Patient & Survivor Care

We are 20 minutes into the visit. My patient is 77 years old, a retired school administrator. She was sent to the oncology clinic for a new diagnosis of lung cancer with metastases to the liver and bones.

I was asking my usual questions – how did this all begin? – and I was hearing the usual answers. The cough that didn’t get better with antibiotics. The unintentional weight loss. The chest x-ray that looked “fuzzy.”

I continue: How many packs of cigarettes a day, and for how many years? Any family history of cancer?

These were my standard questions. They were met by hers: “How did I get this?”

I recently hosted a podcast on common, difficult questions we hear in hematology and oncology. How long do I have to live? What would you do if this were your family member?

This was another. There are variations to be sure. How, why, why me, what did I do, what didn’t I do, did my doctor miss it, if I had this or that test would they have caught it sooner?

When I was an internist, I talked about prevention. Meeting a new patient meant sizing them up for risk factors. In their habits I saw opportunities for healthier choices. In their family histories I gathered warning signs.

Now, I ask the same probing questions, but the purpose is not the same. Smoking, alcohol, family history, I ask these of everyone, I reassure them. It’s no longer about assessing risk. It’s not to place blame. But they read into the fact that I am asking, because they have asked themselves the same.

They ask why.

I try not to overdo the pity. I say that I’m sorry this is happening, but I don’t dwell. What I want to convey is the opposite – it’s normalcy. What I want to convey is: I’ve seen this a million times. This is where we are, and here is where we go. We don’t dwell or regret or wonder what if. My patients don’t want sympathy – at least, not from their doctor. They want a plan.

They ask: How did I get this?

It’s bad luck, I say. It’s a genetic mutation causing a cell to replicate.

My answers do not always satisfy their questions. Because it’s not a question seeking an informational answer. The truth is, medically and existentially, I don’t know. None of us do. The question is an existential itch no medical jargon can scratch.

I have a modern Hippocratic oath tacked to a wall in my room. “I will prevent disease whenever I can, because prevention is preferable to cure,” it says. True, but that offers little solace to those who already have the illness. Yes, we need prevention. And we need a path forward when tragedy has already struck.

I am humbled when I meet a new cancer patient because the visit is a metaphor for a nonjudgmental life. There’s something beautiful about meeting someone exactly where they are, where decisions made in the past are as irrelevant to me now as they were to the cancer.

When they inevitably ask “how did I get this?” and I answer, what I’m really saying is this: I don’t care what you did, or didn’t do, or how we got here. But we are here, and so I am here with you, and from now on the only place we care about is here and now, the only direction forward.

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

We are 20 minutes into the visit. My patient is 77 years old, a retired school administrator. She was sent to the oncology clinic for a new diagnosis of lung cancer with metastases to the liver and bones.

I was asking my usual questions – how did this all begin? – and I was hearing the usual answers. The cough that didn’t get better with antibiotics. The unintentional weight loss. The chest x-ray that looked “fuzzy.”

I continue: How many packs of cigarettes a day, and for how many years? Any family history of cancer?

These were my standard questions. They were met by hers: “How did I get this?”

I recently hosted a podcast on common, difficult questions we hear in hematology and oncology. How long do I have to live? What would you do if this were your family member?

This was another. There are variations to be sure. How, why, why me, what did I do, what didn’t I do, did my doctor miss it, if I had this or that test would they have caught it sooner?

When I was an internist, I talked about prevention. Meeting a new patient meant sizing them up for risk factors. In their habits I saw opportunities for healthier choices. In their family histories I gathered warning signs.

Now, I ask the same probing questions, but the purpose is not the same. Smoking, alcohol, family history, I ask these of everyone, I reassure them. It’s no longer about assessing risk. It’s not to place blame. But they read into the fact that I am asking, because they have asked themselves the same.

They ask why.

I try not to overdo the pity. I say that I’m sorry this is happening, but I don’t dwell. What I want to convey is the opposite – it’s normalcy. What I want to convey is: I’ve seen this a million times. This is where we are, and here is where we go. We don’t dwell or regret or wonder what if. My patients don’t want sympathy – at least, not from their doctor. They want a plan.

They ask: How did I get this?

It’s bad luck, I say. It’s a genetic mutation causing a cell to replicate.

My answers do not always satisfy their questions. Because it’s not a question seeking an informational answer. The truth is, medically and existentially, I don’t know. None of us do. The question is an existential itch no medical jargon can scratch.

I have a modern Hippocratic oath tacked to a wall in my room. “I will prevent disease whenever I can, because prevention is preferable to cure,” it says. True, but that offers little solace to those who already have the illness. Yes, we need prevention. And we need a path forward when tragedy has already struck.

I am humbled when I meet a new cancer patient because the visit is a metaphor for a nonjudgmental life. There’s something beautiful about meeting someone exactly where they are, where decisions made in the past are as irrelevant to me now as they were to the cancer.

When they inevitably ask “how did I get this?” and I answer, what I’m really saying is this: I don’t care what you did, or didn’t do, or how we got here. But we are here, and so I am here with you, and from now on the only place we care about is here and now, the only direction forward.

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

We are 20 minutes into the visit. My patient is 77 years old, a retired school administrator. She was sent to the oncology clinic for a new diagnosis of lung cancer with metastases to the liver and bones.

I was asking my usual questions – how did this all begin? – and I was hearing the usual answers. The cough that didn’t get better with antibiotics. The unintentional weight loss. The chest x-ray that looked “fuzzy.”

I continue: How many packs of cigarettes a day, and for how many years? Any family history of cancer?

These were my standard questions. They were met by hers: “How did I get this?”

I recently hosted a podcast on common, difficult questions we hear in hematology and oncology. How long do I have to live? What would you do if this were your family member?

This was another. There are variations to be sure. How, why, why me, what did I do, what didn’t I do, did my doctor miss it, if I had this or that test would they have caught it sooner?

When I was an internist, I talked about prevention. Meeting a new patient meant sizing them up for risk factors. In their habits I saw opportunities for healthier choices. In their family histories I gathered warning signs.

Now, I ask the same probing questions, but the purpose is not the same. Smoking, alcohol, family history, I ask these of everyone, I reassure them. It’s no longer about assessing risk. It’s not to place blame. But they read into the fact that I am asking, because they have asked themselves the same.

They ask why.

I try not to overdo the pity. I say that I’m sorry this is happening, but I don’t dwell. What I want to convey is the opposite – it’s normalcy. What I want to convey is: I’ve seen this a million times. This is where we are, and here is where we go. We don’t dwell or regret or wonder what if. My patients don’t want sympathy – at least, not from their doctor. They want a plan.

They ask: How did I get this?

It’s bad luck, I say. It’s a genetic mutation causing a cell to replicate.

My answers do not always satisfy their questions. Because it’s not a question seeking an informational answer. The truth is, medically and existentially, I don’t know. None of us do. The question is an existential itch no medical jargon can scratch.

I have a modern Hippocratic oath tacked to a wall in my room. “I will prevent disease whenever I can, because prevention is preferable to cure,” it says. True, but that offers little solace to those who already have the illness. Yes, we need prevention. And we need a path forward when tragedy has already struck.

I am humbled when I meet a new cancer patient because the visit is a metaphor for a nonjudgmental life. There’s something beautiful about meeting someone exactly where they are, where decisions made in the past are as irrelevant to me now as they were to the cancer.

When they inevitably ask “how did I get this?” and I answer, what I’m really saying is this: I don’t care what you did, or didn’t do, or how we got here. But we are here, and so I am here with you, and from now on the only place we care about is here and now, the only direction forward.

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

In Charles M. Schulz’s “It’s the Great Pumpkin, Charlie Brown,” the Peanuts gang goes trick or treating door to door. While everyone else gets candy, chewing gum, and chocolate bars, Charlie Brown just gets a bag of rocks. Everyone got treats except Charlie Brown, who only got tricks. Sometimes it seems that my patients are trick or treating, too. Sadly, the tricks come way too often.

Rawpixel/Getty Images

Linus tried to avoid tricks by staking out a sincere pumpkin patch in the hope that the Great Pumpkin would rise and deliver him candy and toys. Alas, our patients sometimes sincerely believe things like alkalinization, naturopathy, and antineoplastons will deliver the treats they need to cure their cancer. They will be similarly disappointed.

Most patients depend on us to skew the treat to trick ratio favorably. They trust us to know what to recommend to lengthen life and reduce suffering. Their faith is both a profound privilege and a daunting responsibility.

My patient was hospitalized with hypercalcemia, the latest complication deriving from a decade of progressive multiple myeloma. He was on his 11th line of therapy complicated by at least a grade 3 neuropathy resulting in an unstable gait, chronic pain requiring opioid analgesia, two hospitalizations in the last year for severe infections, and venous thromboembolism on anticoagulation, all resulting in an ECOG performance status no better than a 2. He stabilized and then we needed to talk about next steps.

A clinical trial would be ideal, but he would be excluded from any that we have open and travel isn’t really an option for him. I could choose to treat him with selinexor. It is approved by the Food and Drug Administration and has about a one-in-four chance of producing a short remission in a population of patients that would not include my patient. It also has a three-in-four chance of significant side effects. I could also create a combination regimen with drugs that he has already been exposed to, knowing that response is unlikely and side effects are certain.

This situation is not unique; in fact it is an all too frequent occurrence. The easiest path forward for me would be to recommend treatment. The patient expects treatment and would readily consent to whatever regimen I proposed. He would bear whatever side effects resulted as an expected consequence of therapy. On the surface, this easy path appears to be the proverbial “treat.” But really, further treatment is the “trick” because it is not known to prolong life and would certainly add side effects. The problem, of course, is knowing both when treats become tricks and how to let patients know this, too.

No one knows exactly when treats become tricks, least of all me. Every month I get a report updating me on the status of a former patient being treated elsewhere. This is someone who I thought had no more treatment options. I am humbled every time a colleague, or fellow, recommends a treatment I had never considered. I am not perfect; I do the best I can. My recommendation might be wrong.

Yet I have watched my patient steadily deteriorate and cognitively decline no matter what treatment I employed, whether or not the monoclonal spike decreased. There is no evidence that treatment under such circumstances benefits the patient at all. Moreover, I have sat through many morbidity and mortality conferences where the conclusion was that we should have consulted hospice sooner. Like so many hematologists and oncologists every day, I needed to have a goals-of-care conversation with my patient knowing that treatment could possibly help, but probably would not.

Crucial conversations like these are difficult for everybody. There are techniques to employ that my palliative care colleagues recommend. I tried to remember them as I started talking to my patient and his wife. He listened and clearly understood the gravity of the situation and the resulting poor prognosis regardless of treatment. I recommended hospice. He declined.

Getting to this point was uncomfortable enough, but then I came to a decision that I am still struggling with – acquiesce to his wishes and treat while feeling that I should not, or decline to treat further and transfer his care to someone more willing? This is not the kind of trick or treat I enjoy.

I look forward to the day when discussions of end of life are less awkward. Small movements have started to bring these conversations into the open. One such movement choreographs a dinner to encourage frank and open discussion of death (https://deathoverdinner.org/). Another reimagines the doula – a childbirth coach – as a coach at the end of life (https://www.agentlerparting.com/). Another provides a step-by-step approach to generating an end-of-life conversation (https://theconversationproject.org/). These, and many other efforts, did not occur in a vacuum. They emerged because of the growing recognition that the modern delivery of health care, and the culture it created, is inadequate for the end of life.

Until our culture changes, though, we are left with tough conversations and tougher decisions with our patients who are at the end of their cancer journey. I wish I could tell my junior colleagues that it gets easier with experience. In many ways it gets worse because of the long relationships we develop. As long as the rewards of treats are greater than the disappointments of tricks, though, I will continue trick or treating in my white coat costume.

Dr. Kalaycio is editor in chief of Hematology News. He is a hematologist-oncologist at the Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

In Charles M. Schulz’s “It’s the Great Pumpkin, Charlie Brown,” the Peanuts gang goes trick or treating door to door. While everyone else gets candy, chewing gum, and chocolate bars, Charlie Brown just gets a bag of rocks. Everyone got treats except Charlie Brown, who only got tricks. Sometimes it seems that my patients are trick or treating, too. Sadly, the tricks come way too often.

Rawpixel/Getty Images

Linus tried to avoid tricks by staking out a sincere pumpkin patch in the hope that the Great Pumpkin would rise and deliver him candy and toys. Alas, our patients sometimes sincerely believe things like alkalinization, naturopathy, and antineoplastons will deliver the treats they need to cure their cancer. They will be similarly disappointed.

Most patients depend on us to skew the treat to trick ratio favorably. They trust us to know what to recommend to lengthen life and reduce suffering. Their faith is both a profound privilege and a daunting responsibility.

My patient was hospitalized with hypercalcemia, the latest complication deriving from a decade of progressive multiple myeloma. He was on his 11th line of therapy complicated by at least a grade 3 neuropathy resulting in an unstable gait, chronic pain requiring opioid analgesia, two hospitalizations in the last year for severe infections, and venous thromboembolism on anticoagulation, all resulting in an ECOG performance status no better than a 2. He stabilized and then we needed to talk about next steps.

A clinical trial would be ideal, but he would be excluded from any that we have open and travel isn’t really an option for him. I could choose to treat him with selinexor. It is approved by the Food and Drug Administration and has about a one-in-four chance of producing a short remission in a population of patients that would not include my patient. It also has a three-in-four chance of significant side effects. I could also create a combination regimen with drugs that he has already been exposed to, knowing that response is unlikely and side effects are certain.

This situation is not unique; in fact it is an all too frequent occurrence. The easiest path forward for me would be to recommend treatment. The patient expects treatment and would readily consent to whatever regimen I proposed. He would bear whatever side effects resulted as an expected consequence of therapy. On the surface, this easy path appears to be the proverbial “treat.” But really, further treatment is the “trick” because it is not known to prolong life and would certainly add side effects. The problem, of course, is knowing both when treats become tricks and how to let patients know this, too.

No one knows exactly when treats become tricks, least of all me. Every month I get a report updating me on the status of a former patient being treated elsewhere. This is someone who I thought had no more treatment options. I am humbled every time a colleague, or fellow, recommends a treatment I had never considered. I am not perfect; I do the best I can. My recommendation might be wrong.

Yet I have watched my patient steadily deteriorate and cognitively decline no matter what treatment I employed, whether or not the monoclonal spike decreased. There is no evidence that treatment under such circumstances benefits the patient at all. Moreover, I have sat through many morbidity and mortality conferences where the conclusion was that we should have consulted hospice sooner. Like so many hematologists and oncologists every day, I needed to have a goals-of-care conversation with my patient knowing that treatment could possibly help, but probably would not.

Crucial conversations like these are difficult for everybody. There are techniques to employ that my palliative care colleagues recommend. I tried to remember them as I started talking to my patient and his wife. He listened and clearly understood the gravity of the situation and the resulting poor prognosis regardless of treatment. I recommended hospice. He declined.

Getting to this point was uncomfortable enough, but then I came to a decision that I am still struggling with – acquiesce to his wishes and treat while feeling that I should not, or decline to treat further and transfer his care to someone more willing? This is not the kind of trick or treat I enjoy.

I look forward to the day when discussions of end of life are less awkward. Small movements have started to bring these conversations into the open. One such movement choreographs a dinner to encourage frank and open discussion of death (https://deathoverdinner.org/). Another reimagines the doula – a childbirth coach – as a coach at the end of life (https://www.agentlerparting.com/). Another provides a step-by-step approach to generating an end-of-life conversation (https://theconversationproject.org/). These, and many other efforts, did not occur in a vacuum. They emerged because of the growing recognition that the modern delivery of health care, and the culture it created, is inadequate for the end of life.

Until our culture changes, though, we are left with tough conversations and tougher decisions with our patients who are at the end of their cancer journey. I wish I could tell my junior colleagues that it gets easier with experience. In many ways it gets worse because of the long relationships we develop. As long as the rewards of treats are greater than the disappointments of tricks, though, I will continue trick or treating in my white coat costume.

Dr. Kalaycio is editor in chief of Hematology News. He is a hematologist-oncologist at the Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

In Charles M. Schulz’s “It’s the Great Pumpkin, Charlie Brown,” the Peanuts gang goes trick or treating door to door. While everyone else gets candy, chewing gum, and chocolate bars, Charlie Brown just gets a bag of rocks. Everyone got treats except Charlie Brown, who only got tricks. Sometimes it seems that my patients are trick or treating, too. Sadly, the tricks come way too often.

Rawpixel/Getty Images

Linus tried to avoid tricks by staking out a sincere pumpkin patch in the hope that the Great Pumpkin would rise and deliver him candy and toys. Alas, our patients sometimes sincerely believe things like alkalinization, naturopathy, and antineoplastons will deliver the treats they need to cure their cancer. They will be similarly disappointed.

Most patients depend on us to skew the treat to trick ratio favorably. They trust us to know what to recommend to lengthen life and reduce suffering. Their faith is both a profound privilege and a daunting responsibility.

My patient was hospitalized with hypercalcemia, the latest complication deriving from a decade of progressive multiple myeloma. He was on his 11th line of therapy complicated by at least a grade 3 neuropathy resulting in an unstable gait, chronic pain requiring opioid analgesia, two hospitalizations in the last year for severe infections, and venous thromboembolism on anticoagulation, all resulting in an ECOG performance status no better than a 2. He stabilized and then we needed to talk about next steps.

A clinical trial would be ideal, but he would be excluded from any that we have open and travel isn’t really an option for him. I could choose to treat him with selinexor. It is approved by the Food and Drug Administration and has about a one-in-four chance of producing a short remission in a population of patients that would not include my patient. It also has a three-in-four chance of significant side effects. I could also create a combination regimen with drugs that he has already been exposed to, knowing that response is unlikely and side effects are certain.

This situation is not unique; in fact it is an all too frequent occurrence. The easiest path forward for me would be to recommend treatment. The patient expects treatment and would readily consent to whatever regimen I proposed. He would bear whatever side effects resulted as an expected consequence of therapy. On the surface, this easy path appears to be the proverbial “treat.” But really, further treatment is the “trick” because it is not known to prolong life and would certainly add side effects. The problem, of course, is knowing both when treats become tricks and how to let patients know this, too.

No one knows exactly when treats become tricks, least of all me. Every month I get a report updating me on the status of a former patient being treated elsewhere. This is someone who I thought had no more treatment options. I am humbled every time a colleague, or fellow, recommends a treatment I had never considered. I am not perfect; I do the best I can. My recommendation might be wrong.

Yet I have watched my patient steadily deteriorate and cognitively decline no matter what treatment I employed, whether or not the monoclonal spike decreased. There is no evidence that treatment under such circumstances benefits the patient at all. Moreover, I have sat through many morbidity and mortality conferences where the conclusion was that we should have consulted hospice sooner. Like so many hematologists and oncologists every day, I needed to have a goals-of-care conversation with my patient knowing that treatment could possibly help, but probably would not.

Crucial conversations like these are difficult for everybody. There are techniques to employ that my palliative care colleagues recommend. I tried to remember them as I started talking to my patient and his wife. He listened and clearly understood the gravity of the situation and the resulting poor prognosis regardless of treatment. I recommended hospice. He declined.

Getting to this point was uncomfortable enough, but then I came to a decision that I am still struggling with – acquiesce to his wishes and treat while feeling that I should not, or decline to treat further and transfer his care to someone more willing? This is not the kind of trick or treat I enjoy.

I look forward to the day when discussions of end of life are less awkward. Small movements have started to bring these conversations into the open. One such movement choreographs a dinner to encourage frank and open discussion of death (https://deathoverdinner.org/). Another reimagines the doula – a childbirth coach – as a coach at the end of life (https://www.agentlerparting.com/). Another provides a step-by-step approach to generating an end-of-life conversation (https://theconversationproject.org/). These, and many other efforts, did not occur in a vacuum. They emerged because of the growing recognition that the modern delivery of health care, and the culture it created, is inadequate for the end of life.

Until our culture changes, though, we are left with tough conversations and tougher decisions with our patients who are at the end of their cancer journey. I wish I could tell my junior colleagues that it gets easier with experience. In many ways it gets worse because of the long relationships we develop. As long as the rewards of treats are greater than the disappointments of tricks, though, I will continue trick or treating in my white coat costume.

Dr. Kalaycio is editor in chief of Hematology News. He is a hematologist-oncologist at the Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

Cannabidiol is a derivative of marijuana that is sold everywhere from medical marijuana stores to health food markets to gas stations. While this chemical is derived from marijuana plants, it can be sold in many states as a supplement and is largely unregulated. The ubiquity of cannabidiol (CBD) and its potential benefits means that doctors need to be able to counsel patients about what we know, what we don’t, and how to use it safely. For conditions such as chronic pain and addiction, where we have few safe and effective alternatives, CBD may be reasonable to recommend.

To find out what physicians need to know about CBD, Elisabeth Poorman, MD, a general internist at a University of Washington neighborhood clinic in Kent and member of the editorial advisory board of Internal Medicine News, interviewed Peter Grinspoon, MD, who provides free consultation to primary care patients on the benefits and risks of using various forms of cannabis, including CBD. Dr. Grinspoon is an internist at Massachusetts General Hospital Chelsea Healthcare Center and is an instructor at Harvard Medical School, Boston. He has contributed to the Harvard Health Blog on the topic of medical marijuana, delivered grand rounds on cannabis at Massachusetts General Hospital, and lectured at the American College of Physicians. Dr. Grinspoon is also medical director for Galenas, a medical marijuana company.

Dr. Grinspoon is the son of Lester Grinspoon, MD, associate professor emeritus of psychiatry at Harvard Medical School, who researched the medicinal legitimacy of marijuana prohibition and has authored books on the medical benefits of marijuana.

Dr. Poorman queried Dr. Peter Grinspoon about his experiences treating patients with CBD and his knowledge of CBD’s efficacy for various medical conditions. Below are excerpts from that conversation.


Dr. Poorman: How do you explain the difference between THC and CBD to patients?

Dr. Grinspoon: Cannabis contains at least a hundred different chemicals called cannabinoids, of which tetrahydrocannabinol (THC) and CBD are the most prevalent. THC is the one that gets you high and can be used recreationally and medically. The CBD molecule is not intoxicating, and people use it for a variety of medical purposes, most commonly to treat anxiety, insomnia, and pain.

Dr. Poorman: There are a lot of gaps in what we now about CBD’s potential benefits. Why don’t we know more?

Dr. Grinspoon: CBD has no abuse liability according to the World Health Organization, but because it is a cannabinoid, it is still technically a schedule I substance under the Controlled Substances Act, and that makes it difficult to study.


Dr. Poorman: What kinds of conditions can CBD treat?

Dr. Grinspoon: In anxiety, the enthusiasm has outpaced the science; there’s no question about that. And most of the studies have done in animals. That said, some studies have shown that CBD helps treat components of anxiety, like public speaking. Unlike THC, it is nonintoxicating and non–habit forming. But we don’t have the wealth of randomized controlled trials that we have for official psychiatric medications.

CBD’s benefits have been most extensively studied in pediatric epilepsy. The one Food and Drug Administration–approved drug derived from cannabis is Epidiolex, used to treat rare forms of childhood epilepsy. There is some evidence that as an adjunct, it can be used for glioblastoma multiforme in patients receiving other appropriate therapy. There is also some preliminary evidence that it can be used for addiction, including to opioids, cannabis, tobacco, and stimulants.

Most of the evidence for using CBD in chronic pain comes from animal studies, including a study published in the European Journal of Pain in 2016. Among my patients to whom I have suggested CBD for chronic pain, a few have noticed great benefit, a few have noticed some benefit, and a lot have noticed no benefit. For those who have said they noticed benefit it is unclear whether that benefit was just the placebo effect.

In insomnia, I usually have them take CBD under the tongue half an hour time before bedtime, or if it’s an edible, an hour before bedtime. I start with a lower dose and slowly try higher doses. I also encourage them to do the other sleep hygiene things, like no screens, increasing exercise, and decreasing caffeine. It seems that CBD helps them fall asleep, though it’s hard to know if it’s the CBD or the fact that they have started taking something, and have simultaneously made various lifestyle changes.


Dr. Poorman: Can CBD interfere with your normal sleep architecture, the way benzodiazepines and Benadryl can?

Dr. Grinspoon: We know that THC affects your sleep architecture and affects what percentage of REM sleep you have. But I don’t know if the effects of CBD on sleep architecture have been studied.


Dr. Poorman: What harms do you counsel patients about when discussing CBD?

Dr. Grinspoon: There are four main harms. The first is the price. It’s overpriced, and the doses are very low. In most animal studies, the doses are about 20 milligrams per kilogram of weight. And you go to the market, and it’s like a dollar for a hundredth of that.

Number two is that it’s not regulated; it’s a supplement. A few years ago, the government tested a bunch of samples of CBD, and some didn’t actually contain CBD, some didn’t have the right amount; and worse, some contained THC that had not been disclosed in the packaging. So you can’t just go to a roadside gas station and assume that if you buy CBD, it’s actually that. You want a place that has a certificate of assurance. Make sure third-party testing was done, including testing for pesticides and other heavy metals.

The third thing is drug interactions. It affects the body like grapefruit and inhibits the cytochrome P450 system. The medications doctors should be most concerned about are blood thinners like Coumadin. And if you’re on blood thinners, you definitely want to tell your doctor that you are on CBD and he or she might want to check your blood levels more frequently than they usually do.

The fourth concern is liver inflammation. In the childhood epilepsy studies, a bump in some liver enzymes was seen, although I haven’t heard of any clinically significant cases of chemical hepatitis related to CBD. But if someone has liver disease you want to keep an eye on their liver enzymes.

Dr. Poorman: What methods of ingestion do you recommend or not recommend?

Dr. Grinspoon: It’s basically trial and error, but I usually recommend oral form. If people feel comfortable taking a gummy bear, or a pill, I’m not particular about that. If the product being taken contains less than 0.3% THC, it won’t get you high.

The topical form probably works better for treating chronic pain if it contains some THC, suggests a review article published in the Cleveland Clinic Journal of Medicine. Topical THC is nonintoxicating, unless you managed to sit in a bathtub for 8 hours after applying it.

I don’t recommend smoking CBD, and right now, I don’t recommend vaping anything.

If people have severe pain, like moderately severe arthritis, CBD may not be enough, whereas medical cannabis with THC could help, a report suggests.


Dr. Poorman: Do you ever encourage patients to stop using CBD products?

Dr. Grinspoon: I work in a low-income area, and my patients don’t have a ton of disposable income. If it’s not working, I worry about the expense.


Dr. Poorman: The CBD industry is growing quickly. What changes are you seeing in what products are out there, and what changes would you like to see?

Dr. Grinspoon: CBD is being put in everything, and it’s comical. On the one hand, you can say if people want to waste their money on a CBD emitting pillowcase, that’s fine. On the other hand, you can say that certainly seems like misleading advertising, because a CBD emitting pillowcase isn’t going to help you sleep any better.

I think the purported benefits are far beyond what we can say scientifically. We do know that CBD has anti-inflammatory characteristics. But that doesn’t mean that putting CBD in all skin products is good for your skin. It’s bad for your pocketbook, though. I would like there to be less of a gap between the claims and the science.
 

Dr. Elisabeth Poorman has no conflicts to disclose.

Cannabidiol is a derivative of marijuana that is sold everywhere from medical marijuana stores to health food markets to gas stations. While this chemical is derived from marijuana plants, it can be sold in many states as a supplement and is largely unregulated. The ubiquity of cannabidiol (CBD) and its potential benefits means that doctors need to be able to counsel patients about what we know, what we don’t, and how to use it safely. For conditions such as chronic pain and addiction, where we have few safe and effective alternatives, CBD may be reasonable to recommend.

To find out what physicians need to know about CBD, Elisabeth Poorman, MD, a general internist at a University of Washington neighborhood clinic in Kent and member of the editorial advisory board of Internal Medicine News, interviewed Peter Grinspoon, MD, who provides free consultation to primary care patients on the benefits and risks of using various forms of cannabis, including CBD. Dr. Grinspoon is an internist at Massachusetts General Hospital Chelsea Healthcare Center and is an instructor at Harvard Medical School, Boston. He has contributed to the Harvard Health Blog on the topic of medical marijuana, delivered grand rounds on cannabis at Massachusetts General Hospital, and lectured at the American College of Physicians. Dr. Grinspoon is also medical director for Galenas, a medical marijuana company.

Dr. Grinspoon is the son of Lester Grinspoon, MD, associate professor emeritus of psychiatry at Harvard Medical School, who researched the medicinal legitimacy of marijuana prohibition and has authored books on the medical benefits of marijuana.

Dr. Poorman queried Dr. Peter Grinspoon about his experiences treating patients with CBD and his knowledge of CBD’s efficacy for various medical conditions. Below are excerpts from that conversation.


Dr. Poorman: How do you explain the difference between THC and CBD to patients?

Dr. Grinspoon: Cannabis contains at least a hundred different chemicals called cannabinoids, of which tetrahydrocannabinol (THC) and CBD are the most prevalent. THC is the one that gets you high and can be used recreationally and medically. The CBD molecule is not intoxicating, and people use it for a variety of medical purposes, most commonly to treat anxiety, insomnia, and pain.

Dr. Poorman: There are a lot of gaps in what we now about CBD’s potential benefits. Why don’t we know more?

Dr. Grinspoon: CBD has no abuse liability according to the World Health Organization, but because it is a cannabinoid, it is still technically a schedule I substance under the Controlled Substances Act, and that makes it difficult to study.


Dr. Poorman: What kinds of conditions can CBD treat?

Dr. Grinspoon: In anxiety, the enthusiasm has outpaced the science; there’s no question about that. And most of the studies have done in animals. That said, some studies have shown that CBD helps treat components of anxiety, like public speaking. Unlike THC, it is nonintoxicating and non–habit forming. But we don’t have the wealth of randomized controlled trials that we have for official psychiatric medications.

CBD’s benefits have been most extensively studied in pediatric epilepsy. The one Food and Drug Administration–approved drug derived from cannabis is Epidiolex, used to treat rare forms of childhood epilepsy. There is some evidence that as an adjunct, it can be used for glioblastoma multiforme in patients receiving other appropriate therapy. There is also some preliminary evidence that it can be used for addiction, including to opioids, cannabis, tobacco, and stimulants.

Most of the evidence for using CBD in chronic pain comes from animal studies, including a study published in the European Journal of Pain in 2016. Among my patients to whom I have suggested CBD for chronic pain, a few have noticed great benefit, a few have noticed some benefit, and a lot have noticed no benefit. For those who have said they noticed benefit it is unclear whether that benefit was just the placebo effect.

In insomnia, I usually have them take CBD under the tongue half an hour time before bedtime, or if it’s an edible, an hour before bedtime. I start with a lower dose and slowly try higher doses. I also encourage them to do the other sleep hygiene things, like no screens, increasing exercise, and decreasing caffeine. It seems that CBD helps them fall asleep, though it’s hard to know if it’s the CBD or the fact that they have started taking something, and have simultaneously made various lifestyle changes.


Dr. Poorman: Can CBD interfere with your normal sleep architecture, the way benzodiazepines and Benadryl can?

Dr. Grinspoon: We know that THC affects your sleep architecture and affects what percentage of REM sleep you have. But I don’t know if the effects of CBD on sleep architecture have been studied.


Dr. Poorman: What harms do you counsel patients about when discussing CBD?

Dr. Grinspoon: There are four main harms. The first is the price. It’s overpriced, and the doses are very low. In most animal studies, the doses are about 20 milligrams per kilogram of weight. And you go to the market, and it’s like a dollar for a hundredth of that.

Number two is that it’s not regulated; it’s a supplement. A few years ago, the government tested a bunch of samples of CBD, and some didn’t actually contain CBD, some didn’t have the right amount; and worse, some contained THC that had not been disclosed in the packaging. So you can’t just go to a roadside gas station and assume that if you buy CBD, it’s actually that. You want a place that has a certificate of assurance. Make sure third-party testing was done, including testing for pesticides and other heavy metals.

The third thing is drug interactions. It affects the body like grapefruit and inhibits the cytochrome P450 system. The medications doctors should be most concerned about are blood thinners like Coumadin. And if you’re on blood thinners, you definitely want to tell your doctor that you are on CBD and he or she might want to check your blood levels more frequently than they usually do.

The fourth concern is liver inflammation. In the childhood epilepsy studies, a bump in some liver enzymes was seen, although I haven’t heard of any clinically significant cases of chemical hepatitis related to CBD. But if someone has liver disease you want to keep an eye on their liver enzymes.

Dr. Poorman: What methods of ingestion do you recommend or not recommend?

Dr. Grinspoon: It’s basically trial and error, but I usually recommend oral form. If people feel comfortable taking a gummy bear, or a pill, I’m not particular about that. If the product being taken contains less than 0.3% THC, it won’t get you high.

The topical form probably works better for treating chronic pain if it contains some THC, suggests a review article published in the Cleveland Clinic Journal of Medicine. Topical THC is nonintoxicating, unless you managed to sit in a bathtub for 8 hours after applying it.

I don’t recommend smoking CBD, and right now, I don’t recommend vaping anything.

If people have severe pain, like moderately severe arthritis, CBD may not be enough, whereas medical cannabis with THC could help, a report suggests.


Dr. Poorman: Do you ever encourage patients to stop using CBD products?

Dr. Grinspoon: I work in a low-income area, and my patients don’t have a ton of disposable income. If it’s not working, I worry about the expense.


Dr. Poorman: The CBD industry is growing quickly. What changes are you seeing in what products are out there, and what changes would you like to see?

Dr. Grinspoon: CBD is being put in everything, and it’s comical. On the one hand, you can say if people want to waste their money on a CBD emitting pillowcase, that’s fine. On the other hand, you can say that certainly seems like misleading advertising, because a CBD emitting pillowcase isn’t going to help you sleep any better.

I think the purported benefits are far beyond what we can say scientifically. We do know that CBD has anti-inflammatory characteristics. But that doesn’t mean that putting CBD in all skin products is good for your skin. It’s bad for your pocketbook, though. I would like there to be less of a gap between the claims and the science.
 

Dr. Elisabeth Poorman has no conflicts to disclose.

Cannabidiol is a derivative of marijuana that is sold everywhere from medical marijuana stores to health food markets to gas stations. While this chemical is derived from marijuana plants, it can be sold in many states as a supplement and is largely unregulated. The ubiquity of cannabidiol (CBD) and its potential benefits means that doctors need to be able to counsel patients about what we know, what we don’t, and how to use it safely. For conditions such as chronic pain and addiction, where we have few safe and effective alternatives, CBD may be reasonable to recommend.

To find out what physicians need to know about CBD, Elisabeth Poorman, MD, a general internist at a University of Washington neighborhood clinic in Kent and member of the editorial advisory board of Internal Medicine News, interviewed Peter Grinspoon, MD, who provides free consultation to primary care patients on the benefits and risks of using various forms of cannabis, including CBD. Dr. Grinspoon is an internist at Massachusetts General Hospital Chelsea Healthcare Center and is an instructor at Harvard Medical School, Boston. He has contributed to the Harvard Health Blog on the topic of medical marijuana, delivered grand rounds on cannabis at Massachusetts General Hospital, and lectured at the American College of Physicians. Dr. Grinspoon is also medical director for Galenas, a medical marijuana company.

Dr. Grinspoon is the son of Lester Grinspoon, MD, associate professor emeritus of psychiatry at Harvard Medical School, who researched the medicinal legitimacy of marijuana prohibition and has authored books on the medical benefits of marijuana.

Dr. Poorman queried Dr. Peter Grinspoon about his experiences treating patients with CBD and his knowledge of CBD’s efficacy for various medical conditions. Below are excerpts from that conversation.


Dr. Poorman: How do you explain the difference between THC and CBD to patients?

Dr. Grinspoon: Cannabis contains at least a hundred different chemicals called cannabinoids, of which tetrahydrocannabinol (THC) and CBD are the most prevalent. THC is the one that gets you high and can be used recreationally and medically. The CBD molecule is not intoxicating, and people use it for a variety of medical purposes, most commonly to treat anxiety, insomnia, and pain.

Dr. Poorman: There are a lot of gaps in what we now about CBD’s potential benefits. Why don’t we know more?

Dr. Grinspoon: CBD has no abuse liability according to the World Health Organization, but because it is a cannabinoid, it is still technically a schedule I substance under the Controlled Substances Act, and that makes it difficult to study.


Dr. Poorman: What kinds of conditions can CBD treat?

Dr. Grinspoon: In anxiety, the enthusiasm has outpaced the science; there’s no question about that. And most of the studies have done in animals. That said, some studies have shown that CBD helps treat components of anxiety, like public speaking. Unlike THC, it is nonintoxicating and non–habit forming. But we don’t have the wealth of randomized controlled trials that we have for official psychiatric medications.

CBD’s benefits have been most extensively studied in pediatric epilepsy. The one Food and Drug Administration–approved drug derived from cannabis is Epidiolex, used to treat rare forms of childhood epilepsy. There is some evidence that as an adjunct, it can be used for glioblastoma multiforme in patients receiving other appropriate therapy. There is also some preliminary evidence that it can be used for addiction, including to opioids, cannabis, tobacco, and stimulants.

Most of the evidence for using CBD in chronic pain comes from animal studies, including a study published in the European Journal of Pain in 2016. Among my patients to whom I have suggested CBD for chronic pain, a few have noticed great benefit, a few have noticed some benefit, and a lot have noticed no benefit. For those who have said they noticed benefit it is unclear whether that benefit was just the placebo effect.

In insomnia, I usually have them take CBD under the tongue half an hour time before bedtime, or if it’s an edible, an hour before bedtime. I start with a lower dose and slowly try higher doses. I also encourage them to do the other sleep hygiene things, like no screens, increasing exercise, and decreasing caffeine. It seems that CBD helps them fall asleep, though it’s hard to know if it’s the CBD or the fact that they have started taking something, and have simultaneously made various lifestyle changes.


Dr. Poorman: Can CBD interfere with your normal sleep architecture, the way benzodiazepines and Benadryl can?

Dr. Grinspoon: We know that THC affects your sleep architecture and affects what percentage of REM sleep you have. But I don’t know if the effects of CBD on sleep architecture have been studied.


Dr. Poorman: What harms do you counsel patients about when discussing CBD?

Dr. Grinspoon: There are four main harms. The first is the price. It’s overpriced, and the doses are very low. In most animal studies, the doses are about 20 milligrams per kilogram of weight. And you go to the market, and it’s like a dollar for a hundredth of that.

Number two is that it’s not regulated; it’s a supplement. A few years ago, the government tested a bunch of samples of CBD, and some didn’t actually contain CBD, some didn’t have the right amount; and worse, some contained THC that had not been disclosed in the packaging. So you can’t just go to a roadside gas station and assume that if you buy CBD, it’s actually that. You want a place that has a certificate of assurance. Make sure third-party testing was done, including testing for pesticides and other heavy metals.

The third thing is drug interactions. It affects the body like grapefruit and inhibits the cytochrome P450 system. The medications doctors should be most concerned about are blood thinners like Coumadin. And if you’re on blood thinners, you definitely want to tell your doctor that you are on CBD and he or she might want to check your blood levels more frequently than they usually do.

The fourth concern is liver inflammation. In the childhood epilepsy studies, a bump in some liver enzymes was seen, although I haven’t heard of any clinically significant cases of chemical hepatitis related to CBD. But if someone has liver disease you want to keep an eye on their liver enzymes.

Dr. Poorman: What methods of ingestion do you recommend or not recommend?

Dr. Grinspoon: It’s basically trial and error, but I usually recommend oral form. If people feel comfortable taking a gummy bear, or a pill, I’m not particular about that. If the product being taken contains less than 0.3% THC, it won’t get you high.

The topical form probably works better for treating chronic pain if it contains some THC, suggests a review article published in the Cleveland Clinic Journal of Medicine. Topical THC is nonintoxicating, unless you managed to sit in a bathtub for 8 hours after applying it.

I don’t recommend smoking CBD, and right now, I don’t recommend vaping anything.

If people have severe pain, like moderately severe arthritis, CBD may not be enough, whereas medical cannabis with THC could help, a report suggests.


Dr. Poorman: Do you ever encourage patients to stop using CBD products?

Dr. Grinspoon: I work in a low-income area, and my patients don’t have a ton of disposable income. If it’s not working, I worry about the expense.


Dr. Poorman: The CBD industry is growing quickly. What changes are you seeing in what products are out there, and what changes would you like to see?

Dr. Grinspoon: CBD is being put in everything, and it’s comical. On the one hand, you can say if people want to waste their money on a CBD emitting pillowcase, that’s fine. On the other hand, you can say that certainly seems like misleading advertising, because a CBD emitting pillowcase isn’t going to help you sleep any better.

I think the purported benefits are far beyond what we can say scientifically. We do know that CBD has anti-inflammatory characteristics. But that doesn’t mean that putting CBD in all skin products is good for your skin. It’s bad for your pocketbook, though. I would like there to be less of a gap between the claims and the science.
 

Dr. Elisabeth Poorman has no conflicts to disclose.

Breast implants sold in the United States may soon require a boxed warning in their label, along with other label changes proposed by the Food and Drug Administration aimed at better informing prospective patients and clinicians of the potential risks from breast implants.

Mitchel L. Zoler/MDedge News

Other elements of the proposed labeling changes include creation of a patient-decision checklist, new recommendations for follow-up imaging to monitor for implant rupture, inclusion of detailed and understandable information about materials in the device, and provision of a device card to each patient with details on the specific implant they received.

These labeling changes all stemmed from a breast implant hearing held by the agency’s General and Plastic Surgery Devices Panel in March 2019, according to the draft guidance document officially released by the FDA on Oct. 24.

The proposed labeling changes were generally welcomed by patient advocates and by clinicians as a reasonable response to the concerns discussed at the March hearing. In an earlier move to address issues brought up at the hearing, the FDA in July arranged for a recall for certain Allergan models of textured breast implants because of their link with the development of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).

The boxed warning proposed by the FDA would highlight four specific facts that patients, physicians, and surgeons should know about breast implants: They are not considered lifetime devices, the chance of developing complications from implants increases over time, some complications require additional surgery, and placement of breast implants has been associated with development of BIA-ALCL and may also be associated with certain systemic symptoms.

The FDA also proposed four other notable labeling changes:

• Creation of a patient-decision checklist to better systematize the informed consent process and make sure that certain aspects of breast implant placement are clearly brought to patients’ attention. The FDA proposed that patients sign their checklist attesting to having read and understood the information and that patients receive a take-home copy for their future reference. Proposed elements of the checklist include situations to not use breast implants; considerations for successful implant recipients; the risks of breast implant surgery; the importance of appropriate physician education, training, and experience; the risk for developing BIA-ALCL or systemic symptoms; and discussion of options other than breast implants.
• A new scheme for systematically and serially using imaging to screen for implant rupture that designates for the first time that ultrasound is an acceptable alternative to MRI and relies on a schedule by which either method initially screens the implant 5-6 years post operatively and then every 2 years thereafter.
• Detailed and understandable information about each material component of the implant with further information on possible adverse health effects of these compounds.
• A device card that patients should receive after their surgery with the implant’s name, serial number, and other identifiers; the boxed warning information; and a web link for accessing more up-to-date information.

The patient group Breast Implant Victim Advocacy praised the draft guidance. “The March Advisory Committee meeting seems to have prompted a shift by the FDA, surgeons, and industry,” said Jamee Cook, cofounder of the group. “We are definitely seeing a change in patient engagement. The FDA has been cooperating with patients and listening to our concerns. We still have a long way to go in raising public awareness of breast implant issues, but progress over the past 1-2 years has been amazing.”

Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, gave the draft guidance a mixed review. “The FDA’s draft includes the types of information that we had proposed to the FDA in recent months in our work with patient advocates and plastic surgeons,” she said. “However, it is not as informative as it should be in describing well-designed studies indicating a risk of systemic illnesses. Patients deserve to make better-informed decisions in the future than most women considering breast implants have been able to make” in the past.

Patricia McGuire, MD, a St. Louis plastic surgeon who specializes in breast surgery and has studied breast implant illness, declared the guidance to be “reasonable.”

“I think the changes address the concerns expressed by patients during the [March] hearing; I agree with everything the FDA proposed in the guidance document,” Dr. McGuire said. “The boxed warning is reasonable and needs to be part of the informed consent process. I also agree with the changes in screening implants postoperatively. Most patients do not get MRI examinations. High-resolution ultrasound is more convenient and cost effective.”

The boxed warning was rated as “reasonably strong” and “the most serious step the FDA can take short of taking a device off the market,” but in the case of breast implants, a wider recall of textured implants than what the FDA arranged last July would be even more appropriate, commented Sidney M. Wolfe, MD, founder and senior adviser to Public Citizen. He also faulted the agency for not taking quicker action in mandating inclusion of the proposed boxed warning.

Issuing the labeling changes as draft guidance “is a ministep forward,” but also a process that “guarantees delay” and “creeps along at a dangerously slow pace,” Dr. Wolfe said. “The FDA is delaying what should be inevitable. The agency could put the boxed warning in place right now if they had the guts to do it.”

Dr. McGuire has been a consultant to Allergan, Establishment Labs, and Hans Biomed. Ms. Cook, Dr. Zuckerman, and Dr. Wolfe reported having no commercial disclosures.

[email protected]

Breast implants sold in the United States may soon require a boxed warning in their label, along with other label changes proposed by the Food and Drug Administration aimed at better informing prospective patients and clinicians of the potential risks from breast implants.

Mitchel L. Zoler/MDedge News

Other elements of the proposed labeling changes include creation of a patient-decision checklist, new recommendations for follow-up imaging to monitor for implant rupture, inclusion of detailed and understandable information about materials in the device, and provision of a device card to each patient with details on the specific implant they received.

These labeling changes all stemmed from a breast implant hearing held by the agency’s General and Plastic Surgery Devices Panel in March 2019, according to the draft guidance document officially released by the FDA on Oct. 24.

The proposed labeling changes were generally welcomed by patient advocates and by clinicians as a reasonable response to the concerns discussed at the March hearing. In an earlier move to address issues brought up at the hearing, the FDA in July arranged for a recall for certain Allergan models of textured breast implants because of their link with the development of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).

The boxed warning proposed by the FDA would highlight four specific facts that patients, physicians, and surgeons should know about breast implants: They are not considered lifetime devices, the chance of developing complications from implants increases over time, some complications require additional surgery, and placement of breast implants has been associated with development of BIA-ALCL and may also be associated with certain systemic symptoms.

The FDA also proposed four other notable labeling changes:

• Creation of a patient-decision checklist to better systematize the informed consent process and make sure that certain aspects of breast implant placement are clearly brought to patients’ attention. The FDA proposed that patients sign their checklist attesting to having read and understood the information and that patients receive a take-home copy for their future reference. Proposed elements of the checklist include situations to not use breast implants; considerations for successful implant recipients; the risks of breast implant surgery; the importance of appropriate physician education, training, and experience; the risk for developing BIA-ALCL or systemic symptoms; and discussion of options other than breast implants.
• A new scheme for systematically and serially using imaging to screen for implant rupture that designates for the first time that ultrasound is an acceptable alternative to MRI and relies on a schedule by which either method initially screens the implant 5-6 years post operatively and then every 2 years thereafter.
• Detailed and understandable information about each material component of the implant with further information on possible adverse health effects of these compounds.
• A device card that patients should receive after their surgery with the implant’s name, serial number, and other identifiers; the boxed warning information; and a web link for accessing more up-to-date information.

The patient group Breast Implant Victim Advocacy praised the draft guidance. “The March Advisory Committee meeting seems to have prompted a shift by the FDA, surgeons, and industry,” said Jamee Cook, cofounder of the group. “We are definitely seeing a change in patient engagement. The FDA has been cooperating with patients and listening to our concerns. We still have a long way to go in raising public awareness of breast implant issues, but progress over the past 1-2 years has been amazing.”

Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, gave the draft guidance a mixed review. “The FDA’s draft includes the types of information that we had proposed to the FDA in recent months in our work with patient advocates and plastic surgeons,” she said. “However, it is not as informative as it should be in describing well-designed studies indicating a risk of systemic illnesses. Patients deserve to make better-informed decisions in the future than most women considering breast implants have been able to make” in the past.

Patricia McGuire, MD, a St. Louis plastic surgeon who specializes in breast surgery and has studied breast implant illness, declared the guidance to be “reasonable.”

“I think the changes address the concerns expressed by patients during the [March] hearing; I agree with everything the FDA proposed in the guidance document,” Dr. McGuire said. “The boxed warning is reasonable and needs to be part of the informed consent process. I also agree with the changes in screening implants postoperatively. Most patients do not get MRI examinations. High-resolution ultrasound is more convenient and cost effective.”

The boxed warning was rated as “reasonably strong” and “the most serious step the FDA can take short of taking a device off the market,” but in the case of breast implants, a wider recall of textured implants than what the FDA arranged last July would be even more appropriate, commented Sidney M. Wolfe, MD, founder and senior adviser to Public Citizen. He also faulted the agency for not taking quicker action in mandating inclusion of the proposed boxed warning.

Issuing the labeling changes as draft guidance “is a ministep forward,” but also a process that “guarantees delay” and “creeps along at a dangerously slow pace,” Dr. Wolfe said. “The FDA is delaying what should be inevitable. The agency could put the boxed warning in place right now if they had the guts to do it.”

Dr. McGuire has been a consultant to Allergan, Establishment Labs, and Hans Biomed. Ms. Cook, Dr. Zuckerman, and Dr. Wolfe reported having no commercial disclosures.

[email protected]

Breast implants sold in the United States may soon require a boxed warning in their label, along with other label changes proposed by the Food and Drug Administration aimed at better informing prospective patients and clinicians of the potential risks from breast implants.

Mitchel L. Zoler/MDedge News

Other elements of the proposed labeling changes include creation of a patient-decision checklist, new recommendations for follow-up imaging to monitor for implant rupture, inclusion of detailed and understandable information about materials in the device, and provision of a device card to each patient with details on the specific implant they received.

These labeling changes all stemmed from a breast implant hearing held by the agency’s General and Plastic Surgery Devices Panel in March 2019, according to the draft guidance document officially released by the FDA on Oct. 24.

The proposed labeling changes were generally welcomed by patient advocates and by clinicians as a reasonable response to the concerns discussed at the March hearing. In an earlier move to address issues brought up at the hearing, the FDA in July arranged for a recall for certain Allergan models of textured breast implants because of their link with the development of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).

The boxed warning proposed by the FDA would highlight four specific facts that patients, physicians, and surgeons should know about breast implants: They are not considered lifetime devices, the chance of developing complications from implants increases over time, some complications require additional surgery, and placement of breast implants has been associated with development of BIA-ALCL and may also be associated with certain systemic symptoms.

The FDA also proposed four other notable labeling changes:

• Creation of a patient-decision checklist to better systematize the informed consent process and make sure that certain aspects of breast implant placement are clearly brought to patients’ attention. The FDA proposed that patients sign their checklist attesting to having read and understood the information and that patients receive a take-home copy for their future reference. Proposed elements of the checklist include situations to not use breast implants; considerations for successful implant recipients; the risks of breast implant surgery; the importance of appropriate physician education, training, and experience; the risk for developing BIA-ALCL or systemic symptoms; and discussion of options other than breast implants.
• A new scheme for systematically and serially using imaging to screen for implant rupture that designates for the first time that ultrasound is an acceptable alternative to MRI and relies on a schedule by which either method initially screens the implant 5-6 years post operatively and then every 2 years thereafter.
• Detailed and understandable information about each material component of the implant with further information on possible adverse health effects of these compounds.
• A device card that patients should receive after their surgery with the implant’s name, serial number, and other identifiers; the boxed warning information; and a web link for accessing more up-to-date information.

The patient group Breast Implant Victim Advocacy praised the draft guidance. “The March Advisory Committee meeting seems to have prompted a shift by the FDA, surgeons, and industry,” said Jamee Cook, cofounder of the group. “We are definitely seeing a change in patient engagement. The FDA has been cooperating with patients and listening to our concerns. We still have a long way to go in raising public awareness of breast implant issues, but progress over the past 1-2 years has been amazing.”

Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, gave the draft guidance a mixed review. “The FDA’s draft includes the types of information that we had proposed to the FDA in recent months in our work with patient advocates and plastic surgeons,” she said. “However, it is not as informative as it should be in describing well-designed studies indicating a risk of systemic illnesses. Patients deserve to make better-informed decisions in the future than most women considering breast implants have been able to make” in the past.

Patricia McGuire, MD, a St. Louis plastic surgeon who specializes in breast surgery and has studied breast implant illness, declared the guidance to be “reasonable.”

“I think the changes address the concerns expressed by patients during the [March] hearing; I agree with everything the FDA proposed in the guidance document,” Dr. McGuire said. “The boxed warning is reasonable and needs to be part of the informed consent process. I also agree with the changes in screening implants postoperatively. Most patients do not get MRI examinations. High-resolution ultrasound is more convenient and cost effective.”

The boxed warning was rated as “reasonably strong” and “the most serious step the FDA can take short of taking a device off the market,” but in the case of breast implants, a wider recall of textured implants than what the FDA arranged last July would be even more appropriate, commented Sidney M. Wolfe, MD, founder and senior adviser to Public Citizen. He also faulted the agency for not taking quicker action in mandating inclusion of the proposed boxed warning.

Issuing the labeling changes as draft guidance “is a ministep forward,” but also a process that “guarantees delay” and “creeps along at a dangerously slow pace,” Dr. Wolfe said. “The FDA is delaying what should be inevitable. The agency could put the boxed warning in place right now if they had the guts to do it.”

Dr. McGuire has been a consultant to Allergan, Establishment Labs, and Hans Biomed. Ms. Cook, Dr. Zuckerman, and Dr. Wolfe reported having no commercial disclosures.

[email protected]

There is increasing evidence that exercise lowers the risk of developing cancer, improves survival after a cancer diagnosis, and helps ease related health outcomes. However, relatively few cancer patients meet current physical activity guidelines – often because it wasn’t recommended by their oncologist.

thinkstock

“Observed barriers to clinicians referring patients to exercise programming include lack of awareness of the potential value of exercise in cancer populations, uncertainty regarding the safety or suitability of exercise for a particular patient, lack of awareness regarding available programs to help facilitate exercise in cancer populations, need for education and skills development for making referrals, and a belief that referrals to exercise programming are not within the scope of practice for oncology clinicians,” Kathryn H. Schmitz, PhD, from Penn State University in Hershey and coauthors from the American College of Sports Medicine International Multidisciplinary Roundtable wrote in CA: A Cancer Journal for Clinicians.

Dr. Schmitz and colleagues proposed using the American College of Sports Medicine’s Exercise Is Medicine initiative to address this gap, with a focus on asking physicians to take an assess, revise, and refer approach to recommending exercise.

Noting that there is clear evidence that patients are more likely to exercise if their oncologist recommends that they do so, the authors said a clinician’s silence on the subject of exercise could be interpreted as “tacit approval to maintain inactivity.”

To assess a patient’s level of physical activity, the authors suggested asking patients how many days during the past week they had undertaken physical activity during which their heart beat faster or they breathed harder than normal for more than 30 minutes or how often they had undertaken activity to increase muscle strength.

If the patient can safely exercise without medical supervision, the authors recommend that clinicians advise patients to increase their physical activity to achieve current recommended levels. Clinicians can refer patients to community programs to help ramp up their activity.

However, for patients who may not be able to exercise safely on their own, the authors recommend referring them to an outpatient rehabiliation professional.

“Referral to appropriate and effective programs and follow-up with an assessment of progress (or lack thereof) at subsequent visits can serve as key transition points to change a patient’s behavior and affect their tolerance of or recovery from treatment,” they wrote.

The authors stressed that oncology clinicians were not expected to prescribe specific levels of exercise or to perform extensive screening and triage of patients based on their fitness.

“Oncology clinicians, however, play a vital role in telling the patient that it is important to exercise and pointing patients in the right direction to make that happen,” they wrote.

The American College of Sports Medicine International Multidisciplinary Roundtable was funded by the American College of Sports Medicine, the American Cancer Society, and other groups. Four authors declared grant support for participating in the study. One declared private industry funding unrelated to the study. No other conflicts of interest were declared.

[email protected]

SOURCE: Schmitz K et al. CA Cancer J Clin. 2019 Oct 16. doi: 10.3322/caac.21579.

There is increasing evidence that exercise lowers the risk of developing cancer, improves survival after a cancer diagnosis, and helps ease related health outcomes. However, relatively few cancer patients meet current physical activity guidelines – often because it wasn’t recommended by their oncologist.

thinkstock

“Observed barriers to clinicians referring patients to exercise programming include lack of awareness of the potential value of exercise in cancer populations, uncertainty regarding the safety or suitability of exercise for a particular patient, lack of awareness regarding available programs to help facilitate exercise in cancer populations, need for education and skills development for making referrals, and a belief that referrals to exercise programming are not within the scope of practice for oncology clinicians,” Kathryn H. Schmitz, PhD, from Penn State University in Hershey and coauthors from the American College of Sports Medicine International Multidisciplinary Roundtable wrote in CA: A Cancer Journal for Clinicians.

Dr. Schmitz and colleagues proposed using the American College of Sports Medicine’s Exercise Is Medicine initiative to address this gap, with a focus on asking physicians to take an assess, revise, and refer approach to recommending exercise.

Noting that there is clear evidence that patients are more likely to exercise if their oncologist recommends that they do so, the authors said a clinician’s silence on the subject of exercise could be interpreted as “tacit approval to maintain inactivity.”

To assess a patient’s level of physical activity, the authors suggested asking patients how many days during the past week they had undertaken physical activity during which their heart beat faster or they breathed harder than normal for more than 30 minutes or how often they had undertaken activity to increase muscle strength.

If the patient can safely exercise without medical supervision, the authors recommend that clinicians advise patients to increase their physical activity to achieve current recommended levels. Clinicians can refer patients to community programs to help ramp up their activity.

However, for patients who may not be able to exercise safely on their own, the authors recommend referring them to an outpatient rehabiliation professional.

“Referral to appropriate and effective programs and follow-up with an assessment of progress (or lack thereof) at subsequent visits can serve as key transition points to change a patient’s behavior and affect their tolerance of or recovery from treatment,” they wrote.

The authors stressed that oncology clinicians were not expected to prescribe specific levels of exercise or to perform extensive screening and triage of patients based on their fitness.

“Oncology clinicians, however, play a vital role in telling the patient that it is important to exercise and pointing patients in the right direction to make that happen,” they wrote.

The American College of Sports Medicine International Multidisciplinary Roundtable was funded by the American College of Sports Medicine, the American Cancer Society, and other groups. Four authors declared grant support for participating in the study. One declared private industry funding unrelated to the study. No other conflicts of interest were declared.

[email protected]

SOURCE: Schmitz K et al. CA Cancer J Clin. 2019 Oct 16. doi: 10.3322/caac.21579.

There is increasing evidence that exercise lowers the risk of developing cancer, improves survival after a cancer diagnosis, and helps ease related health outcomes. However, relatively few cancer patients meet current physical activity guidelines – often because it wasn’t recommended by their oncologist.

thinkstock

“Observed barriers to clinicians referring patients to exercise programming include lack of awareness of the potential value of exercise in cancer populations, uncertainty regarding the safety or suitability of exercise for a particular patient, lack of awareness regarding available programs to help facilitate exercise in cancer populations, need for education and skills development for making referrals, and a belief that referrals to exercise programming are not within the scope of practice for oncology clinicians,” Kathryn H. Schmitz, PhD, from Penn State University in Hershey and coauthors from the American College of Sports Medicine International Multidisciplinary Roundtable wrote in CA: A Cancer Journal for Clinicians.

Dr. Schmitz and colleagues proposed using the American College of Sports Medicine’s Exercise Is Medicine initiative to address this gap, with a focus on asking physicians to take an assess, revise, and refer approach to recommending exercise.

Noting that there is clear evidence that patients are more likely to exercise if their oncologist recommends that they do so, the authors said a clinician’s silence on the subject of exercise could be interpreted as “tacit approval to maintain inactivity.”

To assess a patient’s level of physical activity, the authors suggested asking patients how many days during the past week they had undertaken physical activity during which their heart beat faster or they breathed harder than normal for more than 30 minutes or how often they had undertaken activity to increase muscle strength.

If the patient can safely exercise without medical supervision, the authors recommend that clinicians advise patients to increase their physical activity to achieve current recommended levels. Clinicians can refer patients to community programs to help ramp up their activity.

However, for patients who may not be able to exercise safely on their own, the authors recommend referring them to an outpatient rehabiliation professional.

“Referral to appropriate and effective programs and follow-up with an assessment of progress (or lack thereof) at subsequent visits can serve as key transition points to change a patient’s behavior and affect their tolerance of or recovery from treatment,” they wrote.

The authors stressed that oncology clinicians were not expected to prescribe specific levels of exercise or to perform extensive screening and triage of patients based on their fitness.

“Oncology clinicians, however, play a vital role in telling the patient that it is important to exercise and pointing patients in the right direction to make that happen,” they wrote.

The American College of Sports Medicine International Multidisciplinary Roundtable was funded by the American College of Sports Medicine, the American Cancer Society, and other groups. Four authors declared grant support for participating in the study. One declared private industry funding unrelated to the study. No other conflicts of interest were declared.

[email protected]

SOURCE: Schmitz K et al. CA Cancer J Clin. 2019 Oct 16. doi: 10.3322/caac.21579.

Exercise intolerance was associated with worse neurocognitive function in adult survivors of pediatric acute lymphoblastic leukemia (ALL), according to results from a cross-sectional study.

kaspiic/thinkstockphotos.com

The findings suggest additional research is needed to better understand the effects of increased exercise capacity on neurocognitive performance in these patients.

“We used a clinically assessed cohort of childhood cancer survivors participating in the St. Jude Lifetime cohort study to determine whether exercise intolerance, expressed as decreased oxygen uptake, is associated with neurocognitive impairments in long-term survivors of childhood ALL and evaluated whether exercise intolerance mediates the association between chronic cardiac or pulmonary conditions and neurocognitive impairment,” wrote Nicholas S. Phillips, MD, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and colleagues. The results were published in Cancer.

The cross-sectional cohort study included 341 young adult survivors of pediatric ALL and 288 evaluable control participants. Survivors were recruited from 1980 to 2003.

Eligible participants were 18 years or older, and remained alive for a minimum of 5 years post ALL diagnosis. Control subjects were non–first-degree relatives of ALL survivors.

The researchers evaluated exercise capacity using cardiopulmonary exercise testing, expressed as relative peak volume of oxygen (rpkVO₂) max scores. Other tests included self-rated questionnaires, as well as a standardized neuropsychological evaluation.

After analysis, the researchers found that ALL survivors had lower mean rpkVO₂ scores, compared with control participants (23.45 vs. 33.03 mL/kg per min; P less than .001).

Survivors also had worse performance on several measures of neurocognitive function, including working memory, verbal intelligence, visual-motor speed, and other math and reading domains, compared with controls (all P less than .001).

The researchers also performed a multivariable analysis and found that a 1-unit metabolic equivalent increase in exercise tolerance was associated with significantly increased performance in some neurocognitive measures, including attention, verbal ability, verbal fluency, motor speed, and academics.

“Our research suggests that a minor improvement in exercise tolerance, such as going from sitting on the couch and watching TV, to walking around the block for 30 minutes a day, can have a significant impact on survivors’ intellectual health,” Dr. Phillips said in a statement.

The researchers noted that recent evidence has shown that structured exercise training may benefit younger survivors. “These studies demonstrate that a low-cost, home-based exercise training program can effectively increase cardiopulmonary fitness during and after completion of therapy,” they wrote.

The team acknowledged a key limitation of the study was the cross-sectional design. As a result, the direction of these associations remains unknown, and warrants future study.

The study was supported by the National Institutes of Health and the American Lebanese Syrian Associated Charities. The researchers did not report conflicts of interest.

SOURCE: Phillips NS et al. Cancer. 2019 Oct 21. doi: 10.1002/cncr.32510.

Exercise intolerance was associated with worse neurocognitive function in adult survivors of pediatric acute lymphoblastic leukemia (ALL), according to results from a cross-sectional study.

kaspiic/thinkstockphotos.com

The findings suggest additional research is needed to better understand the effects of increased exercise capacity on neurocognitive performance in these patients.

“We used a clinically assessed cohort of childhood cancer survivors participating in the St. Jude Lifetime cohort study to determine whether exercise intolerance, expressed as decreased oxygen uptake, is associated with neurocognitive impairments in long-term survivors of childhood ALL and evaluated whether exercise intolerance mediates the association between chronic cardiac or pulmonary conditions and neurocognitive impairment,” wrote Nicholas S. Phillips, MD, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and colleagues. The results were published in Cancer.

The cross-sectional cohort study included 341 young adult survivors of pediatric ALL and 288 evaluable control participants. Survivors were recruited from 1980 to 2003.

Eligible participants were 18 years or older, and remained alive for a minimum of 5 years post ALL diagnosis. Control subjects were non–first-degree relatives of ALL survivors.

The researchers evaluated exercise capacity using cardiopulmonary exercise testing, expressed as relative peak volume of oxygen (rpkVO₂) max scores. Other tests included self-rated questionnaires, as well as a standardized neuropsychological evaluation.

After analysis, the researchers found that ALL survivors had lower mean rpkVO₂ scores, compared with control participants (23.45 vs. 33.03 mL/kg per min; P less than .001).

Survivors also had worse performance on several measures of neurocognitive function, including working memory, verbal intelligence, visual-motor speed, and other math and reading domains, compared with controls (all P less than .001).

The researchers also performed a multivariable analysis and found that a 1-unit metabolic equivalent increase in exercise tolerance was associated with significantly increased performance in some neurocognitive measures, including attention, verbal ability, verbal fluency, motor speed, and academics.

“Our research suggests that a minor improvement in exercise tolerance, such as going from sitting on the couch and watching TV, to walking around the block for 30 minutes a day, can have a significant impact on survivors’ intellectual health,” Dr. Phillips said in a statement.

The researchers noted that recent evidence has shown that structured exercise training may benefit younger survivors. “These studies demonstrate that a low-cost, home-based exercise training program can effectively increase cardiopulmonary fitness during and after completion of therapy,” they wrote.

The team acknowledged a key limitation of the study was the cross-sectional design. As a result, the direction of these associations remains unknown, and warrants future study.

The study was supported by the National Institutes of Health and the American Lebanese Syrian Associated Charities. The researchers did not report conflicts of interest.

SOURCE: Phillips NS et al. Cancer. 2019 Oct 21. doi: 10.1002/cncr.32510.

Exercise intolerance was associated with worse neurocognitive function in adult survivors of pediatric acute lymphoblastic leukemia (ALL), according to results from a cross-sectional study.

kaspiic/thinkstockphotos.com

The findings suggest additional research is needed to better understand the effects of increased exercise capacity on neurocognitive performance in these patients.

“We used a clinically assessed cohort of childhood cancer survivors participating in the St. Jude Lifetime cohort study to determine whether exercise intolerance, expressed as decreased oxygen uptake, is associated with neurocognitive impairments in long-term survivors of childhood ALL and evaluated whether exercise intolerance mediates the association between chronic cardiac or pulmonary conditions and neurocognitive impairment,” wrote Nicholas S. Phillips, MD, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and colleagues. The results were published in Cancer.

The cross-sectional cohort study included 341 young adult survivors of pediatric ALL and 288 evaluable control participants. Survivors were recruited from 1980 to 2003.

Eligible participants were 18 years or older, and remained alive for a minimum of 5 years post ALL diagnosis. Control subjects were non–first-degree relatives of ALL survivors.

The researchers evaluated exercise capacity using cardiopulmonary exercise testing, expressed as relative peak volume of oxygen (rpkVO₂) max scores. Other tests included self-rated questionnaires, as well as a standardized neuropsychological evaluation.

After analysis, the researchers found that ALL survivors had lower mean rpkVO₂ scores, compared with control participants (23.45 vs. 33.03 mL/kg per min; P less than .001).

Survivors also had worse performance on several measures of neurocognitive function, including working memory, verbal intelligence, visual-motor speed, and other math and reading domains, compared with controls (all P less than .001).

The researchers also performed a multivariable analysis and found that a 1-unit metabolic equivalent increase in exercise tolerance was associated with significantly increased performance in some neurocognitive measures, including attention, verbal ability, verbal fluency, motor speed, and academics.

“Our research suggests that a minor improvement in exercise tolerance, such as going from sitting on the couch and watching TV, to walking around the block for 30 minutes a day, can have a significant impact on survivors’ intellectual health,” Dr. Phillips said in a statement.

The researchers noted that recent evidence has shown that structured exercise training may benefit younger survivors. “These studies demonstrate that a low-cost, home-based exercise training program can effectively increase cardiopulmonary fitness during and after completion of therapy,” they wrote.

The team acknowledged a key limitation of the study was the cross-sectional design. As a result, the direction of these associations remains unknown, and warrants future study.

The study was supported by the National Institutes of Health and the American Lebanese Syrian Associated Charities. The researchers did not report conflicts of interest.

SOURCE: Phillips NS et al. Cancer. 2019 Oct 21. doi: 10.1002/cncr.32510.

In this edition of “How I will treat my next patient,” I focus on a recent presentation at the American Society for Radiation Oncology meeting regarding the association of recent closures in women’s health clinics with cervical cancer outcomes and on a publication regarding guideline-concordant radiation exposure and organizational characteristics of lung cancer screening programs.

Cervical cancer screening and outcomes

Between 2010 and 2013, nearly 100 women’s health clinics closed in the United States because of a variety of factors, including concerns by state legislatures about reproductive services. Amar J. Srivastava, MD, and colleagues, performed a database search to determine the effect of closures on cervical cancer screening, stage, and mortality (ASTRO 2019, Abstract 202). The researchers used the Behavioral Risk Factors Surveillance Study, which provided data from 197,143 cases, to assess differences in screening availability in 2008-2009 (before the closures). They used the Surveillance, Epidemiology, and End Results (SEER) registry data from 2014-2015 (after) on 10,652 patients to compare stage at diagnosis and disease-specific mortality in states with women’s health clinic closures and states without closures.

They found that the cervical cancer screening rate in states that had a decline in the number of women’s health clinics was 1.63% lower than in states that did not lose clinics. The disparity was greater in medically underserved subgroups: Hispanic women, women aged 21-34 years, unmarried women, and uninsured women.

Early-stage diagnosis was also significantly less common in states that had a decreased number of women’s health clinics – a 13.2% drop – and the overall mortality rate from cervical cancer was 36% higher. The difference was even higher (40%) when comparing only metro residents. All of these differences between states with and without closures were statistically significant.

How these results influence clinical practice

The law of unintended consequences is that the actions of people, and especially of governments, will have effects that are unanticipated or unintended. All oncologists understand this law – we live it every day.

The data generated by Dr. Srivastava and colleagues bring to mind two presentations at the 2019 annual meeting of the American Society of Clinical Oncology: the impact of Medicaid Expansion on racial disparities in time to cancer treatment (LBA 1) and the impact of the Affordable Care Act on early-stage diagnosis and treatment for women with ovarian cancer (LBA 5563). Collectively, they remind us that health care policy changes influence the timeliness of cancer care delivery and disparities in cancer care. Of course, these analyses describe associations, not necessarily causation. Large databases have quality and completeness limitations. Nonetheless, these abstracts and the associated presentations and discussions support the concept that improved access can be associated with improved cancer care outcomes.

In 1936, American sociologist Robert K. Merton described “imperious immediacy of interest,” referring to instances in which an individual wants the intended consequence of an action so badly that he or she purposefully chooses to ignore unintended effects. As a clinical and research community, we are obliged to highlight those effects when they influence our patients’ suffering.
 

Lung cancer screening

As a component of the Centers for Medicare & Medicaid Services’ requirements for lung cancer screening payment, institutions performing screening must use low-dose techniques and participate in a dose registry. The American College of Radiology (ACR) recommends the dose levels per CT slice (CTDIvol; 3 mGy or lower) and the effective dose (ED; 1 mSr or lower) that would qualify an examination as “low dose,” thereby hoping to minimize the risk of radiation-induced cancers.

Joshua Demb, PhD, and colleagues prospectively collected lung cancer screening examination dose metrics at U.S. institutions in the University of California, San Francisco, International Dose Registry (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3893). Only U.S. institutions that performed more than 24 lung cancer screening scans from 2016-2017 were included in the survey (n = 72, more than 12,500 patients). Institution-level factors were collected via the Partnership for Dose trial, including how CT scans are performed and how CT protocols are established at the institutional level.

In a data-dense analysis, the authors found that 65% of institutions delivered, and more than half of patients received, radiation doses above ACR targets. This suggests that both the potential screening benefits and the margins of benefits over risks might be reduced for patients at those institutions. Factors associated with exceeding ACR guidelines for radiation dose were using an “external” medical physicist, although having a medical physicist of any type was more beneficial than not having one; allowing any radiologist to establish or modify the screening protocol, instead of limiting that role to “lead” radiologists; and updating CT protocols as needed, compared with updating the protocols annually.

How these results influence clinical practice

As with the ASTRO 2019 presentation, the law of unintended consequences applies here. Whenever potentially healthy people are subjected to medical procedures to prevent illness or detect disease at early stages, protecting safety is paramount. For that reason, National Comprehensive Cancer Network (NCCN) guidelines are explicit that all lung cancer screening and follow-up scans should use low-dose techniques, unless evaluating mediastinal abnormalities or adenopathy.

The study by Dr. Demb and colleagues critically examined the proportion of lung cancer screening participants receiving guideline-concordant, low-dose examinations and several factors that could influence conformance with ACR guidelines. The results are instructive despite some of the study’s limits including the fact that the database used did not enable long-term follow-up of screened individuals for lung cancer detection or mortality, the survey relied on self-reporting, and the institutional level data was not solely focused on lung cancer screening examinations.

The survey reminds us that the logistics, quality control, and periodic review of well-intentioned programs like lung cancer screening require the thoughtful, regular involvement of teams of professionals who are cognizant of, adherent to, and vigilant about the guidelines that protect the individuals who entrust their care to us.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I will treat my next patient,” I focus on a recent presentation at the American Society for Radiation Oncology meeting regarding the association of recent closures in women’s health clinics with cervical cancer outcomes and on a publication regarding guideline-concordant radiation exposure and organizational characteristics of lung cancer screening programs.

Cervical cancer screening and outcomes

Between 2010 and 2013, nearly 100 women’s health clinics closed in the United States because of a variety of factors, including concerns by state legislatures about reproductive services. Amar J. Srivastava, MD, and colleagues, performed a database search to determine the effect of closures on cervical cancer screening, stage, and mortality (ASTRO 2019, Abstract 202). The researchers used the Behavioral Risk Factors Surveillance Study, which provided data from 197,143 cases, to assess differences in screening availability in 2008-2009 (before the closures). They used the Surveillance, Epidemiology, and End Results (SEER) registry data from 2014-2015 (after) on 10,652 patients to compare stage at diagnosis and disease-specific mortality in states with women’s health clinic closures and states without closures.

They found that the cervical cancer screening rate in states that had a decline in the number of women’s health clinics was 1.63% lower than in states that did not lose clinics. The disparity was greater in medically underserved subgroups: Hispanic women, women aged 21-34 years, unmarried women, and uninsured women.

Early-stage diagnosis was also significantly less common in states that had a decreased number of women’s health clinics – a 13.2% drop – and the overall mortality rate from cervical cancer was 36% higher. The difference was even higher (40%) when comparing only metro residents. All of these differences between states with and without closures were statistically significant.

How these results influence clinical practice

The law of unintended consequences is that the actions of people, and especially of governments, will have effects that are unanticipated or unintended. All oncologists understand this law – we live it every day.

The data generated by Dr. Srivastava and colleagues bring to mind two presentations at the 2019 annual meeting of the American Society of Clinical Oncology: the impact of Medicaid Expansion on racial disparities in time to cancer treatment (LBA 1) and the impact of the Affordable Care Act on early-stage diagnosis and treatment for women with ovarian cancer (LBA 5563). Collectively, they remind us that health care policy changes influence the timeliness of cancer care delivery and disparities in cancer care. Of course, these analyses describe associations, not necessarily causation. Large databases have quality and completeness limitations. Nonetheless, these abstracts and the associated presentations and discussions support the concept that improved access can be associated with improved cancer care outcomes.

In 1936, American sociologist Robert K. Merton described “imperious immediacy of interest,” referring to instances in which an individual wants the intended consequence of an action so badly that he or she purposefully chooses to ignore unintended effects. As a clinical and research community, we are obliged to highlight those effects when they influence our patients’ suffering.
 

Lung cancer screening

As a component of the Centers for Medicare & Medicaid Services’ requirements for lung cancer screening payment, institutions performing screening must use low-dose techniques and participate in a dose registry. The American College of Radiology (ACR) recommends the dose levels per CT slice (CTDIvol; 3 mGy or lower) and the effective dose (ED; 1 mSr or lower) that would qualify an examination as “low dose,” thereby hoping to minimize the risk of radiation-induced cancers.

Joshua Demb, PhD, and colleagues prospectively collected lung cancer screening examination dose metrics at U.S. institutions in the University of California, San Francisco, International Dose Registry (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3893). Only U.S. institutions that performed more than 24 lung cancer screening scans from 2016-2017 were included in the survey (n = 72, more than 12,500 patients). Institution-level factors were collected via the Partnership for Dose trial, including how CT scans are performed and how CT protocols are established at the institutional level.

In a data-dense analysis, the authors found that 65% of institutions delivered, and more than half of patients received, radiation doses above ACR targets. This suggests that both the potential screening benefits and the margins of benefits over risks might be reduced for patients at those institutions. Factors associated with exceeding ACR guidelines for radiation dose were using an “external” medical physicist, although having a medical physicist of any type was more beneficial than not having one; allowing any radiologist to establish or modify the screening protocol, instead of limiting that role to “lead” radiologists; and updating CT protocols as needed, compared with updating the protocols annually.

How these results influence clinical practice

As with the ASTRO 2019 presentation, the law of unintended consequences applies here. Whenever potentially healthy people are subjected to medical procedures to prevent illness or detect disease at early stages, protecting safety is paramount. For that reason, National Comprehensive Cancer Network (NCCN) guidelines are explicit that all lung cancer screening and follow-up scans should use low-dose techniques, unless evaluating mediastinal abnormalities or adenopathy.

The study by Dr. Demb and colleagues critically examined the proportion of lung cancer screening participants receiving guideline-concordant, low-dose examinations and several factors that could influence conformance with ACR guidelines. The results are instructive despite some of the study’s limits including the fact that the database used did not enable long-term follow-up of screened individuals for lung cancer detection or mortality, the survey relied on self-reporting, and the institutional level data was not solely focused on lung cancer screening examinations.

The survey reminds us that the logistics, quality control, and periodic review of well-intentioned programs like lung cancer screening require the thoughtful, regular involvement of teams of professionals who are cognizant of, adherent to, and vigilant about the guidelines that protect the individuals who entrust their care to us.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I will treat my next patient,” I focus on a recent presentation at the American Society for Radiation Oncology meeting regarding the association of recent closures in women’s health clinics with cervical cancer outcomes and on a publication regarding guideline-concordant radiation exposure and organizational characteristics of lung cancer screening programs.

Cervical cancer screening and outcomes

Between 2010 and 2013, nearly 100 women’s health clinics closed in the United States because of a variety of factors, including concerns by state legislatures about reproductive services. Amar J. Srivastava, MD, and colleagues, performed a database search to determine the effect of closures on cervical cancer screening, stage, and mortality (ASTRO 2019, Abstract 202). The researchers used the Behavioral Risk Factors Surveillance Study, which provided data from 197,143 cases, to assess differences in screening availability in 2008-2009 (before the closures). They used the Surveillance, Epidemiology, and End Results (SEER) registry data from 2014-2015 (after) on 10,652 patients to compare stage at diagnosis and disease-specific mortality in states with women’s health clinic closures and states without closures.

They found that the cervical cancer screening rate in states that had a decline in the number of women’s health clinics was 1.63% lower than in states that did not lose clinics. The disparity was greater in medically underserved subgroups: Hispanic women, women aged 21-34 years, unmarried women, and uninsured women.

Early-stage diagnosis was also significantly less common in states that had a decreased number of women’s health clinics – a 13.2% drop – and the overall mortality rate from cervical cancer was 36% higher. The difference was even higher (40%) when comparing only metro residents. All of these differences between states with and without closures were statistically significant.

How these results influence clinical practice

The law of unintended consequences is that the actions of people, and especially of governments, will have effects that are unanticipated or unintended. All oncologists understand this law – we live it every day.

The data generated by Dr. Srivastava and colleagues bring to mind two presentations at the 2019 annual meeting of the American Society of Clinical Oncology: the impact of Medicaid Expansion on racial disparities in time to cancer treatment (LBA 1) and the impact of the Affordable Care Act on early-stage diagnosis and treatment for women with ovarian cancer (LBA 5563). Collectively, they remind us that health care policy changes influence the timeliness of cancer care delivery and disparities in cancer care. Of course, these analyses describe associations, not necessarily causation. Large databases have quality and completeness limitations. Nonetheless, these abstracts and the associated presentations and discussions support the concept that improved access can be associated with improved cancer care outcomes.

In 1936, American sociologist Robert K. Merton described “imperious immediacy of interest,” referring to instances in which an individual wants the intended consequence of an action so badly that he or she purposefully chooses to ignore unintended effects. As a clinical and research community, we are obliged to highlight those effects when they influence our patients’ suffering.
 

Lung cancer screening

As a component of the Centers for Medicare & Medicaid Services’ requirements for lung cancer screening payment, institutions performing screening must use low-dose techniques and participate in a dose registry. The American College of Radiology (ACR) recommends the dose levels per CT slice (CTDIvol; 3 mGy or lower) and the effective dose (ED; 1 mSr or lower) that would qualify an examination as “low dose,” thereby hoping to minimize the risk of radiation-induced cancers.

Joshua Demb, PhD, and colleagues prospectively collected lung cancer screening examination dose metrics at U.S. institutions in the University of California, San Francisco, International Dose Registry (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3893). Only U.S. institutions that performed more than 24 lung cancer screening scans from 2016-2017 were included in the survey (n = 72, more than 12,500 patients). Institution-level factors were collected via the Partnership for Dose trial, including how CT scans are performed and how CT protocols are established at the institutional level.

In a data-dense analysis, the authors found that 65% of institutions delivered, and more than half of patients received, radiation doses above ACR targets. This suggests that both the potential screening benefits and the margins of benefits over risks might be reduced for patients at those institutions. Factors associated with exceeding ACR guidelines for radiation dose were using an “external” medical physicist, although having a medical physicist of any type was more beneficial than not having one; allowing any radiologist to establish or modify the screening protocol, instead of limiting that role to “lead” radiologists; and updating CT protocols as needed, compared with updating the protocols annually.

How these results influence clinical practice

As with the ASTRO 2019 presentation, the law of unintended consequences applies here. Whenever potentially healthy people are subjected to medical procedures to prevent illness or detect disease at early stages, protecting safety is paramount. For that reason, National Comprehensive Cancer Network (NCCN) guidelines are explicit that all lung cancer screening and follow-up scans should use low-dose techniques, unless evaluating mediastinal abnormalities or adenopathy.

The study by Dr. Demb and colleagues critically examined the proportion of lung cancer screening participants receiving guideline-concordant, low-dose examinations and several factors that could influence conformance with ACR guidelines. The results are instructive despite some of the study’s limits including the fact that the database used did not enable long-term follow-up of screened individuals for lung cancer detection or mortality, the survey relied on self-reporting, and the institutional level data was not solely focused on lung cancer screening examinations.

The survey reminds us that the logistics, quality control, and periodic review of well-intentioned programs like lung cancer screening require the thoughtful, regular involvement of teams of professionals who are cognizant of, adherent to, and vigilant about the guidelines that protect the individuals who entrust their care to us.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

It’s 6:30 on a Friday night, and I am triaging three admissions to the leukemia service at once. The call from the ED about you makes me pause. I recognize your name – you were my patient a few years before. At the time, you were undergoing chemotherapy for acute myeloid leukemia, and I cared for you during the aftermath. I now pull up your chart and fill in the gaps of the last 2 years. You got into remission and received a bone marrow transplant. For 2 years, you were cured. But today, you are back. The ED has picked up an abundance of blasts – cancer cells – in your blood. I walk to your ED gurney slowly, thinking of how to tell you this. You recognize me, too. And I can see in your eyes that you already know. “I am so sorry this is happening,” I say.

You are here for your third cycle of chemotherapy. It’s a standard check-in. The first cycle was tolerable, the second cycle was rough, and now you are exhausted. You wonder if it’s normal to be so beat up from this. You ask how much nausea is too much nausea. But your hair didn’t fall out – isn’t that strange? Is it a sure thing that it will? And, by the way, is there anything to prevent the neuropathy? You wiggle your fingers as if to emphasize the point. We go through each of your symptoms and strategize ways to make this cycle better than the last. “OK,” you conclude triumphantly. “I got this!”

It’s your 1-month follow-up and it’s time to pivot. After you were diagnosed with an aggressive triple-negative breast cancer, you met with a medical oncologist and a surgeon. Chemotherapy first, they agreed. The chemo would shrink the tumor, they said, so that it could all be scooped out with surgery. The medications were rough, but you knew it was for the best. But now it’s been two cycles and the lump in your breast is getting bigger not smaller. I ask if I may draw on your skin, promising I’ll wash it off. I gently trace the mass in pen and pull out a tape measure. Yes. It is bigger. I listen to your heart and hear it racing. “What now?” you ask.

When you saw your doctor for bloating and were told it’s not gas, actually, but stage 4 cancer, you didn’t cry. You didn’t deny it. You prepared. You called your lawyer and made a will. You contacted your job and planned for retirement. You organized your things so your children wouldn’t have to. Your oncologist recommended palliative chemotherapy as it could give you some more good days. The best case scenario would be 1 year. That was 2½ years ago. You still like to be prepared, you tell me, but that’s on the back burner now. You are busy, after all – your feet still ache from dancing all night in heels at your niece’s wedding last weekend. I pull up your latest PET scan and we look together: Again, wonderfully, everything appears stable. “See you in 3 months,” I say.

You called three times to move up this appointment because you didn’t know if you’d be alive this long. You want a second opinion. When your kidney cancer grew after surgery, two immunotherapy drugs, and a chemotherapy pill, the latest setback has been fevers up to 104 ° with drenching night sweats. They found a deep infection gnawing around the edges of your tumor, and antibiotics aren’t touching it. The only chance to stop the cancer is more chemotherapy, but that could make the infection worse and lead to a rapid demise. You can’t decide. Today, in the exam room, you are sweating. Your temperature is 101 °. Your partner is trying to keep it together, but the crumpled tissues in her hand give it away. She looks at me earnestly: “What would you do if this were your family member?”

You teach about this disease in your classes and never thought it would happen to you. It started simply enough – you were bruising. Your joints ached. Small things; odd things. The ER doctor cleverly noticed that some numbers were off in your blood counts and sent you to a hematology-oncology doctor, who then cleverly ordered a molecular blood test. It was a long shot. He didn’t really expect it to come back with chronic myeloid leukemia. But there it is, and here we are. You return to talk about treatment options. You understand in detail the biology of how they work. What you don’t know is which is best for you. I go through the four choices and unpleasant effects of each. Muscle aches; diarrhea; risk of bleeding; twice a day dosing tied to mealtimes. “Is there an Option 5?” you wonder.

You have been in the hospital for 34 days, but who’s counting? You are. Because it has been Thirty. Four. Days. You knew the chemotherapy would suppress your blood counts. Now you know what “impaired immune system” really means. You had the bloodstream bacterial infection, requiring 2 days in the ICU. You had the invasive fungus growing in your lungs. The nurses post a calendar on your wall and kindly fill it in every day with your white blood cell count so you don’t have to ask. For days, it’s the same. Your bag stays packed – “just in case,” you explain. Your spouse diligently keeps your children – 2 and 4 years old – away, as kids are notorious germ factories. Then one Sunday morning and – finally! “Put me on speakerphone,” you tell your spouse. “Daddy is coming home!”

One of the most precious parts of hematology and oncology is the relationships. You are there not just for one difficult moment, but for the journey. I await getting to help you over the years to come. For now, I will settle for snapshots.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

It’s 6:30 on a Friday night, and I am triaging three admissions to the leukemia service at once. The call from the ED about you makes me pause. I recognize your name – you were my patient a few years before. At the time, you were undergoing chemotherapy for acute myeloid leukemia, and I cared for you during the aftermath. I now pull up your chart and fill in the gaps of the last 2 years. You got into remission and received a bone marrow transplant. For 2 years, you were cured. But today, you are back. The ED has picked up an abundance of blasts – cancer cells – in your blood. I walk to your ED gurney slowly, thinking of how to tell you this. You recognize me, too. And I can see in your eyes that you already know. “I am so sorry this is happening,” I say.

You are here for your third cycle of chemotherapy. It’s a standard check-in. The first cycle was tolerable, the second cycle was rough, and now you are exhausted. You wonder if it’s normal to be so beat up from this. You ask how much nausea is too much nausea. But your hair didn’t fall out – isn’t that strange? Is it a sure thing that it will? And, by the way, is there anything to prevent the neuropathy? You wiggle your fingers as if to emphasize the point. We go through each of your symptoms and strategize ways to make this cycle better than the last. “OK,” you conclude triumphantly. “I got this!”

It’s your 1-month follow-up and it’s time to pivot. After you were diagnosed with an aggressive triple-negative breast cancer, you met with a medical oncologist and a surgeon. Chemotherapy first, they agreed. The chemo would shrink the tumor, they said, so that it could all be scooped out with surgery. The medications were rough, but you knew it was for the best. But now it’s been two cycles and the lump in your breast is getting bigger not smaller. I ask if I may draw on your skin, promising I’ll wash it off. I gently trace the mass in pen and pull out a tape measure. Yes. It is bigger. I listen to your heart and hear it racing. “What now?” you ask.

When you saw your doctor for bloating and were told it’s not gas, actually, but stage 4 cancer, you didn’t cry. You didn’t deny it. You prepared. You called your lawyer and made a will. You contacted your job and planned for retirement. You organized your things so your children wouldn’t have to. Your oncologist recommended palliative chemotherapy as it could give you some more good days. The best case scenario would be 1 year. That was 2½ years ago. You still like to be prepared, you tell me, but that’s on the back burner now. You are busy, after all – your feet still ache from dancing all night in heels at your niece’s wedding last weekend. I pull up your latest PET scan and we look together: Again, wonderfully, everything appears stable. “See you in 3 months,” I say.

You called three times to move up this appointment because you didn’t know if you’d be alive this long. You want a second opinion. When your kidney cancer grew after surgery, two immunotherapy drugs, and a chemotherapy pill, the latest setback has been fevers up to 104 ° with drenching night sweats. They found a deep infection gnawing around the edges of your tumor, and antibiotics aren’t touching it. The only chance to stop the cancer is more chemotherapy, but that could make the infection worse and lead to a rapid demise. You can’t decide. Today, in the exam room, you are sweating. Your temperature is 101 °. Your partner is trying to keep it together, but the crumpled tissues in her hand give it away. She looks at me earnestly: “What would you do if this were your family member?”

You teach about this disease in your classes and never thought it would happen to you. It started simply enough – you were bruising. Your joints ached. Small things; odd things. The ER doctor cleverly noticed that some numbers were off in your blood counts and sent you to a hematology-oncology doctor, who then cleverly ordered a molecular blood test. It was a long shot. He didn’t really expect it to come back with chronic myeloid leukemia. But there it is, and here we are. You return to talk about treatment options. You understand in detail the biology of how they work. What you don’t know is which is best for you. I go through the four choices and unpleasant effects of each. Muscle aches; diarrhea; risk of bleeding; twice a day dosing tied to mealtimes. “Is there an Option 5?” you wonder.

You have been in the hospital for 34 days, but who’s counting? You are. Because it has been Thirty. Four. Days. You knew the chemotherapy would suppress your blood counts. Now you know what “impaired immune system” really means. You had the bloodstream bacterial infection, requiring 2 days in the ICU. You had the invasive fungus growing in your lungs. The nurses post a calendar on your wall and kindly fill it in every day with your white blood cell count so you don’t have to ask. For days, it’s the same. Your bag stays packed – “just in case,” you explain. Your spouse diligently keeps your children – 2 and 4 years old – away, as kids are notorious germ factories. Then one Sunday morning and – finally! “Put me on speakerphone,” you tell your spouse. “Daddy is coming home!”

One of the most precious parts of hematology and oncology is the relationships. You are there not just for one difficult moment, but for the journey. I await getting to help you over the years to come. For now, I will settle for snapshots.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

It’s 6:30 on a Friday night, and I am triaging three admissions to the leukemia service at once. The call from the ED about you makes me pause. I recognize your name – you were my patient a few years before. At the time, you were undergoing chemotherapy for acute myeloid leukemia, and I cared for you during the aftermath. I now pull up your chart and fill in the gaps of the last 2 years. You got into remission and received a bone marrow transplant. For 2 years, you were cured. But today, you are back. The ED has picked up an abundance of blasts – cancer cells – in your blood. I walk to your ED gurney slowly, thinking of how to tell you this. You recognize me, too. And I can see in your eyes that you already know. “I am so sorry this is happening,” I say.

You are here for your third cycle of chemotherapy. It’s a standard check-in. The first cycle was tolerable, the second cycle was rough, and now you are exhausted. You wonder if it’s normal to be so beat up from this. You ask how much nausea is too much nausea. But your hair didn’t fall out – isn’t that strange? Is it a sure thing that it will? And, by the way, is there anything to prevent the neuropathy? You wiggle your fingers as if to emphasize the point. We go through each of your symptoms and strategize ways to make this cycle better than the last. “OK,” you conclude triumphantly. “I got this!”

It’s your 1-month follow-up and it’s time to pivot. After you were diagnosed with an aggressive triple-negative breast cancer, you met with a medical oncologist and a surgeon. Chemotherapy first, they agreed. The chemo would shrink the tumor, they said, so that it could all be scooped out with surgery. The medications were rough, but you knew it was for the best. But now it’s been two cycles and the lump in your breast is getting bigger not smaller. I ask if I may draw on your skin, promising I’ll wash it off. I gently trace the mass in pen and pull out a tape measure. Yes. It is bigger. I listen to your heart and hear it racing. “What now?” you ask.

When you saw your doctor for bloating and were told it’s not gas, actually, but stage 4 cancer, you didn’t cry. You didn’t deny it. You prepared. You called your lawyer and made a will. You contacted your job and planned for retirement. You organized your things so your children wouldn’t have to. Your oncologist recommended palliative chemotherapy as it could give you some more good days. The best case scenario would be 1 year. That was 2½ years ago. You still like to be prepared, you tell me, but that’s on the back burner now. You are busy, after all – your feet still ache from dancing all night in heels at your niece’s wedding last weekend. I pull up your latest PET scan and we look together: Again, wonderfully, everything appears stable. “See you in 3 months,” I say.

You called three times to move up this appointment because you didn’t know if you’d be alive this long. You want a second opinion. When your kidney cancer grew after surgery, two immunotherapy drugs, and a chemotherapy pill, the latest setback has been fevers up to 104 ° with drenching night sweats. They found a deep infection gnawing around the edges of your tumor, and antibiotics aren’t touching it. The only chance to stop the cancer is more chemotherapy, but that could make the infection worse and lead to a rapid demise. You can’t decide. Today, in the exam room, you are sweating. Your temperature is 101 °. Your partner is trying to keep it together, but the crumpled tissues in her hand give it away. She looks at me earnestly: “What would you do if this were your family member?”

You teach about this disease in your classes and never thought it would happen to you. It started simply enough – you were bruising. Your joints ached. Small things; odd things. The ER doctor cleverly noticed that some numbers were off in your blood counts and sent you to a hematology-oncology doctor, who then cleverly ordered a molecular blood test. It was a long shot. He didn’t really expect it to come back with chronic myeloid leukemia. But there it is, and here we are. You return to talk about treatment options. You understand in detail the biology of how they work. What you don’t know is which is best for you. I go through the four choices and unpleasant effects of each. Muscle aches; diarrhea; risk of bleeding; twice a day dosing tied to mealtimes. “Is there an Option 5?” you wonder.

You have been in the hospital for 34 days, but who’s counting? You are. Because it has been Thirty. Four. Days. You knew the chemotherapy would suppress your blood counts. Now you know what “impaired immune system” really means. You had the bloodstream bacterial infection, requiring 2 days in the ICU. You had the invasive fungus growing in your lungs. The nurses post a calendar on your wall and kindly fill it in every day with your white blood cell count so you don’t have to ask. For days, it’s the same. Your bag stays packed – “just in case,” you explain. Your spouse diligently keeps your children – 2 and 4 years old – away, as kids are notorious germ factories. Then one Sunday morning and – finally! “Put me on speakerphone,” you tell your spouse. “Daddy is coming home!”

One of the most precious parts of hematology and oncology is the relationships. You are there not just for one difficult moment, but for the journey. I await getting to help you over the years to come. For now, I will settle for snapshots.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

WASHINGTON – The federal official who helps oversee Medicare’s use of quality measures predicted a continued emphasis on patient-reported outcomes in the assessments of physician performance.

Reena Duseja, MD, chief medical officer for quality measurement at the Centers for Medicare & Medicaid Services, said she has seen “more emphasis” in her 2 years with the agency in collecting outcome measures, including ones reported by patients. In doing this, CMS officials are also looking to identify the core elements that willl be part of patient-reported outcomes (PROs).

“We really have to get better at standardization,” Dr. Duseja said during a policy summit sponsored by the National Comprehensive Cancer Network (NCCN). “There is room for improvement there. We’re continuing to think of ways that we can support that.”

She also said the CMS is working, in general, to try to give physicians feedback sooner on how they are faring on measurements.

“The commitment of our agency is trying to think about how we collect data in a way that shortens the cycle of measure development” and speeds the delivery of this data back to providers, Dr. Duseja said.

Her fellow panelists discussed the difficulties in designing PRO measures, including the need to account for special challenges for patients living in or near poverty. Avoiding emergency department visits and hospitalizations, for example, may be a key priority for people who are paid hourly wages, said Kashyap Patel, MD, managing partner of Carolina Blood and Cancer Care in Rock Hill, S.C. These patients will not only face the inconvenience and cost of a hospital stay, but will also lose wages from missed work. He urged policymakers to take these factors into consideration in designing quality measures, and not to forget that “there is a human being behind this.”

Ronald S. Walters, MD, associate head of the Institute for Cancer Care Innovation at the University of Texas MD Anderson Cancer Center, and chair of NCCN’s board of directors, cautioned against continued attempts to devise a “Nirvana” list of outcome measures that can be universally applied. Instead, payers may be better off with a “mix and match” approach. Certain measures may be used across the board, such as pain and quality of life metrics, while other measures could be more tailored.

Dr. Walters also called out a missed opportunity to tie PROs to Medicare payment in the area of chimeric antigen receptor (CAR) T-cell therapy.

In 2018, the CMS indicated it was considering the use of PROs in connection with CAR T-cell payment. The CMS asked its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to consider the role of PROs in connection with payment for CAR T-cell therapy. At an August 2018 meeting, MEDCAC panelists generally expressed confidence in PROs in a series of votes about the use of this approach to quality measurement in cancer trials.

But drugmakers and physician groups raised strong objections at the MEDCAC meeting. In its national coverage decision on CAR T, issued in August 2019, the CMS said it had received many comments on PROs “ranging from support of their collection to recommendations for additional assessment tools to request to remove PRO requirements.” The CMS opted at this time to encourage participation in the Center for International Blood and Marrow Transplantation Research (CIBMTR) database “that currently collects health outcomes (and aims to collect patient reported outcomes in the future) on patients who have received CAR T-cell treatments.”

For Dr. Walters, this setback for the use of PROs in CAR T therapy payment is telling, as the treatment is known to produce serious side effects and is administered in well-controlled circumstances.

“If you can’t organize collecting patient-reported outcomes after CAR T cell, that kind of tells you the state of where we are on collecting them on everybody,” Dr. Walters said.

WASHINGTON – The federal official who helps oversee Medicare’s use of quality measures predicted a continued emphasis on patient-reported outcomes in the assessments of physician performance.

Reena Duseja, MD, chief medical officer for quality measurement at the Centers for Medicare & Medicaid Services, said she has seen “more emphasis” in her 2 years with the agency in collecting outcome measures, including ones reported by patients. In doing this, CMS officials are also looking to identify the core elements that willl be part of patient-reported outcomes (PROs).

“We really have to get better at standardization,” Dr. Duseja said during a policy summit sponsored by the National Comprehensive Cancer Network (NCCN). “There is room for improvement there. We’re continuing to think of ways that we can support that.”

She also said the CMS is working, in general, to try to give physicians feedback sooner on how they are faring on measurements.

“The commitment of our agency is trying to think about how we collect data in a way that shortens the cycle of measure development” and speeds the delivery of this data back to providers, Dr. Duseja said.

Her fellow panelists discussed the difficulties in designing PRO measures, including the need to account for special challenges for patients living in or near poverty. Avoiding emergency department visits and hospitalizations, for example, may be a key priority for people who are paid hourly wages, said Kashyap Patel, MD, managing partner of Carolina Blood and Cancer Care in Rock Hill, S.C. These patients will not only face the inconvenience and cost of a hospital stay, but will also lose wages from missed work. He urged policymakers to take these factors into consideration in designing quality measures, and not to forget that “there is a human being behind this.”

Ronald S. Walters, MD, associate head of the Institute for Cancer Care Innovation at the University of Texas MD Anderson Cancer Center, and chair of NCCN’s board of directors, cautioned against continued attempts to devise a “Nirvana” list of outcome measures that can be universally applied. Instead, payers may be better off with a “mix and match” approach. Certain measures may be used across the board, such as pain and quality of life metrics, while other measures could be more tailored.

Dr. Walters also called out a missed opportunity to tie PROs to Medicare payment in the area of chimeric antigen receptor (CAR) T-cell therapy.

In 2018, the CMS indicated it was considering the use of PROs in connection with CAR T-cell payment. The CMS asked its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to consider the role of PROs in connection with payment for CAR T-cell therapy. At an August 2018 meeting, MEDCAC panelists generally expressed confidence in PROs in a series of votes about the use of this approach to quality measurement in cancer trials.

But drugmakers and physician groups raised strong objections at the MEDCAC meeting. In its national coverage decision on CAR T, issued in August 2019, the CMS said it had received many comments on PROs “ranging from support of their collection to recommendations for additional assessment tools to request to remove PRO requirements.” The CMS opted at this time to encourage participation in the Center for International Blood and Marrow Transplantation Research (CIBMTR) database “that currently collects health outcomes (and aims to collect patient reported outcomes in the future) on patients who have received CAR T-cell treatments.”

For Dr. Walters, this setback for the use of PROs in CAR T therapy payment is telling, as the treatment is known to produce serious side effects and is administered in well-controlled circumstances.

“If you can’t organize collecting patient-reported outcomes after CAR T cell, that kind of tells you the state of where we are on collecting them on everybody,” Dr. Walters said.

WASHINGTON – The federal official who helps oversee Medicare’s use of quality measures predicted a continued emphasis on patient-reported outcomes in the assessments of physician performance.

Reena Duseja, MD, chief medical officer for quality measurement at the Centers for Medicare & Medicaid Services, said she has seen “more emphasis” in her 2 years with the agency in collecting outcome measures, including ones reported by patients. In doing this, CMS officials are also looking to identify the core elements that willl be part of patient-reported outcomes (PROs).

“We really have to get better at standardization,” Dr. Duseja said during a policy summit sponsored by the National Comprehensive Cancer Network (NCCN). “There is room for improvement there. We’re continuing to think of ways that we can support that.”

She also said the CMS is working, in general, to try to give physicians feedback sooner on how they are faring on measurements.

“The commitment of our agency is trying to think about how we collect data in a way that shortens the cycle of measure development” and speeds the delivery of this data back to providers, Dr. Duseja said.

Her fellow panelists discussed the difficulties in designing PRO measures, including the need to account for special challenges for patients living in or near poverty. Avoiding emergency department visits and hospitalizations, for example, may be a key priority for people who are paid hourly wages, said Kashyap Patel, MD, managing partner of Carolina Blood and Cancer Care in Rock Hill, S.C. These patients will not only face the inconvenience and cost of a hospital stay, but will also lose wages from missed work. He urged policymakers to take these factors into consideration in designing quality measures, and not to forget that “there is a human being behind this.”

Ronald S. Walters, MD, associate head of the Institute for Cancer Care Innovation at the University of Texas MD Anderson Cancer Center, and chair of NCCN’s board of directors, cautioned against continued attempts to devise a “Nirvana” list of outcome measures that can be universally applied. Instead, payers may be better off with a “mix and match” approach. Certain measures may be used across the board, such as pain and quality of life metrics, while other measures could be more tailored.

Dr. Walters also called out a missed opportunity to tie PROs to Medicare payment in the area of chimeric antigen receptor (CAR) T-cell therapy.

In 2018, the CMS indicated it was considering the use of PROs in connection with CAR T-cell payment. The CMS asked its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to consider the role of PROs in connection with payment for CAR T-cell therapy. At an August 2018 meeting, MEDCAC panelists generally expressed confidence in PROs in a series of votes about the use of this approach to quality measurement in cancer trials.

But drugmakers and physician groups raised strong objections at the MEDCAC meeting. In its national coverage decision on CAR T, issued in August 2019, the CMS said it had received many comments on PROs “ranging from support of their collection to recommendations for additional assessment tools to request to remove PRO requirements.” The CMS opted at this time to encourage participation in the Center for International Blood and Marrow Transplantation Research (CIBMTR) database “that currently collects health outcomes (and aims to collect patient reported outcomes in the future) on patients who have received CAR T-cell treatments.”

For Dr. Walters, this setback for the use of PROs in CAR T therapy payment is telling, as the treatment is known to produce serious side effects and is administered in well-controlled circumstances.

“If you can’t organize collecting patient-reported outcomes after CAR T cell, that kind of tells you the state of where we are on collecting them on everybody,” Dr. Walters said.

Women with early-stage breast cancer are at elevated risk for atrial fibrillation (AF) short term and, to a lesser extent, long term, finds a large Canadian cohort study. Risk was higher for those who had received chemotherapy but not tied to specific cardiotoxic drugs or drug classes.

“Cardiovascular disease is a particularly pertinent clinical concern for women diagnosed with early-stage breast cancer,” note the investigators, led by Husam Abdel-Qadir, MD, PhD, FRCPC, Cardiology Clinic, Women’s College Hospital, Toronto. “Many early-stage breast cancer survivors are older than 65 years and have hypertension, diabetes, or left ventricular dysfunction. Accordingly, a diagnosis of AF would translate to a clinically relevant stroke risk for many early-stage breast cancer survivors.”

The investigators undertook a population-based retrospective cohort study of women in the province of Ontario with stage I-III breast cancer diagnosed between April 2007 and December 2016, matching them 1:3 to cancer-free control women on birth year and receipt of breast imaging.

An initial analysis, based on 95,539 breast cancer patients and 217,456 cancer-free controls, showed that the former and latter groups did not differ significantly on the prevalence of preexisting AF (5.3% vs. 5.2%; P = .21), according to results reported in JAMA Network Open.

Main analyses excluded women with preexisting AF, leaving 68,113 breast cancer patients and 204,330 cancer-free controls having a mean follow-up of 5.7 years. Both groups had a mean age of 60 years at baseline, and prevalences of cardiovascular comorbidities were similar. Within the breast cancer group, 50.4% had left-sided disease; overall, 53.2% received chemotherapy and 71.7% received radiation therapy.

At 10 years after diagnosis, breast cancer patients had a small but significant increase in AF incidence relative to control peers (7.4% vs. 6.8%; P less than .001). When the investigators looked at specific time periods, survivors had a significantly elevated AF risk in year 1 postdiagnosis (hazard ratio, 2.16) and after year 5 postdiagnosis (hazard ratio, 1.20), but not during years 2 through 5.

Analyses beginning 1 year after diagnosis showed a slightly smaller but still significant elevation of AF incidence for the breast cancer group at 9 years of follow-up (10 years after diagnosis) (7.0% vs. 6.5%; P less than .001).

Among breast cancer patients, those who received chemotherapy had a higher risk of AF than those who did not (adjusted hazard ratio, 1.23); however, this elevation of risk was not specifically tied to receipt of anthracyclines or trastuzumab (Herceptin) versus other chemotherapy. Risk was not elevated for those who received radiation therapy.

“Our study findings suggest that a diagnosis of early-stage breast cancer may be associated with a small increase in the risk of AF compared with that for cancer-free women,” Dr. Abdel-Qadir and coinvestigators noted. “Since the absolute risk is small, this finding does not warrant routine surveillance but rather should prompt consideration of AF in the differential diagnosis for women with compatible symptoms.

“The early and late periods of increased AF risk in early-stage breast cancer survivors warrant focused research to better understand the underlying causes and subsequent implications,” they concluded.

Dr. Abdel-Qadir reported receiving grants from the Canadian Cardiovascular Society during the conduct of the study, speaker fees from Amgen, and an honorarium for clinical events adjudication committee membership from the Canadian Vigour Centre for a study funded by AstraZeneca. The study was funded by the Canadian Cardiovascular Society Atrial Fibrillation Research Award.

SOURCE: Abdel-Qadir H et al. JAMA Netw Open. 2019 Sep 4;2(9):e1911838.

Women with early-stage breast cancer are at elevated risk for atrial fibrillation (AF) short term and, to a lesser extent, long term, finds a large Canadian cohort study. Risk was higher for those who had received chemotherapy but not tied to specific cardiotoxic drugs or drug classes.

“Cardiovascular disease is a particularly pertinent clinical concern for women diagnosed with early-stage breast cancer,” note the investigators, led by Husam Abdel-Qadir, MD, PhD, FRCPC, Cardiology Clinic, Women’s College Hospital, Toronto. “Many early-stage breast cancer survivors are older than 65 years and have hypertension, diabetes, or left ventricular dysfunction. Accordingly, a diagnosis of AF would translate to a clinically relevant stroke risk for many early-stage breast cancer survivors.”

The investigators undertook a population-based retrospective cohort study of women in the province of Ontario with stage I-III breast cancer diagnosed between April 2007 and December 2016, matching them 1:3 to cancer-free control women on birth year and receipt of breast imaging.

An initial analysis, based on 95,539 breast cancer patients and 217,456 cancer-free controls, showed that the former and latter groups did not differ significantly on the prevalence of preexisting AF (5.3% vs. 5.2%; P = .21), according to results reported in JAMA Network Open.

Main analyses excluded women with preexisting AF, leaving 68,113 breast cancer patients and 204,330 cancer-free controls having a mean follow-up of 5.7 years. Both groups had a mean age of 60 years at baseline, and prevalences of cardiovascular comorbidities were similar. Within the breast cancer group, 50.4% had left-sided disease; overall, 53.2% received chemotherapy and 71.7% received radiation therapy.

At 10 years after diagnosis, breast cancer patients had a small but significant increase in AF incidence relative to control peers (7.4% vs. 6.8%; P less than .001). When the investigators looked at specific time periods, survivors had a significantly elevated AF risk in year 1 postdiagnosis (hazard ratio, 2.16) and after year 5 postdiagnosis (hazard ratio, 1.20), but not during years 2 through 5.

Analyses beginning 1 year after diagnosis showed a slightly smaller but still significant elevation of AF incidence for the breast cancer group at 9 years of follow-up (10 years after diagnosis) (7.0% vs. 6.5%; P less than .001).

Among breast cancer patients, those who received chemotherapy had a higher risk of AF than those who did not (adjusted hazard ratio, 1.23); however, this elevation of risk was not specifically tied to receipt of anthracyclines or trastuzumab (Herceptin) versus other chemotherapy. Risk was not elevated for those who received radiation therapy.

“Our study findings suggest that a diagnosis of early-stage breast cancer may be associated with a small increase in the risk of AF compared with that for cancer-free women,” Dr. Abdel-Qadir and coinvestigators noted. “Since the absolute risk is small, this finding does not warrant routine surveillance but rather should prompt consideration of AF in the differential diagnosis for women with compatible symptoms.

“The early and late periods of increased AF risk in early-stage breast cancer survivors warrant focused research to better understand the underlying causes and subsequent implications,” they concluded.

Dr. Abdel-Qadir reported receiving grants from the Canadian Cardiovascular Society during the conduct of the study, speaker fees from Amgen, and an honorarium for clinical events adjudication committee membership from the Canadian Vigour Centre for a study funded by AstraZeneca. The study was funded by the Canadian Cardiovascular Society Atrial Fibrillation Research Award.

SOURCE: Abdel-Qadir H et al. JAMA Netw Open. 2019 Sep 4;2(9):e1911838.

Women with early-stage breast cancer are at elevated risk for atrial fibrillation (AF) short term and, to a lesser extent, long term, finds a large Canadian cohort study. Risk was higher for those who had received chemotherapy but not tied to specific cardiotoxic drugs or drug classes.

“Cardiovascular disease is a particularly pertinent clinical concern for women diagnosed with early-stage breast cancer,” note the investigators, led by Husam Abdel-Qadir, MD, PhD, FRCPC, Cardiology Clinic, Women’s College Hospital, Toronto. “Many early-stage breast cancer survivors are older than 65 years and have hypertension, diabetes, or left ventricular dysfunction. Accordingly, a diagnosis of AF would translate to a clinically relevant stroke risk for many early-stage breast cancer survivors.”

The investigators undertook a population-based retrospective cohort study of women in the province of Ontario with stage I-III breast cancer diagnosed between April 2007 and December 2016, matching them 1:3 to cancer-free control women on birth year and receipt of breast imaging.

An initial analysis, based on 95,539 breast cancer patients and 217,456 cancer-free controls, showed that the former and latter groups did not differ significantly on the prevalence of preexisting AF (5.3% vs. 5.2%; P = .21), according to results reported in JAMA Network Open.

Main analyses excluded women with preexisting AF, leaving 68,113 breast cancer patients and 204,330 cancer-free controls having a mean follow-up of 5.7 years. Both groups had a mean age of 60 years at baseline, and prevalences of cardiovascular comorbidities were similar. Within the breast cancer group, 50.4% had left-sided disease; overall, 53.2% received chemotherapy and 71.7% received radiation therapy.

At 10 years after diagnosis, breast cancer patients had a small but significant increase in AF incidence relative to control peers (7.4% vs. 6.8%; P less than .001). When the investigators looked at specific time periods, survivors had a significantly elevated AF risk in year 1 postdiagnosis (hazard ratio, 2.16) and after year 5 postdiagnosis (hazard ratio, 1.20), but not during years 2 through 5.

Analyses beginning 1 year after diagnosis showed a slightly smaller but still significant elevation of AF incidence for the breast cancer group at 9 years of follow-up (10 years after diagnosis) (7.0% vs. 6.5%; P less than .001).

Among breast cancer patients, those who received chemotherapy had a higher risk of AF than those who did not (adjusted hazard ratio, 1.23); however, this elevation of risk was not specifically tied to receipt of anthracyclines or trastuzumab (Herceptin) versus other chemotherapy. Risk was not elevated for those who received radiation therapy.

“Our study findings suggest that a diagnosis of early-stage breast cancer may be associated with a small increase in the risk of AF compared with that for cancer-free women,” Dr. Abdel-Qadir and coinvestigators noted. “Since the absolute risk is small, this finding does not warrant routine surveillance but rather should prompt consideration of AF in the differential diagnosis for women with compatible symptoms.

“The early and late periods of increased AF risk in early-stage breast cancer survivors warrant focused research to better understand the underlying causes and subsequent implications,” they concluded.

Dr. Abdel-Qadir reported receiving grants from the Canadian Cardiovascular Society during the conduct of the study, speaker fees from Amgen, and an honorarium for clinical events adjudication committee membership from the Canadian Vigour Centre for a study funded by AstraZeneca. The study was funded by the Canadian Cardiovascular Society Atrial Fibrillation Research Award.

SOURCE: Abdel-Qadir H et al. JAMA Netw Open. 2019 Sep 4;2(9):e1911838.