among trial-ineligible patients than patients who met the criteria for clinical trials.
No survival benefit was found for trial-ineligible patients who were treated with ICI monotherapy or combination therapy. Overall survival rates were similar at 12 and 36 months for both treatment groups. The overall median survival was less than 10 months, but 40% of trial ineligible patients treated with ICIs died within 6 months.
The use of ICIs for patients with poor performance status was found to be associated with lower hospice enrollment, more inpatient deaths, and more treatment during the last month of life. “It is critical to ensure that vulnerable, trial-ineligible patients are not exposed to non–evidence-based therapies that could cause harm and contradict patient goals,” the authors wrote.
The harms of treating unfit patients
The use of immune checkpoint inhibitor monotherapy in trial-ineligible patients is concerning, the authors said, because for patients with UCC and NSCLC, the standard of care is platinum-based chemotherapy. For patients with HCC and RCC, the standard of care is oral anti–vascular endothelial growth factor therapy. Immune checkpoint inhibitors may be prescribed in these cases to avoid side effects associated with other therapies, despite the lack of evidence showing that ICIs are effective in these cases.
“Individuals with poor performance status and/or organ dysfunction are vulnerable to receiving treatments that may not benefit them or cause disproportionately high side effects,” Dr. Parikh said in an interview. “Immunotherapy causes fewer side effects overall and is an attractive option, but there is no good phase 3 evidence that immunotherapy has benefits in this population.
“Physicians are preferentially using immunotherapy for unfit patients despite the fact that these individuals are usually excluded from clinical trials. Trial-ineligible patients – despite making up 30% of the cancer population – are different from patients studied in clinical trials. They are generally sicker, older and more prone to treatment adverse effects (including death), However, excluding these groups means that we don’t have good data on what treatments could benefit this vulnerable group. Thus, we are usually left to extrapolating results from healthier patients to unhealthy patients which risks giving them the wrong treatment,” he said.
A review that looked at immunotherapy in older adults suggested that, while those aged 65 or older represent most cancer patients, they are under-represented in clinical trials, including studies that led to approval of immunotherapy agents. A 2019 report suggested that, while 11 pivotal phase 3, randomized clinical trials have estimated the activity of ICIs in locally advanced and advanced NSCLC, each trial excluded patients with poor performance status.
Phase 3 trials needed for patients with poor performance
This retrospective study included 34,131 patients (median age, 70 years; 42% women) of which 27.3% had poor performance status and/or organ dysfunction and were classed as trial ineligible. The researchers assessed the use and overall survival outcomes following first-line ICI and non-ICI therapy that was initiated from January 2014 through December 2019.
Over the course of the study, the proportion of patients receiving ICI monotherapy increased from 0%-30.2% among trial-ineligible patients and from 0.1%-19.4% among eligible patients. However, among trial-ineligible patients, there were no overall survival differences between treatment with ICI monotherapy, ICI combination therapy and non-ICI therapy at 12 and 36 months.
Among trial-ineligible patients, ICI use was linked to a 14%-19% greater risk of death during the first 6 months after ICI initiation, but a 20% lower risk of death among those who survived 6 months after ICI initiation. Further, ICI combination therapy was associated with potential early harm among trial-ineligible patients.
“Phase 3 trials are sorely needed in patients with poor performance status or organ dysfunction so that we can adequately counsel patients who are unfit about expectations with novel cancer therapies,” Dr. Parikh said.
The cohort only included patients who received systemic therapy, which is a limitation of the study, so conclusions cannot be made about the efficacy of systemic therapy versus no systemic therapy in trial-ineligible patients.
Dr. Parikh reported nonfinancial support from Flatiron Health, grants from Humana, personal fees and equity from GNS Healthcare and Onc.AI, along with personal fees from the Cancer Study Group and Nanology outside the submitted work.
FROM JAMA ONCOLOGY
Dogs show potential as medical detectives in breast cancer
Breast cancer screening using urine samples based on the volatile organic compounds (VOCs) sensed by a trained dog is feasible, according to a preliminary study published in the journal Biology June 10.
“The extrapolation of our results to widespread implementation is still uncertain,” wrote Shoko Kure, MD, PhD, of Nippon Medical School in Tokyo, and colleagues. “However, even if few dogs could be trained to detect breast cancer, the result may open the door to a robust and inexpensive way to detect breast cancer.” They added that “dog cancer detection is entirely noninvasive, safe and easy for both patients and everyone.”
Early detection of breast cancer, which is the leading cause of death globally, is essential for more efficient treatment. While mammography can detect asymptomatic breast cancer and reduce mortality, it has a poor compliance, is less sensitive in dense breast tissue, detects nonmalignant lesions, and has not been shown to reduce mortality in women younger than 40. VOCs are emitted in the breath, blood, and urine, with different volatile patterns correlated with a variety of diseases including cancers, which dogs can be trained to detect. Breast cancer screening by dog sniffing of the VOCs in urine samples has not been attempted.
Dogs have been used as medical detectives for several cancers and conditions. A study published in 2018 showed that trained dogs who were able to differentiate the specific odor from the metabolic waste of breast cancer in vitro could identify that of colorectal cancer, and vice versa. More recently, research showed that trained dogs could detect advanced prostate cancer in urine samples with high specificity and sensitivity. In this double-blinded pilot study, two dogs were trained to detect Gleason 9 prostate cancer in urine collected from biopsy-confirmed patients. The canine olfaction system was 71% sensitive and as much as 76% specific at detecting Gleason 9 cancer. Along with cancer, trained dogs have been shown to identify people with COVID-19, even those who were asymptomatic. In this study, dogs who sniffed swab samples of armpit sweat could identify which samples came from patients infected with COVID-19 with up to 100% accuracy, while ruling out infection with up to 99% accuracy.
The double-blind study by Dr. Kure aimed to assess the potential of VOCs in urine samples for breast cancer screening by using a single trained sniffer dog – in this case a 9-year-old female Labrador retriever. Urine samples from 40 patients with primary breast cancer and 142 patients with non-breast malignant diseases were included along with samples from 18 healthy volunteers. In 40 times out of 40 runs of the double-blind test, the dog correctly identified urine samples of patients with breast cancer, with 100% sensitivity and 100% specificity.
“The dog in this test successfully differentiated breast cancer from non-breast malignancies and healthy controls,” the authors wrote. “This is the first, preliminary study indicating the feasibility of developing a new breast cancer screening method using urine samples based on VOCs.”
While the authors noted that the study was limited as it relied on one trained dog, they suggested that this method has potential in low-income countries where access to mammography is inadequate.
“Some well-trained sniffing dogs traveling around medically underserved [countries] all over the world could save many lives. Even when a healthy control was indicated by a trained dog, there would be a suspicion of undiagnosed/early-stage cancer, and the person would be advised to undergo medical screening,” the authors wrote.
The authors declared no conflicts of interest.
Breast cancer screening using urine samples based on the volatile organic compounds (VOCs) sensed by a trained dog is feasible, according to a preliminary study published in the journal Biology June 10.
“The extrapolation of our results to widespread implementation is still uncertain,” wrote Shoko Kure, MD, PhD, of Nippon Medical School in Tokyo, and colleagues. “However, even if few dogs could be trained to detect breast cancer, the result may open the door to a robust and inexpensive way to detect breast cancer.” They added that “dog cancer detection is entirely noninvasive, safe and easy for both patients and everyone.”
Early detection of breast cancer, which is the leading cause of death globally, is essential for more efficient treatment. While mammography can detect asymptomatic breast cancer and reduce mortality, it has a poor compliance, is less sensitive in dense breast tissue, detects nonmalignant lesions, and has not been shown to reduce mortality in women younger than 40. VOCs are emitted in the breath, blood, and urine, with different volatile patterns correlated with a variety of diseases including cancers, which dogs can be trained to detect. Breast cancer screening by dog sniffing of the VOCs in urine samples has not been attempted.
Dogs have been used as medical detectives for several cancers and conditions. A study published in 2018 showed that trained dogs who were able to differentiate the specific odor from the metabolic waste of breast cancer in vitro could identify that of colorectal cancer, and vice versa. More recently, research showed that trained dogs could detect advanced prostate cancer in urine samples with high specificity and sensitivity. In this double-blinded pilot study, two dogs were trained to detect Gleason 9 prostate cancer in urine collected from biopsy-confirmed patients. The canine olfaction system was 71% sensitive and as much as 76% specific at detecting Gleason 9 cancer. Along with cancer, trained dogs have been shown to identify people with COVID-19, even those who were asymptomatic. In this study, dogs who sniffed swab samples of armpit sweat could identify which samples came from patients infected with COVID-19 with up to 100% accuracy, while ruling out infection with up to 99% accuracy.
The double-blind study by Dr. Kure aimed to assess the potential of VOCs in urine samples for breast cancer screening by using a single trained sniffer dog – in this case a 9-year-old female Labrador retriever. Urine samples from 40 patients with primary breast cancer and 142 patients with non-breast malignant diseases were included along with samples from 18 healthy volunteers. In 40 times out of 40 runs of the double-blind test, the dog correctly identified urine samples of patients with breast cancer, with 100% sensitivity and 100% specificity.
“The dog in this test successfully differentiated breast cancer from non-breast malignancies and healthy controls,” the authors wrote. “This is the first, preliminary study indicating the feasibility of developing a new breast cancer screening method using urine samples based on VOCs.”
While the authors noted that the study was limited as it relied on one trained dog, they suggested that this method has potential in low-income countries where access to mammography is inadequate.
“Some well-trained sniffing dogs traveling around medically underserved [countries] all over the world could save many lives. Even when a healthy control was indicated by a trained dog, there would be a suspicion of undiagnosed/early-stage cancer, and the person would be advised to undergo medical screening,” the authors wrote.
The authors declared no conflicts of interest.
Breast cancer screening using urine samples based on the volatile organic compounds (VOCs) sensed by a trained dog is feasible, according to a preliminary study published in the journal Biology June 10.
“The extrapolation of our results to widespread implementation is still uncertain,” wrote Shoko Kure, MD, PhD, of Nippon Medical School in Tokyo, and colleagues. “However, even if few dogs could be trained to detect breast cancer, the result may open the door to a robust and inexpensive way to detect breast cancer.” They added that “dog cancer detection is entirely noninvasive, safe and easy for both patients and everyone.”
Early detection of breast cancer, which is the leading cause of death globally, is essential for more efficient treatment. While mammography can detect asymptomatic breast cancer and reduce mortality, it has a poor compliance, is less sensitive in dense breast tissue, detects nonmalignant lesions, and has not been shown to reduce mortality in women younger than 40. VOCs are emitted in the breath, blood, and urine, with different volatile patterns correlated with a variety of diseases including cancers, which dogs can be trained to detect. Breast cancer screening by dog sniffing of the VOCs in urine samples has not been attempted.
Dogs have been used as medical detectives for several cancers and conditions. A study published in 2018 showed that trained dogs who were able to differentiate the specific odor from the metabolic waste of breast cancer in vitro could identify that of colorectal cancer, and vice versa. More recently, research showed that trained dogs could detect advanced prostate cancer in urine samples with high specificity and sensitivity. In this double-blinded pilot study, two dogs were trained to detect Gleason 9 prostate cancer in urine collected from biopsy-confirmed patients. The canine olfaction system was 71% sensitive and as much as 76% specific at detecting Gleason 9 cancer. Along with cancer, trained dogs have been shown to identify people with COVID-19, even those who were asymptomatic. In this study, dogs who sniffed swab samples of armpit sweat could identify which samples came from patients infected with COVID-19 with up to 100% accuracy, while ruling out infection with up to 99% accuracy.
The double-blind study by Dr. Kure aimed to assess the potential of VOCs in urine samples for breast cancer screening by using a single trained sniffer dog – in this case a 9-year-old female Labrador retriever. Urine samples from 40 patients with primary breast cancer and 142 patients with non-breast malignant diseases were included along with samples from 18 healthy volunteers. In 40 times out of 40 runs of the double-blind test, the dog correctly identified urine samples of patients with breast cancer, with 100% sensitivity and 100% specificity.
“The dog in this test successfully differentiated breast cancer from non-breast malignancies and healthy controls,” the authors wrote. “This is the first, preliminary study indicating the feasibility of developing a new breast cancer screening method using urine samples based on VOCs.”
While the authors noted that the study was limited as it relied on one trained dog, they suggested that this method has potential in low-income countries where access to mammography is inadequate.
“Some well-trained sniffing dogs traveling around medically underserved [countries] all over the world could save many lives. Even when a healthy control was indicated by a trained dog, there would be a suspicion of undiagnosed/early-stage cancer, and the person would be advised to undergo medical screening,” the authors wrote.
The authors declared no conflicts of interest.
FROM BIOLOGY
In and out surgeries become the norm during pandemic
Urologist Ronney Abaza, MD, a robotic surgery specialist in Dublin, Ohio, and colleagues, reviewed robotic surgeries at their hospital during COVID-19 restrictions on surgery in Ohio between March 17 and June 5, 2020, and compared them with robotic procedures before COVID-19 and after restrictions were lifted. They published their results in Urology.
Since 2016, the hospital has offered the option of same-day discharge (SDD) to all robotic urologic surgery patients, regardless of procedure or patient-specific factors.
Among patients who had surgery during COVID-19 restrictions, 98% (87/89 patients) opted for SDD versus 52% in the group having surgery before the restrictions (P < .00001). After the COVID-19 surgery restrictions were lifted, the higher rate of SDD remained at 98%.
“There were no differences in 30-day complications or readmissions between SDD and overnight patients,” the authors write.
The right patient, the right motivation for successful surgery
Brian Lane, MD, PhD, a urologic oncologist with Spectrum Health in Grand Rapids, Michigan, told this news organization that, for nephrectomies, uptake of same-day discharge will continue to be slow.
“You have to have the right patient, the right patient motivation, and the surgery has to go smoothly,” he said. “If you start sending everyone home the same day, you will certainly see readmissions,” he said.
Dr. Lane is part of the Michigan Urologic Surgery Improvement Collaborative and he said the group recently looked at same-day discharge outcomes after robotic prostatectomies with SDD as compared with 1-2 nights in the hospital.
The work has not yet been published but, “There was a slight signal that there were increased readmissions with same-day discharge vs. 0-1 day,” he said.
A paper on outcomes of same-day discharge in total knee arthroplasty in the Journal of Bone & Joint Surgery found a higher risk of perioperative complications “including component failure, surgical site infection, knee stiffness, and deep vein thrombosis.” Researchers compared outcomes between 4,391 patients who underwent outpatient TKA and 128,951 patients who underwent inpatient TKA.
But for other many surgeries, same-day discharge numbers are increasing without worsening outcomes.
A paper in the Journal of Robotic Surgery found that same-day discharge following robotic-assisted endometrial cancer staging is “safe and feasible.”
Stephen Bradley, MD, MPH, with the Minneapolis Heart Institute in Minneapolis, and colleagues write in the Journal of the American College of Cardiology: Cardiovascular Interventions that they found a large increase in the use of same-day discharge after elective percutaneous coronary intervention (PCI) was not associated with worse 30-day mortality rates or readmission.
In that study, 114,461 patients were discharged the same day they underwent PCI. The proportion of patients who had a same-day discharge increased from 4.5% in 2009 to 28.6% in the fourth quarter of 2017.
Risk-adjusted 30-day mortality did not change in that time, while risk-adjusted rehospitalization decreased over time and more quickly when patients had same-day discharge.
Deepak L. Bhatt, MD, MPH, and Jonathan G. Sung, MBCHB, both of Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, wrote in an accompanying article that, “Advances in the devices and techniques of PCI have improved the safety and efficacy of the procedure. In selected patients, same-day discharge has become possible, and overnight in-hospital observation can be avoided. By reducing unnecessary hospital stays, both patients and hospitals could benefit.”
Evan Garden, a medical student at Icahn School of Medicine at Mount Sinai in New York, presented findings at the American Urological Association 2021 annual meeting that show patients selected for same-day discharge after partial or radical nephrectomy did not have increased rates of postoperative complications or readmissions in the immediate postoperative period, compared with standard discharge of 1-3 days.
Case studies in nephrectomy
While several case studies have looked at the feasibility and safety of performing partial and radical nephrectomy with same-day discharge in select cases, “this topic has not been addressed on a national level,” Mr. Garden said.
Few patients who have partial or radical nephrectomies have same-day discharges. The researchers found that fewer than 1% of patients who have either procedure in the sample studied were discharged the same day.
Researchers used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, a nationally representative deidentified database that prospectively tracks patient characteristics and 30-day perioperative outcomes for major inpatient and outpatient surgical procedures at more than 700 hospitals.
They extracted all minimally invasive partial and radical nephrectomies from 2012 to 2019 and refined the cohort to 28,140 patients who were theoretically eligible for same-day discharge: Of those, 237 (0.8%) had SSD, and 27,903 (99.2%) had a standard-length discharge (SLD).
The team found that there were no differences in 30-day complications or readmissions between same-day discharge (Clavien-Dindo [CD] I/II, 4.22%; CD III, 0%; CD IV, 1.27%; readmission, 4.64%); and SLD (CD I/II, 4.11%; CD III, 0.95%; CD IV, 0.79%; readmission, 3.90%; all P > .05).
Controlling for demographic and clinical variables, SDD was not associated with greater risk of 30-day complications or readmissions (CD I/II: odds ratio, 1.08; 95% confidence interval, 0.57-2.048; P = .813; CD IV: OR 1.699; 95% CI, 0.537-5.375; P = .367; readmission: OR, 1.254; 95% CI, 0.681-2.31; P = .467).
Mr. Garden and coauthors report no relevant financial relationships.
Dr. Lane reports no relevant financial relationships.
Urologist Ronney Abaza, MD, a robotic surgery specialist in Dublin, Ohio, and colleagues, reviewed robotic surgeries at their hospital during COVID-19 restrictions on surgery in Ohio between March 17 and June 5, 2020, and compared them with robotic procedures before COVID-19 and after restrictions were lifted. They published their results in Urology.
Since 2016, the hospital has offered the option of same-day discharge (SDD) to all robotic urologic surgery patients, regardless of procedure or patient-specific factors.
Among patients who had surgery during COVID-19 restrictions, 98% (87/89 patients) opted for SDD versus 52% in the group having surgery before the restrictions (P < .00001). After the COVID-19 surgery restrictions were lifted, the higher rate of SDD remained at 98%.
“There were no differences in 30-day complications or readmissions between SDD and overnight patients,” the authors write.
The right patient, the right motivation for successful surgery
Brian Lane, MD, PhD, a urologic oncologist with Spectrum Health in Grand Rapids, Michigan, told this news organization that, for nephrectomies, uptake of same-day discharge will continue to be slow.
“You have to have the right patient, the right patient motivation, and the surgery has to go smoothly,” he said. “If you start sending everyone home the same day, you will certainly see readmissions,” he said.
Dr. Lane is part of the Michigan Urologic Surgery Improvement Collaborative and he said the group recently looked at same-day discharge outcomes after robotic prostatectomies with SDD as compared with 1-2 nights in the hospital.
The work has not yet been published but, “There was a slight signal that there were increased readmissions with same-day discharge vs. 0-1 day,” he said.
A paper on outcomes of same-day discharge in total knee arthroplasty in the Journal of Bone & Joint Surgery found a higher risk of perioperative complications “including component failure, surgical site infection, knee stiffness, and deep vein thrombosis.” Researchers compared outcomes between 4,391 patients who underwent outpatient TKA and 128,951 patients who underwent inpatient TKA.
But for other many surgeries, same-day discharge numbers are increasing without worsening outcomes.
A paper in the Journal of Robotic Surgery found that same-day discharge following robotic-assisted endometrial cancer staging is “safe and feasible.”
Stephen Bradley, MD, MPH, with the Minneapolis Heart Institute in Minneapolis, and colleagues write in the Journal of the American College of Cardiology: Cardiovascular Interventions that they found a large increase in the use of same-day discharge after elective percutaneous coronary intervention (PCI) was not associated with worse 30-day mortality rates or readmission.
In that study, 114,461 patients were discharged the same day they underwent PCI. The proportion of patients who had a same-day discharge increased from 4.5% in 2009 to 28.6% in the fourth quarter of 2017.
Risk-adjusted 30-day mortality did not change in that time, while risk-adjusted rehospitalization decreased over time and more quickly when patients had same-day discharge.
Deepak L. Bhatt, MD, MPH, and Jonathan G. Sung, MBCHB, both of Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, wrote in an accompanying article that, “Advances in the devices and techniques of PCI have improved the safety and efficacy of the procedure. In selected patients, same-day discharge has become possible, and overnight in-hospital observation can be avoided. By reducing unnecessary hospital stays, both patients and hospitals could benefit.”
Evan Garden, a medical student at Icahn School of Medicine at Mount Sinai in New York, presented findings at the American Urological Association 2021 annual meeting that show patients selected for same-day discharge after partial or radical nephrectomy did not have increased rates of postoperative complications or readmissions in the immediate postoperative period, compared with standard discharge of 1-3 days.
Case studies in nephrectomy
While several case studies have looked at the feasibility and safety of performing partial and radical nephrectomy with same-day discharge in select cases, “this topic has not been addressed on a national level,” Mr. Garden said.
Few patients who have partial or radical nephrectomies have same-day discharges. The researchers found that fewer than 1% of patients who have either procedure in the sample studied were discharged the same day.
Researchers used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, a nationally representative deidentified database that prospectively tracks patient characteristics and 30-day perioperative outcomes for major inpatient and outpatient surgical procedures at more than 700 hospitals.
They extracted all minimally invasive partial and radical nephrectomies from 2012 to 2019 and refined the cohort to 28,140 patients who were theoretically eligible for same-day discharge: Of those, 237 (0.8%) had SSD, and 27,903 (99.2%) had a standard-length discharge (SLD).
The team found that there were no differences in 30-day complications or readmissions between same-day discharge (Clavien-Dindo [CD] I/II, 4.22%; CD III, 0%; CD IV, 1.27%; readmission, 4.64%); and SLD (CD I/II, 4.11%; CD III, 0.95%; CD IV, 0.79%; readmission, 3.90%; all P > .05).
Controlling for demographic and clinical variables, SDD was not associated with greater risk of 30-day complications or readmissions (CD I/II: odds ratio, 1.08; 95% confidence interval, 0.57-2.048; P = .813; CD IV: OR 1.699; 95% CI, 0.537-5.375; P = .367; readmission: OR, 1.254; 95% CI, 0.681-2.31; P = .467).
Mr. Garden and coauthors report no relevant financial relationships.
Dr. Lane reports no relevant financial relationships.
Urologist Ronney Abaza, MD, a robotic surgery specialist in Dublin, Ohio, and colleagues, reviewed robotic surgeries at their hospital during COVID-19 restrictions on surgery in Ohio between March 17 and June 5, 2020, and compared them with robotic procedures before COVID-19 and after restrictions were lifted. They published their results in Urology.
Since 2016, the hospital has offered the option of same-day discharge (SDD) to all robotic urologic surgery patients, regardless of procedure or patient-specific factors.
Among patients who had surgery during COVID-19 restrictions, 98% (87/89 patients) opted for SDD versus 52% in the group having surgery before the restrictions (P < .00001). After the COVID-19 surgery restrictions were lifted, the higher rate of SDD remained at 98%.
“There were no differences in 30-day complications or readmissions between SDD and overnight patients,” the authors write.
The right patient, the right motivation for successful surgery
Brian Lane, MD, PhD, a urologic oncologist with Spectrum Health in Grand Rapids, Michigan, told this news organization that, for nephrectomies, uptake of same-day discharge will continue to be slow.
“You have to have the right patient, the right patient motivation, and the surgery has to go smoothly,” he said. “If you start sending everyone home the same day, you will certainly see readmissions,” he said.
Dr. Lane is part of the Michigan Urologic Surgery Improvement Collaborative and he said the group recently looked at same-day discharge outcomes after robotic prostatectomies with SDD as compared with 1-2 nights in the hospital.
The work has not yet been published but, “There was a slight signal that there were increased readmissions with same-day discharge vs. 0-1 day,” he said.
A paper on outcomes of same-day discharge in total knee arthroplasty in the Journal of Bone & Joint Surgery found a higher risk of perioperative complications “including component failure, surgical site infection, knee stiffness, and deep vein thrombosis.” Researchers compared outcomes between 4,391 patients who underwent outpatient TKA and 128,951 patients who underwent inpatient TKA.
But for other many surgeries, same-day discharge numbers are increasing without worsening outcomes.
A paper in the Journal of Robotic Surgery found that same-day discharge following robotic-assisted endometrial cancer staging is “safe and feasible.”
Stephen Bradley, MD, MPH, with the Minneapolis Heart Institute in Minneapolis, and colleagues write in the Journal of the American College of Cardiology: Cardiovascular Interventions that they found a large increase in the use of same-day discharge after elective percutaneous coronary intervention (PCI) was not associated with worse 30-day mortality rates or readmission.
In that study, 114,461 patients were discharged the same day they underwent PCI. The proportion of patients who had a same-day discharge increased from 4.5% in 2009 to 28.6% in the fourth quarter of 2017.
Risk-adjusted 30-day mortality did not change in that time, while risk-adjusted rehospitalization decreased over time and more quickly when patients had same-day discharge.
Deepak L. Bhatt, MD, MPH, and Jonathan G. Sung, MBCHB, both of Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, wrote in an accompanying article that, “Advances in the devices and techniques of PCI have improved the safety and efficacy of the procedure. In selected patients, same-day discharge has become possible, and overnight in-hospital observation can be avoided. By reducing unnecessary hospital stays, both patients and hospitals could benefit.”
Evan Garden, a medical student at Icahn School of Medicine at Mount Sinai in New York, presented findings at the American Urological Association 2021 annual meeting that show patients selected for same-day discharge after partial or radical nephrectomy did not have increased rates of postoperative complications or readmissions in the immediate postoperative period, compared with standard discharge of 1-3 days.
Case studies in nephrectomy
While several case studies have looked at the feasibility and safety of performing partial and radical nephrectomy with same-day discharge in select cases, “this topic has not been addressed on a national level,” Mr. Garden said.
Few patients who have partial or radical nephrectomies have same-day discharges. The researchers found that fewer than 1% of patients who have either procedure in the sample studied were discharged the same day.
Researchers used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, a nationally representative deidentified database that prospectively tracks patient characteristics and 30-day perioperative outcomes for major inpatient and outpatient surgical procedures at more than 700 hospitals.
They extracted all minimally invasive partial and radical nephrectomies from 2012 to 2019 and refined the cohort to 28,140 patients who were theoretically eligible for same-day discharge: Of those, 237 (0.8%) had SSD, and 27,903 (99.2%) had a standard-length discharge (SLD).
The team found that there were no differences in 30-day complications or readmissions between same-day discharge (Clavien-Dindo [CD] I/II, 4.22%; CD III, 0%; CD IV, 1.27%; readmission, 4.64%); and SLD (CD I/II, 4.11%; CD III, 0.95%; CD IV, 0.79%; readmission, 3.90%; all P > .05).
Controlling for demographic and clinical variables, SDD was not associated with greater risk of 30-day complications or readmissions (CD I/II: odds ratio, 1.08; 95% confidence interval, 0.57-2.048; P = .813; CD IV: OR 1.699; 95% CI, 0.537-5.375; P = .367; readmission: OR, 1.254; 95% CI, 0.681-2.31; P = .467).
Mr. Garden and coauthors report no relevant financial relationships.
Dr. Lane reports no relevant financial relationships.
Convenience, not outcomes may drive robot-assisted surgeries
“The problem in minimally invasive surgery, especially in cancer surgery, is that the concept has been flip-flopped,” said Hooman Noorchashm, MD, PhD, a retired cardiothoracic surgeon turned patient advocate. “The main purpose of surgery should be removal of diseased tissue or repair of damaged tissue with adequate safety. The size of the incision on that triage scheme is secondary.”
In 2013, Dr. Noorchashm’s wife, Amy Reed, MD, an anesthesiologist, had a hysterectomy for treatment of severe uterine fibroids. The surgery was performed with a laparoscopic power morcellator, which led to the dissemination of cells from a previously undetected abdominal lesion. She was later diagnosed with stage 4 leiomyosarcoma and died in May 2017.
Dr. Noorchashm said the problem with robotic surgery isn’t the technology itself or how it’s used, but why it’s used in the first place. “Not only was there an extreme level of laxity with respect to the malignant potential of fibroids, but also that the size of the incision supersedes the safety of the procedure.”
The ultimate goal of oncologic surgery is to achieve an en bloc resection with clean surgical margins and removal of the tumor intact, Dr. Noorchashm said. The only scientific way of showing the benefits or therapeutic equivalence of new technology is through noninferiority comparison trials.
Robotic surgery inching toward $14 billion in revenue by 2028
Although robotic surgical technology has been in use since the 1990s, the technology is still considered to be its infancy. The first Food and Drug Administration–approved robotics platform, the da Vinci Surgical System (Intuitive Surgical) was approved by the FDA in 2000. And, now, with its patent expiring in 2022, competitors will be developing and launching new products for abdominal and colorectal surgery, partial knee replacements, cardiovascular procedures, head and neck surgery, and spinal procedures.
Robotic surgery is a rapidly expanding area with new product launches announced daily. In August 2021, the market research firm Grand View Research, reported the surgical robot marketplace is projected to reach $14 billion by 2028, up from $3.6 billion this year.
“This new era of robotic-assisted surgery attracts both surgeons and patients. Robotic surgery has reshaped our surgeries over the last 2 decades, and robots are now used in almost in every surgical field. Still, as surgeons, we continue to look – with great interest – to new robotic companies that may be able to provide better robots in a more cost-effective manner,” wrote urologists Ahmad Almujalhem and Koon Ho Rha in a review published in the journal BJUI Compass.
However, the authors wrote that, although the market is competitive, cost remains an issue, as are competing interests. In addition, many companies are creating replicas of existing technologies instead of focusing on new designs and new technology. “Although the da Vinci system propelled many robots to market, there has been no significant improvement in the console,” they added.
The technology is attractive to both surgeons and patients. “Surgeons are attracted to newer technologies, better vision, and easier learning curves. Patients are also attracted to robotic surgery, as this technology is considered state of the art and is associated with reduced pain and scar size,” the authors wrote.
Outcomes depend on many variables
In terms of outcomes, the literature is mixed. It largely depends on a number of variables from the site of surgery, the type of cancer, technology used, and the surgeon’s skill.
Jung Mogg Kim, MD, PhD, a microbiologist with Hanyang University, Seoul, South Korea, published a systemic review and meta-analysis of 27 clinical reports in PLoS ONE assessing clinical outcomes. They found that robot-assisted laparoscopic surgery did not result in statistically superior outcomes, compared with conventional laparoscopic surgery, except for lower estimated blood loss with robots. Operative time and total complications rates were “significantly more favorable” with conventional laparoscopic procedures.
Thomas E. Ahlering, MD, a robotic prostatectomy specialist at the University of California, Irvine, explained that the success or failure of robot-assisted surgery can be highly dependent on the body site and tumor type.
“The oncologic outcome, as long as the surgeon is up to speed, is not going to be better, but the goal is to be as good,” he said in an interview.
In most cases, Dr. Ahlering said, the goal of surgery is to remove a viable tumor with clean margins while leaving the organ intact. But in prostate surgery, the goal is to remove the entire organ while trying to preserve urinary continence and sexual function.
“One of the biggest benefits of the robot is that we’re able to use it in a laparoscopic environment meaning that we need a pneumoperitoneum [which] dramatically decreases bleeding. In prostate cancer, the area is so highly vascular that bleeding is a major issue,” he said.
The same benefits of reduced bleeding, improved visualization, and precision are also seen with robotic-assisted surgery for renal cancer, he noted.
He also emphasized that positive surgical margins, while less desirable than complete elimination of malignant cells, is not nearly as dire in prostate cancer as it is in surgery for other malignancies, such as soft-tissue sarcomas.
“The majority of cases are never going to recur, and if they do recur they essentially never lead to metastatic disease to bone, much less to prostate cancer–related death. The only thing they can do is slightly increase the PSA [prostate-specific antigen] recurrence,” he said.
Assuming that outcomes are comparable between an open procedure, conventional laparoscopic procedure, or robot-assisted approach, surgeons “will almost all go for the robot. It’s easier on the surgeon and it’s easier on the system,” Dr. Ahlering said.
In skilled hands for select patients, the use of a carefully researched and well-designed surgical assistive device can result in outcomes that are comparable with those seen in open surgical procedures, with robot-assisted surgery offering the possibility of less perioperative bleeding, lower postoperative morbidity, and faster recovery times.
“In our program we have been using robots to perform robotic radical prostatectomy and nephron-sparing surgery – partial nephrectomy and we’re also using them to perform intracorporeal bowel reconstruction and robotic radical cystectomy,” said Ashutosh Tewari, MD, of the Icahn School of Medicine at Mount Sinai, New York.
Robot-assisted surgery can be used “anywhere where you have to be selective, anywhere where you have to be reconstructive, anywhere where [assisted] vision can help, anywhere where the lack of bleeding will be of help to patients, and anywhere where a smaller incision can achieve the same goals,” Dr. Tewari said in an interview. Dr. Tewari’s Mount Sinai colleagues reported at the 2021 American Urological Association annual meeting, robotic-assisted salvage radical and partial nephrectomies were found to be safe and feasible procedures in patients with metachronous kidney tumors. For patients with early invasive cancer (stage pT1), oncologic outcomes with robotic-assisted partial nephrectomy were similar to those of patients who underwent radical surgery. The authors concluded that salvage robotic-assisted partial nephrectomy “can be considered in this group of patients due to the risk of future recurrences and need to preserve renal function.”
The National Comprehensive Cancer Network guideline for prostate cancer, updated in September 2021, states that “laparoscopic and robot-assisted radical prostatectomy are commonly used and are considered comparable to conventional approaches in experienced hands.”
In 2018, researchers in a multinational comparison trial reported that patients with cervical cancer who were randomly assigned to minimally invasive robot-assisted radical hysterectomy had significantly lower rates of both disease-free survival and overall survival than women randomized to open abdominal radical hysterectomy. The study results were published in the New England Journal of Medicine.
The use of robotically assisted surgical (RAS) devices could possibly create a “shielding layer” between the surgical team and patient reducing the risk of infection, according to Ajmal Zemmar, MD, PhD, FMH, a neurosurgeon with the University of Louisville (Ky.) Dr. Zemmar and colleagues recently published a perspective in Nature Machine Intelligence on trends in the use of surgical robots.
“In the operating theatre, robots can place intravascular lines, intubate the patient and manage the airway. The integration of a robot as a shielding layer, physically separating the health care worker and patient, is a powerful tool to combat the omnipresent fear of pathogen contamination and maintain surgical volumes,” Dr. Zemmar and colleagues wrote.
Surgical vs. clinical outcomes
In July 2021, this news organization reported that clinical trials of RAS for nipple-sparing mastectomy procedures were looking primarily at cosmetic or surgical outcomes and were not collecting cancer outcomes and if they were, it was secondary to cosmetic or surgical outcomes.
The FDA followed up by issuing a safety communication in August warning patients and providers that neither the safety nor efficacy of RAS for use in mastectomy procedures or treatment of breast cancer have been established.
“In addition, the FDA is aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies,” the communication stated.
Dr. Tewari disclosed relationships with various companies. Dr. Noorchashm had no relevant disclosures. Dr. Ahlering disclosed past funding or other considerations from Intuitive Robotics.
“The problem in minimally invasive surgery, especially in cancer surgery, is that the concept has been flip-flopped,” said Hooman Noorchashm, MD, PhD, a retired cardiothoracic surgeon turned patient advocate. “The main purpose of surgery should be removal of diseased tissue or repair of damaged tissue with adequate safety. The size of the incision on that triage scheme is secondary.”
In 2013, Dr. Noorchashm’s wife, Amy Reed, MD, an anesthesiologist, had a hysterectomy for treatment of severe uterine fibroids. The surgery was performed with a laparoscopic power morcellator, which led to the dissemination of cells from a previously undetected abdominal lesion. She was later diagnosed with stage 4 leiomyosarcoma and died in May 2017.
Dr. Noorchashm said the problem with robotic surgery isn’t the technology itself or how it’s used, but why it’s used in the first place. “Not only was there an extreme level of laxity with respect to the malignant potential of fibroids, but also that the size of the incision supersedes the safety of the procedure.”
The ultimate goal of oncologic surgery is to achieve an en bloc resection with clean surgical margins and removal of the tumor intact, Dr. Noorchashm said. The only scientific way of showing the benefits or therapeutic equivalence of new technology is through noninferiority comparison trials.
Robotic surgery inching toward $14 billion in revenue by 2028
Although robotic surgical technology has been in use since the 1990s, the technology is still considered to be its infancy. The first Food and Drug Administration–approved robotics platform, the da Vinci Surgical System (Intuitive Surgical) was approved by the FDA in 2000. And, now, with its patent expiring in 2022, competitors will be developing and launching new products for abdominal and colorectal surgery, partial knee replacements, cardiovascular procedures, head and neck surgery, and spinal procedures.
Robotic surgery is a rapidly expanding area with new product launches announced daily. In August 2021, the market research firm Grand View Research, reported the surgical robot marketplace is projected to reach $14 billion by 2028, up from $3.6 billion this year.
“This new era of robotic-assisted surgery attracts both surgeons and patients. Robotic surgery has reshaped our surgeries over the last 2 decades, and robots are now used in almost in every surgical field. Still, as surgeons, we continue to look – with great interest – to new robotic companies that may be able to provide better robots in a more cost-effective manner,” wrote urologists Ahmad Almujalhem and Koon Ho Rha in a review published in the journal BJUI Compass.
However, the authors wrote that, although the market is competitive, cost remains an issue, as are competing interests. In addition, many companies are creating replicas of existing technologies instead of focusing on new designs and new technology. “Although the da Vinci system propelled many robots to market, there has been no significant improvement in the console,” they added.
The technology is attractive to both surgeons and patients. “Surgeons are attracted to newer technologies, better vision, and easier learning curves. Patients are also attracted to robotic surgery, as this technology is considered state of the art and is associated with reduced pain and scar size,” the authors wrote.
Outcomes depend on many variables
In terms of outcomes, the literature is mixed. It largely depends on a number of variables from the site of surgery, the type of cancer, technology used, and the surgeon’s skill.
Jung Mogg Kim, MD, PhD, a microbiologist with Hanyang University, Seoul, South Korea, published a systemic review and meta-analysis of 27 clinical reports in PLoS ONE assessing clinical outcomes. They found that robot-assisted laparoscopic surgery did not result in statistically superior outcomes, compared with conventional laparoscopic surgery, except for lower estimated blood loss with robots. Operative time and total complications rates were “significantly more favorable” with conventional laparoscopic procedures.
Thomas E. Ahlering, MD, a robotic prostatectomy specialist at the University of California, Irvine, explained that the success or failure of robot-assisted surgery can be highly dependent on the body site and tumor type.
“The oncologic outcome, as long as the surgeon is up to speed, is not going to be better, but the goal is to be as good,” he said in an interview.
In most cases, Dr. Ahlering said, the goal of surgery is to remove a viable tumor with clean margins while leaving the organ intact. But in prostate surgery, the goal is to remove the entire organ while trying to preserve urinary continence and sexual function.
“One of the biggest benefits of the robot is that we’re able to use it in a laparoscopic environment meaning that we need a pneumoperitoneum [which] dramatically decreases bleeding. In prostate cancer, the area is so highly vascular that bleeding is a major issue,” he said.
The same benefits of reduced bleeding, improved visualization, and precision are also seen with robotic-assisted surgery for renal cancer, he noted.
He also emphasized that positive surgical margins, while less desirable than complete elimination of malignant cells, is not nearly as dire in prostate cancer as it is in surgery for other malignancies, such as soft-tissue sarcomas.
“The majority of cases are never going to recur, and if they do recur they essentially never lead to metastatic disease to bone, much less to prostate cancer–related death. The only thing they can do is slightly increase the PSA [prostate-specific antigen] recurrence,” he said.
Assuming that outcomes are comparable between an open procedure, conventional laparoscopic procedure, or robot-assisted approach, surgeons “will almost all go for the robot. It’s easier on the surgeon and it’s easier on the system,” Dr. Ahlering said.
In skilled hands for select patients, the use of a carefully researched and well-designed surgical assistive device can result in outcomes that are comparable with those seen in open surgical procedures, with robot-assisted surgery offering the possibility of less perioperative bleeding, lower postoperative morbidity, and faster recovery times.
“In our program we have been using robots to perform robotic radical prostatectomy and nephron-sparing surgery – partial nephrectomy and we’re also using them to perform intracorporeal bowel reconstruction and robotic radical cystectomy,” said Ashutosh Tewari, MD, of the Icahn School of Medicine at Mount Sinai, New York.
Robot-assisted surgery can be used “anywhere where you have to be selective, anywhere where you have to be reconstructive, anywhere where [assisted] vision can help, anywhere where the lack of bleeding will be of help to patients, and anywhere where a smaller incision can achieve the same goals,” Dr. Tewari said in an interview. Dr. Tewari’s Mount Sinai colleagues reported at the 2021 American Urological Association annual meeting, robotic-assisted salvage radical and partial nephrectomies were found to be safe and feasible procedures in patients with metachronous kidney tumors. For patients with early invasive cancer (stage pT1), oncologic outcomes with robotic-assisted partial nephrectomy were similar to those of patients who underwent radical surgery. The authors concluded that salvage robotic-assisted partial nephrectomy “can be considered in this group of patients due to the risk of future recurrences and need to preserve renal function.”
The National Comprehensive Cancer Network guideline for prostate cancer, updated in September 2021, states that “laparoscopic and robot-assisted radical prostatectomy are commonly used and are considered comparable to conventional approaches in experienced hands.”
In 2018, researchers in a multinational comparison trial reported that patients with cervical cancer who were randomly assigned to minimally invasive robot-assisted radical hysterectomy had significantly lower rates of both disease-free survival and overall survival than women randomized to open abdominal radical hysterectomy. The study results were published in the New England Journal of Medicine.
The use of robotically assisted surgical (RAS) devices could possibly create a “shielding layer” between the surgical team and patient reducing the risk of infection, according to Ajmal Zemmar, MD, PhD, FMH, a neurosurgeon with the University of Louisville (Ky.) Dr. Zemmar and colleagues recently published a perspective in Nature Machine Intelligence on trends in the use of surgical robots.
“In the operating theatre, robots can place intravascular lines, intubate the patient and manage the airway. The integration of a robot as a shielding layer, physically separating the health care worker and patient, is a powerful tool to combat the omnipresent fear of pathogen contamination and maintain surgical volumes,” Dr. Zemmar and colleagues wrote.
Surgical vs. clinical outcomes
In July 2021, this news organization reported that clinical trials of RAS for nipple-sparing mastectomy procedures were looking primarily at cosmetic or surgical outcomes and were not collecting cancer outcomes and if they were, it was secondary to cosmetic or surgical outcomes.
The FDA followed up by issuing a safety communication in August warning patients and providers that neither the safety nor efficacy of RAS for use in mastectomy procedures or treatment of breast cancer have been established.
“In addition, the FDA is aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies,” the communication stated.
Dr. Tewari disclosed relationships with various companies. Dr. Noorchashm had no relevant disclosures. Dr. Ahlering disclosed past funding or other considerations from Intuitive Robotics.
“The problem in minimally invasive surgery, especially in cancer surgery, is that the concept has been flip-flopped,” said Hooman Noorchashm, MD, PhD, a retired cardiothoracic surgeon turned patient advocate. “The main purpose of surgery should be removal of diseased tissue or repair of damaged tissue with adequate safety. The size of the incision on that triage scheme is secondary.”
In 2013, Dr. Noorchashm’s wife, Amy Reed, MD, an anesthesiologist, had a hysterectomy for treatment of severe uterine fibroids. The surgery was performed with a laparoscopic power morcellator, which led to the dissemination of cells from a previously undetected abdominal lesion. She was later diagnosed with stage 4 leiomyosarcoma and died in May 2017.
Dr. Noorchashm said the problem with robotic surgery isn’t the technology itself or how it’s used, but why it’s used in the first place. “Not only was there an extreme level of laxity with respect to the malignant potential of fibroids, but also that the size of the incision supersedes the safety of the procedure.”
The ultimate goal of oncologic surgery is to achieve an en bloc resection with clean surgical margins and removal of the tumor intact, Dr. Noorchashm said. The only scientific way of showing the benefits or therapeutic equivalence of new technology is through noninferiority comparison trials.
Robotic surgery inching toward $14 billion in revenue by 2028
Although robotic surgical technology has been in use since the 1990s, the technology is still considered to be its infancy. The first Food and Drug Administration–approved robotics platform, the da Vinci Surgical System (Intuitive Surgical) was approved by the FDA in 2000. And, now, with its patent expiring in 2022, competitors will be developing and launching new products for abdominal and colorectal surgery, partial knee replacements, cardiovascular procedures, head and neck surgery, and spinal procedures.
Robotic surgery is a rapidly expanding area with new product launches announced daily. In August 2021, the market research firm Grand View Research, reported the surgical robot marketplace is projected to reach $14 billion by 2028, up from $3.6 billion this year.
“This new era of robotic-assisted surgery attracts both surgeons and patients. Robotic surgery has reshaped our surgeries over the last 2 decades, and robots are now used in almost in every surgical field. Still, as surgeons, we continue to look – with great interest – to new robotic companies that may be able to provide better robots in a more cost-effective manner,” wrote urologists Ahmad Almujalhem and Koon Ho Rha in a review published in the journal BJUI Compass.
However, the authors wrote that, although the market is competitive, cost remains an issue, as are competing interests. In addition, many companies are creating replicas of existing technologies instead of focusing on new designs and new technology. “Although the da Vinci system propelled many robots to market, there has been no significant improvement in the console,” they added.
The technology is attractive to both surgeons and patients. “Surgeons are attracted to newer technologies, better vision, and easier learning curves. Patients are also attracted to robotic surgery, as this technology is considered state of the art and is associated with reduced pain and scar size,” the authors wrote.
Outcomes depend on many variables
In terms of outcomes, the literature is mixed. It largely depends on a number of variables from the site of surgery, the type of cancer, technology used, and the surgeon’s skill.
Jung Mogg Kim, MD, PhD, a microbiologist with Hanyang University, Seoul, South Korea, published a systemic review and meta-analysis of 27 clinical reports in PLoS ONE assessing clinical outcomes. They found that robot-assisted laparoscopic surgery did not result in statistically superior outcomes, compared with conventional laparoscopic surgery, except for lower estimated blood loss with robots. Operative time and total complications rates were “significantly more favorable” with conventional laparoscopic procedures.
Thomas E. Ahlering, MD, a robotic prostatectomy specialist at the University of California, Irvine, explained that the success or failure of robot-assisted surgery can be highly dependent on the body site and tumor type.
“The oncologic outcome, as long as the surgeon is up to speed, is not going to be better, but the goal is to be as good,” he said in an interview.
In most cases, Dr. Ahlering said, the goal of surgery is to remove a viable tumor with clean margins while leaving the organ intact. But in prostate surgery, the goal is to remove the entire organ while trying to preserve urinary continence and sexual function.
“One of the biggest benefits of the robot is that we’re able to use it in a laparoscopic environment meaning that we need a pneumoperitoneum [which] dramatically decreases bleeding. In prostate cancer, the area is so highly vascular that bleeding is a major issue,” he said.
The same benefits of reduced bleeding, improved visualization, and precision are also seen with robotic-assisted surgery for renal cancer, he noted.
He also emphasized that positive surgical margins, while less desirable than complete elimination of malignant cells, is not nearly as dire in prostate cancer as it is in surgery for other malignancies, such as soft-tissue sarcomas.
“The majority of cases are never going to recur, and if they do recur they essentially never lead to metastatic disease to bone, much less to prostate cancer–related death. The only thing they can do is slightly increase the PSA [prostate-specific antigen] recurrence,” he said.
Assuming that outcomes are comparable between an open procedure, conventional laparoscopic procedure, or robot-assisted approach, surgeons “will almost all go for the robot. It’s easier on the surgeon and it’s easier on the system,” Dr. Ahlering said.
In skilled hands for select patients, the use of a carefully researched and well-designed surgical assistive device can result in outcomes that are comparable with those seen in open surgical procedures, with robot-assisted surgery offering the possibility of less perioperative bleeding, lower postoperative morbidity, and faster recovery times.
“In our program we have been using robots to perform robotic radical prostatectomy and nephron-sparing surgery – partial nephrectomy and we’re also using them to perform intracorporeal bowel reconstruction and robotic radical cystectomy,” said Ashutosh Tewari, MD, of the Icahn School of Medicine at Mount Sinai, New York.
Robot-assisted surgery can be used “anywhere where you have to be selective, anywhere where you have to be reconstructive, anywhere where [assisted] vision can help, anywhere where the lack of bleeding will be of help to patients, and anywhere where a smaller incision can achieve the same goals,” Dr. Tewari said in an interview. Dr. Tewari’s Mount Sinai colleagues reported at the 2021 American Urological Association annual meeting, robotic-assisted salvage radical and partial nephrectomies were found to be safe and feasible procedures in patients with metachronous kidney tumors. For patients with early invasive cancer (stage pT1), oncologic outcomes with robotic-assisted partial nephrectomy were similar to those of patients who underwent radical surgery. The authors concluded that salvage robotic-assisted partial nephrectomy “can be considered in this group of patients due to the risk of future recurrences and need to preserve renal function.”
The National Comprehensive Cancer Network guideline for prostate cancer, updated in September 2021, states that “laparoscopic and robot-assisted radical prostatectomy are commonly used and are considered comparable to conventional approaches in experienced hands.”
In 2018, researchers in a multinational comparison trial reported that patients with cervical cancer who were randomly assigned to minimally invasive robot-assisted radical hysterectomy had significantly lower rates of both disease-free survival and overall survival than women randomized to open abdominal radical hysterectomy. The study results were published in the New England Journal of Medicine.
The use of robotically assisted surgical (RAS) devices could possibly create a “shielding layer” between the surgical team and patient reducing the risk of infection, according to Ajmal Zemmar, MD, PhD, FMH, a neurosurgeon with the University of Louisville (Ky.) Dr. Zemmar and colleagues recently published a perspective in Nature Machine Intelligence on trends in the use of surgical robots.
“In the operating theatre, robots can place intravascular lines, intubate the patient and manage the airway. The integration of a robot as a shielding layer, physically separating the health care worker and patient, is a powerful tool to combat the omnipresent fear of pathogen contamination and maintain surgical volumes,” Dr. Zemmar and colleagues wrote.
Surgical vs. clinical outcomes
In July 2021, this news organization reported that clinical trials of RAS for nipple-sparing mastectomy procedures were looking primarily at cosmetic or surgical outcomes and were not collecting cancer outcomes and if they were, it was secondary to cosmetic or surgical outcomes.
The FDA followed up by issuing a safety communication in August warning patients and providers that neither the safety nor efficacy of RAS for use in mastectomy procedures or treatment of breast cancer have been established.
“In addition, the FDA is aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies,” the communication stated.
Dr. Tewari disclosed relationships with various companies. Dr. Noorchashm had no relevant disclosures. Dr. Ahlering disclosed past funding or other considerations from Intuitive Robotics.
Many patients, doctors unaware of advancements in cancer care
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.
This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.
The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.
When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.
Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.
“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.
After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”
Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.
Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.
He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.
“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.
That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.
For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
Findings from the patient survey
It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.
“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients
The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.
The survey asked them about how immunotherapy works, what it costs, and its side effects.
Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”
Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.
“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.
A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.
“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.
Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
Results of the doctor survey
The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.
Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).
Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.
Both groups of doctors had a hard time estimating the survival of common cancers.
Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.
However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.
“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.
A version of this article first appeared on Medscape.com.