It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.

The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.

Meanwhile, there are many near-term opportunities for AI to improve health care and reduce tedious and time consuming tasks. Specifically, some AI-based tools are available to use in your office right now, with no “existential” threat to anybody.

The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.

I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.

Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)

AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.

AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.

With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human. 

If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.

Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.

If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.

The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.

Meanwhile, there are many near-term opportunities for AI to improve health care and reduce tedious and time consuming tasks. Specifically, some AI-based tools are available to use in your office right now, with no “existential” threat to anybody.

The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.

I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.

Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)

AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.

AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.

With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human. 

If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.

Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.

If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.

The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.

Meanwhile, there are many near-term opportunities for AI to improve health care and reduce tedious and time consuming tasks. Specifically, some AI-based tools are available to use in your office right now, with no “existential” threat to anybody.

The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.

I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.

Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)

AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.

AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.

With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human. 

If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.

Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.

If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Key clinical point: In patients with locally advanced triple-negative breast cancer (TNBC), neoadjuvant apatinib (Apa) plus dose-dense paclitaxel and carboplatin (ddTCb) was more effective in improving clinical outcomes than ddTCb alone and showed an acceptable safety profile.

Major finding: A significantly higher proportion of patients in the Apa + ddTCb vs ddTCb treatment group achieved pathological complete response (60.9% vs 30.4%; P = .009) and underwent breast-conserving surgery (47.8% vs 21.7%; P = .016). The incidence of adverse events was higher in the Apa + ddTCb treatment arm, but they were generally acceptable.

Study details: This prospective cohort study included 23 patients with stages I-IIIC TNBC who received neoadjuvant Apa + ddTCb therapy matched with 69 patients with stages I-IIIC TNBC who received neoadjuvant ddTCb therapy only.

Disclosures: This study was supported by CAMS Innovation Fund for Medical Sciences and the Translational research project of Medical Oncology Key Foundation of Cancer Hospital, Chinese Academy of Medical Sciences. The authors declared no conflicts of interest.

Source: Liu J, Xu B, Zhang P, et al. Efficacy and safety of apatinib combined with dose-dense paclitaxel and carboplatin in neoadjuvant therapy for locally advanced triple-negative breast cancer: A prospective cohort study with propensity-matched analysis. Int J Cancer. 2023 (Sep 7). doi: 10.1002/ijc.34717

Key clinical point: In patients with locally advanced triple-negative breast cancer (TNBC), neoadjuvant apatinib (Apa) plus dose-dense paclitaxel and carboplatin (ddTCb) was more effective in improving clinical outcomes than ddTCb alone and showed an acceptable safety profile.

Major finding: A significantly higher proportion of patients in the Apa + ddTCb vs ddTCb treatment group achieved pathological complete response (60.9% vs 30.4%; P = .009) and underwent breast-conserving surgery (47.8% vs 21.7%; P = .016). The incidence of adverse events was higher in the Apa + ddTCb treatment arm, but they were generally acceptable.

Study details: This prospective cohort study included 23 patients with stages I-IIIC TNBC who received neoadjuvant Apa + ddTCb therapy matched with 69 patients with stages I-IIIC TNBC who received neoadjuvant ddTCb therapy only.

Disclosures: This study was supported by CAMS Innovation Fund for Medical Sciences and the Translational research project of Medical Oncology Key Foundation of Cancer Hospital, Chinese Academy of Medical Sciences. The authors declared no conflicts of interest.

Source: Liu J, Xu B, Zhang P, et al. Efficacy and safety of apatinib combined with dose-dense paclitaxel and carboplatin in neoadjuvant therapy for locally advanced triple-negative breast cancer: A prospective cohort study with propensity-matched analysis. Int J Cancer. 2023 (Sep 7). doi: 10.1002/ijc.34717

Key clinical point: In patients with locally advanced triple-negative breast cancer (TNBC), neoadjuvant apatinib (Apa) plus dose-dense paclitaxel and carboplatin (ddTCb) was more effective in improving clinical outcomes than ddTCb alone and showed an acceptable safety profile.

Major finding: A significantly higher proportion of patients in the Apa + ddTCb vs ddTCb treatment group achieved pathological complete response (60.9% vs 30.4%; P = .009) and underwent breast-conserving surgery (47.8% vs 21.7%; P = .016). The incidence of adverse events was higher in the Apa + ddTCb treatment arm, but they were generally acceptable.

Study details: This prospective cohort study included 23 patients with stages I-IIIC TNBC who received neoadjuvant Apa + ddTCb therapy matched with 69 patients with stages I-IIIC TNBC who received neoadjuvant ddTCb therapy only.

Disclosures: This study was supported by CAMS Innovation Fund for Medical Sciences and the Translational research project of Medical Oncology Key Foundation of Cancer Hospital, Chinese Academy of Medical Sciences. The authors declared no conflicts of interest.

Source: Liu J, Xu B, Zhang P, et al. Efficacy and safety of apatinib combined with dose-dense paclitaxel and carboplatin in neoadjuvant therapy for locally advanced triple-negative breast cancer: A prospective cohort study with propensity-matched analysis. Int J Cancer. 2023 (Sep 7). doi: 10.1002/ijc.34717

Key clinical point: Trifluridine/tipiracil (FTD/TPI) showed promising anti-tumor activity with a manageable safety profile regardless of prior exposure to fluoropyrimidine therapy in patients with metastatic breast cancer (BC).

Major finding: The median durations of progression-free survival were 5.7 months and 9.4 months in patients with and without prior exposure to fluoropyrimidine therapy, respectively. Neutropenia (81.8%), fatigue (29.7%), anorexia (25.7%), and nausea (25.7%) were the most common all-grade treatment-related adverse events.

Study details: Findings are from a phase 2 study including 74 patients with metastatic BC with or without prior exposure to fluoropyrimidine therapy who received FTD/TPI.

Disclosures: This study was funded by a grant from the National Medical Research Council, Singapore. Some authors declared receiving research funding, honoraria, consulting fees, or travel support from or having other ties with various sources.

Source: Lim JSJ et al. Phase II study of trifluridine/tipiracil (FTD/TPI) in metastatic breast cancers with or without prior exposure to fluoropyrimidines. Eur J Cancer. 2023;113311 (Aug 25). doi: 10.1016/j.ejca.2023.113311

Key clinical point: Trifluridine/tipiracil (FTD/TPI) showed promising anti-tumor activity with a manageable safety profile regardless of prior exposure to fluoropyrimidine therapy in patients with metastatic breast cancer (BC).

Major finding: The median durations of progression-free survival were 5.7 months and 9.4 months in patients with and without prior exposure to fluoropyrimidine therapy, respectively. Neutropenia (81.8%), fatigue (29.7%), anorexia (25.7%), and nausea (25.7%) were the most common all-grade treatment-related adverse events.

Study details: Findings are from a phase 2 study including 74 patients with metastatic BC with or without prior exposure to fluoropyrimidine therapy who received FTD/TPI.

Disclosures: This study was funded by a grant from the National Medical Research Council, Singapore. Some authors declared receiving research funding, honoraria, consulting fees, or travel support from or having other ties with various sources.

Source: Lim JSJ et al. Phase II study of trifluridine/tipiracil (FTD/TPI) in metastatic breast cancers with or without prior exposure to fluoropyrimidines. Eur J Cancer. 2023;113311 (Aug 25). doi: 10.1016/j.ejca.2023.113311

Key clinical point: Trifluridine/tipiracil (FTD/TPI) showed promising anti-tumor activity with a manageable safety profile regardless of prior exposure to fluoropyrimidine therapy in patients with metastatic breast cancer (BC).

Major finding: The median durations of progression-free survival were 5.7 months and 9.4 months in patients with and without prior exposure to fluoropyrimidine therapy, respectively. Neutropenia (81.8%), fatigue (29.7%), anorexia (25.7%), and nausea (25.7%) were the most common all-grade treatment-related adverse events.

Study details: Findings are from a phase 2 study including 74 patients with metastatic BC with or without prior exposure to fluoropyrimidine therapy who received FTD/TPI.

Disclosures: This study was funded by a grant from the National Medical Research Council, Singapore. Some authors declared receiving research funding, honoraria, consulting fees, or travel support from or having other ties with various sources.

Source: Lim JSJ et al. Phase II study of trifluridine/tipiracil (FTD/TPI) in metastatic breast cancers with or without prior exposure to fluoropyrimidines. Eur J Cancer. 2023;113311 (Aug 25). doi: 10.1016/j.ejca.2023.113311

Key clinical point: Giredestrant demonstrated stronger anti-proliferative activity than anastrozole and was well-tolerated in patients with estrogen receptor-positive (ER+ ), human epidermal growth factor receptor 2-negative (HER2−), untreated early breast cancer (BC).

Major finding: At week 2, giredestrant vs anastrozole had a stronger anti-proliferative effect as indicated by greater relative geometric mean reduction of Ki67 scores (−75% vs −67%; P = .043). Neutropenia (26% and 27%, respectively) and decreased neutrophil count (15% and 15%, respectively) were the most common grade 3-4 adverse events observed in the giredestrant + palbociclib and anastrozole + palbociclib treatment arms.

Study details: Findings are from the phase 2 coopERA Breast Cancer trial including 221 postmenopausal patients with clinical T stage (cT)1c to cT4a-c, ER+ /HER2− early BC who were randomly assigned to receive giredestrant or anastrozole in combination with palbociclib.

Disclosures: This study was funded by F Hoffmann-La Roche. Seven authors declared being employees or stockholders of F Hoffmann-La Roche, and the other authors declared ties with various sources.

Source: Hurvitz SA et al on behalf of thecoopERA Breast Cancer study group. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): An open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2023;24(9):1029-1041 (Aug 29). doi: 10.1016/S1470-2045(23)00268-1

Key clinical point: Giredestrant demonstrated stronger anti-proliferative activity than anastrozole and was well-tolerated in patients with estrogen receptor-positive (ER+ ), human epidermal growth factor receptor 2-negative (HER2−), untreated early breast cancer (BC).

Major finding: At week 2, giredestrant vs anastrozole had a stronger anti-proliferative effect as indicated by greater relative geometric mean reduction of Ki67 scores (−75% vs −67%; P = .043). Neutropenia (26% and 27%, respectively) and decreased neutrophil count (15% and 15%, respectively) were the most common grade 3-4 adverse events observed in the giredestrant + palbociclib and anastrozole + palbociclib treatment arms.

Study details: Findings are from the phase 2 coopERA Breast Cancer trial including 221 postmenopausal patients with clinical T stage (cT)1c to cT4a-c, ER+ /HER2− early BC who were randomly assigned to receive giredestrant or anastrozole in combination with palbociclib.

Disclosures: This study was funded by F Hoffmann-La Roche. Seven authors declared being employees or stockholders of F Hoffmann-La Roche, and the other authors declared ties with various sources.

Source: Hurvitz SA et al on behalf of thecoopERA Breast Cancer study group. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): An open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2023;24(9):1029-1041 (Aug 29). doi: 10.1016/S1470-2045(23)00268-1

Key clinical point: Giredestrant demonstrated stronger anti-proliferative activity than anastrozole and was well-tolerated in patients with estrogen receptor-positive (ER+ ), human epidermal growth factor receptor 2-negative (HER2−), untreated early breast cancer (BC).

Major finding: At week 2, giredestrant vs anastrozole had a stronger anti-proliferative effect as indicated by greater relative geometric mean reduction of Ki67 scores (−75% vs −67%; P = .043). Neutropenia (26% and 27%, respectively) and decreased neutrophil count (15% and 15%, respectively) were the most common grade 3-4 adverse events observed in the giredestrant + palbociclib and anastrozole + palbociclib treatment arms.

Study details: Findings are from the phase 2 coopERA Breast Cancer trial including 221 postmenopausal patients with clinical T stage (cT)1c to cT4a-c, ER+ /HER2− early BC who were randomly assigned to receive giredestrant or anastrozole in combination with palbociclib.

Disclosures: This study was funded by F Hoffmann-La Roche. Seven authors declared being employees or stockholders of F Hoffmann-La Roche, and the other authors declared ties with various sources.

Source: Hurvitz SA et al on behalf of thecoopERA Breast Cancer study group. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): An open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2023;24(9):1029-1041 (Aug 29). doi: 10.1016/S1470-2045(23)00268-1

Key clinical point: The incidence rate of local recurrence was low even after omitting radiotherapy in women with luminal A breast cancer (BC) age ≥55 years who underwent breast-conserving surgery (BCS) followed by endocrine therapy.

Major finding: At 5 years, the cumulative incidence of local recurrence was low (2.3%; 95% CI 1.2%-4.1%), with 1.9% of patients (90% CI 1.1%-3.2%) reporting contralateral BC recurrences and 2.7% of patients (90% CI 1.6%-4.1%) reporting recurrences of any type.

Study details: This prospective cohort study included 500 women with T1N0 (tumor size < 2 cm and node negative) luminal A BC age ≥ 55 years who had undergone BCS followed by adjuvant endocrine therapy.

Disclosures: This study was supported by the Canadian Cancer Society and Canadian Breast Cancer Foundation. Some authors declared serving as consultants or members of data safety and monitoring boards or having ties with various sources.

Source: Whelan TJ et al for the LUMINA Study Investigators. Omitting radiotherapy after breast-conserving surgery in luminal A breast cancer. N Engl J Med. 2023;389(7):612-619 (Aug 17). doi: 10.1056/NEJMoa2302344

Key clinical point: The incidence rate of local recurrence was low even after omitting radiotherapy in women with luminal A breast cancer (BC) age ≥55 years who underwent breast-conserving surgery (BCS) followed by endocrine therapy.

Major finding: At 5 years, the cumulative incidence of local recurrence was low (2.3%; 95% CI 1.2%-4.1%), with 1.9% of patients (90% CI 1.1%-3.2%) reporting contralateral BC recurrences and 2.7% of patients (90% CI 1.6%-4.1%) reporting recurrences of any type.

Study details: This prospective cohort study included 500 women with T1N0 (tumor size < 2 cm and node negative) luminal A BC age ≥ 55 years who had undergone BCS followed by adjuvant endocrine therapy.

Disclosures: This study was supported by the Canadian Cancer Society and Canadian Breast Cancer Foundation. Some authors declared serving as consultants or members of data safety and monitoring boards or having ties with various sources.

Source: Whelan TJ et al for the LUMINA Study Investigators. Omitting radiotherapy after breast-conserving surgery in luminal A breast cancer. N Engl J Med. 2023;389(7):612-619 (Aug 17). doi: 10.1056/NEJMoa2302344

Key clinical point: The incidence rate of local recurrence was low even after omitting radiotherapy in women with luminal A breast cancer (BC) age ≥55 years who underwent breast-conserving surgery (BCS) followed by endocrine therapy.

Major finding: At 5 years, the cumulative incidence of local recurrence was low (2.3%; 95% CI 1.2%-4.1%), with 1.9% of patients (90% CI 1.1%-3.2%) reporting contralateral BC recurrences and 2.7% of patients (90% CI 1.6%-4.1%) reporting recurrences of any type.

Study details: This prospective cohort study included 500 women with T1N0 (tumor size < 2 cm and node negative) luminal A BC age ≥ 55 years who had undergone BCS followed by adjuvant endocrine therapy.

Disclosures: This study was supported by the Canadian Cancer Society and Canadian Breast Cancer Foundation. Some authors declared serving as consultants or members of data safety and monitoring boards or having ties with various sources.

Source: Whelan TJ et al for the LUMINA Study Investigators. Omitting radiotherapy after breast-conserving surgery in luminal A breast cancer. N Engl J Med. 2023;389(7):612-619 (Aug 17). doi: 10.1056/NEJMoa2302344

The RNA interference therapeutic patisiran (Onpattro) is one step closer to being approved in the United States for treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.

The Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration has voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy – although many panel members questioned whether the benefits are clinically meaningful.

ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, and fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.

Intravenously administered patisiran is already approved in the United States and Canada for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.

In the APOLLO-B trial, patisiran showed a statistically significant and clinically meaningful benefit on functional capacity, as measured by the 6-minute walk test, compared with placebo, in patients with ATTR amyloidosis with cardiomyopathy.

The study also met its first secondary endpoint, demonstrating a statistically significant and clinically meaningful benefit on health status and quality of life.

But in explaining her “no” vote, committee member C. Noel Bairey Merz, MD, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said she “did not feel like there was benefit” using existing clinically relevant thresholds typically used in cardiology.

Committee chair Javed Butler, MD, MPH, Baylor Scott & White Research Institute, Dallas, who also voted no, said he “struggled” with this vote and emphasized that it “absolutely does not reflect that there is not a potential with the therapy.”

Dr. Butler said he voted no largely because he wasn’t sure whether the benefits are clinically meaningful in the context of the study design and how it was conducted. He did not have any safety concerns, which was the general feeling of the committee.

Edward Kasper, MD, Johns Hopkins University, Baltimore, who voted in favor of patisiran for ATTR amyloidosis with cardiomyopathy, said there is a “light wind for benefit and no wind for risk. So, if you’re asking do benefits outweigh the risks, the answer is yes.”

But Dr. Kasper also noted: “It would have been a more difficult question to answer: Is there clinically meaningful benefit versus risk? But that’s not what the question asked.”

In explaining his “yes” vote, Ravi Thadhani, MD, MPH, Emory University, Atlanta, said: “We’re dealing with a rare disease with few options and devastating consequences. We heard from clinicians loud and clear, and from patients for that matter, that options and alternatives are critical, and that there is a continuous decline of cardiac function and worsening of disease in a number of patients that have received the current standard of care. For me, the benefits outweigh the risks.”

Dr. Thadhani also noted that from the data provided, no benefit was shown – ”disappointingly” he lamented – for women, for Black persons, and among individuals who were receiving tafamidis, and he urged the FDA and sponsor to consider this.

The FDA has set a target action date for patisiran for ATTR amyloidosis cardiomyopathy of Oct. 8.

A version of this article first appeared on Medscape.com.

The RNA interference therapeutic patisiran (Onpattro) is one step closer to being approved in the United States for treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.

The Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration has voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy – although many panel members questioned whether the benefits are clinically meaningful.

ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, and fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.

Intravenously administered patisiran is already approved in the United States and Canada for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.

In the APOLLO-B trial, patisiran showed a statistically significant and clinically meaningful benefit on functional capacity, as measured by the 6-minute walk test, compared with placebo, in patients with ATTR amyloidosis with cardiomyopathy.

The study also met its first secondary endpoint, demonstrating a statistically significant and clinically meaningful benefit on health status and quality of life.

But in explaining her “no” vote, committee member C. Noel Bairey Merz, MD, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said she “did not feel like there was benefit” using existing clinically relevant thresholds typically used in cardiology.

Committee chair Javed Butler, MD, MPH, Baylor Scott & White Research Institute, Dallas, who also voted no, said he “struggled” with this vote and emphasized that it “absolutely does not reflect that there is not a potential with the therapy.”

Dr. Butler said he voted no largely because he wasn’t sure whether the benefits are clinically meaningful in the context of the study design and how it was conducted. He did not have any safety concerns, which was the general feeling of the committee.

Edward Kasper, MD, Johns Hopkins University, Baltimore, who voted in favor of patisiran for ATTR amyloidosis with cardiomyopathy, said there is a “light wind for benefit and no wind for risk. So, if you’re asking do benefits outweigh the risks, the answer is yes.”

But Dr. Kasper also noted: “It would have been a more difficult question to answer: Is there clinically meaningful benefit versus risk? But that’s not what the question asked.”

In explaining his “yes” vote, Ravi Thadhani, MD, MPH, Emory University, Atlanta, said: “We’re dealing with a rare disease with few options and devastating consequences. We heard from clinicians loud and clear, and from patients for that matter, that options and alternatives are critical, and that there is a continuous decline of cardiac function and worsening of disease in a number of patients that have received the current standard of care. For me, the benefits outweigh the risks.”

Dr. Thadhani also noted that from the data provided, no benefit was shown – ”disappointingly” he lamented – for women, for Black persons, and among individuals who were receiving tafamidis, and he urged the FDA and sponsor to consider this.

The FDA has set a target action date for patisiran for ATTR amyloidosis cardiomyopathy of Oct. 8.

A version of this article first appeared on Medscape.com.

The RNA interference therapeutic patisiran (Onpattro) is one step closer to being approved in the United States for treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.

The Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration has voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy – although many panel members questioned whether the benefits are clinically meaningful.

ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, and fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.

Intravenously administered patisiran is already approved in the United States and Canada for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.

In the APOLLO-B trial, patisiran showed a statistically significant and clinically meaningful benefit on functional capacity, as measured by the 6-minute walk test, compared with placebo, in patients with ATTR amyloidosis with cardiomyopathy.

The study also met its first secondary endpoint, demonstrating a statistically significant and clinically meaningful benefit on health status and quality of life.

But in explaining her “no” vote, committee member C. Noel Bairey Merz, MD, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said she “did not feel like there was benefit” using existing clinically relevant thresholds typically used in cardiology.

Committee chair Javed Butler, MD, MPH, Baylor Scott & White Research Institute, Dallas, who also voted no, said he “struggled” with this vote and emphasized that it “absolutely does not reflect that there is not a potential with the therapy.”

Dr. Butler said he voted no largely because he wasn’t sure whether the benefits are clinically meaningful in the context of the study design and how it was conducted. He did not have any safety concerns, which was the general feeling of the committee.

Edward Kasper, MD, Johns Hopkins University, Baltimore, who voted in favor of patisiran for ATTR amyloidosis with cardiomyopathy, said there is a “light wind for benefit and no wind for risk. So, if you’re asking do benefits outweigh the risks, the answer is yes.”

But Dr. Kasper also noted: “It would have been a more difficult question to answer: Is there clinically meaningful benefit versus risk? But that’s not what the question asked.”

In explaining his “yes” vote, Ravi Thadhani, MD, MPH, Emory University, Atlanta, said: “We’re dealing with a rare disease with few options and devastating consequences. We heard from clinicians loud and clear, and from patients for that matter, that options and alternatives are critical, and that there is a continuous decline of cardiac function and worsening of disease in a number of patients that have received the current standard of care. For me, the benefits outweigh the risks.”

Dr. Thadhani also noted that from the data provided, no benefit was shown – ”disappointingly” he lamented – for women, for Black persons, and among individuals who were receiving tafamidis, and he urged the FDA and sponsor to consider this.

The FDA has set a target action date for patisiran for ATTR amyloidosis cardiomyopathy of Oct. 8.

A version of this article first appeared on Medscape.com.

Recently, my office received several phone calls from patients asking if I perform “trap tox.” Having not been on social media around that time, I assumed the term had something to do with botulinum toxin and the trapezius muscle, but I had never heard it before. Not too long afterwards, patients were asking me about it in the office, using the same terminology, and I had several calls about it in one day. When I asked one trusted patient where she’d heard this term, which seemed to be trending, she told me that she had seen it on Instagram, as an ad or a “suggested for you” post.

Whether it’s a different name or term for a cosmetic procedure or laser we use that I’ve never heard before – such as “lip flip” or trap tox (also known as “Barbie Botox”) – many of these trendy terms spread like wildfire on social media. Some of the terms may be marketing tools started and spread by doctors who perform aesthetic procedures, something I don’t recommend as it only creates confusion for patients and practitioners, similar to the confusion consumers face regarding the plethora of over-the-counter skin care options and the marketing terms used for them. Other terms and trends are also started by nonphysician or non–professionally trained providers, sometimes leading to an unsafe or misleading term for an aesthetic procedure.

Over the past few years, several articles about the impact of social media in aesthetics have been published. In one recent paper, published in 2022, Boen and Jerdan noted that 72% of people in the United States use social media, up from 5% of American adults in 2005. In the United States, they note, “YouTube is the most popular platform with 73% of adult users, followed by Facebook (69%), Instagram (37%), SnapChat (24%), and Twitter (22%). Of the sites used daily, Facebook has the most activity (74%), followed by Instagram (64%), SnapChat (63%), YouTube (51%), and Twitter (42%).” They argue that the pros of social media in aesthetic medicine include its use as an educational tool by medical professionals to educate and provide accurate information about cosmetic procedures, and that “providing factual and evidence-based medical information to the public can help to counteract the abundant misinformation that is out there.” The cons include misinformation, no credentialing verification of the provider of the information – essentially anyone can be an “influencer” – as well as the addictive nature of social media for the consumer.

Along the same lines, younger patients tend to rely more on social media in choosing treatments and providers, further perpetuating any anxiety created from misinformation and unrealistic expectations from nonmedical influencers regarding procedures, filters used on photographs, photo editing, etc., in achieving an aesthetic result.

Physicians, particularly fellowship-trained aesthetic and surgical dermatologists, plastic and reconstructive surgeons, oculoplastic surgeons, and ENT facial plastic surgeons, who have the most training, knowledge, and expertise about aesthetic procedures, often have the least amount of time to devote to education via social media, compared with nonmedical influencers. Unless sponsored, they are also not being compensated for using it as an educational tool, except for potential indirect compensation from using it as a marketing tool for themselves and their practices. In contrast, nonmedical influencers often have many followers and time to create content, and in some cases, this is their full-time job.

All in all, most authors agree that social media has been associated with an increased acceptance of cosmetic surgery and procedures. Whether it be a trend seen on social media, or viewing one’s appearance in a filtered or photoediting app, or seeing an image of how another person looks (similar to how people in magazines, films and on television, were viewed in the past), social media has piqued people’s interest in aesthetics. It remains a balance for interested physicians to help keep information about cosmetic procedures presented in a healthy, interesting, professional, and accurate manner, and in a non–time-consuming way.

Dr. Wesley practices dermatology in Beverly Hills, Calif. Write to her at [email protected]. She had no relevant disclosures.
 

References

Boen M and Jerdan K. Clin Dermatol. 2022 Jan-Feb;40(1):45-8.

Chen J et al. JAMA Facial Plast Surg. 2019 Sep 1;21(5):361-7.

Chopan M et al. Plast Reconstr Surg. 2019 Apr;143(4):1259-65.

Recently, my office received several phone calls from patients asking if I perform “trap tox.” Having not been on social media around that time, I assumed the term had something to do with botulinum toxin and the trapezius muscle, but I had never heard it before. Not too long afterwards, patients were asking me about it in the office, using the same terminology, and I had several calls about it in one day. When I asked one trusted patient where she’d heard this term, which seemed to be trending, she told me that she had seen it on Instagram, as an ad or a “suggested for you” post.

Whether it’s a different name or term for a cosmetic procedure or laser we use that I’ve never heard before – such as “lip flip” or trap tox (also known as “Barbie Botox”) – many of these trendy terms spread like wildfire on social media. Some of the terms may be marketing tools started and spread by doctors who perform aesthetic procedures, something I don’t recommend as it only creates confusion for patients and practitioners, similar to the confusion consumers face regarding the plethora of over-the-counter skin care options and the marketing terms used for them. Other terms and trends are also started by nonphysician or non–professionally trained providers, sometimes leading to an unsafe or misleading term for an aesthetic procedure.

Over the past few years, several articles about the impact of social media in aesthetics have been published. In one recent paper, published in 2022, Boen and Jerdan noted that 72% of people in the United States use social media, up from 5% of American adults in 2005. In the United States, they note, “YouTube is the most popular platform with 73% of adult users, followed by Facebook (69%), Instagram (37%), SnapChat (24%), and Twitter (22%). Of the sites used daily, Facebook has the most activity (74%), followed by Instagram (64%), SnapChat (63%), YouTube (51%), and Twitter (42%).” They argue that the pros of social media in aesthetic medicine include its use as an educational tool by medical professionals to educate and provide accurate information about cosmetic procedures, and that “providing factual and evidence-based medical information to the public can help to counteract the abundant misinformation that is out there.” The cons include misinformation, no credentialing verification of the provider of the information – essentially anyone can be an “influencer” – as well as the addictive nature of social media for the consumer.

Along the same lines, younger patients tend to rely more on social media in choosing treatments and providers, further perpetuating any anxiety created from misinformation and unrealistic expectations from nonmedical influencers regarding procedures, filters used on photographs, photo editing, etc., in achieving an aesthetic result.

Physicians, particularly fellowship-trained aesthetic and surgical dermatologists, plastic and reconstructive surgeons, oculoplastic surgeons, and ENT facial plastic surgeons, who have the most training, knowledge, and expertise about aesthetic procedures, often have the least amount of time to devote to education via social media, compared with nonmedical influencers. Unless sponsored, they are also not being compensated for using it as an educational tool, except for potential indirect compensation from using it as a marketing tool for themselves and their practices. In contrast, nonmedical influencers often have many followers and time to create content, and in some cases, this is their full-time job.

All in all, most authors agree that social media has been associated with an increased acceptance of cosmetic surgery and procedures. Whether it be a trend seen on social media, or viewing one’s appearance in a filtered or photoediting app, or seeing an image of how another person looks (similar to how people in magazines, films and on television, were viewed in the past), social media has piqued people’s interest in aesthetics. It remains a balance for interested physicians to help keep information about cosmetic procedures presented in a healthy, interesting, professional, and accurate manner, and in a non–time-consuming way.

Dr. Wesley practices dermatology in Beverly Hills, Calif. Write to her at [email protected]. She had no relevant disclosures.
 

References

Boen M and Jerdan K. Clin Dermatol. 2022 Jan-Feb;40(1):45-8.

Chen J et al. JAMA Facial Plast Surg. 2019 Sep 1;21(5):361-7.

Chopan M et al. Plast Reconstr Surg. 2019 Apr;143(4):1259-65.

Recently, my office received several phone calls from patients asking if I perform “trap tox.” Having not been on social media around that time, I assumed the term had something to do with botulinum toxin and the trapezius muscle, but I had never heard it before. Not too long afterwards, patients were asking me about it in the office, using the same terminology, and I had several calls about it in one day. When I asked one trusted patient where she’d heard this term, which seemed to be trending, she told me that she had seen it on Instagram, as an ad or a “suggested for you” post.

Whether it’s a different name or term for a cosmetic procedure or laser we use that I’ve never heard before – such as “lip flip” or trap tox (also known as “Barbie Botox”) – many of these trendy terms spread like wildfire on social media. Some of the terms may be marketing tools started and spread by doctors who perform aesthetic procedures, something I don’t recommend as it only creates confusion for patients and practitioners, similar to the confusion consumers face regarding the plethora of over-the-counter skin care options and the marketing terms used for them. Other terms and trends are also started by nonphysician or non–professionally trained providers, sometimes leading to an unsafe or misleading term for an aesthetic procedure.

Over the past few years, several articles about the impact of social media in aesthetics have been published. In one recent paper, published in 2022, Boen and Jerdan noted that 72% of people in the United States use social media, up from 5% of American adults in 2005. In the United States, they note, “YouTube is the most popular platform with 73% of adult users, followed by Facebook (69%), Instagram (37%), SnapChat (24%), and Twitter (22%). Of the sites used daily, Facebook has the most activity (74%), followed by Instagram (64%), SnapChat (63%), YouTube (51%), and Twitter (42%).” They argue that the pros of social media in aesthetic medicine include its use as an educational tool by medical professionals to educate and provide accurate information about cosmetic procedures, and that “providing factual and evidence-based medical information to the public can help to counteract the abundant misinformation that is out there.” The cons include misinformation, no credentialing verification of the provider of the information – essentially anyone can be an “influencer” – as well as the addictive nature of social media for the consumer.

Along the same lines, younger patients tend to rely more on social media in choosing treatments and providers, further perpetuating any anxiety created from misinformation and unrealistic expectations from nonmedical influencers regarding procedures, filters used on photographs, photo editing, etc., in achieving an aesthetic result.

Physicians, particularly fellowship-trained aesthetic and surgical dermatologists, plastic and reconstructive surgeons, oculoplastic surgeons, and ENT facial plastic surgeons, who have the most training, knowledge, and expertise about aesthetic procedures, often have the least amount of time to devote to education via social media, compared with nonmedical influencers. Unless sponsored, they are also not being compensated for using it as an educational tool, except for potential indirect compensation from using it as a marketing tool for themselves and their practices. In contrast, nonmedical influencers often have many followers and time to create content, and in some cases, this is their full-time job.

All in all, most authors agree that social media has been associated with an increased acceptance of cosmetic surgery and procedures. Whether it be a trend seen on social media, or viewing one’s appearance in a filtered or photoediting app, or seeing an image of how another person looks (similar to how people in magazines, films and on television, were viewed in the past), social media has piqued people’s interest in aesthetics. It remains a balance for interested physicians to help keep information about cosmetic procedures presented in a healthy, interesting, professional, and accurate manner, and in a non–time-consuming way.

Dr. Wesley practices dermatology in Beverly Hills, Calif. Write to her at [email protected]. She had no relevant disclosures.
 

References

Boen M and Jerdan K. Clin Dermatol. 2022 Jan-Feb;40(1):45-8.

Chen J et al. JAMA Facial Plast Surg. 2019 Sep 1;21(5):361-7.

Chopan M et al. Plast Reconstr Surg. 2019 Apr;143(4):1259-65.

In 2017, a survey of 20 U.S. residency programs in family medicine, internal medicine, and ob.gyn. showed that only 6.8% of residents felt they were being adequately prepared to manage menopausal patients effectively, including how to use hormone therapy (HT).

Of the 177 residents who responded to the survey, 102 (56%) were in either family medicine or internal medicine.

“My guess is that there has been no substantial evolution in medical training to this day,” said lead survey study author Juliana Kling, MD, MPH, professor of medicine, chair of women’s health internal medicine, and dean, Mayo Clinic Alix School of Medicine, Scottsdale, Ariz.

The survey showed that overall 98% of residents thought it was important to know about menopause. However, 34% said they wouldn’t recommend HT in a severely symptomatic woman with no contraindications, and 60% said they wouldn’t recommend HT until at least the natural age of menopause in a prematurely menopausal woman. Some even recommended against it.

“Hormone therapy is effective, and for most healthy women younger than 60, the benefits are going to outweigh the risks,” said Dr. Kling. “We need to be comfortable, even in internal medicine, with prescribing hormones for the right women.”

The researchers concluded that “residual ambivalence about [hormone therapy] on the part of educators” may have played a role in curriculums that didn’t acknowledge the clinical relevance of menopause or include current evidence on the use of HT. Physicians should be taught to recognize menopausal symptoms, know the risks and benefits of HT and the alternatives, and how to select suitable candidates, they said.

Up to 80% of women in the United States are affected by menopausal vasomotor symptoms, but only one in four receive treatment, Dr. Kling pointed out. “Women will spend about a third of their lives after menopause, so being prepared to manage the consequences of menopause, such as bone health, vaginal dryness and painful intercourse, and increased cardiovascular disease risk, is critically important to all of us caring for women,” she emphasized. “These aren’t just ‘bothersome symptoms.’ ”

It is estimated that by 2060, there will be 90 million postmenopausal women in the United States. “Given the number of women who will experience symptoms of menopause and the considerable associated burden to their health and to the health care system, it is important to invest in educating future clinicians to provide evidence-based, comprehensive menopause management,” said Dr. Kling and coauthors in a February 2023 review of menopause treatments.

HT is the standard for the treatment of hot flashes and night sweats, and is highly effective for the prevention of bone loss and managing genitourinary syndrome of menopause. Among the alternatives to HT, the nonhormonal pharmacologic fezolinetant (Veozah) was approved by the U.S. Food and Drug Administration last May.

Following the early negative reports from the Women’s Health Initiative study of HT in 2002 and 2004, however, steep declines in HT prescription rates were seen among internists and family medicine practitioners. By 2009, only 18% of all HT prescriptions were written by primary care providers, and today, many remain wary about prescribing HT, despite evidence of its clinical value and safety.

“I think there’s a whole generation of family physicians who were taught that [hormone therapy] is dangerous and still feel very uncomfortable about using it to treat menopausal symptoms,” said Santina J.G. Wheat, MD, MPH, associate professor of family and community medicine at Northwestern University, Chicago. “These are the physicians educating the next generation of physicians,” said Dr. Wheat, who is program director for the McGaw Northwestern Family Medicine Residency Erie Humboldt Park.

Heather Hirsch, MD, an internist who specializes in menopause medicine in Columbus, Ohio, estimates that there are 300 internists among the 1,000 or so health care providers currently certified in menopause medicine through The Menopause Society (formerly the North American Menopause Society or NAMS). With 63 million women in the United States between the ages of 34 and 65, “that adds up to one doctor for several million patients,” she pointed out.

“In my opinion, the impact on menopausal care is profound,” said Jennifer T. Allen, MD, associate professor of obstetrics and gynecology, and director of menopause and midlife health at the Medical College of Georgia, Augusta. “If a physician was not exposed to menopause medicine in medical school or residency and does not choose to learn about menopause after training, then the opportunity to fully care for perimenopausal and postmenopausal women is extinguished.”

Not everyone agrees. “There’s no question that women’s health in general and menopausal issues specifically are a critical part of health care that is typically covered in most family medicine curriculums,” said Neil S. Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College in Philadelphia. “In family medicine, we really do attend to women’s health – particularly women’s health around menopause – as an important part of resident physician training,” emphasized Dr. Skolnik who is also and also associate director of the family medicine residency program at Abington Jefferson Health in Jenkintown, Penn.

"Family physicians are in a unique position to offer female patients effective care at perimenopause and beyond," added Karen L. Smith, MD, a family physician from Raeford, N.C., who is a board member of the American Academy of Family Physicians.*  

Even so, many primary care physicians remain unsure about the use of HT, according to William E. Golden, MD, an internist and geriatrician, and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock.

“On the whole area of hot flashes and vasomotor instability, I think we’re in a state of significant flux and confusion,” Dr. Golden said in an interview. “For a long time, a lot of doctors told patients, ‘It’s okay, you’ll age out of it.’ Then the data started showing that the vasomotor symptoms continued for years so physicians began to reevaluate how to manage them. Now, the pendulum has swung back to giving estrogen.”

Many family physicians have been left to their own devices to figure out how to manage menopausal patients, said Dr. Wheat. “When there are significant changes to clinical management – or in the case of HT, a real reversal in how menopausal symptoms are managed – getting information out to physicians can be challenging.”

Meanwhile, patient demand for answers to their questions about menopause and the use of HT is changing the conversation, where it’s taking place, and with whom.

Some media-savvy doctors have taken to TikTok, where a lot of women started educating themselves about menopause during the pandemic. Dr. Hirsch is one of them. She uses the social media platform to talk about menopause and FDA-approved HT, but warned that for every clinician who is certified in menopause medicine “there are five more selling snake oil.”

Mainstream media has also jumped on the menopause bandwagon. The New York Times was one of the first, declaring that “menopause is having a moment.” On Feb. 1, the newspaper stormed the gates of the medical establishment with an article asking why more doctors weren’t offering HT to women experiencing hot flashes, sleeplessness, and pain during sex. The headline: “Women have been misled about menopause.”

On April 5, “The Menopause Talk” was posted to Oprah Daily, along with a menopause curriculum to give viewers “the tools to stay firmly in the driver’s seat as you navigate perimenopause and then menopause.” Popular topics included how to get your sex life back, premature menopause survival, and ways to work with insurers so that treatment is affordable.

“There’s been a sea-change in the culture that’s being driven by patient demand,” said Dr. Kling. “The conversation, colloquially, in the media, and with our patients, is evolving. Menopause is no longer such a taboo topic, and our patients are really demanding that we have answers for them. Clinicians are recognizing that they need better training in menopause and seeking that out.”

Last June, “Transforming Women’s Health” – the Mayo Clinic’s annual CME program held in partnership with The Menopause Society – had record physician attendance. “We’re going to make sure that our trainees are learning the up-to-date recommendations, not the ones from 20 years ago when the initial WHI reports made everyone fearful of hormones,” said Dr. Kling.

Dr. Kling disclosed that she is a medical editor for Everyday Health, and has a relationship with Evolve Medical Education. Dr. Skolnik reported relationships with numerous pharmaceutical companies. He is an MDedge Family Medicine board member. Dr. Golden is an MDedge Internal Medicine board member, and Dr. Wheat is an MDedge Family Medicine board member. Dr. Allen reported having no potential conflicts of interest.

* This story was updated on Sept 18, 2023. The quotation is attributable to Dr. Smith, not Dr. Skolnik.

In 2017, a survey of 20 U.S. residency programs in family medicine, internal medicine, and ob.gyn. showed that only 6.8% of residents felt they were being adequately prepared to manage menopausal patients effectively, including how to use hormone therapy (HT).

Of the 177 residents who responded to the survey, 102 (56%) were in either family medicine or internal medicine.

“My guess is that there has been no substantial evolution in medical training to this day,” said lead survey study author Juliana Kling, MD, MPH, professor of medicine, chair of women’s health internal medicine, and dean, Mayo Clinic Alix School of Medicine, Scottsdale, Ariz.

The survey showed that overall 98% of residents thought it was important to know about menopause. However, 34% said they wouldn’t recommend HT in a severely symptomatic woman with no contraindications, and 60% said they wouldn’t recommend HT until at least the natural age of menopause in a prematurely menopausal woman. Some even recommended against it.

“Hormone therapy is effective, and for most healthy women younger than 60, the benefits are going to outweigh the risks,” said Dr. Kling. “We need to be comfortable, even in internal medicine, with prescribing hormones for the right women.”

The researchers concluded that “residual ambivalence about [hormone therapy] on the part of educators” may have played a role in curriculums that didn’t acknowledge the clinical relevance of menopause or include current evidence on the use of HT. Physicians should be taught to recognize menopausal symptoms, know the risks and benefits of HT and the alternatives, and how to select suitable candidates, they said.

Up to 80% of women in the United States are affected by menopausal vasomotor symptoms, but only one in four receive treatment, Dr. Kling pointed out. “Women will spend about a third of their lives after menopause, so being prepared to manage the consequences of menopause, such as bone health, vaginal dryness and painful intercourse, and increased cardiovascular disease risk, is critically important to all of us caring for women,” she emphasized. “These aren’t just ‘bothersome symptoms.’ ”

It is estimated that by 2060, there will be 90 million postmenopausal women in the United States. “Given the number of women who will experience symptoms of menopause and the considerable associated burden to their health and to the health care system, it is important to invest in educating future clinicians to provide evidence-based, comprehensive menopause management,” said Dr. Kling and coauthors in a February 2023 review of menopause treatments.

HT is the standard for the treatment of hot flashes and night sweats, and is highly effective for the prevention of bone loss and managing genitourinary syndrome of menopause. Among the alternatives to HT, the nonhormonal pharmacologic fezolinetant (Veozah) was approved by the U.S. Food and Drug Administration last May.

Following the early negative reports from the Women’s Health Initiative study of HT in 2002 and 2004, however, steep declines in HT prescription rates were seen among internists and family medicine practitioners. By 2009, only 18% of all HT prescriptions were written by primary care providers, and today, many remain wary about prescribing HT, despite evidence of its clinical value and safety.

“I think there’s a whole generation of family physicians who were taught that [hormone therapy] is dangerous and still feel very uncomfortable about using it to treat menopausal symptoms,” said Santina J.G. Wheat, MD, MPH, associate professor of family and community medicine at Northwestern University, Chicago. “These are the physicians educating the next generation of physicians,” said Dr. Wheat, who is program director for the McGaw Northwestern Family Medicine Residency Erie Humboldt Park.

Heather Hirsch, MD, an internist who specializes in menopause medicine in Columbus, Ohio, estimates that there are 300 internists among the 1,000 or so health care providers currently certified in menopause medicine through The Menopause Society (formerly the North American Menopause Society or NAMS). With 63 million women in the United States between the ages of 34 and 65, “that adds up to one doctor for several million patients,” she pointed out.

“In my opinion, the impact on menopausal care is profound,” said Jennifer T. Allen, MD, associate professor of obstetrics and gynecology, and director of menopause and midlife health at the Medical College of Georgia, Augusta. “If a physician was not exposed to menopause medicine in medical school or residency and does not choose to learn about menopause after training, then the opportunity to fully care for perimenopausal and postmenopausal women is extinguished.”

Not everyone agrees. “There’s no question that women’s health in general and menopausal issues specifically are a critical part of health care that is typically covered in most family medicine curriculums,” said Neil S. Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College in Philadelphia. “In family medicine, we really do attend to women’s health – particularly women’s health around menopause – as an important part of resident physician training,” emphasized Dr. Skolnik who is also and also associate director of the family medicine residency program at Abington Jefferson Health in Jenkintown, Penn.

"Family physicians are in a unique position to offer female patients effective care at perimenopause and beyond," added Karen L. Smith, MD, a family physician from Raeford, N.C., who is a board member of the American Academy of Family Physicians.*  

Even so, many primary care physicians remain unsure about the use of HT, according to William E. Golden, MD, an internist and geriatrician, and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock.

“On the whole area of hot flashes and vasomotor instability, I think we’re in a state of significant flux and confusion,” Dr. Golden said in an interview. “For a long time, a lot of doctors told patients, ‘It’s okay, you’ll age out of it.’ Then the data started showing that the vasomotor symptoms continued for years so physicians began to reevaluate how to manage them. Now, the pendulum has swung back to giving estrogen.”

Many family physicians have been left to their own devices to figure out how to manage menopausal patients, said Dr. Wheat. “When there are significant changes to clinical management – or in the case of HT, a real reversal in how menopausal symptoms are managed – getting information out to physicians can be challenging.”

Meanwhile, patient demand for answers to their questions about menopause and the use of HT is changing the conversation, where it’s taking place, and with whom.

Some media-savvy doctors have taken to TikTok, where a lot of women started educating themselves about menopause during the pandemic. Dr. Hirsch is one of them. She uses the social media platform to talk about menopause and FDA-approved HT, but warned that for every clinician who is certified in menopause medicine “there are five more selling snake oil.”

Mainstream media has also jumped on the menopause bandwagon. The New York Times was one of the first, declaring that “menopause is having a moment.” On Feb. 1, the newspaper stormed the gates of the medical establishment with an article asking why more doctors weren’t offering HT to women experiencing hot flashes, sleeplessness, and pain during sex. The headline: “Women have been misled about menopause.”

On April 5, “The Menopause Talk” was posted to Oprah Daily, along with a menopause curriculum to give viewers “the tools to stay firmly in the driver’s seat as you navigate perimenopause and then menopause.” Popular topics included how to get your sex life back, premature menopause survival, and ways to work with insurers so that treatment is affordable.

“There’s been a sea-change in the culture that’s being driven by patient demand,” said Dr. Kling. “The conversation, colloquially, in the media, and with our patients, is evolving. Menopause is no longer such a taboo topic, and our patients are really demanding that we have answers for them. Clinicians are recognizing that they need better training in menopause and seeking that out.”

Last June, “Transforming Women’s Health” – the Mayo Clinic’s annual CME program held in partnership with The Menopause Society – had record physician attendance. “We’re going to make sure that our trainees are learning the up-to-date recommendations, not the ones from 20 years ago when the initial WHI reports made everyone fearful of hormones,” said Dr. Kling.

Dr. Kling disclosed that she is a medical editor for Everyday Health, and has a relationship with Evolve Medical Education. Dr. Skolnik reported relationships with numerous pharmaceutical companies. He is an MDedge Family Medicine board member. Dr. Golden is an MDedge Internal Medicine board member, and Dr. Wheat is an MDedge Family Medicine board member. Dr. Allen reported having no potential conflicts of interest.

* This story was updated on Sept 18, 2023. The quotation is attributable to Dr. Smith, not Dr. Skolnik.

In 2017, a survey of 20 U.S. residency programs in family medicine, internal medicine, and ob.gyn. showed that only 6.8% of residents felt they were being adequately prepared to manage menopausal patients effectively, including how to use hormone therapy (HT).

Of the 177 residents who responded to the survey, 102 (56%) were in either family medicine or internal medicine.

“My guess is that there has been no substantial evolution in medical training to this day,” said lead survey study author Juliana Kling, MD, MPH, professor of medicine, chair of women’s health internal medicine, and dean, Mayo Clinic Alix School of Medicine, Scottsdale, Ariz.

The survey showed that overall 98% of residents thought it was important to know about menopause. However, 34% said they wouldn’t recommend HT in a severely symptomatic woman with no contraindications, and 60% said they wouldn’t recommend HT until at least the natural age of menopause in a prematurely menopausal woman. Some even recommended against it.

“Hormone therapy is effective, and for most healthy women younger than 60, the benefits are going to outweigh the risks,” said Dr. Kling. “We need to be comfortable, even in internal medicine, with prescribing hormones for the right women.”

The researchers concluded that “residual ambivalence about [hormone therapy] on the part of educators” may have played a role in curriculums that didn’t acknowledge the clinical relevance of menopause or include current evidence on the use of HT. Physicians should be taught to recognize menopausal symptoms, know the risks and benefits of HT and the alternatives, and how to select suitable candidates, they said.

Up to 80% of women in the United States are affected by menopausal vasomotor symptoms, but only one in four receive treatment, Dr. Kling pointed out. “Women will spend about a third of their lives after menopause, so being prepared to manage the consequences of menopause, such as bone health, vaginal dryness and painful intercourse, and increased cardiovascular disease risk, is critically important to all of us caring for women,” she emphasized. “These aren’t just ‘bothersome symptoms.’ ”

It is estimated that by 2060, there will be 90 million postmenopausal women in the United States. “Given the number of women who will experience symptoms of menopause and the considerable associated burden to their health and to the health care system, it is important to invest in educating future clinicians to provide evidence-based, comprehensive menopause management,” said Dr. Kling and coauthors in a February 2023 review of menopause treatments.

HT is the standard for the treatment of hot flashes and night sweats, and is highly effective for the prevention of bone loss and managing genitourinary syndrome of menopause. Among the alternatives to HT, the nonhormonal pharmacologic fezolinetant (Veozah) was approved by the U.S. Food and Drug Administration last May.

Following the early negative reports from the Women’s Health Initiative study of HT in 2002 and 2004, however, steep declines in HT prescription rates were seen among internists and family medicine practitioners. By 2009, only 18% of all HT prescriptions were written by primary care providers, and today, many remain wary about prescribing HT, despite evidence of its clinical value and safety.

“I think there’s a whole generation of family physicians who were taught that [hormone therapy] is dangerous and still feel very uncomfortable about using it to treat menopausal symptoms,” said Santina J.G. Wheat, MD, MPH, associate professor of family and community medicine at Northwestern University, Chicago. “These are the physicians educating the next generation of physicians,” said Dr. Wheat, who is program director for the McGaw Northwestern Family Medicine Residency Erie Humboldt Park.

Heather Hirsch, MD, an internist who specializes in menopause medicine in Columbus, Ohio, estimates that there are 300 internists among the 1,000 or so health care providers currently certified in menopause medicine through The Menopause Society (formerly the North American Menopause Society or NAMS). With 63 million women in the United States between the ages of 34 and 65, “that adds up to one doctor for several million patients,” she pointed out.

“In my opinion, the impact on menopausal care is profound,” said Jennifer T. Allen, MD, associate professor of obstetrics and gynecology, and director of menopause and midlife health at the Medical College of Georgia, Augusta. “If a physician was not exposed to menopause medicine in medical school or residency and does not choose to learn about menopause after training, then the opportunity to fully care for perimenopausal and postmenopausal women is extinguished.”

Not everyone agrees. “There’s no question that women’s health in general and menopausal issues specifically are a critical part of health care that is typically covered in most family medicine curriculums,” said Neil S. Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College in Philadelphia. “In family medicine, we really do attend to women’s health – particularly women’s health around menopause – as an important part of resident physician training,” emphasized Dr. Skolnik who is also and also associate director of the family medicine residency program at Abington Jefferson Health in Jenkintown, Penn.

"Family physicians are in a unique position to offer female patients effective care at perimenopause and beyond," added Karen L. Smith, MD, a family physician from Raeford, N.C., who is a board member of the American Academy of Family Physicians.*  

Even so, many primary care physicians remain unsure about the use of HT, according to William E. Golden, MD, an internist and geriatrician, and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock.

“On the whole area of hot flashes and vasomotor instability, I think we’re in a state of significant flux and confusion,” Dr. Golden said in an interview. “For a long time, a lot of doctors told patients, ‘It’s okay, you’ll age out of it.’ Then the data started showing that the vasomotor symptoms continued for years so physicians began to reevaluate how to manage them. Now, the pendulum has swung back to giving estrogen.”

Many family physicians have been left to their own devices to figure out how to manage menopausal patients, said Dr. Wheat. “When there are significant changes to clinical management – or in the case of HT, a real reversal in how menopausal symptoms are managed – getting information out to physicians can be challenging.”

Meanwhile, patient demand for answers to their questions about menopause and the use of HT is changing the conversation, where it’s taking place, and with whom.

Some media-savvy doctors have taken to TikTok, where a lot of women started educating themselves about menopause during the pandemic. Dr. Hirsch is one of them. She uses the social media platform to talk about menopause and FDA-approved HT, but warned that for every clinician who is certified in menopause medicine “there are five more selling snake oil.”

Mainstream media has also jumped on the menopause bandwagon. The New York Times was one of the first, declaring that “menopause is having a moment.” On Feb. 1, the newspaper stormed the gates of the medical establishment with an article asking why more doctors weren’t offering HT to women experiencing hot flashes, sleeplessness, and pain during sex. The headline: “Women have been misled about menopause.”

On April 5, “The Menopause Talk” was posted to Oprah Daily, along with a menopause curriculum to give viewers “the tools to stay firmly in the driver’s seat as you navigate perimenopause and then menopause.” Popular topics included how to get your sex life back, premature menopause survival, and ways to work with insurers so that treatment is affordable.

“There’s been a sea-change in the culture that’s being driven by patient demand,” said Dr. Kling. “The conversation, colloquially, in the media, and with our patients, is evolving. Menopause is no longer such a taboo topic, and our patients are really demanding that we have answers for them. Clinicians are recognizing that they need better training in menopause and seeking that out.”

Last June, “Transforming Women’s Health” – the Mayo Clinic’s annual CME program held in partnership with The Menopause Society – had record physician attendance. “We’re going to make sure that our trainees are learning the up-to-date recommendations, not the ones from 20 years ago when the initial WHI reports made everyone fearful of hormones,” said Dr. Kling.

Dr. Kling disclosed that she is a medical editor for Everyday Health, and has a relationship with Evolve Medical Education. Dr. Skolnik reported relationships with numerous pharmaceutical companies. He is an MDedge Family Medicine board member. Dr. Golden is an MDedge Internal Medicine board member, and Dr. Wheat is an MDedge Family Medicine board member. Dr. Allen reported having no potential conflicts of interest.

* This story was updated on Sept 18, 2023. The quotation is attributable to Dr. Smith, not Dr. Skolnik.

TOPLINE:

The COVID-19 booster vaccine typically causes transient, clinically insignificant elevations in glucose levels in people with type 1 diabetes, but some individuals may develop more pronounced hyperglycemia.

METHODOLOGY:

• In a single-center prospective cohort study of 21 adults with type 1 diabetes, patients were given a blinded Dexcom G6 Pro continuous glucose monitor (CGM) at the first research clinic visit.
• After 3-4 days, participants received a COVID-19 booster vaccine.
• They returned to the clinic 10 days after the initial visit (5-6 days after booster vaccination) to have the CGM removed and glycemia assessed.

TAKEAWAY:

• Compared with baseline, the mean daily glucose level was significantly increased at day 2 (162.9 mg/dL vs. 172.8 mg/dL; P = .04) and day 3 (173.1 mg/dL; P = .02) post vaccination.
• Glucose excursions at day 0 (173.2 mg/dL; P = .058) and day 1 (173.1 mg/dL; P = .078) didn’t quite reach statistical significance.
• One participant experienced increases in glucose of 36%, 69%, 35%, 26%, 22%, and 19% on days 0-5, respectively, compared with baseline.
• Glucose excursions of at least 25% above baseline occurred in four participants on day 0 and day 1 and in three participants on days 2 and 5.
• Insulin resistance, as measured by Total Daily Insulin Resistance (a metric that integrates daily mean glucose concentration with total daily insulin dose), was also significantly increased from baseline to day 2 post vaccination (7,171 mg/dL vs. 8,070 mg/dL units; P = .03).
• No other measures of glycemia differed significantly, compared with baseline.
• Outcomes didn’t differ significantly by sex, age, or vaccine manufacturer.

IN PRACTICE:

• “To our knowledge this is the first study investigating the effect of the COVID-19 booster vaccine on glycemia specifically in people with type 1 diabetes,” say the authors.
• “Clinicians, pharmacists, and other health care providers may need to counsel people with T1D to be more vigilant with glucose testing and insulin dosing for the first 5 days after vaccination. Most importantly, insulin, required to control glycemia, may need to be transiently increased.”
• “Further studies are warranted to investigate whether other vaccines have similar glycemic effects, and which individuals are at highest risk for profound glucose perturbations post vaccination.”

SOURCE:

The study was conducted by Mihail Zilbermint, MD, of the division of hospital medicine, Johns Hopkins Medicine, Bethesda, Md., and colleagues. It was published in Diabetes Research and Clinical Practice.

LIMITATIONS:

• The sample size was small.
• There were no measurements of inflammatory markers, dietary intake, physical activity, or survey patient symptomatology to adjust for variables that may have influenced glycemic control.
• In the study cohort, glycemia was moderately well controlled at baseline.

DISCLOSURES:

The study was supported by an investigator-initiated study grant from DexCom Inc. Dr. Zilbermint has consulted for EMD Serono.

A version of this article first appeared on Medscape.com.

TOPLINE:

The COVID-19 booster vaccine typically causes transient, clinically insignificant elevations in glucose levels in people with type 1 diabetes, but some individuals may develop more pronounced hyperglycemia.

METHODOLOGY:

• In a single-center prospective cohort study of 21 adults with type 1 diabetes, patients were given a blinded Dexcom G6 Pro continuous glucose monitor (CGM) at the first research clinic visit.
• After 3-4 days, participants received a COVID-19 booster vaccine.
• They returned to the clinic 10 days after the initial visit (5-6 days after booster vaccination) to have the CGM removed and glycemia assessed.

TAKEAWAY:

• Compared with baseline, the mean daily glucose level was significantly increased at day 2 (162.9 mg/dL vs. 172.8 mg/dL; P = .04) and day 3 (173.1 mg/dL; P = .02) post vaccination.
• Glucose excursions at day 0 (173.2 mg/dL; P = .058) and day 1 (173.1 mg/dL; P = .078) didn’t quite reach statistical significance.
• One participant experienced increases in glucose of 36%, 69%, 35%, 26%, 22%, and 19% on days 0-5, respectively, compared with baseline.
• Glucose excursions of at least 25% above baseline occurred in four participants on day 0 and day 1 and in three participants on days 2 and 5.
• Insulin resistance, as measured by Total Daily Insulin Resistance (a metric that integrates daily mean glucose concentration with total daily insulin dose), was also significantly increased from baseline to day 2 post vaccination (7,171 mg/dL vs. 8,070 mg/dL units; P = .03).
• No other measures of glycemia differed significantly, compared with baseline.
• Outcomes didn’t differ significantly by sex, age, or vaccine manufacturer.

IN PRACTICE:

• “To our knowledge this is the first study investigating the effect of the COVID-19 booster vaccine on glycemia specifically in people with type 1 diabetes,” say the authors.
• “Clinicians, pharmacists, and other health care providers may need to counsel people with T1D to be more vigilant with glucose testing and insulin dosing for the first 5 days after vaccination. Most importantly, insulin, required to control glycemia, may need to be transiently increased.”
• “Further studies are warranted to investigate whether other vaccines have similar glycemic effects, and which individuals are at highest risk for profound glucose perturbations post vaccination.”

SOURCE:

The study was conducted by Mihail Zilbermint, MD, of the division of hospital medicine, Johns Hopkins Medicine, Bethesda, Md., and colleagues. It was published in Diabetes Research and Clinical Practice.

LIMITATIONS:

• The sample size was small.
• There were no measurements of inflammatory markers, dietary intake, physical activity, or survey patient symptomatology to adjust for variables that may have influenced glycemic control.
• In the study cohort, glycemia was moderately well controlled at baseline.

DISCLOSURES:

The study was supported by an investigator-initiated study grant from DexCom Inc. Dr. Zilbermint has consulted for EMD Serono.

A version of this article first appeared on Medscape.com.

TOPLINE:

The COVID-19 booster vaccine typically causes transient, clinically insignificant elevations in glucose levels in people with type 1 diabetes, but some individuals may develop more pronounced hyperglycemia.

METHODOLOGY:

• In a single-center prospective cohort study of 21 adults with type 1 diabetes, patients were given a blinded Dexcom G6 Pro continuous glucose monitor (CGM) at the first research clinic visit.
• After 3-4 days, participants received a COVID-19 booster vaccine.
• They returned to the clinic 10 days after the initial visit (5-6 days after booster vaccination) to have the CGM removed and glycemia assessed.

TAKEAWAY:

• Compared with baseline, the mean daily glucose level was significantly increased at day 2 (162.9 mg/dL vs. 172.8 mg/dL; P = .04) and day 3 (173.1 mg/dL; P = .02) post vaccination.
• Glucose excursions at day 0 (173.2 mg/dL; P = .058) and day 1 (173.1 mg/dL; P = .078) didn’t quite reach statistical significance.
• One participant experienced increases in glucose of 36%, 69%, 35%, 26%, 22%, and 19% on days 0-5, respectively, compared with baseline.
• Glucose excursions of at least 25% above baseline occurred in four participants on day 0 and day 1 and in three participants on days 2 and 5.
• Insulin resistance, as measured by Total Daily Insulin Resistance (a metric that integrates daily mean glucose concentration with total daily insulin dose), was also significantly increased from baseline to day 2 post vaccination (7,171 mg/dL vs. 8,070 mg/dL units; P = .03).
• No other measures of glycemia differed significantly, compared with baseline.
• Outcomes didn’t differ significantly by sex, age, or vaccine manufacturer.

IN PRACTICE:

• “To our knowledge this is the first study investigating the effect of the COVID-19 booster vaccine on glycemia specifically in people with type 1 diabetes,” say the authors.
• “Clinicians, pharmacists, and other health care providers may need to counsel people with T1D to be more vigilant with glucose testing and insulin dosing for the first 5 days after vaccination. Most importantly, insulin, required to control glycemia, may need to be transiently increased.”
• “Further studies are warranted to investigate whether other vaccines have similar glycemic effects, and which individuals are at highest risk for profound glucose perturbations post vaccination.”

SOURCE:

The study was conducted by Mihail Zilbermint, MD, of the division of hospital medicine, Johns Hopkins Medicine, Bethesda, Md., and colleagues. It was published in Diabetes Research and Clinical Practice.

LIMITATIONS:

• The sample size was small.
• There were no measurements of inflammatory markers, dietary intake, physical activity, or survey patient symptomatology to adjust for variables that may have influenced glycemic control.
• In the study cohort, glycemia was moderately well controlled at baseline.

DISCLOSURES:

The study was supported by an investigator-initiated study grant from DexCom Inc. Dr. Zilbermint has consulted for EMD Serono.

A version of this article first appeared on Medscape.com.

Proposed updates to the tumor-node-metastasis (TNM) classification for lung cancer will affect the way patients are staged, experts say.

The updates for the 9th edition of the TNM Classification of Malignant Tumors: Lung Cancer were presented at the annual World Conference on Lung Cancer. The final version will be published Jan. 1, 2024.

The core proposed change, according to Hisao Asamura, MD, chair of the IASLC Staging and Prognostic Factors Committee, is to divide N2 and M1c disease into two subcategories, while leaving the T descriptors unchanged.

This update is based on large survival differences among patients with these tumor characteristics, following an analysis of outcomes in more than 87,000 individuals diagnosed with lung cancer.

Session cochair Ramón Rami-Porta, MD, PhD, explained that previous editions of the classification were based on “pathologic stage, not clinical stage” but ultimately “we could not validate those findings” clinically.

“This is the first time that some sort of very simple quantification” of lung tumors “could be validated at the clinical stage as well,” which means that clinical staging can improve all over the world, said Dr. Rami-Porta, medical oncologist at Hospital Universitari Mútua Terrassa (Spain).

Session cochair Paul Van Schil, MD, PhD, of Antwerp (the Netherlands) University Hospital explained that the proposed changes reflect what clinicians already see in their daily practice.

The latest TNM classification included data submitted on 124,581 patients diagnosed with lung cancer between 2011 and 2019, 56% of whom were from Asia/Australia, 25% from Europe, and 16% from North America.

Overall, 87,339 patients were included in the analysis – 83% with non–small cell lung cancer (NSCLC) and 7% with small cell lung cancer (SCLC). Most (62%) underwent surgery, either alone (47%), alongside chemotherapy (13%), or plus radiotherapy (2%). A minority (13%) received chemotherapy alone, and 13% received all three modalities.

The committee working on the update to the TNM classification had 112 members and comprised 14 subcommittees, which focused on different aspects of diagnosing and assessing the disease.

The committee agreed there should be no changes to the T category in the upcoming 9th Edition.

Evaluating the T category, some members expressed concern that patients with T3 disease embedded in the chest wall have worse survival outcomes than those with other forms of T3 disease. But, Dr. Asamura explained, the pathological versus clinical findings were inconsistent.

On pathological assessment, patients with T3 disease in the chest wall had a worse prognosis but clinical assessment indicated no survival difference. Given the lack of consensus, “we do not recommend any changes” to the current criteria, said Dr. Asamura.

Turning to the N category, Dr. Asamura explained that N2 disease will be divided into two subcategories: N2a, categorized by single N2 station involvement, and N2b, defined as multiple N2 station involvement.

Further analysis indicated that the estimated 5-year survival was significantly worse for patients with N2b disease on clinical assessment (31% vs. 42% with N2a disease; hazard ratio for death, 1.27; P < .0001) and on pathological assessment (HR, 1.46; P < .0001).

The committee also proposed a change to the M category, dividing M1c disease into two subcategories:

• M1c1 – defined as multiple extrathoracic metastases in a single organ system
• M1c2 – defined as multiple extrathoracic metastases in multiple organ systems

This change was driven by estimates of 5-year survival among patients with M1c1 (27%) versus M1c2 disease (19%). Compared with M1b disease, M1c1 was associated with a lower risk for death than M1c2 disease (HR, 1.27 vs. 1.39).

These changes, particularly those for the N category, will have a notable impact on how patients are staged, Dr. Asamura said.

Dividing the N2 category into N2a and N2b disease will push patients with T1, N1 disease from the IIB category (8th edition) to the IIA category (9th edition). The 8th edition categorized all T1, N2 patients as IIIA but the new edition would categorize patients with T1, N2a disease as IIB overall and those with N2b disease as IIIA. And patients with T2, N2a disease will be staged as IIIA — the same category as T2, N2 disease in the 8th edition – while those with N2b disease will be staged as IIIB.

By contrast, the division of M1c into M1c1 and M1c2 disease will not affect a patient’s overall stage, which will be IVB in all cases.

Upal Basu Roy, PhD, MPH, who was not part of the committee, said the TNM classification stage of cancers is “incredibly important in cataloguing the extent of disease” and to “decide the optimal treatment option.”

TNM classification is also “used to describe the burden of disease to be eligible for a clinical trial,” said Dr. Roy, executive director of research, LUNGevity Foundation, Chicago.

The changes in N staging may require sampling more lymph nodes than the current sampling frame of six, Dr. Roy said, adding that “surgeons and pathologists may need to be educated about the need for additional sampling.”

The subcategories for M1c disease will also need to be aligned with definitions of oligometastatic disease. “This is critical,” Dr. Roy said, as this staging may affect treatment choices.

No funding was declared. Dr. Asamura declares relationships with Medtronic, Taiho Pharmaceutical, Johnson & Johnson, Lily, Astellas, and Ono Pharmaceutical. Dr. Roy declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Proposed updates to the tumor-node-metastasis (TNM) classification for lung cancer will affect the way patients are staged, experts say.

The updates for the 9th edition of the TNM Classification of Malignant Tumors: Lung Cancer were presented at the annual World Conference on Lung Cancer. The final version will be published Jan. 1, 2024.

The core proposed change, according to Hisao Asamura, MD, chair of the IASLC Staging and Prognostic Factors Committee, is to divide N2 and M1c disease into two subcategories, while leaving the T descriptors unchanged.

This update is based on large survival differences among patients with these tumor characteristics, following an analysis of outcomes in more than 87,000 individuals diagnosed with lung cancer.

Session cochair Ramón Rami-Porta, MD, PhD, explained that previous editions of the classification were based on “pathologic stage, not clinical stage” but ultimately “we could not validate those findings” clinically.

“This is the first time that some sort of very simple quantification” of lung tumors “could be validated at the clinical stage as well,” which means that clinical staging can improve all over the world, said Dr. Rami-Porta, medical oncologist at Hospital Universitari Mútua Terrassa (Spain).

Session cochair Paul Van Schil, MD, PhD, of Antwerp (the Netherlands) University Hospital explained that the proposed changes reflect what clinicians already see in their daily practice.

The latest TNM classification included data submitted on 124,581 patients diagnosed with lung cancer between 2011 and 2019, 56% of whom were from Asia/Australia, 25% from Europe, and 16% from North America.

Overall, 87,339 patients were included in the analysis – 83% with non–small cell lung cancer (NSCLC) and 7% with small cell lung cancer (SCLC). Most (62%) underwent surgery, either alone (47%), alongside chemotherapy (13%), or plus radiotherapy (2%). A minority (13%) received chemotherapy alone, and 13% received all three modalities.

The committee working on the update to the TNM classification had 112 members and comprised 14 subcommittees, which focused on different aspects of diagnosing and assessing the disease.

The committee agreed there should be no changes to the T category in the upcoming 9th Edition.

Evaluating the T category, some members expressed concern that patients with T3 disease embedded in the chest wall have worse survival outcomes than those with other forms of T3 disease. But, Dr. Asamura explained, the pathological versus clinical findings were inconsistent.

On pathological assessment, patients with T3 disease in the chest wall had a worse prognosis but clinical assessment indicated no survival difference. Given the lack of consensus, “we do not recommend any changes” to the current criteria, said Dr. Asamura.

Turning to the N category, Dr. Asamura explained that N2 disease will be divided into two subcategories: N2a, categorized by single N2 station involvement, and N2b, defined as multiple N2 station involvement.

Further analysis indicated that the estimated 5-year survival was significantly worse for patients with N2b disease on clinical assessment (31% vs. 42% with N2a disease; hazard ratio for death, 1.27; P < .0001) and on pathological assessment (HR, 1.46; P < .0001).

The committee also proposed a change to the M category, dividing M1c disease into two subcategories:

• M1c1 – defined as multiple extrathoracic metastases in a single organ system
• M1c2 – defined as multiple extrathoracic metastases in multiple organ systems

This change was driven by estimates of 5-year survival among patients with M1c1 (27%) versus M1c2 disease (19%). Compared with M1b disease, M1c1 was associated with a lower risk for death than M1c2 disease (HR, 1.27 vs. 1.39).

These changes, particularly those for the N category, will have a notable impact on how patients are staged, Dr. Asamura said.

Dividing the N2 category into N2a and N2b disease will push patients with T1, N1 disease from the IIB category (8th edition) to the IIA category (9th edition). The 8th edition categorized all T1, N2 patients as IIIA but the new edition would categorize patients with T1, N2a disease as IIB overall and those with N2b disease as IIIA. And patients with T2, N2a disease will be staged as IIIA — the same category as T2, N2 disease in the 8th edition – while those with N2b disease will be staged as IIIB.

By contrast, the division of M1c into M1c1 and M1c2 disease will not affect a patient’s overall stage, which will be IVB in all cases.

Upal Basu Roy, PhD, MPH, who was not part of the committee, said the TNM classification stage of cancers is “incredibly important in cataloguing the extent of disease” and to “decide the optimal treatment option.”

TNM classification is also “used to describe the burden of disease to be eligible for a clinical trial,” said Dr. Roy, executive director of research, LUNGevity Foundation, Chicago.

The changes in N staging may require sampling more lymph nodes than the current sampling frame of six, Dr. Roy said, adding that “surgeons and pathologists may need to be educated about the need for additional sampling.”

The subcategories for M1c disease will also need to be aligned with definitions of oligometastatic disease. “This is critical,” Dr. Roy said, as this staging may affect treatment choices.

No funding was declared. Dr. Asamura declares relationships with Medtronic, Taiho Pharmaceutical, Johnson & Johnson, Lily, Astellas, and Ono Pharmaceutical. Dr. Roy declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Proposed updates to the tumor-node-metastasis (TNM) classification for lung cancer will affect the way patients are staged, experts say.

The updates for the 9th edition of the TNM Classification of Malignant Tumors: Lung Cancer were presented at the annual World Conference on Lung Cancer. The final version will be published Jan. 1, 2024.

The core proposed change, according to Hisao Asamura, MD, chair of the IASLC Staging and Prognostic Factors Committee, is to divide N2 and M1c disease into two subcategories, while leaving the T descriptors unchanged.

This update is based on large survival differences among patients with these tumor characteristics, following an analysis of outcomes in more than 87,000 individuals diagnosed with lung cancer.

Session cochair Ramón Rami-Porta, MD, PhD, explained that previous editions of the classification were based on “pathologic stage, not clinical stage” but ultimately “we could not validate those findings” clinically.

“This is the first time that some sort of very simple quantification” of lung tumors “could be validated at the clinical stage as well,” which means that clinical staging can improve all over the world, said Dr. Rami-Porta, medical oncologist at Hospital Universitari Mútua Terrassa (Spain).

Session cochair Paul Van Schil, MD, PhD, of Antwerp (the Netherlands) University Hospital explained that the proposed changes reflect what clinicians already see in their daily practice.

The latest TNM classification included data submitted on 124,581 patients diagnosed with lung cancer between 2011 and 2019, 56% of whom were from Asia/Australia, 25% from Europe, and 16% from North America.

Overall, 87,339 patients were included in the analysis – 83% with non–small cell lung cancer (NSCLC) and 7% with small cell lung cancer (SCLC). Most (62%) underwent surgery, either alone (47%), alongside chemotherapy (13%), or plus radiotherapy (2%). A minority (13%) received chemotherapy alone, and 13% received all three modalities.

The committee working on the update to the TNM classification had 112 members and comprised 14 subcommittees, which focused on different aspects of diagnosing and assessing the disease.

The committee agreed there should be no changes to the T category in the upcoming 9th Edition.

Evaluating the T category, some members expressed concern that patients with T3 disease embedded in the chest wall have worse survival outcomes than those with other forms of T3 disease. But, Dr. Asamura explained, the pathological versus clinical findings were inconsistent.

On pathological assessment, patients with T3 disease in the chest wall had a worse prognosis but clinical assessment indicated no survival difference. Given the lack of consensus, “we do not recommend any changes” to the current criteria, said Dr. Asamura.

Turning to the N category, Dr. Asamura explained that N2 disease will be divided into two subcategories: N2a, categorized by single N2 station involvement, and N2b, defined as multiple N2 station involvement.

Further analysis indicated that the estimated 5-year survival was significantly worse for patients with N2b disease on clinical assessment (31% vs. 42% with N2a disease; hazard ratio for death, 1.27; P < .0001) and on pathological assessment (HR, 1.46; P < .0001).

The committee also proposed a change to the M category, dividing M1c disease into two subcategories:

• M1c1 – defined as multiple extrathoracic metastases in a single organ system
• M1c2 – defined as multiple extrathoracic metastases in multiple organ systems

This change was driven by estimates of 5-year survival among patients with M1c1 (27%) versus M1c2 disease (19%). Compared with M1b disease, M1c1 was associated with a lower risk for death than M1c2 disease (HR, 1.27 vs. 1.39).

These changes, particularly those for the N category, will have a notable impact on how patients are staged, Dr. Asamura said.

Dividing the N2 category into N2a and N2b disease will push patients with T1, N1 disease from the IIB category (8th edition) to the IIA category (9th edition). The 8th edition categorized all T1, N2 patients as IIIA but the new edition would categorize patients with T1, N2a disease as IIB overall and those with N2b disease as IIIA. And patients with T2, N2a disease will be staged as IIIA — the same category as T2, N2 disease in the 8th edition – while those with N2b disease will be staged as IIIB.

By contrast, the division of M1c into M1c1 and M1c2 disease will not affect a patient’s overall stage, which will be IVB in all cases.

Upal Basu Roy, PhD, MPH, who was not part of the committee, said the TNM classification stage of cancers is “incredibly important in cataloguing the extent of disease” and to “decide the optimal treatment option.”

TNM classification is also “used to describe the burden of disease to be eligible for a clinical trial,” said Dr. Roy, executive director of research, LUNGevity Foundation, Chicago.

The changes in N staging may require sampling more lymph nodes than the current sampling frame of six, Dr. Roy said, adding that “surgeons and pathologists may need to be educated about the need for additional sampling.”

The subcategories for M1c disease will also need to be aligned with definitions of oligometastatic disease. “This is critical,” Dr. Roy said, as this staging may affect treatment choices.

No funding was declared. Dr. Asamura declares relationships with Medtronic, Taiho Pharmaceutical, Johnson & Johnson, Lily, Astellas, and Ono Pharmaceutical. Dr. Roy declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.