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MDedge conference coverage features onsite reporting of the latest study results and expert perspectives from leading researchers.
Asynchronous Bilateral Breast Cancer in a Male Patient
Background
Bilateral male breast cancer remains a rare occurrence with limited representation in published literature. Here we present a case of an 82-yearold male with asynchronous bilateral breast cancer.
Case Presentation
Our patient is an 82-year-old male past smoker initially diagnosed with left T1aN0M0 invasive lobular carcinoma in 2010 that was ER, PR positive and HER2 negative. He underwent a left mastectomy with sentinel node biopsy and was given tamoxifen therapy for 10 years. In 2020, the patient was also diagnosed with lung squamous cell carcinoma and was treated with stereotactic body radiotherapy. In September 2023, he started noticing discharge from his right nipple. A PET CT scan revealed hyper-metabolic activity in the bilateral upper lung lobes and slightly increased activity in the right breast. A biopsy of the left upper lobe showed atypical cells. He also underwent a right breast mastectomy and sentinel lymph node biopsy which showed grade 1-2 ductal carcinoma in situ and negative sentinel lymph nodes. The tumor board recommended no further treatment after his mastectomy and genetic testing which is currently pending.
Discussion
Male breast cancer comprises just 1% of breast cancer cases, with asynchronous bilateral occurrences being exceedingly rare. A review of PubMed literature yielded only 2 documented case reports. Male breast cancer usually diagnosed around ages 60 to 70 years. The predominant histopathological diagnosis is invasive ductal adenocarcinoma that more frequently expresses ER/PR over HER2. It often manifests as a painless lump, frequently diagnosed at an advanced stage, possibly due to factors such as lower screening rates in males and less breast parenchyma. Local treatment options include surgery and radiotherapy. Neoadjuvant tamoxifen therapy is appropriate for ER and PR expressing cancers and chemotherapy can be used for non-hormone expressing or metastatic tumors. Given its rarity, management and diagnostic strategies for male breast cancer are often adapted from research on female breast cancer
Conclusions
Our case is of a relatively uncommon incident of asynchronous bilateral male breast cancer, emphasizing the need for expanded research efforts in male breast cancer. An enhanced understanding could lead to improved diagnosis and management strategies, potentially enhancing survival outcomes.
Background
Bilateral male breast cancer remains a rare occurrence with limited representation in published literature. Here we present a case of an 82-yearold male with asynchronous bilateral breast cancer.
Case Presentation
Our patient is an 82-year-old male past smoker initially diagnosed with left T1aN0M0 invasive lobular carcinoma in 2010 that was ER, PR positive and HER2 negative. He underwent a left mastectomy with sentinel node biopsy and was given tamoxifen therapy for 10 years. In 2020, the patient was also diagnosed with lung squamous cell carcinoma and was treated with stereotactic body radiotherapy. In September 2023, he started noticing discharge from his right nipple. A PET CT scan revealed hyper-metabolic activity in the bilateral upper lung lobes and slightly increased activity in the right breast. A biopsy of the left upper lobe showed atypical cells. He also underwent a right breast mastectomy and sentinel lymph node biopsy which showed grade 1-2 ductal carcinoma in situ and negative sentinel lymph nodes. The tumor board recommended no further treatment after his mastectomy and genetic testing which is currently pending.
Discussion
Male breast cancer comprises just 1% of breast cancer cases, with asynchronous bilateral occurrences being exceedingly rare. A review of PubMed literature yielded only 2 documented case reports. Male breast cancer usually diagnosed around ages 60 to 70 years. The predominant histopathological diagnosis is invasive ductal adenocarcinoma that more frequently expresses ER/PR over HER2. It often manifests as a painless lump, frequently diagnosed at an advanced stage, possibly due to factors such as lower screening rates in males and less breast parenchyma. Local treatment options include surgery and radiotherapy. Neoadjuvant tamoxifen therapy is appropriate for ER and PR expressing cancers and chemotherapy can be used for non-hormone expressing or metastatic tumors. Given its rarity, management and diagnostic strategies for male breast cancer are often adapted from research on female breast cancer
Conclusions
Our case is of a relatively uncommon incident of asynchronous bilateral male breast cancer, emphasizing the need for expanded research efforts in male breast cancer. An enhanced understanding could lead to improved diagnosis and management strategies, potentially enhancing survival outcomes.
Background
Bilateral male breast cancer remains a rare occurrence with limited representation in published literature. Here we present a case of an 82-yearold male with asynchronous bilateral breast cancer.
Case Presentation
Our patient is an 82-year-old male past smoker initially diagnosed with left T1aN0M0 invasive lobular carcinoma in 2010 that was ER, PR positive and HER2 negative. He underwent a left mastectomy with sentinel node biopsy and was given tamoxifen therapy for 10 years. In 2020, the patient was also diagnosed with lung squamous cell carcinoma and was treated with stereotactic body radiotherapy. In September 2023, he started noticing discharge from his right nipple. A PET CT scan revealed hyper-metabolic activity in the bilateral upper lung lobes and slightly increased activity in the right breast. A biopsy of the left upper lobe showed atypical cells. He also underwent a right breast mastectomy and sentinel lymph node biopsy which showed grade 1-2 ductal carcinoma in situ and negative sentinel lymph nodes. The tumor board recommended no further treatment after his mastectomy and genetic testing which is currently pending.
Discussion
Male breast cancer comprises just 1% of breast cancer cases, with asynchronous bilateral occurrences being exceedingly rare. A review of PubMed literature yielded only 2 documented case reports. Male breast cancer usually diagnosed around ages 60 to 70 years. The predominant histopathological diagnosis is invasive ductal adenocarcinoma that more frequently expresses ER/PR over HER2. It often manifests as a painless lump, frequently diagnosed at an advanced stage, possibly due to factors such as lower screening rates in males and less breast parenchyma. Local treatment options include surgery and radiotherapy. Neoadjuvant tamoxifen therapy is appropriate for ER and PR expressing cancers and chemotherapy can be used for non-hormone expressing or metastatic tumors. Given its rarity, management and diagnostic strategies for male breast cancer are often adapted from research on female breast cancer
Conclusions
Our case is of a relatively uncommon incident of asynchronous bilateral male breast cancer, emphasizing the need for expanded research efforts in male breast cancer. An enhanced understanding could lead to improved diagnosis and management strategies, potentially enhancing survival outcomes.
Metastatic Prostate Cancer Presenting as Pleural and Pericardial Metastases: A Case Report and Literature Review
Background
Metastatic prostate cancer typically manifests with metastases to the lungs, bones, and adrenal glands. Here, we report a unique case where the initial presentation involved pleural nodules, subsequently leading to the discovery of pleural and pericardial metastases.
Case Presentation
Our patient, a 73-year-old male with a history of active tobacco use disorder, COPD, and right shoulder melanoma (2004), initially presented to his primary care physician for a routine visit. Following a Low Dose Chest CT scan (LDCT), numerous new pleural nodules were identified. Physical examination revealed small nevi and skin tags, but no malignant characteristics. Initial concerns centered on the potential recurrence of malignant melanoma with pleural metastases or an inflammatory condition. Subsequent PET scan results raised significant suspicion of malignancy. PSA was 2.41. Pleuroscopy biopsies revealed invasive nonsmall cell carcinoma, positive for NKX31 and MOC31, but negative for S100, PSA, and synaptophysin. This pattern strongly suggests metastatic prostate cancer despite the absence of PSA staining. (Stage IV B: cTxcN1cM1c). A subsequent PSMA PET highlighted extensive metastatic involvement in the pericardium, posterior and mediastinal pleura, mediastinum, and ribs. Treatment commenced with Degarelix followed by the standard regimen of Docetaxel, Abiraterone, and prednisone. Genetic counseling and palliative care services were additionally recommended.
Discussion
Prostate cancer typically spreads to bones, lungs, liver, and adrenal glands. Rarely, it appears in sites like pericardium and pleura. Pleural metastases are usually found postmortem; clinical diagnosis is rare. Pericardial metastases are exceptionally uncommon, with few documented cases. The precise mechanism of metastatic dissemination remains uncertain, with theories suggesting spread through the vertebral-venous plexus or via the vena cava to distant organs. Treatment approaches vary based on symptomatic effusions, ranging from pericardiocentesis, thoracocentesis to chemotherapy, radiotherapy, and hormone therapy. Studies have shown systemic docetaxel to be effective in managing pleural and pericardial symptoms. Despite their rarity, healthcare providers should consider these possibilities when encountering pleural thickening or pericardial abnormalities on imaging studies.
Conclusions
Pleural and pericardial metastases represent uncommon occurrences in prostate cancer. Continued research efforts can facilitate early detection of metastatic disease, enabling more effective and precisely targeted management strategies when symptoms manifest.
Background
Metastatic prostate cancer typically manifests with metastases to the lungs, bones, and adrenal glands. Here, we report a unique case where the initial presentation involved pleural nodules, subsequently leading to the discovery of pleural and pericardial metastases.
Case Presentation
Our patient, a 73-year-old male with a history of active tobacco use disorder, COPD, and right shoulder melanoma (2004), initially presented to his primary care physician for a routine visit. Following a Low Dose Chest CT scan (LDCT), numerous new pleural nodules were identified. Physical examination revealed small nevi and skin tags, but no malignant characteristics. Initial concerns centered on the potential recurrence of malignant melanoma with pleural metastases or an inflammatory condition. Subsequent PET scan results raised significant suspicion of malignancy. PSA was 2.41. Pleuroscopy biopsies revealed invasive nonsmall cell carcinoma, positive for NKX31 and MOC31, but negative for S100, PSA, and synaptophysin. This pattern strongly suggests metastatic prostate cancer despite the absence of PSA staining. (Stage IV B: cTxcN1cM1c). A subsequent PSMA PET highlighted extensive metastatic involvement in the pericardium, posterior and mediastinal pleura, mediastinum, and ribs. Treatment commenced with Degarelix followed by the standard regimen of Docetaxel, Abiraterone, and prednisone. Genetic counseling and palliative care services were additionally recommended.
Discussion
Prostate cancer typically spreads to bones, lungs, liver, and adrenal glands. Rarely, it appears in sites like pericardium and pleura. Pleural metastases are usually found postmortem; clinical diagnosis is rare. Pericardial metastases are exceptionally uncommon, with few documented cases. The precise mechanism of metastatic dissemination remains uncertain, with theories suggesting spread through the vertebral-venous plexus or via the vena cava to distant organs. Treatment approaches vary based on symptomatic effusions, ranging from pericardiocentesis, thoracocentesis to chemotherapy, radiotherapy, and hormone therapy. Studies have shown systemic docetaxel to be effective in managing pleural and pericardial symptoms. Despite their rarity, healthcare providers should consider these possibilities when encountering pleural thickening or pericardial abnormalities on imaging studies.
Conclusions
Pleural and pericardial metastases represent uncommon occurrences in prostate cancer. Continued research efforts can facilitate early detection of metastatic disease, enabling more effective and precisely targeted management strategies when symptoms manifest.
Background
Metastatic prostate cancer typically manifests with metastases to the lungs, bones, and adrenal glands. Here, we report a unique case where the initial presentation involved pleural nodules, subsequently leading to the discovery of pleural and pericardial metastases.
Case Presentation
Our patient, a 73-year-old male with a history of active tobacco use disorder, COPD, and right shoulder melanoma (2004), initially presented to his primary care physician for a routine visit. Following a Low Dose Chest CT scan (LDCT), numerous new pleural nodules were identified. Physical examination revealed small nevi and skin tags, but no malignant characteristics. Initial concerns centered on the potential recurrence of malignant melanoma with pleural metastases or an inflammatory condition. Subsequent PET scan results raised significant suspicion of malignancy. PSA was 2.41. Pleuroscopy biopsies revealed invasive nonsmall cell carcinoma, positive for NKX31 and MOC31, but negative for S100, PSA, and synaptophysin. This pattern strongly suggests metastatic prostate cancer despite the absence of PSA staining. (Stage IV B: cTxcN1cM1c). A subsequent PSMA PET highlighted extensive metastatic involvement in the pericardium, posterior and mediastinal pleura, mediastinum, and ribs. Treatment commenced with Degarelix followed by the standard regimen of Docetaxel, Abiraterone, and prednisone. Genetic counseling and palliative care services were additionally recommended.
Discussion
Prostate cancer typically spreads to bones, lungs, liver, and adrenal glands. Rarely, it appears in sites like pericardium and pleura. Pleural metastases are usually found postmortem; clinical diagnosis is rare. Pericardial metastases are exceptionally uncommon, with few documented cases. The precise mechanism of metastatic dissemination remains uncertain, with theories suggesting spread through the vertebral-venous plexus or via the vena cava to distant organs. Treatment approaches vary based on symptomatic effusions, ranging from pericardiocentesis, thoracocentesis to chemotherapy, radiotherapy, and hormone therapy. Studies have shown systemic docetaxel to be effective in managing pleural and pericardial symptoms. Despite their rarity, healthcare providers should consider these possibilities when encountering pleural thickening or pericardial abnormalities on imaging studies.
Conclusions
Pleural and pericardial metastases represent uncommon occurrences in prostate cancer. Continued research efforts can facilitate early detection of metastatic disease, enabling more effective and precisely targeted management strategies when symptoms manifest.
Timing of Blood Pressure Dosing Doesn’t Matter (Again): BedMed and BedMed-Frail
This transcript has been edited for clarity.
Tricia Ward: I’m joined today by Dr. Scott R. Garrison, MD, PhD. He is a professor in the Department of Family Medicine at the University of Alberta in Edmonton, Alberta, Canada, and director of the Pragmatic Trials Collaborative.
You presented two studies at ESC. One is the BedMed study, comparing day vs nighttime dosing of blood pressure therapy. Can you tell us the top-line findings?
BedMed and BedMed-Frail
Dr. Garrison: We were looking to validate an earlier study that suggested a large benefit of taking blood pressure medication at bedtime, as far as reducing major adverse cardiovascular events (MACEs). That was the MAPEC study. They suggested a 60% reduction. The BedMed trial was in hypertensive primary care patients in five Canadian provinces. We randomized well over 3000 patients to bedtime or morning medications. We looked at MACEs — so all-cause death or hospitalizations for acute coronary syndrome, stroke, or heart failure, and a bunch of safety outcomes.
Essentially, . It was safe to take it at bedtime. But it did not convey any extra cardiovascular benefit.
Ms. Ward: And then you did a second study, called BedMed-Frail. Do you want to tell us the reason you did that?
Dr. Garrison: BedMed-Frail took place in a nursing home population. We believed that it was possible that frail, older adults might have very different risks and benefits, and that they would probably be underrepresented, as they normally are in the main trial.
We thought that because bedtime blood pressure medications would be theoretically preferentially lowering night pressure, which is already the lowest pressure of the day, that if you were at risk for hypotensive or ischemic adverse events, that might make it worse. We looked at falls and fractures; worsening cognition in case they had vascular dementia; and whether they developed decubitus ulcers (pressure sores) because you need a certain amount of pressure to get past any obstruction — in this case, it’s the weight of your body if you’re lying in bed all the time.
We also looked at problem behaviors. People who have dementia have what’s called “sundowning,” where agitation and confusion are worse as the evening is going on. We looked at that on the off chance that it had anything to do with blood pressures being lower. And the BedMed-Frail results mirror those of BedMed exactly. So there was no cardiovascular benefit, and in this population, that was largely driven by mortality; one third of these people died every year.
Ms. Ward: The median age was about 88?
Dr. Garrison: Yes, the median age was 88. There was no cardiovascular mortality advantage to bedtime dosing, but neither was there any signal of safety concerns.
Other Complementary and Conflicting Studies
Ms. Ward: These two studies mirror the TIME study from the United Kingdom.
Dr. Garrison: Yes. We found exactly what TIME found. Our point estimate was pretty much the same. The hazard ratio in the main trial was 0.96. Theirs, I believe, was 0.95. Our findings agree completely with those of TIME and differ substantially from the previous trials that suggested a large benefit.
Ms. Ward: Those previous trials were MAPEC and the Hygia Chronotherapy Trial.
Dr. Garrison: MAPEC was the first one. While we were doing our trial, and while the TIME investigators were doing their trial, both of us trying to validate MAPEC, the same group published another study called Hygia, which also reported a large reduction: a 45% reduction in MACE with bedtime dosing.
Ms. Ward: You didn’t present it, but there was also a meta-analysis presented here by somebody independent.
Dr. Garrison: Yes, Ricky Turgeon. I know Ricky. We gave him patient-level data for his meta-analysis, but I was not otherwise involved.
Ms. Ward: And the conclusion is the same.
Dr. Garrison: It’s the same. He only found the same five trials: MAPEC, Hygia, TIME, BedMed, and BedMed-Frail. Combining them all together, the CIs still span 1.0, so it didn’t end up being significant. But he also analyzed TIME and the BedMed trials separately — again suggesting that those trials showed no benefit.
Ms. Ward: There was a TIME substudy of night owls vs early risers or morning people, and there was a hint (or whatever you should say for a subanalysis of a neutral trial) that timing might make a difference there.
Dr. Garrison: They recently published, I guess it is a substudy, where they looked at people’s chronotype according to whether you consider yourself an early bird or a night owl. Their assessment was more detailed. They reported that if people were tending toward being early birds and they took their blood pressure medicine in the morning, or if they were night owls and they took it in the evening, that they tended to have statistically significantly better outcomes than the opposite timing. In that analysis, they were only looking at nonfatal myocardial infarction and nonfatal stroke.
We did ask something that was related. We asked people: “Do we consider yourself more of an early bird or a night owl?” So we do have those data. For what I presented at ESC, we just looked at the primary outcome; we did subgroups according to early bird, night owl, and neither, and that was not statistically significant. It didn’t rule it out. There were some trends in the direction that the TIME group were suggesting. We do intend to do a closer look at that.
But, you know, they call these “late-breaking trials,” and it really was in our case. We didn’t get the last of our data from the last province until the end of June, so we still are finishing up the analysis of the chronotype portion — so more to come in another month or so.
Do What You Like, or Stick to Morning Dosing?
Ms. Ward: For the purposes of people’s take-home message, does this mostly apply to once-daily–dosed antihypertensives?
Dr. Garrison: It was essentially once-daily medicines that were changed. The docs did have the opportunity to consolidate twice-daily meds into once-daily or switch to a different medication. That’s probably the area where adherence was the biggest issue, because it’s largely beta-blockers that were given twice daily at baseline, and they were less likely to want to change.
At 6 months, 83% of once-daily medications were taken per allocation in the bedtime group and 95% per allocation in the morning group, which was actually pretty good. For angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and calcium-channel blockers, the adherence was excellent. Again, it was beta-blockers taken twice a day where it fell down, and then also diuretics. But if you combine all diuretic medications (ie, pure diuretics and combo agents), still, 75% of them were successful at taking them at bedtime. Only 15% of people switching a diuretic to bedtime dosing actually had problems with nocturia. Most physicians think that they can’t get their patients to take those meds at bedtime, but you can. There’s probably no reason to take it at bedtime, but most people do tolerate it.
Ms. Ward: Is your advice to take it whenever you feel like? I know when TIME came out, Professor George Stergiou, who’s the incoming president of the International Society of Hypertension, said, well, maybe we should stick with the morning, because that’s what most of the trials did.
Dr. Garrison: I think that›s a perfectly valid point of view, and maybe for a lot of people, that could be the default. There are some people, though, who will have a particular reason why one time is better. For instance, most people have no problems with calcium-channel blockers, but some get ankle swelling and you’re more likely to have that happen if you take them in the morning. Or lots of people want to take all their pills at the same time; blood pressure pills are easy ones to switch the timing of if you’re trying to accomplish that, and if that will help adherence. Basically, whatever time of day you can remember to take it the best is probably the right time.
Ms. Ward: Given where we are today, with your trials and TIME, do you think this is now settled science that it doesn’t make a difference?
Dr. Garrison: I’m probably the wrong person to ask, because I clearly have a bias. I think the methods in the TIME trial are really transparent and solid. I hope that when our papers come out, people will feel the same. You just have to look at the different trials. You need people like Dr. Stergiou to wade through the trials to help you with that.
Ms. Ward: Thank you very much for joining me today and discussing this trial.
Scott R. Garrison, MD, PhD, is Professor, Department of Family Medicine, University of Alberta in Edmonton, Alberta, Canada, and Staff Physician, Department of Family Medicine, Kaye Edmonton Clinic, and he has disclosed receiving research grants from Alberta Innovates (the Alberta Provincial Government) and the Canadian Institutes of Health Research (the Canadian Federal Government).
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Tricia Ward: I’m joined today by Dr. Scott R. Garrison, MD, PhD. He is a professor in the Department of Family Medicine at the University of Alberta in Edmonton, Alberta, Canada, and director of the Pragmatic Trials Collaborative.
You presented two studies at ESC. One is the BedMed study, comparing day vs nighttime dosing of blood pressure therapy. Can you tell us the top-line findings?
BedMed and BedMed-Frail
Dr. Garrison: We were looking to validate an earlier study that suggested a large benefit of taking blood pressure medication at bedtime, as far as reducing major adverse cardiovascular events (MACEs). That was the MAPEC study. They suggested a 60% reduction. The BedMed trial was in hypertensive primary care patients in five Canadian provinces. We randomized well over 3000 patients to bedtime or morning medications. We looked at MACEs — so all-cause death or hospitalizations for acute coronary syndrome, stroke, or heart failure, and a bunch of safety outcomes.
Essentially, . It was safe to take it at bedtime. But it did not convey any extra cardiovascular benefit.
Ms. Ward: And then you did a second study, called BedMed-Frail. Do you want to tell us the reason you did that?
Dr. Garrison: BedMed-Frail took place in a nursing home population. We believed that it was possible that frail, older adults might have very different risks and benefits, and that they would probably be underrepresented, as they normally are in the main trial.
We thought that because bedtime blood pressure medications would be theoretically preferentially lowering night pressure, which is already the lowest pressure of the day, that if you were at risk for hypotensive or ischemic adverse events, that might make it worse. We looked at falls and fractures; worsening cognition in case they had vascular dementia; and whether they developed decubitus ulcers (pressure sores) because you need a certain amount of pressure to get past any obstruction — in this case, it’s the weight of your body if you’re lying in bed all the time.
We also looked at problem behaviors. People who have dementia have what’s called “sundowning,” where agitation and confusion are worse as the evening is going on. We looked at that on the off chance that it had anything to do with blood pressures being lower. And the BedMed-Frail results mirror those of BedMed exactly. So there was no cardiovascular benefit, and in this population, that was largely driven by mortality; one third of these people died every year.
Ms. Ward: The median age was about 88?
Dr. Garrison: Yes, the median age was 88. There was no cardiovascular mortality advantage to bedtime dosing, but neither was there any signal of safety concerns.
Other Complementary and Conflicting Studies
Ms. Ward: These two studies mirror the TIME study from the United Kingdom.
Dr. Garrison: Yes. We found exactly what TIME found. Our point estimate was pretty much the same. The hazard ratio in the main trial was 0.96. Theirs, I believe, was 0.95. Our findings agree completely with those of TIME and differ substantially from the previous trials that suggested a large benefit.
Ms. Ward: Those previous trials were MAPEC and the Hygia Chronotherapy Trial.
Dr. Garrison: MAPEC was the first one. While we were doing our trial, and while the TIME investigators were doing their trial, both of us trying to validate MAPEC, the same group published another study called Hygia, which also reported a large reduction: a 45% reduction in MACE with bedtime dosing.
Ms. Ward: You didn’t present it, but there was also a meta-analysis presented here by somebody independent.
Dr. Garrison: Yes, Ricky Turgeon. I know Ricky. We gave him patient-level data for his meta-analysis, but I was not otherwise involved.
Ms. Ward: And the conclusion is the same.
Dr. Garrison: It’s the same. He only found the same five trials: MAPEC, Hygia, TIME, BedMed, and BedMed-Frail. Combining them all together, the CIs still span 1.0, so it didn’t end up being significant. But he also analyzed TIME and the BedMed trials separately — again suggesting that those trials showed no benefit.
Ms. Ward: There was a TIME substudy of night owls vs early risers or morning people, and there was a hint (or whatever you should say for a subanalysis of a neutral trial) that timing might make a difference there.
Dr. Garrison: They recently published, I guess it is a substudy, where they looked at people’s chronotype according to whether you consider yourself an early bird or a night owl. Their assessment was more detailed. They reported that if people were tending toward being early birds and they took their blood pressure medicine in the morning, or if they were night owls and they took it in the evening, that they tended to have statistically significantly better outcomes than the opposite timing. In that analysis, they were only looking at nonfatal myocardial infarction and nonfatal stroke.
We did ask something that was related. We asked people: “Do we consider yourself more of an early bird or a night owl?” So we do have those data. For what I presented at ESC, we just looked at the primary outcome; we did subgroups according to early bird, night owl, and neither, and that was not statistically significant. It didn’t rule it out. There were some trends in the direction that the TIME group were suggesting. We do intend to do a closer look at that.
But, you know, they call these “late-breaking trials,” and it really was in our case. We didn’t get the last of our data from the last province until the end of June, so we still are finishing up the analysis of the chronotype portion — so more to come in another month or so.
Do What You Like, or Stick to Morning Dosing?
Ms. Ward: For the purposes of people’s take-home message, does this mostly apply to once-daily–dosed antihypertensives?
Dr. Garrison: It was essentially once-daily medicines that were changed. The docs did have the opportunity to consolidate twice-daily meds into once-daily or switch to a different medication. That’s probably the area where adherence was the biggest issue, because it’s largely beta-blockers that were given twice daily at baseline, and they were less likely to want to change.
At 6 months, 83% of once-daily medications were taken per allocation in the bedtime group and 95% per allocation in the morning group, which was actually pretty good. For angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and calcium-channel blockers, the adherence was excellent. Again, it was beta-blockers taken twice a day where it fell down, and then also diuretics. But if you combine all diuretic medications (ie, pure diuretics and combo agents), still, 75% of them were successful at taking them at bedtime. Only 15% of people switching a diuretic to bedtime dosing actually had problems with nocturia. Most physicians think that they can’t get their patients to take those meds at bedtime, but you can. There’s probably no reason to take it at bedtime, but most people do tolerate it.
Ms. Ward: Is your advice to take it whenever you feel like? I know when TIME came out, Professor George Stergiou, who’s the incoming president of the International Society of Hypertension, said, well, maybe we should stick with the morning, because that’s what most of the trials did.
Dr. Garrison: I think that›s a perfectly valid point of view, and maybe for a lot of people, that could be the default. There are some people, though, who will have a particular reason why one time is better. For instance, most people have no problems with calcium-channel blockers, but some get ankle swelling and you’re more likely to have that happen if you take them in the morning. Or lots of people want to take all their pills at the same time; blood pressure pills are easy ones to switch the timing of if you’re trying to accomplish that, and if that will help adherence. Basically, whatever time of day you can remember to take it the best is probably the right time.
Ms. Ward: Given where we are today, with your trials and TIME, do you think this is now settled science that it doesn’t make a difference?
Dr. Garrison: I’m probably the wrong person to ask, because I clearly have a bias. I think the methods in the TIME trial are really transparent and solid. I hope that when our papers come out, people will feel the same. You just have to look at the different trials. You need people like Dr. Stergiou to wade through the trials to help you with that.
Ms. Ward: Thank you very much for joining me today and discussing this trial.
Scott R. Garrison, MD, PhD, is Professor, Department of Family Medicine, University of Alberta in Edmonton, Alberta, Canada, and Staff Physician, Department of Family Medicine, Kaye Edmonton Clinic, and he has disclosed receiving research grants from Alberta Innovates (the Alberta Provincial Government) and the Canadian Institutes of Health Research (the Canadian Federal Government).
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Tricia Ward: I’m joined today by Dr. Scott R. Garrison, MD, PhD. He is a professor in the Department of Family Medicine at the University of Alberta in Edmonton, Alberta, Canada, and director of the Pragmatic Trials Collaborative.
You presented two studies at ESC. One is the BedMed study, comparing day vs nighttime dosing of blood pressure therapy. Can you tell us the top-line findings?
BedMed and BedMed-Frail
Dr. Garrison: We were looking to validate an earlier study that suggested a large benefit of taking blood pressure medication at bedtime, as far as reducing major adverse cardiovascular events (MACEs). That was the MAPEC study. They suggested a 60% reduction. The BedMed trial was in hypertensive primary care patients in five Canadian provinces. We randomized well over 3000 patients to bedtime or morning medications. We looked at MACEs — so all-cause death or hospitalizations for acute coronary syndrome, stroke, or heart failure, and a bunch of safety outcomes.
Essentially, . It was safe to take it at bedtime. But it did not convey any extra cardiovascular benefit.
Ms. Ward: And then you did a second study, called BedMed-Frail. Do you want to tell us the reason you did that?
Dr. Garrison: BedMed-Frail took place in a nursing home population. We believed that it was possible that frail, older adults might have very different risks and benefits, and that they would probably be underrepresented, as they normally are in the main trial.
We thought that because bedtime blood pressure medications would be theoretically preferentially lowering night pressure, which is already the lowest pressure of the day, that if you were at risk for hypotensive or ischemic adverse events, that might make it worse. We looked at falls and fractures; worsening cognition in case they had vascular dementia; and whether they developed decubitus ulcers (pressure sores) because you need a certain amount of pressure to get past any obstruction — in this case, it’s the weight of your body if you’re lying in bed all the time.
We also looked at problem behaviors. People who have dementia have what’s called “sundowning,” where agitation and confusion are worse as the evening is going on. We looked at that on the off chance that it had anything to do with blood pressures being lower. And the BedMed-Frail results mirror those of BedMed exactly. So there was no cardiovascular benefit, and in this population, that was largely driven by mortality; one third of these people died every year.
Ms. Ward: The median age was about 88?
Dr. Garrison: Yes, the median age was 88. There was no cardiovascular mortality advantage to bedtime dosing, but neither was there any signal of safety concerns.
Other Complementary and Conflicting Studies
Ms. Ward: These two studies mirror the TIME study from the United Kingdom.
Dr. Garrison: Yes. We found exactly what TIME found. Our point estimate was pretty much the same. The hazard ratio in the main trial was 0.96. Theirs, I believe, was 0.95. Our findings agree completely with those of TIME and differ substantially from the previous trials that suggested a large benefit.
Ms. Ward: Those previous trials were MAPEC and the Hygia Chronotherapy Trial.
Dr. Garrison: MAPEC was the first one. While we were doing our trial, and while the TIME investigators were doing their trial, both of us trying to validate MAPEC, the same group published another study called Hygia, which also reported a large reduction: a 45% reduction in MACE with bedtime dosing.
Ms. Ward: You didn’t present it, but there was also a meta-analysis presented here by somebody independent.
Dr. Garrison: Yes, Ricky Turgeon. I know Ricky. We gave him patient-level data for his meta-analysis, but I was not otherwise involved.
Ms. Ward: And the conclusion is the same.
Dr. Garrison: It’s the same. He only found the same five trials: MAPEC, Hygia, TIME, BedMed, and BedMed-Frail. Combining them all together, the CIs still span 1.0, so it didn’t end up being significant. But he also analyzed TIME and the BedMed trials separately — again suggesting that those trials showed no benefit.
Ms. Ward: There was a TIME substudy of night owls vs early risers or morning people, and there was a hint (or whatever you should say for a subanalysis of a neutral trial) that timing might make a difference there.
Dr. Garrison: They recently published, I guess it is a substudy, where they looked at people’s chronotype according to whether you consider yourself an early bird or a night owl. Their assessment was more detailed. They reported that if people were tending toward being early birds and they took their blood pressure medicine in the morning, or if they were night owls and they took it in the evening, that they tended to have statistically significantly better outcomes than the opposite timing. In that analysis, they were only looking at nonfatal myocardial infarction and nonfatal stroke.
We did ask something that was related. We asked people: “Do we consider yourself more of an early bird or a night owl?” So we do have those data. For what I presented at ESC, we just looked at the primary outcome; we did subgroups according to early bird, night owl, and neither, and that was not statistically significant. It didn’t rule it out. There were some trends in the direction that the TIME group were suggesting. We do intend to do a closer look at that.
But, you know, they call these “late-breaking trials,” and it really was in our case. We didn’t get the last of our data from the last province until the end of June, so we still are finishing up the analysis of the chronotype portion — so more to come in another month or so.
Do What You Like, or Stick to Morning Dosing?
Ms. Ward: For the purposes of people’s take-home message, does this mostly apply to once-daily–dosed antihypertensives?
Dr. Garrison: It was essentially once-daily medicines that were changed. The docs did have the opportunity to consolidate twice-daily meds into once-daily or switch to a different medication. That’s probably the area where adherence was the biggest issue, because it’s largely beta-blockers that were given twice daily at baseline, and they were less likely to want to change.
At 6 months, 83% of once-daily medications were taken per allocation in the bedtime group and 95% per allocation in the morning group, which was actually pretty good. For angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and calcium-channel blockers, the adherence was excellent. Again, it was beta-blockers taken twice a day where it fell down, and then also diuretics. But if you combine all diuretic medications (ie, pure diuretics and combo agents), still, 75% of them were successful at taking them at bedtime. Only 15% of people switching a diuretic to bedtime dosing actually had problems with nocturia. Most physicians think that they can’t get their patients to take those meds at bedtime, but you can. There’s probably no reason to take it at bedtime, but most people do tolerate it.
Ms. Ward: Is your advice to take it whenever you feel like? I know when TIME came out, Professor George Stergiou, who’s the incoming president of the International Society of Hypertension, said, well, maybe we should stick with the morning, because that’s what most of the trials did.
Dr. Garrison: I think that›s a perfectly valid point of view, and maybe for a lot of people, that could be the default. There are some people, though, who will have a particular reason why one time is better. For instance, most people have no problems with calcium-channel blockers, but some get ankle swelling and you’re more likely to have that happen if you take them in the morning. Or lots of people want to take all their pills at the same time; blood pressure pills are easy ones to switch the timing of if you’re trying to accomplish that, and if that will help adherence. Basically, whatever time of day you can remember to take it the best is probably the right time.
Ms. Ward: Given where we are today, with your trials and TIME, do you think this is now settled science that it doesn’t make a difference?
Dr. Garrison: I’m probably the wrong person to ask, because I clearly have a bias. I think the methods in the TIME trial are really transparent and solid. I hope that when our papers come out, people will feel the same. You just have to look at the different trials. You need people like Dr. Stergiou to wade through the trials to help you with that.
Ms. Ward: Thank you very much for joining me today and discussing this trial.
Scott R. Garrison, MD, PhD, is Professor, Department of Family Medicine, University of Alberta in Edmonton, Alberta, Canada, and Staff Physician, Department of Family Medicine, Kaye Edmonton Clinic, and he has disclosed receiving research grants from Alberta Innovates (the Alberta Provincial Government) and the Canadian Institutes of Health Research (the Canadian Federal Government).
A version of this article first appeared on Medscape.com.
FROM ESC 2024
Beyond Borders: Tonsillar Squamous Cell Carcinoma with Intriguing Liver Metastasis
Background
Oropharyngeal squamous cell carcinoma (OPSCC) arises in the middle pharynx, including the tonsils, base of the tongue, and surrounding tissues. While OPSCC commonly metastasizes to regional lymph nodes, distant metastases to sites like the liver are rare, occurring in about 1-4% of cases with advanced disease.
Case Presentation
A 66-year-old male presented to the emergency department with recurrent right-sided facial swelling and a two-week history of sore throat. CT imaging revealed a large right tonsillar mass extending to the base of the tongue. Further evaluation with PET scan showed hypermetabolic activity in the right tonsil, multiple hypermetabolic lymph nodes in the right neck (stations 1B, 2, 3, 4, 5), right supraclavicular fossa, and small retropharyngeal nodes. Additionally, PET scan detected a hypermetabolic lesion in the liver and focal activity at T10 suggestive of bone metastasis. Fine needle aspiration (FNA) confirmed squamous cell carcinoma. Biopsy of the liver lesion revealed metastatic squamous cell carcinoma with basaloid differentiation, positive for p40 and p63 stains. Clinical staging was T2b cN2 cM1. The patient’s case was discussed in tumor boards, leading to a treatment plan of palliative radiotherapy with radiosensitizer (weekly carboplatin/paclitaxel) due to recent myocardial infarction, precluding cisplatin or 5FU use. Post-radiotherapy, Pembrolizumab was planned based on 60% PD-L1 expression. The patient opted to forego additional systemic chemotherapy and currently receives Keytruda every three weeks.
Discussion
Liver metastases from head and neck SCC are rare, highlighting the complexity of treatment decisions in such cases. Effective management requires a multidisciplinary approach to optimize therapeutic outcomes while considering patient-specific factors and comorbidities.
Conclusions
This case underscores the challenges and poor prognosis associated with tonsillar SCC with liver metastases. It underscores the need for personalized treatment strategies tailored to the unique characteristics of each patient’s disease.
Background
Oropharyngeal squamous cell carcinoma (OPSCC) arises in the middle pharynx, including the tonsils, base of the tongue, and surrounding tissues. While OPSCC commonly metastasizes to regional lymph nodes, distant metastases to sites like the liver are rare, occurring in about 1-4% of cases with advanced disease.
Case Presentation
A 66-year-old male presented to the emergency department with recurrent right-sided facial swelling and a two-week history of sore throat. CT imaging revealed a large right tonsillar mass extending to the base of the tongue. Further evaluation with PET scan showed hypermetabolic activity in the right tonsil, multiple hypermetabolic lymph nodes in the right neck (stations 1B, 2, 3, 4, 5), right supraclavicular fossa, and small retropharyngeal nodes. Additionally, PET scan detected a hypermetabolic lesion in the liver and focal activity at T10 suggestive of bone metastasis. Fine needle aspiration (FNA) confirmed squamous cell carcinoma. Biopsy of the liver lesion revealed metastatic squamous cell carcinoma with basaloid differentiation, positive for p40 and p63 stains. Clinical staging was T2b cN2 cM1. The patient’s case was discussed in tumor boards, leading to a treatment plan of palliative radiotherapy with radiosensitizer (weekly carboplatin/paclitaxel) due to recent myocardial infarction, precluding cisplatin or 5FU use. Post-radiotherapy, Pembrolizumab was planned based on 60% PD-L1 expression. The patient opted to forego additional systemic chemotherapy and currently receives Keytruda every three weeks.
Discussion
Liver metastases from head and neck SCC are rare, highlighting the complexity of treatment decisions in such cases. Effective management requires a multidisciplinary approach to optimize therapeutic outcomes while considering patient-specific factors and comorbidities.
Conclusions
This case underscores the challenges and poor prognosis associated with tonsillar SCC with liver metastases. It underscores the need for personalized treatment strategies tailored to the unique characteristics of each patient’s disease.
Background
Oropharyngeal squamous cell carcinoma (OPSCC) arises in the middle pharynx, including the tonsils, base of the tongue, and surrounding tissues. While OPSCC commonly metastasizes to regional lymph nodes, distant metastases to sites like the liver are rare, occurring in about 1-4% of cases with advanced disease.
Case Presentation
A 66-year-old male presented to the emergency department with recurrent right-sided facial swelling and a two-week history of sore throat. CT imaging revealed a large right tonsillar mass extending to the base of the tongue. Further evaluation with PET scan showed hypermetabolic activity in the right tonsil, multiple hypermetabolic lymph nodes in the right neck (stations 1B, 2, 3, 4, 5), right supraclavicular fossa, and small retropharyngeal nodes. Additionally, PET scan detected a hypermetabolic lesion in the liver and focal activity at T10 suggestive of bone metastasis. Fine needle aspiration (FNA) confirmed squamous cell carcinoma. Biopsy of the liver lesion revealed metastatic squamous cell carcinoma with basaloid differentiation, positive for p40 and p63 stains. Clinical staging was T2b cN2 cM1. The patient’s case was discussed in tumor boards, leading to a treatment plan of palliative radiotherapy with radiosensitizer (weekly carboplatin/paclitaxel) due to recent myocardial infarction, precluding cisplatin or 5FU use. Post-radiotherapy, Pembrolizumab was planned based on 60% PD-L1 expression. The patient opted to forego additional systemic chemotherapy and currently receives Keytruda every three weeks.
Discussion
Liver metastases from head and neck SCC are rare, highlighting the complexity of treatment decisions in such cases. Effective management requires a multidisciplinary approach to optimize therapeutic outcomes while considering patient-specific factors and comorbidities.
Conclusions
This case underscores the challenges and poor prognosis associated with tonsillar SCC with liver metastases. It underscores the need for personalized treatment strategies tailored to the unique characteristics of each patient’s disease.
ENT Multidisciplinary Workgroup
Background
The care of veterans with head and neck cancers requires a team approach among multiple disciplines throughout the entire trajectory of their cancer treatment course. Veterans with head and neck cancer have complicated treatments including surgery, radiation, chemotherapy and reconstructive surgery which can affect swallow function, speech, taste and physical appearance. Many patients who get treated for head and neck cancer will have lasting side effects of treatment. Veterans with cancer are more likely than the general population to have mental health comorbidities such as anxiety, depression and PTSD. Many head and neck cancer patients have used tobacco and/or alcohol as coping mechanisms for these issues. A new diagnosis of cancer may exacerbate their mental illness. Tobacco cessation may exacerbate anxiety for patients who have used tobacco as a coping mechanism. Ongoing alcohol use can complicate treatment. All of these issues can create delays in care.
Methods
In August 2019, a task force (“the ENT Multidisciplinary Workgroup”) was formed at VA Connecticut Healthcare System (“VACHS”) including representatives from ENT, Speech Pathology, Nutrition, Palliative Care and Oncology with the specific goal of improved coordination of care for head and neck cancer patients. Regular weekly meetings began in September 2019 to identify and track patients and to make referrals for appropriate diagnostic testing, treatment and supportive care.
Discussion
Weekly meeting among the core members of the ENT workgroup led to identification of patient needs earlier in the illness course than was observed prior to this workgroup initiative. Each week several opportunities are identified to improve patient care. This is a dynamic, ongoing process that has improved communication among key members of the interdisciplinary team that cares for these very complex patients and has led to the development of quality improvement initiatives that are reproducible at other VA sites.
Background
The care of veterans with head and neck cancers requires a team approach among multiple disciplines throughout the entire trajectory of their cancer treatment course. Veterans with head and neck cancer have complicated treatments including surgery, radiation, chemotherapy and reconstructive surgery which can affect swallow function, speech, taste and physical appearance. Many patients who get treated for head and neck cancer will have lasting side effects of treatment. Veterans with cancer are more likely than the general population to have mental health comorbidities such as anxiety, depression and PTSD. Many head and neck cancer patients have used tobacco and/or alcohol as coping mechanisms for these issues. A new diagnosis of cancer may exacerbate their mental illness. Tobacco cessation may exacerbate anxiety for patients who have used tobacco as a coping mechanism. Ongoing alcohol use can complicate treatment. All of these issues can create delays in care.
Methods
In August 2019, a task force (“the ENT Multidisciplinary Workgroup”) was formed at VA Connecticut Healthcare System (“VACHS”) including representatives from ENT, Speech Pathology, Nutrition, Palliative Care and Oncology with the specific goal of improved coordination of care for head and neck cancer patients. Regular weekly meetings began in September 2019 to identify and track patients and to make referrals for appropriate diagnostic testing, treatment and supportive care.
Discussion
Weekly meeting among the core members of the ENT workgroup led to identification of patient needs earlier in the illness course than was observed prior to this workgroup initiative. Each week several opportunities are identified to improve patient care. This is a dynamic, ongoing process that has improved communication among key members of the interdisciplinary team that cares for these very complex patients and has led to the development of quality improvement initiatives that are reproducible at other VA sites.
Background
The care of veterans with head and neck cancers requires a team approach among multiple disciplines throughout the entire trajectory of their cancer treatment course. Veterans with head and neck cancer have complicated treatments including surgery, radiation, chemotherapy and reconstructive surgery which can affect swallow function, speech, taste and physical appearance. Many patients who get treated for head and neck cancer will have lasting side effects of treatment. Veterans with cancer are more likely than the general population to have mental health comorbidities such as anxiety, depression and PTSD. Many head and neck cancer patients have used tobacco and/or alcohol as coping mechanisms for these issues. A new diagnosis of cancer may exacerbate their mental illness. Tobacco cessation may exacerbate anxiety for patients who have used tobacco as a coping mechanism. Ongoing alcohol use can complicate treatment. All of these issues can create delays in care.
Methods
In August 2019, a task force (“the ENT Multidisciplinary Workgroup”) was formed at VA Connecticut Healthcare System (“VACHS”) including representatives from ENT, Speech Pathology, Nutrition, Palliative Care and Oncology with the specific goal of improved coordination of care for head and neck cancer patients. Regular weekly meetings began in September 2019 to identify and track patients and to make referrals for appropriate diagnostic testing, treatment and supportive care.
Discussion
Weekly meeting among the core members of the ENT workgroup led to identification of patient needs earlier in the illness course than was observed prior to this workgroup initiative. Each week several opportunities are identified to improve patient care. This is a dynamic, ongoing process that has improved communication among key members of the interdisciplinary team that cares for these very complex patients and has led to the development of quality improvement initiatives that are reproducible at other VA sites.
Multimodal Treatment Approaches for Basaloid Squamous Cell Carcinoma of the Larynx
Background
Basaloid squamous cell carcinoma (BSCC) is an aggressive laryngeal cancer with high recurrence and metastasis rates. Its rarity complicates diagnosis and optimal treatment selection, underscoring the significance of comprehensive data collection through national cancer registries. Historically, surgical intervention has been the primary approach to management.The RTOG 91-11 randomized trial catalyzed a paradigm shift, prioritizing laryngealpreserving treatments. The study provided evidence for radiotherapy in early-stage disease (stages 1-2) and combined chemoradiotherapy in advanced disease (stages 3-4). Consequently, organ preservation protocols gained traction, maintaining laryngeal anatomy while achieving comparable oncologic outcomes to total laryngectomy. This shift emphasizes exploring multimodal, laryngeal-sparing regimens to optimize quality of life without compromising disease control. However, further research utilizing large databases is needed to elucidate survival outcomes associated with these approaches.
Methods
We used the National Cancer Database to identify patients diagnosed with BSCC of the larynx (ICD-O-3 histology code 8083) between 2004-2019 (Nf1487). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p< 0.05.
Results
For early-stage patients, the estimated survival was 93.179 months. Surgery demonstrated the most favorable outcome with a median survival of 100.957 months, significantly higher than non-surgical patients (85.895 months, p=0.028). Survival did not differ between patients who received only chemotherapy (p=0.281), radiation (p=0.326), or chemoradiation (p=0.919) and those received other treatment modalities. In late-stage patients, the estimated survival was 61.993 months. Surgery yielded the most favorable outcome with a median survival of 70.484 months, significantly higher than non-surgical patients (54.153 months, p< 0.001). Patients who received only chemotherapy (p< 0.001), radiation (p< 0.001) and chemoradiation (p=0.24) had a worse survival outcome compared to those who received other treatment modalities.
Conclusions
The study results indicate that surgical resection could potentially improve survival outcomes for patients diagnosed with advanced-stage laryngeal BSCC. Conversely, for those with earlystage BSCC, larynx-preserving treatment modalities such as radiation, chemotherapy or concurrent chemoradiation appear to achieve comparable survival rates to primary surgical management. These results highlight the importance of careful consideration of treatment modalities based on disease staging at initial presentation.
Background
Basaloid squamous cell carcinoma (BSCC) is an aggressive laryngeal cancer with high recurrence and metastasis rates. Its rarity complicates diagnosis and optimal treatment selection, underscoring the significance of comprehensive data collection through national cancer registries. Historically, surgical intervention has been the primary approach to management.The RTOG 91-11 randomized trial catalyzed a paradigm shift, prioritizing laryngealpreserving treatments. The study provided evidence for radiotherapy in early-stage disease (stages 1-2) and combined chemoradiotherapy in advanced disease (stages 3-4). Consequently, organ preservation protocols gained traction, maintaining laryngeal anatomy while achieving comparable oncologic outcomes to total laryngectomy. This shift emphasizes exploring multimodal, laryngeal-sparing regimens to optimize quality of life without compromising disease control. However, further research utilizing large databases is needed to elucidate survival outcomes associated with these approaches.
Methods
We used the National Cancer Database to identify patients diagnosed with BSCC of the larynx (ICD-O-3 histology code 8083) between 2004-2019 (Nf1487). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p< 0.05.
Results
For early-stage patients, the estimated survival was 93.179 months. Surgery demonstrated the most favorable outcome with a median survival of 100.957 months, significantly higher than non-surgical patients (85.895 months, p=0.028). Survival did not differ between patients who received only chemotherapy (p=0.281), radiation (p=0.326), or chemoradiation (p=0.919) and those received other treatment modalities. In late-stage patients, the estimated survival was 61.993 months. Surgery yielded the most favorable outcome with a median survival of 70.484 months, significantly higher than non-surgical patients (54.153 months, p< 0.001). Patients who received only chemotherapy (p< 0.001), radiation (p< 0.001) and chemoradiation (p=0.24) had a worse survival outcome compared to those who received other treatment modalities.
Conclusions
The study results indicate that surgical resection could potentially improve survival outcomes for patients diagnosed with advanced-stage laryngeal BSCC. Conversely, for those with earlystage BSCC, larynx-preserving treatment modalities such as radiation, chemotherapy or concurrent chemoradiation appear to achieve comparable survival rates to primary surgical management. These results highlight the importance of careful consideration of treatment modalities based on disease staging at initial presentation.
Background
Basaloid squamous cell carcinoma (BSCC) is an aggressive laryngeal cancer with high recurrence and metastasis rates. Its rarity complicates diagnosis and optimal treatment selection, underscoring the significance of comprehensive data collection through national cancer registries. Historically, surgical intervention has been the primary approach to management.The RTOG 91-11 randomized trial catalyzed a paradigm shift, prioritizing laryngealpreserving treatments. The study provided evidence for radiotherapy in early-stage disease (stages 1-2) and combined chemoradiotherapy in advanced disease (stages 3-4). Consequently, organ preservation protocols gained traction, maintaining laryngeal anatomy while achieving comparable oncologic outcomes to total laryngectomy. This shift emphasizes exploring multimodal, laryngeal-sparing regimens to optimize quality of life without compromising disease control. However, further research utilizing large databases is needed to elucidate survival outcomes associated with these approaches.
Methods
We used the National Cancer Database to identify patients diagnosed with BSCC of the larynx (ICD-O-3 histology code 8083) between 2004-2019 (Nf1487). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p< 0.05.
Results
For early-stage patients, the estimated survival was 93.179 months. Surgery demonstrated the most favorable outcome with a median survival of 100.957 months, significantly higher than non-surgical patients (85.895 months, p=0.028). Survival did not differ between patients who received only chemotherapy (p=0.281), radiation (p=0.326), or chemoradiation (p=0.919) and those received other treatment modalities. In late-stage patients, the estimated survival was 61.993 months. Surgery yielded the most favorable outcome with a median survival of 70.484 months, significantly higher than non-surgical patients (54.153 months, p< 0.001). Patients who received only chemotherapy (p< 0.001), radiation (p< 0.001) and chemoradiation (p=0.24) had a worse survival outcome compared to those who received other treatment modalities.
Conclusions
The study results indicate that surgical resection could potentially improve survival outcomes for patients diagnosed with advanced-stage laryngeal BSCC. Conversely, for those with earlystage BSCC, larynx-preserving treatment modalities such as radiation, chemotherapy or concurrent chemoradiation appear to achieve comparable survival rates to primary surgical management. These results highlight the importance of careful consideration of treatment modalities based on disease staging at initial presentation.
National Tele-Oncology High-Risk Breast Clinic Program
Background
Assess implementation outcomes of the National Tele-Oncology’s first high-risk breast clinic program, part of the Breast and Gynecological System of Excellence (BGSOE). Women Veterans are the fastest-growing demographic in the Veteran population. Breast cancer (BC) is the most prevalent cancer among women. An estimated 15% of women will be considered high risk for BC at some point during their lifetime. For these reasons, the BGSOE high-risk breast clinic offers screening and risk reduction care to women with an increased risk for BC.
Methods
We described the patients seen in the BGSOE high-risk breast clinic since its implementation in 2023. We collected demographic and geographic information, genetic testing status, imaging, and risk-reducing agents (RRA) use. We reported percentages for categorical variables, followed by the total number of patients in parenthesis.
Results
There are a total of 124 patients served since 2023 (123 female, 1 male). The average age was 44.6 years. 61.3% (76) of patients lived in an urban setting, while 38.7% (48) lived in rural areas. Most patients were White at 63.7% (79), followed by African American 20.2%(25), Other 5.6% (7), and Unknown/declined 10.5%(13). Regarding ethnicity, 9% (12) were Hispanic. The most common reasons for referral to the clinic were a family history of breast cancer 89.2% (111), followed by high-risk genetic pathogenic variants 5.6% (7), mammary dysplasia 3.2% (4), inconclusive imaging 0.8% (1) and personal history of radiation 0.8%(1). 2 patients were started on RRAs. 56% (70) of patients had genetic testing discussions. The clinic coordinated 50 mammograms and 10 breast MRIs.
Conclusions
We demonstrated the successful implementation of the BGSOE high-risk breast program. We reached multiple historically underserved populations, including a high percentage of rural and African American patients. We also facilitated breast MRIs. Similar to other studies, there was a low uptake of RRA in our clinic. BGSOE is now working on a clinical pathway to standardize RRA and breast imaging recommendations for high-risk women. There are many more women Veterans at risk for BC and future expansion of the highrisk breast clinic could further raise awareness of lifetime breast cancer risk and risk-reducing and surveillance options in Veterans.
Background
Assess implementation outcomes of the National Tele-Oncology’s first high-risk breast clinic program, part of the Breast and Gynecological System of Excellence (BGSOE). Women Veterans are the fastest-growing demographic in the Veteran population. Breast cancer (BC) is the most prevalent cancer among women. An estimated 15% of women will be considered high risk for BC at some point during their lifetime. For these reasons, the BGSOE high-risk breast clinic offers screening and risk reduction care to women with an increased risk for BC.
Methods
We described the patients seen in the BGSOE high-risk breast clinic since its implementation in 2023. We collected demographic and geographic information, genetic testing status, imaging, and risk-reducing agents (RRA) use. We reported percentages for categorical variables, followed by the total number of patients in parenthesis.
Results
There are a total of 124 patients served since 2023 (123 female, 1 male). The average age was 44.6 years. 61.3% (76) of patients lived in an urban setting, while 38.7% (48) lived in rural areas. Most patients were White at 63.7% (79), followed by African American 20.2%(25), Other 5.6% (7), and Unknown/declined 10.5%(13). Regarding ethnicity, 9% (12) were Hispanic. The most common reasons for referral to the clinic were a family history of breast cancer 89.2% (111), followed by high-risk genetic pathogenic variants 5.6% (7), mammary dysplasia 3.2% (4), inconclusive imaging 0.8% (1) and personal history of radiation 0.8%(1). 2 patients were started on RRAs. 56% (70) of patients had genetic testing discussions. The clinic coordinated 50 mammograms and 10 breast MRIs.
Conclusions
We demonstrated the successful implementation of the BGSOE high-risk breast program. We reached multiple historically underserved populations, including a high percentage of rural and African American patients. We also facilitated breast MRIs. Similar to other studies, there was a low uptake of RRA in our clinic. BGSOE is now working on a clinical pathway to standardize RRA and breast imaging recommendations for high-risk women. There are many more women Veterans at risk for BC and future expansion of the highrisk breast clinic could further raise awareness of lifetime breast cancer risk and risk-reducing and surveillance options in Veterans.
Background
Assess implementation outcomes of the National Tele-Oncology’s first high-risk breast clinic program, part of the Breast and Gynecological System of Excellence (BGSOE). Women Veterans are the fastest-growing demographic in the Veteran population. Breast cancer (BC) is the most prevalent cancer among women. An estimated 15% of women will be considered high risk for BC at some point during their lifetime. For these reasons, the BGSOE high-risk breast clinic offers screening and risk reduction care to women with an increased risk for BC.
Methods
We described the patients seen in the BGSOE high-risk breast clinic since its implementation in 2023. We collected demographic and geographic information, genetic testing status, imaging, and risk-reducing agents (RRA) use. We reported percentages for categorical variables, followed by the total number of patients in parenthesis.
Results
There are a total of 124 patients served since 2023 (123 female, 1 male). The average age was 44.6 years. 61.3% (76) of patients lived in an urban setting, while 38.7% (48) lived in rural areas. Most patients were White at 63.7% (79), followed by African American 20.2%(25), Other 5.6% (7), and Unknown/declined 10.5%(13). Regarding ethnicity, 9% (12) were Hispanic. The most common reasons for referral to the clinic were a family history of breast cancer 89.2% (111), followed by high-risk genetic pathogenic variants 5.6% (7), mammary dysplasia 3.2% (4), inconclusive imaging 0.8% (1) and personal history of radiation 0.8%(1). 2 patients were started on RRAs. 56% (70) of patients had genetic testing discussions. The clinic coordinated 50 mammograms and 10 breast MRIs.
Conclusions
We demonstrated the successful implementation of the BGSOE high-risk breast program. We reached multiple historically underserved populations, including a high percentage of rural and African American patients. We also facilitated breast MRIs. Similar to other studies, there was a low uptake of RRA in our clinic. BGSOE is now working on a clinical pathway to standardize RRA and breast imaging recommendations for high-risk women. There are many more women Veterans at risk for BC and future expansion of the highrisk breast clinic could further raise awareness of lifetime breast cancer risk and risk-reducing and surveillance options in Veterans.
Creating a Urology Prostate Cancer Note, a National Oncology and Surgery Office Collaboration for Prostate Cancer Clinical Pathway Utilization
Background
Prostate cancer is the most common non-cutaneous malignancy diagnosis within the Department of Veterans Affairs (VA). The Prostate Cancer Clinical Pathways (PCCP) were developed to enable providers to treat all Veterans with prostate cancer at subject matter expert level.
Discussion
The PCCP was launched in February 2021; however, provider documentation of PCCP is variable across the VA healthcare system and within the PCCP, specific flow maps have differential use. For example, the Very Low Risk flow map has seven unique Veterans entered, whereas the Molecular Testing flow map has over 3,900 unique Veterans entered. One clear reason for this disparity in pathway documentation use is that local prostate cancer is managed by urology and their documentation of the PCCP is not as widespread as the medical oncologists. The National Oncology Program developed clinical note templates to document PCCP that medical oncologist use which has increased utilization. To increase urology specific flow map use, a collaboration between the National Surgery Office and National Oncology Program was established to develop a Urology Prostate Cancer Note (UPCN). The UPCN was designed by urologists with assistance from a medical oncologist and a clinical applications coordinator. The UPCN will function as a working clinical note for urologists and has the PCCPs embedded into reminder dialog templates, which when completed generate health factors. The health factors that are generated from the UPCN are data mined to record PCCP use and to perform data analytics. The UPCN is in the testing phase at three pilot test sites and is scheduled to be deployed summer 2024. The collaborative effort is aligned with the VHA directives outlined in the Cleland Dole Act.
Background
Prostate cancer is the most common non-cutaneous malignancy diagnosis within the Department of Veterans Affairs (VA). The Prostate Cancer Clinical Pathways (PCCP) were developed to enable providers to treat all Veterans with prostate cancer at subject matter expert level.
Discussion
The PCCP was launched in February 2021; however, provider documentation of PCCP is variable across the VA healthcare system and within the PCCP, specific flow maps have differential use. For example, the Very Low Risk flow map has seven unique Veterans entered, whereas the Molecular Testing flow map has over 3,900 unique Veterans entered. One clear reason for this disparity in pathway documentation use is that local prostate cancer is managed by urology and their documentation of the PCCP is not as widespread as the medical oncologists. The National Oncology Program developed clinical note templates to document PCCP that medical oncologist use which has increased utilization. To increase urology specific flow map use, a collaboration between the National Surgery Office and National Oncology Program was established to develop a Urology Prostate Cancer Note (UPCN). The UPCN was designed by urologists with assistance from a medical oncologist and a clinical applications coordinator. The UPCN will function as a working clinical note for urologists and has the PCCPs embedded into reminder dialog templates, which when completed generate health factors. The health factors that are generated from the UPCN are data mined to record PCCP use and to perform data analytics. The UPCN is in the testing phase at three pilot test sites and is scheduled to be deployed summer 2024. The collaborative effort is aligned with the VHA directives outlined in the Cleland Dole Act.
Background
Prostate cancer is the most common non-cutaneous malignancy diagnosis within the Department of Veterans Affairs (VA). The Prostate Cancer Clinical Pathways (PCCP) were developed to enable providers to treat all Veterans with prostate cancer at subject matter expert level.
Discussion
The PCCP was launched in February 2021; however, provider documentation of PCCP is variable across the VA healthcare system and within the PCCP, specific flow maps have differential use. For example, the Very Low Risk flow map has seven unique Veterans entered, whereas the Molecular Testing flow map has over 3,900 unique Veterans entered. One clear reason for this disparity in pathway documentation use is that local prostate cancer is managed by urology and their documentation of the PCCP is not as widespread as the medical oncologists. The National Oncology Program developed clinical note templates to document PCCP that medical oncologist use which has increased utilization. To increase urology specific flow map use, a collaboration between the National Surgery Office and National Oncology Program was established to develop a Urology Prostate Cancer Note (UPCN). The UPCN was designed by urologists with assistance from a medical oncologist and a clinical applications coordinator. The UPCN will function as a working clinical note for urologists and has the PCCPs embedded into reminder dialog templates, which when completed generate health factors. The health factors that are generated from the UPCN are data mined to record PCCP use and to perform data analytics. The UPCN is in the testing phase at three pilot test sites and is scheduled to be deployed summer 2024. The collaborative effort is aligned with the VHA directives outlined in the Cleland Dole Act.
Inhaled Insulin Aids Patients With Fear of Needles
This transcript has been edited for clarity.
Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada.
Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.
One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.
Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles.
Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.
Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin?
James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.
The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.
I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.
I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.
Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.
Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.
Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin.
Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided.
Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.
That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.
What are your thoughts, Dr. Kim, based on this for your practice in primary care?
Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.
I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?
What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.
Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.
If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?
Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.
However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging.
On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.
Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge.
I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada.
Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.
One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.
Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles.
Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.
Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin?
James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.
The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.
I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.
I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.
Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.
Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.
Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin.
Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided.
Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.
That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.
What are your thoughts, Dr. Kim, based on this for your practice in primary care?
Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.
I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?
What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.
Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.
If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?
Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.
However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging.
On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.
Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge.
I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Akshay B. Jain, MD: I’m Dr. Akshay Jain, an endocrinologist from Vancouver, and I’m joined by Dr. James Kim, a primary care physician from Calgary, Canada.
Both Dr. Kim and I attended ADA 2024. We went over all our learnings and decided that there was a whole heap of clinical pearls that we learned from the conference. We thought it would be awesome if we could share our learnings with all of you, both from a primary care lens and from an endocrinology perspective.
One study Dr. Kim and I learned about, and we think has some definite nuances in management of people living with diabetes, regards inhaled insulin. When we have patients in our clinic who have perhaps failed multiple oral agents or have very high blood sugars, we obviously want to consider starting them on insulin for type 2 diabetes.
Sometimes there is a significant barrier, which is related to the needles. There’s an actual term for this: trypanophobia — a fear of needles.
Enter now inhaled insulin. We saw studies at the ADA 2024 conference that looked at a new inhaled insulin called Afrezza. Afrezza essentially is a short-acting insulin, so it’s kind of like a prandial insulin derivative, where it can be inhaled by an individual and it will work for mealtime control of blood sugars.
Dr. Kim, in your practice, how often do you see people not wanting to take shots, and has this been a big barrier for you in starting insulin?
James W. Kim, MBBCh, PgDip, MScCH: Thank you for having me. To answer your question, absolutely I encounter this on a weekly basis — and I’m not even an endocrinologist. I just have an interest in diabetes. There are a number of patients that I think will benefit massively with insulin but they’re needle-phobic. You taught me that word, but I can never pronounce it, so my apologies for not remembering that phobia. I’m just going to call it needle phobia because I’m a simple-minded person.
The needle phobia is massive. I think there’s a definite fear of the needle, but there’s also a fear of failure. As soon as an injection is mentioned, many patients feel they failed miserably. There’s an emotional roller coaster that happens.
I’m sure, Dr. Jain, you have seen many patients, especially from Asia, who would say: “Oh, my auntie got on insulin and 3 months later, she got a kidney transplant.” “My uncle started on insulin and he unfortunately passed away a couple of months later.” Unfortunately, they’re blaming many of those things on insulin.
I also have a number of patients who said they were on insulin before many years ago, and they experienced some severe hypoglycemic events, and they don’t want to get on the insulin ever again. This is unfortunate because you know that if those patients, those aunties and uncles, were on insulin long before, maybe we could have saved their legs and kidneys, and potentially death.
Now we have advanced so much with insulin that hypoglycemia does occur, but much less than before. We still have many barriers when it comes to insulin initiations. Therefore, having this idea of inhaled insulin is fantastic, and I think we can get many more patients on insulin — the medication they actually need.
Dr. Jain: Absolutely. From the studies on inhaled insulin at ADA 2024, the key thing I found very interesting, regarding the pharmacokinetics of the insulin, was that it’s working very quickly. It starts working within minutes of administering it.
Additionally, it lasts in the body only for a shorter duration of time, compared with other injectable short-acting insulins, so it lasts in the body. The active insulin time is roughly about 2 hours or so, based on the studies, which in my mind opens up a whole world of possibilities because it means that people can take another correctional insulin if the blood sugars are still high after taking their first inhaled dose. You can take another dose subsequently without worrying about stacking of insulin.
Many of us are familiar with this term, which is if you take two shots of short-acting insulin too close to each other, the insulin doses might add up and there can be a big drop in the blood sugars; it’s called stacking of insulin. This can be potentially avoided.
Similarly, if you take your dinnertime inhaled insulin and the sugars are still high around bedtime, you could take a smaller dose of the inhaled insulin and not worry about middle-of-the-night hypoglycemia because the effect of the insulin would be only for a little while.
That’s one key learning that I found very helpful. The other important thing that I found was that this is not for everyone, so there are some restrictions. Essentially, the contraindication is that people who have asthma or COPD cannot be prescribed an inhaled insulin.
What are your thoughts, Dr. Kim, based on this for your practice in primary care?
Dr. Kim: It is very fascinating, for sure. I cannot wait to get hold of this insulin. I can already think of some patients who may benefit. You’ve mentioned the asthma and COPD patients, and that makes more sense because there is an actual airway problem.
I also wonder what will happen to patients who have restrictive airway disease, where asthma and COPD fall under obstructive airway disease. What if they have obesity, where it’s really pressing into the diaphragm, and where they may not be able to take the deep breath in? How will they react?
What about someone who’s got a cold, someone who has postnasal drip, or someone who tends to cough frequently? What about egg allergies? There are many question marks around this insulin before initiating these medications. There is excitement, but there are also many questions at the same time.
Dr. Jain: I think these are very important, practical considerations that we’ll uncover as we start using more of this in clinical practice. The other important thing to note is that the presenters told us it’s important to monitor pulmonary function tests. It’s important to get a baseline pulmonary function test, and then we have to do another one in 6 months, followed by annually thereafter.
If, at any point of time, the FEV1 drops by 20% or more, then that would be an indication for discontinuation of the inhaled insulin. The pulmonary function test does not need to be one of those fancier ones. The study group would just do office spirometries. I’m wondering, Dr. Kim, in primary care, do you think this could potentially be a rate-limiting factor?
Dr. Kim: In Alberta, where I reside, no. Spirometry is very easily accessible in the province. For example, in Calgary alone, we have a population of about 1.3 million people. We have over 13 or 15 companies that can do this spirometry. We can get these things done literally within a week or 2.
However, I am aware that, in other provinces in Canada, it can definitely be a huge rate-limiting factor. Not everyone has the office-based spirometry, and definitely not within the primary care office. It has to be referred out to these private companies, most likely, and some of the rural areas will have to rely on the provincial hospitals, where the access can be even more challenging.
On the day of the actual spirometry, if the person has a cough or is not feeling well, it’s going to be a problem because you don’t want the spirometry to be infected with a whole bunch of viruses. You’ll have to cancel that and it can be a bit of an issue.
Dr. Jain: Many of our viewers are from the United States and other parts of the world, and spirometry is quite easily accessible in most places. As an endocrinologist, I must confess that it’s been a long time since I’ve even ordered a spirometry or any clinical form of pulmonary function test. Once I start using the inhaled insulin, I’ll need to start brushing up on my pulmonary function test knowledge.
I think these are exciting times. At least we’ve got something to offer to people who would have otherwise not taken any insulin at all. There’s certainly that hope that now there’s a different way to administer this, and hopefully it can only get better from here on.
Dr. Jain is a clinical instructor, Department of Endocrinology, University of British Columbia, Vancouver. Dr. Kim is a clinical assistant professor, Department of Family Medicine, University of Calgary in Alberta. Both disclosed conflicts of interest with numerous pharmaceutical companies.
A version of this article first appeared on Medscape.com.
FROM ADA 2024
Baseline Patient-Reported Care Metrics in a VA Hematology/Oncology Clinic Prior to Implementation of the 4R (Right Information and Right Care for the Right Patient at the Right Time) Oncology Model
Background
The Jesse Brown Veterans Affairs Medical Center (JBVAMC) serves predominantly Black American veterans, many with significant psychosocial needs, who live in Chicago’s South and West sides and Northwest Indiana. The JBVAMC hematology/oncology clinic is adopting the 4R Oncology Model (Right Info/ Care/Patient/Time) for patient-facing care planning and self-management, to enhance supportive and health maintenance care delivery. In order to guide the integration of the 4R model, baseline data were collected regarding patients’ understanding of their disease, social determinants of health, and use of services offered by JBVAMC.
Methods
Patients at JBVAMC were surveyed from February 2023 to September 2023. As a small incentive, these veterans received a $25 gift card for their participation. Analysis was conducted using descriptive statistics.
Results
Survey response rate was 67% (30/45). Median age was 66 (range 38-80). The population was 93% male, 83% black, 57% with highest level of education being high school or less, 59% with annual income less than $30k, and 47% living alone. Less than half (43%) of respondents knew their stage of cancer at diagnosis, and only 63% were aware of their treatment goals. Furthermore, only 17% remember receiving recommendations for support services that may be available through JBVAMC such as transportation assistance and home care. Information regarding “emotional distress or worry support recommendations” was acquired by 24% of veteran respondents. More than half, 57%, of veterans were encouraged to talk to their primary care provider about routine health maintenance during cancer treatment. Just over a quarter, 27%, were referred to a dietician.
Conclusions
This survey uncovered gaps in care planning, supportive services, and health maintenance care. These data will serve as a baseline to assess the effectiveness of the 4R care plan model. The implementation of the 4R Oncology Model is designed to address these gaps by providing a personalized care sequence that establishes a clear roadmap through the patient’s care trajectory, ultimately enhancing patient-centered care. Post-intervention survey results will be shared when available.
Background
The Jesse Brown Veterans Affairs Medical Center (JBVAMC) serves predominantly Black American veterans, many with significant psychosocial needs, who live in Chicago’s South and West sides and Northwest Indiana. The JBVAMC hematology/oncology clinic is adopting the 4R Oncology Model (Right Info/ Care/Patient/Time) for patient-facing care planning and self-management, to enhance supportive and health maintenance care delivery. In order to guide the integration of the 4R model, baseline data were collected regarding patients’ understanding of their disease, social determinants of health, and use of services offered by JBVAMC.
Methods
Patients at JBVAMC were surveyed from February 2023 to September 2023. As a small incentive, these veterans received a $25 gift card for their participation. Analysis was conducted using descriptive statistics.
Results
Survey response rate was 67% (30/45). Median age was 66 (range 38-80). The population was 93% male, 83% black, 57% with highest level of education being high school or less, 59% with annual income less than $30k, and 47% living alone. Less than half (43%) of respondents knew their stage of cancer at diagnosis, and only 63% were aware of their treatment goals. Furthermore, only 17% remember receiving recommendations for support services that may be available through JBVAMC such as transportation assistance and home care. Information regarding “emotional distress or worry support recommendations” was acquired by 24% of veteran respondents. More than half, 57%, of veterans were encouraged to talk to their primary care provider about routine health maintenance during cancer treatment. Just over a quarter, 27%, were referred to a dietician.
Conclusions
This survey uncovered gaps in care planning, supportive services, and health maintenance care. These data will serve as a baseline to assess the effectiveness of the 4R care plan model. The implementation of the 4R Oncology Model is designed to address these gaps by providing a personalized care sequence that establishes a clear roadmap through the patient’s care trajectory, ultimately enhancing patient-centered care. Post-intervention survey results will be shared when available.
Background
The Jesse Brown Veterans Affairs Medical Center (JBVAMC) serves predominantly Black American veterans, many with significant psychosocial needs, who live in Chicago’s South and West sides and Northwest Indiana. The JBVAMC hematology/oncology clinic is adopting the 4R Oncology Model (Right Info/ Care/Patient/Time) for patient-facing care planning and self-management, to enhance supportive and health maintenance care delivery. In order to guide the integration of the 4R model, baseline data were collected regarding patients’ understanding of their disease, social determinants of health, and use of services offered by JBVAMC.
Methods
Patients at JBVAMC were surveyed from February 2023 to September 2023. As a small incentive, these veterans received a $25 gift card for their participation. Analysis was conducted using descriptive statistics.
Results
Survey response rate was 67% (30/45). Median age was 66 (range 38-80). The population was 93% male, 83% black, 57% with highest level of education being high school or less, 59% with annual income less than $30k, and 47% living alone. Less than half (43%) of respondents knew their stage of cancer at diagnosis, and only 63% were aware of their treatment goals. Furthermore, only 17% remember receiving recommendations for support services that may be available through JBVAMC such as transportation assistance and home care. Information regarding “emotional distress or worry support recommendations” was acquired by 24% of veteran respondents. More than half, 57%, of veterans were encouraged to talk to their primary care provider about routine health maintenance during cancer treatment. Just over a quarter, 27%, were referred to a dietician.
Conclusions
This survey uncovered gaps in care planning, supportive services, and health maintenance care. These data will serve as a baseline to assess the effectiveness of the 4R care plan model. The implementation of the 4R Oncology Model is designed to address these gaps by providing a personalized care sequence that establishes a clear roadmap through the patient’s care trajectory, ultimately enhancing patient-centered care. Post-intervention survey results will be shared when available.