Key clinical point: Early age at first pregnancy (less than 22 years) and early menopause (45 years and earlier) were associated with a higher risk of rheumatoid arthritis (RA), whereas long-term progestogen use (more than 24 months) before menopause was associated with a reduced risk.

Major finding: The risk of RA was a significantly increased with early age at first pregnancy (less than 22 vs. 27 or more years; hazard ratio [HR], 1.34; P_trend = .028) and menopause (45 or less vs. 53 or more years; HR, 1.40; P_trend = .039). Risk of RA was inversely related to exposure to progestogen only in perimenopause (more than 24 vs. 0 months; multi-adjusted HR, 0.77; P_trend = .004).

Study details: This study included 78,452 women, with 698 incident cases of RA using data from the French E3N-EPIC cohort study.

Disclosures: The study was funded by a research grant from FOREUM Foundation for Research in Rheumatology. The authors declared no conflicts of interest.

Source: Salliot C et al. Rheumatology (Oxford). 2021 Feb 6. doi: 10.1093/rheumatology/keab101.

Key clinical point: Early age at first pregnancy (less than 22 years) and early menopause (45 years and earlier) were associated with a higher risk of rheumatoid arthritis (RA), whereas long-term progestogen use (more than 24 months) before menopause was associated with a reduced risk.

Major finding: The risk of RA was a significantly increased with early age at first pregnancy (less than 22 vs. 27 or more years; hazard ratio [HR], 1.34; P_trend = .028) and menopause (45 or less vs. 53 or more years; HR, 1.40; P_trend = .039). Risk of RA was inversely related to exposure to progestogen only in perimenopause (more than 24 vs. 0 months; multi-adjusted HR, 0.77; P_trend = .004).

Study details: This study included 78,452 women, with 698 incident cases of RA using data from the French E3N-EPIC cohort study.

Disclosures: The study was funded by a research grant from FOREUM Foundation for Research in Rheumatology. The authors declared no conflicts of interest.

Source: Salliot C et al. Rheumatology (Oxford). 2021 Feb 6. doi: 10.1093/rheumatology/keab101.

Key clinical point: Early age at first pregnancy (less than 22 years) and early menopause (45 years and earlier) were associated with a higher risk of rheumatoid arthritis (RA), whereas long-term progestogen use (more than 24 months) before menopause was associated with a reduced risk.

Major finding: The risk of RA was a significantly increased with early age at first pregnancy (less than 22 vs. 27 or more years; hazard ratio [HR], 1.34; P_trend = .028) and menopause (45 or less vs. 53 or more years; HR, 1.40; P_trend = .039). Risk of RA was inversely related to exposure to progestogen only in perimenopause (more than 24 vs. 0 months; multi-adjusted HR, 0.77; P_trend = .004).

Study details: This study included 78,452 women, with 698 incident cases of RA using data from the French E3N-EPIC cohort study.

Disclosures: The study was funded by a research grant from FOREUM Foundation for Research in Rheumatology. The authors declared no conflicts of interest.

Source: Salliot C et al. Rheumatology (Oxford). 2021 Feb 6. doi: 10.1093/rheumatology/keab101.

Key clinical point: A modern treat-to-target (T2T) approach with the use of tumor necrosis factor inhibitors (TNFi) resulted in low disease activity (LDA) and remission in 90% of pregnant patients with rheumatoid arthritis (RA).

Major finding: Among patients treated with T2T, 90.4% and 76.1% of patients were in LDA or remission, respectively, in the third trimester. Mean disease activity over time was lower in patients treated with the T2T approach vs. reference cohort (P less than .001).

Study details: Findings are from an analysis of 309 patients with RA from the PreCARA cohort who wished to conceive or were pregnant. Patients were treated with a T2T approach with the use of TNFi and/or a combination of disease-modifying antirheumatic drugs along with obvious pregnancy restrictions. The reference cohort consisted of pregnant patients with RA treated according to the 2002-2010 standards from the PARA study.

Disclosures: This investigator-initiated study was supported by UCB and Dutch Arthritis Foundation (ReumaNederland). The investigators did not report any competing interests.

Source: Smeele HTW et al. Ann Rheum Dis. 2021 Feb 10. doi: 10.1136/annrheumdis-2020-219547.

Key clinical point: A modern treat-to-target (T2T) approach with the use of tumor necrosis factor inhibitors (TNFi) resulted in low disease activity (LDA) and remission in 90% of pregnant patients with rheumatoid arthritis (RA).

Major finding: Among patients treated with T2T, 90.4% and 76.1% of patients were in LDA or remission, respectively, in the third trimester. Mean disease activity over time was lower in patients treated with the T2T approach vs. reference cohort (P less than .001).

Study details: Findings are from an analysis of 309 patients with RA from the PreCARA cohort who wished to conceive or were pregnant. Patients were treated with a T2T approach with the use of TNFi and/or a combination of disease-modifying antirheumatic drugs along with obvious pregnancy restrictions. The reference cohort consisted of pregnant patients with RA treated according to the 2002-2010 standards from the PARA study.

Disclosures: This investigator-initiated study was supported by UCB and Dutch Arthritis Foundation (ReumaNederland). The investigators did not report any competing interests.

Source: Smeele HTW et al. Ann Rheum Dis. 2021 Feb 10. doi: 10.1136/annrheumdis-2020-219547.

Key clinical point: A modern treat-to-target (T2T) approach with the use of tumor necrosis factor inhibitors (TNFi) resulted in low disease activity (LDA) and remission in 90% of pregnant patients with rheumatoid arthritis (RA).

Major finding: Among patients treated with T2T, 90.4% and 76.1% of patients were in LDA or remission, respectively, in the third trimester. Mean disease activity over time was lower in patients treated with the T2T approach vs. reference cohort (P less than .001).

Study details: Findings are from an analysis of 309 patients with RA from the PreCARA cohort who wished to conceive or were pregnant. Patients were treated with a T2T approach with the use of TNFi and/or a combination of disease-modifying antirheumatic drugs along with obvious pregnancy restrictions. The reference cohort consisted of pregnant patients with RA treated according to the 2002-2010 standards from the PARA study.

Disclosures: This investigator-initiated study was supported by UCB and Dutch Arthritis Foundation (ReumaNederland). The investigators did not report any competing interests.

Source: Smeele HTW et al. Ann Rheum Dis. 2021 Feb 10. doi: 10.1136/annrheumdis-2020-219547.

Key clinical point: Citrate-free adalimumab biosimilar (CT-P17) and European Union-approved adalimumab (EU-adalimumab) demonstrated equivalent efficacy and comparable safety in patients with rheumatoid arthritis (RA).

Major finding: At week 24, CT-P17 and EU-adalimumab groups showed similar 20% improvement by the American College of Rheumatology criteria response rate (82.7%). The 95% confidence interval (CI; −5.94 to 5.94) and 90% CI (−4.98 to 4.98) for estimated treatment difference were within predefined equivalence margin, demonstrating therapeutic equivalence. Overall, safety was similar between both treatment groups.

Study details: This was a randomized, double-blind phase 3 study of 648 patients with RA who were randomly allocated to receive 40 mg of either CT-P17 (n=324) or EU-adalimumab (n=324), every 2 weeks until week 48.

Disclosures: This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The authors reported receiving support, investigator fees, speaking fees, and/or consulting for various pharmaceutical companies including Celltrion, Inc. SJ Lee, YJ Bae, GE Yang, and JK Yoo reported being employees of Celltrion, Inc.

Source: Kay J et al. Arthritis Res Ther. 2021 Feb 5. doi: 10.1186/s13075-020-02394-7.

Key clinical point: Citrate-free adalimumab biosimilar (CT-P17) and European Union-approved adalimumab (EU-adalimumab) demonstrated equivalent efficacy and comparable safety in patients with rheumatoid arthritis (RA).

Major finding: At week 24, CT-P17 and EU-adalimumab groups showed similar 20% improvement by the American College of Rheumatology criteria response rate (82.7%). The 95% confidence interval (CI; −5.94 to 5.94) and 90% CI (−4.98 to 4.98) for estimated treatment difference were within predefined equivalence margin, demonstrating therapeutic equivalence. Overall, safety was similar between both treatment groups.

Study details: This was a randomized, double-blind phase 3 study of 648 patients with RA who were randomly allocated to receive 40 mg of either CT-P17 (n=324) or EU-adalimumab (n=324), every 2 weeks until week 48.

Disclosures: This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The authors reported receiving support, investigator fees, speaking fees, and/or consulting for various pharmaceutical companies including Celltrion, Inc. SJ Lee, YJ Bae, GE Yang, and JK Yoo reported being employees of Celltrion, Inc.

Source: Kay J et al. Arthritis Res Ther. 2021 Feb 5. doi: 10.1186/s13075-020-02394-7.

Key clinical point: Citrate-free adalimumab biosimilar (CT-P17) and European Union-approved adalimumab (EU-adalimumab) demonstrated equivalent efficacy and comparable safety in patients with rheumatoid arthritis (RA).

Major finding: At week 24, CT-P17 and EU-adalimumab groups showed similar 20% improvement by the American College of Rheumatology criteria response rate (82.7%). The 95% confidence interval (CI; −5.94 to 5.94) and 90% CI (−4.98 to 4.98) for estimated treatment difference were within predefined equivalence margin, demonstrating therapeutic equivalence. Overall, safety was similar between both treatment groups.

Study details: This was a randomized, double-blind phase 3 study of 648 patients with RA who were randomly allocated to receive 40 mg of either CT-P17 (n=324) or EU-adalimumab (n=324), every 2 weeks until week 48.

Disclosures: This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The authors reported receiving support, investigator fees, speaking fees, and/or consulting for various pharmaceutical companies including Celltrion, Inc. SJ Lee, YJ Bae, GE Yang, and JK Yoo reported being employees of Celltrion, Inc.

Source: Kay J et al. Arthritis Res Ther. 2021 Feb 5. doi: 10.1186/s13075-020-02394-7.

Key clinical point: Positivity for antipeptidyl-arginine deiminase type-3 (anti-PAD3) antibodies was associated with higher disease activity and joint damage scores in patients with rheumatoid arthritis (RA).

Major finding: Patients positive vs. negative for anti-PAD3 had significantly higher 28-swollen joint count (7.1 vs. 4.3; P less than .0001), 28-joint disease activity score-erythrocyte sedimentation rate (4.2 vs. 3.7; P = .005), and radiographic damage (14.9 vs. 8.8; P = .02).

Study details: Findings are from the assessment of biomarkers in 851 patients with RA and 516 disease controls (axial spondyloarthritis, n=320; psoriatic arthritis, n=196) from the Swiss Clinical Quality Management registry.

Disclosures: This work was supported by the De Reuter Foundation. M Mahler, C Bentow, and L Martinez-Prat declared being current or former employees at Inova Diagnostics. All the other authors declared no conflicts of interest.

Source: Lamacchia C et al. Rheumatology (Oxford). 2021 Jan 27. doi: 10.1093/rheumatology/keab050.

Key clinical point: Positivity for antipeptidyl-arginine deiminase type-3 (anti-PAD3) antibodies was associated with higher disease activity and joint damage scores in patients with rheumatoid arthritis (RA).

Major finding: Patients positive vs. negative for anti-PAD3 had significantly higher 28-swollen joint count (7.1 vs. 4.3; P less than .0001), 28-joint disease activity score-erythrocyte sedimentation rate (4.2 vs. 3.7; P = .005), and radiographic damage (14.9 vs. 8.8; P = .02).

Study details: Findings are from the assessment of biomarkers in 851 patients with RA and 516 disease controls (axial spondyloarthritis, n=320; psoriatic arthritis, n=196) from the Swiss Clinical Quality Management registry.

Disclosures: This work was supported by the De Reuter Foundation. M Mahler, C Bentow, and L Martinez-Prat declared being current or former employees at Inova Diagnostics. All the other authors declared no conflicts of interest.

Source: Lamacchia C et al. Rheumatology (Oxford). 2021 Jan 27. doi: 10.1093/rheumatology/keab050.

Key clinical point: Positivity for antipeptidyl-arginine deiminase type-3 (anti-PAD3) antibodies was associated with higher disease activity and joint damage scores in patients with rheumatoid arthritis (RA).

Major finding: Patients positive vs. negative for anti-PAD3 had significantly higher 28-swollen joint count (7.1 vs. 4.3; P less than .0001), 28-joint disease activity score-erythrocyte sedimentation rate (4.2 vs. 3.7; P = .005), and radiographic damage (14.9 vs. 8.8; P = .02).

Study details: Findings are from the assessment of biomarkers in 851 patients with RA and 516 disease controls (axial spondyloarthritis, n=320; psoriatic arthritis, n=196) from the Swiss Clinical Quality Management registry.

Disclosures: This work was supported by the De Reuter Foundation. M Mahler, C Bentow, and L Martinez-Prat declared being current or former employees at Inova Diagnostics. All the other authors declared no conflicts of interest.

Source: Lamacchia C et al. Rheumatology (Oxford). 2021 Jan 27. doi: 10.1093/rheumatology/keab050.

Key clinical point: Treatment with filgotinib and methotrexate (MTX) reduced signs and symptoms of rheumatoid arthritis (RA) in patients with moderate-to-severe active RA and inadequate response to MTX.

Major finding: Proportion of patients achieving 20% improvement in American College of Rheumatology criteria at week 12 was significantly higher with filgotinib 200 mg (76.6%) and 100 mg (69.8%) vs. placebo (49.9%; P for all less than .001). Overall, both filgotinib doses were well tolerated.

Study details: Findings are from FINCH I phase 3 study including 1,755 patients with moderate-to-severe active RA and inadequate response to MTX. Patients were randomly assigned to once-daily oral filgotinib 200 mg or filgotinib 100 mg, subcutaneous adalimumab 40 mg biweekly, or placebo, all with stable background MTX.

Disclosures: The study was funded by Gilead Sciences. Study investigators including the lead author reported ties with various pharmaceutical companies, including Gilead Sciences. MC Genovese, F Matzkies, B Bartok, L Ye, and Y Guo declared being employees and shareholders of Gilead Sciences. JS Sundy, A Jahreis, and N Mozaffarian declared being former employees of Gilead Sciences and may hold shares. C Tasset declared being an employee and shareholder of Galapagos NV. JA Simon, U Kumar U, and S-C Bae report no disclosures.

Source: Combe B et al. Ann Rheum Dis. 2021 Jan 27. doi: 10.1136/annrheumdis-2020-219214.

Key clinical point: Treatment with filgotinib and methotrexate (MTX) reduced signs and symptoms of rheumatoid arthritis (RA) in patients with moderate-to-severe active RA and inadequate response to MTX.

Major finding: Proportion of patients achieving 20% improvement in American College of Rheumatology criteria at week 12 was significantly higher with filgotinib 200 mg (76.6%) and 100 mg (69.8%) vs. placebo (49.9%; P for all less than .001). Overall, both filgotinib doses were well tolerated.

Study details: Findings are from FINCH I phase 3 study including 1,755 patients with moderate-to-severe active RA and inadequate response to MTX. Patients were randomly assigned to once-daily oral filgotinib 200 mg or filgotinib 100 mg, subcutaneous adalimumab 40 mg biweekly, or placebo, all with stable background MTX.

Disclosures: The study was funded by Gilead Sciences. Study investigators including the lead author reported ties with various pharmaceutical companies, including Gilead Sciences. MC Genovese, F Matzkies, B Bartok, L Ye, and Y Guo declared being employees and shareholders of Gilead Sciences. JS Sundy, A Jahreis, and N Mozaffarian declared being former employees of Gilead Sciences and may hold shares. C Tasset declared being an employee and shareholder of Galapagos NV. JA Simon, U Kumar U, and S-C Bae report no disclosures.

Source: Combe B et al. Ann Rheum Dis. 2021 Jan 27. doi: 10.1136/annrheumdis-2020-219214.

Key clinical point: Treatment with filgotinib and methotrexate (MTX) reduced signs and symptoms of rheumatoid arthritis (RA) in patients with moderate-to-severe active RA and inadequate response to MTX.

Major finding: Proportion of patients achieving 20% improvement in American College of Rheumatology criteria at week 12 was significantly higher with filgotinib 200 mg (76.6%) and 100 mg (69.8%) vs. placebo (49.9%; P for all less than .001). Overall, both filgotinib doses were well tolerated.

Study details: Findings are from FINCH I phase 3 study including 1,755 patients with moderate-to-severe active RA and inadequate response to MTX. Patients were randomly assigned to once-daily oral filgotinib 200 mg or filgotinib 100 mg, subcutaneous adalimumab 40 mg biweekly, or placebo, all with stable background MTX.

Disclosures: The study was funded by Gilead Sciences. Study investigators including the lead author reported ties with various pharmaceutical companies, including Gilead Sciences. MC Genovese, F Matzkies, B Bartok, L Ye, and Y Guo declared being employees and shareholders of Gilead Sciences. JS Sundy, A Jahreis, and N Mozaffarian declared being former employees of Gilead Sciences and may hold shares. C Tasset declared being an employee and shareholder of Galapagos NV. JA Simon, U Kumar U, and S-C Bae report no disclosures.

Source: Combe B et al. Ann Rheum Dis. 2021 Jan 27. doi: 10.1136/annrheumdis-2020-219214.

I passed the neurology boards, for the first time, in 1998. Then again in 2009, and most recently in 2019.

So I’m up again in 2029. Regrettably, I missed grandfathering in for life by a few years.

Some people don’t study for them, but I’m a little too compulsive not to. I’d guess I put 40-50 hours into doing so in the 3 months beforehand. I didn’t want to fail and have to pay a hefty fee to retake them (the test fee for once is enough as it is).

I’ll be 63 when my next certification is due.

So I wonder (if I’m still in practice) will it even be worthwhile to do it all again? I like what I do, but certainly don’t plan on practicing forever.

Board certification looks good on paper, but certainly isn’t a requirement to practice. One of the best cardiologists I know has never bothered to get his board certification and I don’t think any less of him for it. He also isn’t wanting for patients, and those he has think he’s awesome.

That said, there are things, like being involved in research and legal work, where board certification is strongly recommended, if not mandatory. Since I do both, I certainly wouldn’t want to do anything that might affect my participating in them – if I’m still doing this in 8 years.

By the same token, my office lease runs out when I’m 62. At that point I’ll have been in the same place for 17 years. I don’t consider that a bad thing. I like my current office, and will be perfectly happy to wrap up my career here.

It brings up the same question, though, with logistics that are an even bigger PIA. The last thing I want to do is move my office as my career is winding down. But a lease extension for a few years can be negotiated, a board certification can’t.

I can’t help but wonder: What is the point of recertification over time? If I’ve already passed it three times, hopefully that means I know what I’m doing. One side will argue that it’s purely greed, as the people who run the boards need money and a way to justify their existence. On the other side are those who argue that maintenance of certification, while not perfect, is the only way we have of making sure practicing physicians are staying up to snuff.

The truth, as always, is somewhere in between.

But it still raises a question that I, fortunately, have another 8 years to think about. Because I’m not in a position to debate if it’s right or wrong, I just have to play by the rules.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I passed the neurology boards, for the first time, in 1998. Then again in 2009, and most recently in 2019.

So I’m up again in 2029. Regrettably, I missed grandfathering in for life by a few years.

Some people don’t study for them, but I’m a little too compulsive not to. I’d guess I put 40-50 hours into doing so in the 3 months beforehand. I didn’t want to fail and have to pay a hefty fee to retake them (the test fee for once is enough as it is).

I’ll be 63 when my next certification is due.

So I wonder (if I’m still in practice) will it even be worthwhile to do it all again? I like what I do, but certainly don’t plan on practicing forever.

Board certification looks good on paper, but certainly isn’t a requirement to practice. One of the best cardiologists I know has never bothered to get his board certification and I don’t think any less of him for it. He also isn’t wanting for patients, and those he has think he’s awesome.

That said, there are things, like being involved in research and legal work, where board certification is strongly recommended, if not mandatory. Since I do both, I certainly wouldn’t want to do anything that might affect my participating in them – if I’m still doing this in 8 years.

By the same token, my office lease runs out when I’m 62. At that point I’ll have been in the same place for 17 years. I don’t consider that a bad thing. I like my current office, and will be perfectly happy to wrap up my career here.

It brings up the same question, though, with logistics that are an even bigger PIA. The last thing I want to do is move my office as my career is winding down. But a lease extension for a few years can be negotiated, a board certification can’t.

I can’t help but wonder: What is the point of recertification over time? If I’ve already passed it three times, hopefully that means I know what I’m doing. One side will argue that it’s purely greed, as the people who run the boards need money and a way to justify their existence. On the other side are those who argue that maintenance of certification, while not perfect, is the only way we have of making sure practicing physicians are staying up to snuff.

The truth, as always, is somewhere in between.

But it still raises a question that I, fortunately, have another 8 years to think about. Because I’m not in a position to debate if it’s right or wrong, I just have to play by the rules.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I passed the neurology boards, for the first time, in 1998. Then again in 2009, and most recently in 2019.

So I’m up again in 2029. Regrettably, I missed grandfathering in for life by a few years.

Some people don’t study for them, but I’m a little too compulsive not to. I’d guess I put 40-50 hours into doing so in the 3 months beforehand. I didn’t want to fail and have to pay a hefty fee to retake them (the test fee for once is enough as it is).

I’ll be 63 when my next certification is due.

So I wonder (if I’m still in practice) will it even be worthwhile to do it all again? I like what I do, but certainly don’t plan on practicing forever.

Board certification looks good on paper, but certainly isn’t a requirement to practice. One of the best cardiologists I know has never bothered to get his board certification and I don’t think any less of him for it. He also isn’t wanting for patients, and those he has think he’s awesome.

That said, there are things, like being involved in research and legal work, where board certification is strongly recommended, if not mandatory. Since I do both, I certainly wouldn’t want to do anything that might affect my participating in them – if I’m still doing this in 8 years.

By the same token, my office lease runs out when I’m 62. At that point I’ll have been in the same place for 17 years. I don’t consider that a bad thing. I like my current office, and will be perfectly happy to wrap up my career here.

It brings up the same question, though, with logistics that are an even bigger PIA. The last thing I want to do is move my office as my career is winding down. But a lease extension for a few years can be negotiated, a board certification can’t.

I can’t help but wonder: What is the point of recertification over time? If I’ve already passed it three times, hopefully that means I know what I’m doing. One side will argue that it’s purely greed, as the people who run the boards need money and a way to justify their existence. On the other side are those who argue that maintenance of certification, while not perfect, is the only way we have of making sure practicing physicians are staying up to snuff.

The truth, as always, is somewhere in between.

But it still raises a question that I, fortunately, have another 8 years to think about. Because I’m not in a position to debate if it’s right or wrong, I just have to play by the rules.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Non-Hispanic Black and Hispanic patients are underrepresented on many liver transplant waiting lists, whereas non-Hispanic White patients are often overrepresented, according to data from 109 centers.

pixelheadphoto/Thinkstock

While racial disparities “greatly diminished” after placement on a waiting list, which suggests recent progress in the field, pre–wait-listing disparities may be more challenging to overcome, reported lead author Curtis Warren, MPH, CPH, of the University of Florida, Gainesville, and colleagues.

“In 2020, the Organ Procurement and Transplantation Network implemented a new allocation system for liver transplantation based on concentric circles of geographic proximity rather than somewhat arbitrarily delineated Donor Service Areas (DSAs),” the investigators wrote in Journal of the American College of Surgeons. “Although this was a step toward improving and equalizing access to lifesaving organs for those on the liver transplant wait list, the listing process determining which patients will be considered for transplantation has continued to be a significant hurdle.”

The process is “rife with impediments to equal access to listing,” according to Dr. Warren and colleagues; getting on a waiting list can be affected by factors such as inequitable access to primary care, lack of private health insurance, and subjective selection by transplant centers.

To better characterize these impediments, the investigators gathered center-specific data from the Scientific Registry of Transplant Recipients and the U.S. Census Bureau. The final dataset included 30,353 patients from treated at 109 transplant centers, each of which performed more than 250 transplants between January 2013 and December 2018. The investigators compared waiting list data for each center with demographics from its DSA. Primary variables included race/ethnicity, education level, poverty, and insurance coverage.

Multiple logistic regression analysis was used to compare expected waiting list demographics with observed waiting list demographics with the aid of observed/expected ratios for each race/ethnicity. Univariate and multivariate analyses were used to identify significant predictors, including covariates such as age at listing, distance traveled to transplant center, and center type.

On an adjusted basis, the observed/expected ratios showed that non-Hispanic Black patients were underrepresented on waiting lists at 88 out of 109 centers (81%) and Hispanic patients were underrepresented at 68 centers (62%). In contrast, non-Hispanic White patients were overrepresented on waiting lists at 65 centers (58%). Non-Hispanic White patients were underrepresented on waiting lists at 49 centers, or 45%. Minority underrepresentation was further supported by mean MELD (Model for End-Stage Liver Disease) scores, which were significantly higher among non-Hispanic Black patients (20.2) and Hispanic patients (19.4), compared with non-Hispanic White patients (18.7) (P < .0001 for all) at the time of wait-listing.

Based on the multivariate model, underrepresentation among Black patients was most common in areas with a higher proportion of Black individuals in the population, longer travel distances to transplant centers, and a higher rate of private insurance among transplant recipients. For Hispanic patients, rates of private insurance alone predicted underrepresentation.

Once patients were listed, however, these disparities faded. Non-Hispanic Black patients accounted for 9.8% of all transplants across all hospitals, compared with 7.9% of wait-listed individuals (P < .0001). At approximately two out of three hospitals (65%), the transplanted percentage of Black patients exceeded the wait-listed percentage (P = .002).

“Data from this study show that the wait lists at many transplant centers in the United States underrepresent minority populations, compared with what would be expected based on their service areas,” the investigators concluded. “Future work will need to be devoted to increasing awareness of these trends to promote equitable access to listing for liver transplantation.”

Looking at social determinants of health

According to Lauren D. Nephew, MD, MSc, MAE, of Indiana University, Indianapolis, “The question of access to care is particularly important at this juncture as we examine the inequities that COVID-19 exposed in access to care for racial minorities, and as we prepare for potential changes to health insurance coverage with the new administration.”

Dr. Nephew noted that the reported racial disparities stem from social determinants of health, such as proximity to transplant centers and type of insurance coverage.

“Another striking finding was that the disparity in wait-listing non-Hispanic Black patients increased with the percentage of non-Hispanic Black patients living in the area, further highlighting barriers in access to care in majority Black neighborhoods,” she said. “Inequities such as these are unacceptable, given our mandate to distribute organs in a fair and equitable fashion, and they require prospective studies for further examination.”
 

Identifying discrimination

Lanla Conteh, MD, MPH, of the Ohio State University Wexner Medical Center, Columbus, described how these inequities are magnified through bias in patient selection.

“Often times two very similar patients may present with the same medical profile and social circumstances; however, one is turned down,” she said. “Often the patient turned down is the non-Hispanic Black patient while the non-Hispanic White patient is given a pass.”

Dr. Conteh suggested that the first step in fixing this bias is recognizing that it is a problem and calling it by its proper name.

“As transplant centers, in order to address and change these significant disparities, we must first be willing to acknowledge that they do exist,” she said. “Only then can we move to the next step of developing awareness and methods to actively combat what we should label as systemic discrimination in medicine. Transplantation is a lifesaving treatment for many patients with decompensated liver disease or liver cancer. Ensuring equitable access for all patients and populations is of paramount importance.”

The study was supported by a Health Resources and Services Administration contract, as well as grants from the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. The investigators and interviewees reported no conflicts of interest.

Non-Hispanic Black and Hispanic patients are underrepresented on many liver transplant waiting lists, whereas non-Hispanic White patients are often overrepresented, according to data from 109 centers.

pixelheadphoto/Thinkstock

While racial disparities “greatly diminished” after placement on a waiting list, which suggests recent progress in the field, pre–wait-listing disparities may be more challenging to overcome, reported lead author Curtis Warren, MPH, CPH, of the University of Florida, Gainesville, and colleagues.

“In 2020, the Organ Procurement and Transplantation Network implemented a new allocation system for liver transplantation based on concentric circles of geographic proximity rather than somewhat arbitrarily delineated Donor Service Areas (DSAs),” the investigators wrote in Journal of the American College of Surgeons. “Although this was a step toward improving and equalizing access to lifesaving organs for those on the liver transplant wait list, the listing process determining which patients will be considered for transplantation has continued to be a significant hurdle.”

The process is “rife with impediments to equal access to listing,” according to Dr. Warren and colleagues; getting on a waiting list can be affected by factors such as inequitable access to primary care, lack of private health insurance, and subjective selection by transplant centers.

To better characterize these impediments, the investigators gathered center-specific data from the Scientific Registry of Transplant Recipients and the U.S. Census Bureau. The final dataset included 30,353 patients from treated at 109 transplant centers, each of which performed more than 250 transplants between January 2013 and December 2018. The investigators compared waiting list data for each center with demographics from its DSA. Primary variables included race/ethnicity, education level, poverty, and insurance coverage.

Multiple logistic regression analysis was used to compare expected waiting list demographics with observed waiting list demographics with the aid of observed/expected ratios for each race/ethnicity. Univariate and multivariate analyses were used to identify significant predictors, including covariates such as age at listing, distance traveled to transplant center, and center type.

On an adjusted basis, the observed/expected ratios showed that non-Hispanic Black patients were underrepresented on waiting lists at 88 out of 109 centers (81%) and Hispanic patients were underrepresented at 68 centers (62%). In contrast, non-Hispanic White patients were overrepresented on waiting lists at 65 centers (58%). Non-Hispanic White patients were underrepresented on waiting lists at 49 centers, or 45%. Minority underrepresentation was further supported by mean MELD (Model for End-Stage Liver Disease) scores, which were significantly higher among non-Hispanic Black patients (20.2) and Hispanic patients (19.4), compared with non-Hispanic White patients (18.7) (P < .0001 for all) at the time of wait-listing.

Based on the multivariate model, underrepresentation among Black patients was most common in areas with a higher proportion of Black individuals in the population, longer travel distances to transplant centers, and a higher rate of private insurance among transplant recipients. For Hispanic patients, rates of private insurance alone predicted underrepresentation.

Once patients were listed, however, these disparities faded. Non-Hispanic Black patients accounted for 9.8% of all transplants across all hospitals, compared with 7.9% of wait-listed individuals (P < .0001). At approximately two out of three hospitals (65%), the transplanted percentage of Black patients exceeded the wait-listed percentage (P = .002).

“Data from this study show that the wait lists at many transplant centers in the United States underrepresent minority populations, compared with what would be expected based on their service areas,” the investigators concluded. “Future work will need to be devoted to increasing awareness of these trends to promote equitable access to listing for liver transplantation.”

Looking at social determinants of health

According to Lauren D. Nephew, MD, MSc, MAE, of Indiana University, Indianapolis, “The question of access to care is particularly important at this juncture as we examine the inequities that COVID-19 exposed in access to care for racial minorities, and as we prepare for potential changes to health insurance coverage with the new administration.”

Dr. Nephew noted that the reported racial disparities stem from social determinants of health, such as proximity to transplant centers and type of insurance coverage.

“Another striking finding was that the disparity in wait-listing non-Hispanic Black patients increased with the percentage of non-Hispanic Black patients living in the area, further highlighting barriers in access to care in majority Black neighborhoods,” she said. “Inequities such as these are unacceptable, given our mandate to distribute organs in a fair and equitable fashion, and they require prospective studies for further examination.”
 

Identifying discrimination

Lanla Conteh, MD, MPH, of the Ohio State University Wexner Medical Center, Columbus, described how these inequities are magnified through bias in patient selection.

“Often times two very similar patients may present with the same medical profile and social circumstances; however, one is turned down,” she said. “Often the patient turned down is the non-Hispanic Black patient while the non-Hispanic White patient is given a pass.”

Dr. Conteh suggested that the first step in fixing this bias is recognizing that it is a problem and calling it by its proper name.

“As transplant centers, in order to address and change these significant disparities, we must first be willing to acknowledge that they do exist,” she said. “Only then can we move to the next step of developing awareness and methods to actively combat what we should label as systemic discrimination in medicine. Transplantation is a lifesaving treatment for many patients with decompensated liver disease or liver cancer. Ensuring equitable access for all patients and populations is of paramount importance.”

The study was supported by a Health Resources and Services Administration contract, as well as grants from the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. The investigators and interviewees reported no conflicts of interest.

Non-Hispanic Black and Hispanic patients are underrepresented on many liver transplant waiting lists, whereas non-Hispanic White patients are often overrepresented, according to data from 109 centers.

pixelheadphoto/Thinkstock

While racial disparities “greatly diminished” after placement on a waiting list, which suggests recent progress in the field, pre–wait-listing disparities may be more challenging to overcome, reported lead author Curtis Warren, MPH, CPH, of the University of Florida, Gainesville, and colleagues.

“In 2020, the Organ Procurement and Transplantation Network implemented a new allocation system for liver transplantation based on concentric circles of geographic proximity rather than somewhat arbitrarily delineated Donor Service Areas (DSAs),” the investigators wrote in Journal of the American College of Surgeons. “Although this was a step toward improving and equalizing access to lifesaving organs for those on the liver transplant wait list, the listing process determining which patients will be considered for transplantation has continued to be a significant hurdle.”

The process is “rife with impediments to equal access to listing,” according to Dr. Warren and colleagues; getting on a waiting list can be affected by factors such as inequitable access to primary care, lack of private health insurance, and subjective selection by transplant centers.

To better characterize these impediments, the investigators gathered center-specific data from the Scientific Registry of Transplant Recipients and the U.S. Census Bureau. The final dataset included 30,353 patients from treated at 109 transplant centers, each of which performed more than 250 transplants between January 2013 and December 2018. The investigators compared waiting list data for each center with demographics from its DSA. Primary variables included race/ethnicity, education level, poverty, and insurance coverage.

Multiple logistic regression analysis was used to compare expected waiting list demographics with observed waiting list demographics with the aid of observed/expected ratios for each race/ethnicity. Univariate and multivariate analyses were used to identify significant predictors, including covariates such as age at listing, distance traveled to transplant center, and center type.

On an adjusted basis, the observed/expected ratios showed that non-Hispanic Black patients were underrepresented on waiting lists at 88 out of 109 centers (81%) and Hispanic patients were underrepresented at 68 centers (62%). In contrast, non-Hispanic White patients were overrepresented on waiting lists at 65 centers (58%). Non-Hispanic White patients were underrepresented on waiting lists at 49 centers, or 45%. Minority underrepresentation was further supported by mean MELD (Model for End-Stage Liver Disease) scores, which were significantly higher among non-Hispanic Black patients (20.2) and Hispanic patients (19.4), compared with non-Hispanic White patients (18.7) (P < .0001 for all) at the time of wait-listing.

Based on the multivariate model, underrepresentation among Black patients was most common in areas with a higher proportion of Black individuals in the population, longer travel distances to transplant centers, and a higher rate of private insurance among transplant recipients. For Hispanic patients, rates of private insurance alone predicted underrepresentation.

Once patients were listed, however, these disparities faded. Non-Hispanic Black patients accounted for 9.8% of all transplants across all hospitals, compared with 7.9% of wait-listed individuals (P < .0001). At approximately two out of three hospitals (65%), the transplanted percentage of Black patients exceeded the wait-listed percentage (P = .002).

“Data from this study show that the wait lists at many transplant centers in the United States underrepresent minority populations, compared with what would be expected based on their service areas,” the investigators concluded. “Future work will need to be devoted to increasing awareness of these trends to promote equitable access to listing for liver transplantation.”

Looking at social determinants of health

According to Lauren D. Nephew, MD, MSc, MAE, of Indiana University, Indianapolis, “The question of access to care is particularly important at this juncture as we examine the inequities that COVID-19 exposed in access to care for racial minorities, and as we prepare for potential changes to health insurance coverage with the new administration.”

Dr. Nephew noted that the reported racial disparities stem from social determinants of health, such as proximity to transplant centers and type of insurance coverage.

“Another striking finding was that the disparity in wait-listing non-Hispanic Black patients increased with the percentage of non-Hispanic Black patients living in the area, further highlighting barriers in access to care in majority Black neighborhoods,” she said. “Inequities such as these are unacceptable, given our mandate to distribute organs in a fair and equitable fashion, and they require prospective studies for further examination.”
 

Identifying discrimination

Lanla Conteh, MD, MPH, of the Ohio State University Wexner Medical Center, Columbus, described how these inequities are magnified through bias in patient selection.

“Often times two very similar patients may present with the same medical profile and social circumstances; however, one is turned down,” she said. “Often the patient turned down is the non-Hispanic Black patient while the non-Hispanic White patient is given a pass.”

Dr. Conteh suggested that the first step in fixing this bias is recognizing that it is a problem and calling it by its proper name.

“As transplant centers, in order to address and change these significant disparities, we must first be willing to acknowledge that they do exist,” she said. “Only then can we move to the next step of developing awareness and methods to actively combat what we should label as systemic discrimination in medicine. Transplantation is a lifesaving treatment for many patients with decompensated liver disease or liver cancer. Ensuring equitable access for all patients and populations is of paramount importance.”

The study was supported by a Health Resources and Services Administration contract, as well as grants from the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. The investigators and interviewees reported no conflicts of interest.

For patients with triple-negative breast cancer (TNBC), neoadjuvant carboplatin plus docetaxel yields the same pathologic complete response and survival rates as a standard anthracycline-based neoadjuvant regimen – carboplatin and paclitaxel followed by doxorubicin/cyclophosphamide – but with less toxicity, higher completion rates, and at lower cost.

The results come from a phase 2 trial that involved 100 women. The study was published online in February in Clinical Cancer Research.

The doublet provides a safe, effective alternative for patients who are not candidates for treatment with anthracyclines and should be explored further for neoadjuvant deescalation, according to investigators led by Priyanka Sharma, MD, TNBC specialist and professor at the University of Kansas Medical Center, Westwood.

The trial wasn’t powered to demonstrate noninferiority, so it “probably does not provide enough evidence to state that [taxane/platinum] should replace other regimens,” Dr. Sharma said in an interview.

A proper noninferiority trial would require more than 2,500 participants, she said, adding that such a trial is unlikely, because companies are focused on immunotherapies for neoadjuvant TNBC.

“Our study does, however, provide a very effective alternative for patients and providers who want to use or prefer an anthracycline-sparing neoadjuvant chemotherapy regimen. We are very encouraged” by the findings, Dr. Sharma said.

This is “a provocative study that should make us pause and reevaluate our current approach. Further study of this approach in early-stage TNBC is warranted,” Melinda L. Telli, MD, associate professor of medicine and director of the breast cancer program at Stanford (Calif.) University, said when asked for comment.

Avoiding the risks associated with anthracycline “is great. I would be particularly enthusiastic using this regimen in patients with known increased risk of cardiac toxicity,” said Amy Tiersten, MD, a breast cancer specialist and professor at Mount Sinai Hospital, New York.

Anthracycline-based regimens are the standard of care for neoadjuvant TNBC. They typically include a taxane with or without carboplatin plus an anthracycline/cyclophosphamide combination. The regimen is highly active, but there is a small but serious risk for cardiomyopathy and leukemia with anthracycline/cyclophosphamide. In the current trial, one woman in the anthracycline arm died of secondary acute myeloid leukemia.

Given its tolerability and effectiveness, a taxane/carboplatin doublet might serve as a good backbone for the addition of novel immunotherapies in trials. Dr. Sharma is the principal investigator in one such trial, a phase 2 trial of carboplatin/docetaxel plus pembrolizumab for stage I–III TNBC.
 

Study details

The Neoadjuvant Study of Two Platinum Regimens in Stage I–III Triple Negative Breast Cancer (NeoSTOP) involved 100 women with stage I–III TNBC.

In the experimental arm, 52 women received carboplatin AUC 6 plus docetaxel 75 mg/m² every 21 days for six cycles.

In the standard-of-care anthracycline arm, 48 women received carboplatin AUC 6 every 21 days for four cycles plus paclitaxel 80 mg/m² weekly for 12 weeks, followed by doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for four cycles.

Docetaxel and paclitaxel in the two regimens are interchangeable because they have shown equal efficacy in adjuvant trials, Dr. Sharma said.

At surgery, 54% of women in both arms had a breast/axilla pathologic complete response – the primary endpoint – and 67% in both arms had a residual cancer burden of 0-1. Event-free and overall survival (about 55% at 3 years for both) were similar with the two regimens.

Grade 3/4 adverse events were more common in the anthracycline arm. They included neutropenia, which occurred in 60% of women in the anthracycline arm, vs. 8% with the doublet; and febrile neutropenia, which occurred in 19% with anthracycline, vs. none with the doublet.

The toxicity profile of the anthracycline regimen was comparable to those in previous reports.

Ninety-two percent of the docetaxel/carboplatin group completed all six cycles; 72% of women in the anthracycline arm completed 10 or more doses of paclitaxel, and 85% completed all 4 carboplatin doses.

Mean costs of treatment, patient transportation, and lost productivity were $36,720 in the anthracycline arm, vs. $33,148 with the doublet.

The two arms were well balanced with respect to patient characteristics. The median age was 51 years, 30% of patients had axillary lymph node–positive disease, and 16% had ER/PgR expression of 1% to 10%. Of the study population, 17% carried deleterious BRCA1/2 mutations. Women were enrolled from July 2015 to May 2018. Median follow-up was 38 months.

Of the study population, 17% had stage I disease, so NeoSTOP included a lower-risk population than some neoadjuvant trials. However, there was no significant change in pathologic complete response rates in the two arms after exclusion of women with stage I disease (doublet, 50%; anthracycline, 54%).

The study was funded by the University of Kansas Cancer Center, the Breast Cancer Research Foundation, and the National Institute of General Medical Sciences. The investigators disclosed no relevant financial relationships.

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

For patients with triple-negative breast cancer (TNBC), neoadjuvant carboplatin plus docetaxel yields the same pathologic complete response and survival rates as a standard anthracycline-based neoadjuvant regimen – carboplatin and paclitaxel followed by doxorubicin/cyclophosphamide – but with less toxicity, higher completion rates, and at lower cost.

The results come from a phase 2 trial that involved 100 women. The study was published online in February in Clinical Cancer Research.

The doublet provides a safe, effective alternative for patients who are not candidates for treatment with anthracyclines and should be explored further for neoadjuvant deescalation, according to investigators led by Priyanka Sharma, MD, TNBC specialist and professor at the University of Kansas Medical Center, Westwood.

The trial wasn’t powered to demonstrate noninferiority, so it “probably does not provide enough evidence to state that [taxane/platinum] should replace other regimens,” Dr. Sharma said in an interview.

A proper noninferiority trial would require more than 2,500 participants, she said, adding that such a trial is unlikely, because companies are focused on immunotherapies for neoadjuvant TNBC.

“Our study does, however, provide a very effective alternative for patients and providers who want to use or prefer an anthracycline-sparing neoadjuvant chemotherapy regimen. We are very encouraged” by the findings, Dr. Sharma said.

This is “a provocative study that should make us pause and reevaluate our current approach. Further study of this approach in early-stage TNBC is warranted,” Melinda L. Telli, MD, associate professor of medicine and director of the breast cancer program at Stanford (Calif.) University, said when asked for comment.

Avoiding the risks associated with anthracycline “is great. I would be particularly enthusiastic using this regimen in patients with known increased risk of cardiac toxicity,” said Amy Tiersten, MD, a breast cancer specialist and professor at Mount Sinai Hospital, New York.

Anthracycline-based regimens are the standard of care for neoadjuvant TNBC. They typically include a taxane with or without carboplatin plus an anthracycline/cyclophosphamide combination. The regimen is highly active, but there is a small but serious risk for cardiomyopathy and leukemia with anthracycline/cyclophosphamide. In the current trial, one woman in the anthracycline arm died of secondary acute myeloid leukemia.

Given its tolerability and effectiveness, a taxane/carboplatin doublet might serve as a good backbone for the addition of novel immunotherapies in trials. Dr. Sharma is the principal investigator in one such trial, a phase 2 trial of carboplatin/docetaxel plus pembrolizumab for stage I–III TNBC.
 

Study details

The Neoadjuvant Study of Two Platinum Regimens in Stage I–III Triple Negative Breast Cancer (NeoSTOP) involved 100 women with stage I–III TNBC.

In the experimental arm, 52 women received carboplatin AUC 6 plus docetaxel 75 mg/m² every 21 days for six cycles.

In the standard-of-care anthracycline arm, 48 women received carboplatin AUC 6 every 21 days for four cycles plus paclitaxel 80 mg/m² weekly for 12 weeks, followed by doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for four cycles.

Docetaxel and paclitaxel in the two regimens are interchangeable because they have shown equal efficacy in adjuvant trials, Dr. Sharma said.

At surgery, 54% of women in both arms had a breast/axilla pathologic complete response – the primary endpoint – and 67% in both arms had a residual cancer burden of 0-1. Event-free and overall survival (about 55% at 3 years for both) were similar with the two regimens.

Grade 3/4 adverse events were more common in the anthracycline arm. They included neutropenia, which occurred in 60% of women in the anthracycline arm, vs. 8% with the doublet; and febrile neutropenia, which occurred in 19% with anthracycline, vs. none with the doublet.

The toxicity profile of the anthracycline regimen was comparable to those in previous reports.

Ninety-two percent of the docetaxel/carboplatin group completed all six cycles; 72% of women in the anthracycline arm completed 10 or more doses of paclitaxel, and 85% completed all 4 carboplatin doses.

Mean costs of treatment, patient transportation, and lost productivity were $36,720 in the anthracycline arm, vs. $33,148 with the doublet.

The two arms were well balanced with respect to patient characteristics. The median age was 51 years, 30% of patients had axillary lymph node–positive disease, and 16% had ER/PgR expression of 1% to 10%. Of the study population, 17% carried deleterious BRCA1/2 mutations. Women were enrolled from July 2015 to May 2018. Median follow-up was 38 months.

Of the study population, 17% had stage I disease, so NeoSTOP included a lower-risk population than some neoadjuvant trials. However, there was no significant change in pathologic complete response rates in the two arms after exclusion of women with stage I disease (doublet, 50%; anthracycline, 54%).

The study was funded by the University of Kansas Cancer Center, the Breast Cancer Research Foundation, and the National Institute of General Medical Sciences. The investigators disclosed no relevant financial relationships.

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

For patients with triple-negative breast cancer (TNBC), neoadjuvant carboplatin plus docetaxel yields the same pathologic complete response and survival rates as a standard anthracycline-based neoadjuvant regimen – carboplatin and paclitaxel followed by doxorubicin/cyclophosphamide – but with less toxicity, higher completion rates, and at lower cost.

The results come from a phase 2 trial that involved 100 women. The study was published online in February in Clinical Cancer Research.

The doublet provides a safe, effective alternative for patients who are not candidates for treatment with anthracyclines and should be explored further for neoadjuvant deescalation, according to investigators led by Priyanka Sharma, MD, TNBC specialist and professor at the University of Kansas Medical Center, Westwood.

The trial wasn’t powered to demonstrate noninferiority, so it “probably does not provide enough evidence to state that [taxane/platinum] should replace other regimens,” Dr. Sharma said in an interview.

A proper noninferiority trial would require more than 2,500 participants, she said, adding that such a trial is unlikely, because companies are focused on immunotherapies for neoadjuvant TNBC.

“Our study does, however, provide a very effective alternative for patients and providers who want to use or prefer an anthracycline-sparing neoadjuvant chemotherapy regimen. We are very encouraged” by the findings, Dr. Sharma said.

This is “a provocative study that should make us pause and reevaluate our current approach. Further study of this approach in early-stage TNBC is warranted,” Melinda L. Telli, MD, associate professor of medicine and director of the breast cancer program at Stanford (Calif.) University, said when asked for comment.

Avoiding the risks associated with anthracycline “is great. I would be particularly enthusiastic using this regimen in patients with known increased risk of cardiac toxicity,” said Amy Tiersten, MD, a breast cancer specialist and professor at Mount Sinai Hospital, New York.

Anthracycline-based regimens are the standard of care for neoadjuvant TNBC. They typically include a taxane with or without carboplatin plus an anthracycline/cyclophosphamide combination. The regimen is highly active, but there is a small but serious risk for cardiomyopathy and leukemia with anthracycline/cyclophosphamide. In the current trial, one woman in the anthracycline arm died of secondary acute myeloid leukemia.

Given its tolerability and effectiveness, a taxane/carboplatin doublet might serve as a good backbone for the addition of novel immunotherapies in trials. Dr. Sharma is the principal investigator in one such trial, a phase 2 trial of carboplatin/docetaxel plus pembrolizumab for stage I–III TNBC.
 

Study details

The Neoadjuvant Study of Two Platinum Regimens in Stage I–III Triple Negative Breast Cancer (NeoSTOP) involved 100 women with stage I–III TNBC.

In the experimental arm, 52 women received carboplatin AUC 6 plus docetaxel 75 mg/m² every 21 days for six cycles.

In the standard-of-care anthracycline arm, 48 women received carboplatin AUC 6 every 21 days for four cycles plus paclitaxel 80 mg/m² weekly for 12 weeks, followed by doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for four cycles.

Docetaxel and paclitaxel in the two regimens are interchangeable because they have shown equal efficacy in adjuvant trials, Dr. Sharma said.

At surgery, 54% of women in both arms had a breast/axilla pathologic complete response – the primary endpoint – and 67% in both arms had a residual cancer burden of 0-1. Event-free and overall survival (about 55% at 3 years for both) were similar with the two regimens.

Grade 3/4 adverse events were more common in the anthracycline arm. They included neutropenia, which occurred in 60% of women in the anthracycline arm, vs. 8% with the doublet; and febrile neutropenia, which occurred in 19% with anthracycline, vs. none with the doublet.

The toxicity profile of the anthracycline regimen was comparable to those in previous reports.

Ninety-two percent of the docetaxel/carboplatin group completed all six cycles; 72% of women in the anthracycline arm completed 10 or more doses of paclitaxel, and 85% completed all 4 carboplatin doses.

Mean costs of treatment, patient transportation, and lost productivity were $36,720 in the anthracycline arm, vs. $33,148 with the doublet.

The two arms were well balanced with respect to patient characteristics. The median age was 51 years, 30% of patients had axillary lymph node–positive disease, and 16% had ER/PgR expression of 1% to 10%. Of the study population, 17% carried deleterious BRCA1/2 mutations. Women were enrolled from July 2015 to May 2018. Median follow-up was 38 months.

Of the study population, 17% had stage I disease, so NeoSTOP included a lower-risk population than some neoadjuvant trials. However, there was no significant change in pathologic complete response rates in the two arms after exclusion of women with stage I disease (doublet, 50%; anthracycline, 54%).

The study was funded by the University of Kansas Cancer Center, the Breast Cancer Research Foundation, and the National Institute of General Medical Sciences. The investigators disclosed no relevant financial relationships.

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

Vaping cannabis significantly increased the risk of respiratory symptoms in adolescents, according to findings of a study based on a national sample of teens.

HAZEMMKAMAL/Getty Images

Most studies of electronic nicotine delivery systems (ENDS) use in teens have not addressed cannabis vaping, although e-cigarette– or vaping product use–associated lung injury (EVALI) has been predominately associated with cannabis products, wrote Carol J. Boyd, PhD, of the University of Michigan School of Nursing, Ann Arbor, and colleagues.

“At this time, relatively little is known about the population-level health consequences of adolescents’ use of ENDS, including use with cannabis and controlling for a history of asthma,” they said.

In a study published in the Journal of Adolescent Health, the researchers identified 14,798 adolescents aged 12-17 years using Wave 4 data from the Population Assessment of Tobacco and Health Study. Of these, 17.6% had a baseline asthma diagnosis, 8.9% reported ever using cannabis in ENDS, and 4.7% reported any cannabis use. In addition, 4.2% reported current e-cigarette use, 3.1% reported current cigarette use, 51% were male, and 69.2% were white.
 

Any cannabis vaping makes impact

In a fully-adjusted model, teens who had ever vaped cannabis had higher odds of five respiratory symptoms in the past year, compared with those with no history of cannabis vaping: wheezing or whistling in the chest (adjusted odds ratio, 1.81); sleep disturbed by wheezing or whistling (AOR, 1.71); speech limited because of wheezing (AOR, 1.96); wheezy during and after exercise (AOR, 1.33), and a dry cough at night independent of a cold or chest infection (AOR, 1.26).

Neither e-cigarettes nor cigarettes were significantly associated with any of these five respiratory symptoms in the fully adjusted models. In addition, “past 30-day use of cigarettes, e-cigarettes and cannabis use were associated with some respiratory symptoms in bivariate analyses but not in the adjusted models,” the researchers noted. In addition, the associations of an asthma diagnosis and respiratory symptoms had greater magnitudes than either cigarette, e-cigarette, and cannabis use or vaping cannabis with ENDS.

The study findings were limited by several factors including the inherent limitations of secondary database analysis, the researchers noted. “Another limitation is that co-use of cannabis and tobacco/nicotine was not assessed and, in the future, should be examined: Researchers have found that co-use is related to EVALI symptoms among young adults,” they said.

However, the study is the first known to include ENDS product use and respiratory symptoms while accounting for baseline asthma, and an asthma diagnosis was even more strongly associated with all five respiratory symptoms, the researchers said.

The results suggest that “the inhalation of cannabis via vaping is associated with some pulmonary irritation and symptoms of lung diseases (both known and unknown),” that may be predictive of later EVALI, they concluded.
 

Product details aid in diagnosis

“As we continue to see patients presenting with EVALI in pediatric hospitals, it is important for us to identify if there are specific products (or categories) that are more likely to cause it,” said Brandon Seay, MD, FCCP, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta, in an interview. “When we are trying to diagnose EVALI, we should be asking appropriate questions about exposures to specific products to get the best answers. If we simply ask ‘Are you smoking e-cigarettes?’ the patient may not [equate] e-cigarette smoking to vaping cannabis products,” he said. 

Dr. Seay said he was not surprised by the study findings. “A lot of the patients I see with EVALI have reported vaping THC products, and most of them also report that the products were mixed by a friend or an individual instead of being a commercially produced product,” he noted. “This is not surprising, as THC is still illegal in most states and there would not be any commercially available products,” he said. “The mixing of these products by individuals increases the risk of ingredients being more toxic or irritating to the lungs,” Dr. Seay added. “This does highlight the need for more regulation of vaping products. As more states legalize marijuana, more of these products will become available, which will provide an opportunity for increased regulation, he said. 

The take-home message for clinicians is to seek specific details from their young patients, Dr. Seay emphasized. “When we are educating our patients on the dangers of vaping/e-cigarettes, we need to make sure we are asking specifically which products they are using and know the terminology,” he said. “The use of THC-containing products will be increasing across the country with more legalization, so we need to keep ourselves apprised of the different risks between THC- and nicotine-containing devices,” he added.  

As for additional research, it would be interesting to know whether patients were asked where they had gotten their products (commercially available products vs. those mixed by individuals) and explore any difference between the two, said Dr. Seay. “Also, as these products are relatively new to the market, compared to cigarettes, data on the longitudinal effects of vaping (nicotine and THC) over a long period of time, compared to traditional combustible cigarettes, will be needed,” he said.

The study was funded by grants from the National Institutes of Health, National Institute on Drug Abuse, and National Cancer Institute. The researchers had no financial conflicts to disclose.

Dr. Seay had no financial disclosures, but serves as a member of the CHEST Physician editorial board.

Vaping cannabis significantly increased the risk of respiratory symptoms in adolescents, according to findings of a study based on a national sample of teens.

HAZEMMKAMAL/Getty Images

Most studies of electronic nicotine delivery systems (ENDS) use in teens have not addressed cannabis vaping, although e-cigarette– or vaping product use–associated lung injury (EVALI) has been predominately associated with cannabis products, wrote Carol J. Boyd, PhD, of the University of Michigan School of Nursing, Ann Arbor, and colleagues.

“At this time, relatively little is known about the population-level health consequences of adolescents’ use of ENDS, including use with cannabis and controlling for a history of asthma,” they said.

In a study published in the Journal of Adolescent Health, the researchers identified 14,798 adolescents aged 12-17 years using Wave 4 data from the Population Assessment of Tobacco and Health Study. Of these, 17.6% had a baseline asthma diagnosis, 8.9% reported ever using cannabis in ENDS, and 4.7% reported any cannabis use. In addition, 4.2% reported current e-cigarette use, 3.1% reported current cigarette use, 51% were male, and 69.2% were white.
 

Any cannabis vaping makes impact

In a fully-adjusted model, teens who had ever vaped cannabis had higher odds of five respiratory symptoms in the past year, compared with those with no history of cannabis vaping: wheezing or whistling in the chest (adjusted odds ratio, 1.81); sleep disturbed by wheezing or whistling (AOR, 1.71); speech limited because of wheezing (AOR, 1.96); wheezy during and after exercise (AOR, 1.33), and a dry cough at night independent of a cold or chest infection (AOR, 1.26).

Neither e-cigarettes nor cigarettes were significantly associated with any of these five respiratory symptoms in the fully adjusted models. In addition, “past 30-day use of cigarettes, e-cigarettes and cannabis use were associated with some respiratory symptoms in bivariate analyses but not in the adjusted models,” the researchers noted. In addition, the associations of an asthma diagnosis and respiratory symptoms had greater magnitudes than either cigarette, e-cigarette, and cannabis use or vaping cannabis with ENDS.

The study findings were limited by several factors including the inherent limitations of secondary database analysis, the researchers noted. “Another limitation is that co-use of cannabis and tobacco/nicotine was not assessed and, in the future, should be examined: Researchers have found that co-use is related to EVALI symptoms among young adults,” they said.

However, the study is the first known to include ENDS product use and respiratory symptoms while accounting for baseline asthma, and an asthma diagnosis was even more strongly associated with all five respiratory symptoms, the researchers said.

The results suggest that “the inhalation of cannabis via vaping is associated with some pulmonary irritation and symptoms of lung diseases (both known and unknown),” that may be predictive of later EVALI, they concluded.
 

Product details aid in diagnosis

“As we continue to see patients presenting with EVALI in pediatric hospitals, it is important for us to identify if there are specific products (or categories) that are more likely to cause it,” said Brandon Seay, MD, FCCP, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta, in an interview. “When we are trying to diagnose EVALI, we should be asking appropriate questions about exposures to specific products to get the best answers. If we simply ask ‘Are you smoking e-cigarettes?’ the patient may not [equate] e-cigarette smoking to vaping cannabis products,” he said. 

Dr. Seay said he was not surprised by the study findings. “A lot of the patients I see with EVALI have reported vaping THC products, and most of them also report that the products were mixed by a friend or an individual instead of being a commercially produced product,” he noted. “This is not surprising, as THC is still illegal in most states and there would not be any commercially available products,” he said. “The mixing of these products by individuals increases the risk of ingredients being more toxic or irritating to the lungs,” Dr. Seay added. “This does highlight the need for more regulation of vaping products. As more states legalize marijuana, more of these products will become available, which will provide an opportunity for increased regulation, he said. 

The take-home message for clinicians is to seek specific details from their young patients, Dr. Seay emphasized. “When we are educating our patients on the dangers of vaping/e-cigarettes, we need to make sure we are asking specifically which products they are using and know the terminology,” he said. “The use of THC-containing products will be increasing across the country with more legalization, so we need to keep ourselves apprised of the different risks between THC- and nicotine-containing devices,” he added.  

As for additional research, it would be interesting to know whether patients were asked where they had gotten their products (commercially available products vs. those mixed by individuals) and explore any difference between the two, said Dr. Seay. “Also, as these products are relatively new to the market, compared to cigarettes, data on the longitudinal effects of vaping (nicotine and THC) over a long period of time, compared to traditional combustible cigarettes, will be needed,” he said.

The study was funded by grants from the National Institutes of Health, National Institute on Drug Abuse, and National Cancer Institute. The researchers had no financial conflicts to disclose.

Dr. Seay had no financial disclosures, but serves as a member of the CHEST Physician editorial board.

Vaping cannabis significantly increased the risk of respiratory symptoms in adolescents, according to findings of a study based on a national sample of teens.

HAZEMMKAMAL/Getty Images

Most studies of electronic nicotine delivery systems (ENDS) use in teens have not addressed cannabis vaping, although e-cigarette– or vaping product use–associated lung injury (EVALI) has been predominately associated with cannabis products, wrote Carol J. Boyd, PhD, of the University of Michigan School of Nursing, Ann Arbor, and colleagues.

“At this time, relatively little is known about the population-level health consequences of adolescents’ use of ENDS, including use with cannabis and controlling for a history of asthma,” they said.

In a study published in the Journal of Adolescent Health, the researchers identified 14,798 adolescents aged 12-17 years using Wave 4 data from the Population Assessment of Tobacco and Health Study. Of these, 17.6% had a baseline asthma diagnosis, 8.9% reported ever using cannabis in ENDS, and 4.7% reported any cannabis use. In addition, 4.2% reported current e-cigarette use, 3.1% reported current cigarette use, 51% were male, and 69.2% were white.
 

Any cannabis vaping makes impact

In a fully-adjusted model, teens who had ever vaped cannabis had higher odds of five respiratory symptoms in the past year, compared with those with no history of cannabis vaping: wheezing or whistling in the chest (adjusted odds ratio, 1.81); sleep disturbed by wheezing or whistling (AOR, 1.71); speech limited because of wheezing (AOR, 1.96); wheezy during and after exercise (AOR, 1.33), and a dry cough at night independent of a cold or chest infection (AOR, 1.26).

Neither e-cigarettes nor cigarettes were significantly associated with any of these five respiratory symptoms in the fully adjusted models. In addition, “past 30-day use of cigarettes, e-cigarettes and cannabis use were associated with some respiratory symptoms in bivariate analyses but not in the adjusted models,” the researchers noted. In addition, the associations of an asthma diagnosis and respiratory symptoms had greater magnitudes than either cigarette, e-cigarette, and cannabis use or vaping cannabis with ENDS.

The study findings were limited by several factors including the inherent limitations of secondary database analysis, the researchers noted. “Another limitation is that co-use of cannabis and tobacco/nicotine was not assessed and, in the future, should be examined: Researchers have found that co-use is related to EVALI symptoms among young adults,” they said.

However, the study is the first known to include ENDS product use and respiratory symptoms while accounting for baseline asthma, and an asthma diagnosis was even more strongly associated with all five respiratory symptoms, the researchers said.

The results suggest that “the inhalation of cannabis via vaping is associated with some pulmonary irritation and symptoms of lung diseases (both known and unknown),” that may be predictive of later EVALI, they concluded.
 

Product details aid in diagnosis

“As we continue to see patients presenting with EVALI in pediatric hospitals, it is important for us to identify if there are specific products (or categories) that are more likely to cause it,” said Brandon Seay, MD, FCCP, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta, in an interview. “When we are trying to diagnose EVALI, we should be asking appropriate questions about exposures to specific products to get the best answers. If we simply ask ‘Are you smoking e-cigarettes?’ the patient may not [equate] e-cigarette smoking to vaping cannabis products,” he said. 

Dr. Seay said he was not surprised by the study findings. “A lot of the patients I see with EVALI have reported vaping THC products, and most of them also report that the products were mixed by a friend or an individual instead of being a commercially produced product,” he noted. “This is not surprising, as THC is still illegal in most states and there would not be any commercially available products,” he said. “The mixing of these products by individuals increases the risk of ingredients being more toxic or irritating to the lungs,” Dr. Seay added. “This does highlight the need for more regulation of vaping products. As more states legalize marijuana, more of these products will become available, which will provide an opportunity for increased regulation, he said. 

The take-home message for clinicians is to seek specific details from their young patients, Dr. Seay emphasized. “When we are educating our patients on the dangers of vaping/e-cigarettes, we need to make sure we are asking specifically which products they are using and know the terminology,” he said. “The use of THC-containing products will be increasing across the country with more legalization, so we need to keep ourselves apprised of the different risks between THC- and nicotine-containing devices,” he added.  

As for additional research, it would be interesting to know whether patients were asked where they had gotten their products (commercially available products vs. those mixed by individuals) and explore any difference between the two, said Dr. Seay. “Also, as these products are relatively new to the market, compared to cigarettes, data on the longitudinal effects of vaping (nicotine and THC) over a long period of time, compared to traditional combustible cigarettes, will be needed,” he said.

The study was funded by grants from the National Institutes of Health, National Institute on Drug Abuse, and National Cancer Institute. The researchers had no financial conflicts to disclose.

Dr. Seay had no financial disclosures, but serves as a member of the CHEST Physician editorial board.