User login
Novel Treatment Promising for Cutaneous Lupus in Phase 2 Trial
TOPLINE:
particularly in subacute and chronic cases.
METHODOLOGY:
- Researchers conducted a randomized phase 2 trial to evaluate the efficacy and safety of iberdomide in 288 patients with CLE (mean age, 45 years; 97% women). Iberdomide is a cereblon modulator, which results in degradation of two transcription factors of immune cell development and homeostasis — Ikaros and Aiolos — that have been implicated in the genetic predisposition of systemic lupus.
- CLE Disease Area and Severity Index Activity (CLASI-A) endpoints included mean percent change from baseline and ≥ 50% reduction from baseline (CLASI-50), which were evaluated in all patients with baseline CLASI-A scores ≥ 8 and by CLE subtypes (acute, subacute, and chronic).
- At baseline, 56% of patients had acute CLE, 29% had chronic CLE, and 16% had subacute CLE; 28% of patients had a baseline CLASI-A score ≥ 8.
- Patients were randomly assigned to receive oral iberdomide (0.45 mg, 0.30 mg, 0.15 mg, or placebo daily) for 24 weeks while continuing standard lupus medications. At week 24, patients on placebo were rerandomized to iberdomide 0.45 mg or 0.30 mg once a day, while those on iberdomide continued their assigned dose through week 52.
TAKEAWAY:
- Among patients with baseline CLASI-A ≥ 8, the mean change in CLASI-A score from baseline at week 24 was −66.7% for those on iberdomide 0.45 mg vs −54.2% for placebo (P = .295).
- At week 24, patients with subacute CLE showed a significantly greater mean percent change from baseline in CLASI-A with iberdomide 0.45 mg vs placebo (−90.5% vs −51.2%; P = .007), while no significant differences were observed with the 0.45-mg dose vs placebo in patients with chronic or acute CLE.
- Overall, CLASI-50 responses were not significantly different among those on 0.45 mg vs placebo (55.6% vs 44.6%). The proportions of patients achieving CLASI-50 at week 24 were significantly greater for iberdomide 0.45 mg vs placebo for those with subacute CLE (91.7% vs 52.9%; P = .035) and chronic CLE (62.1% vs 27.8%; P = .029), but not for those with baseline CLASI-A ≥ 8 (66.7% vs 50%).
- More than 80% of patients had treatment-emergent adverse events (TEAEs), which were mostly mild to moderate. Over 2 years, the most common were urinary tract infections, upper respiratory tract infections, neutropenia, and nasopharyngitis. TEAEs leading to iberdomide discontinuation in one or more patients were neutropenia (n = 7), rash (n = 7), increased hepatic enzymes (n = 4), and deep vein thrombosis (n = 3).
IN PRACTICE:
“Data from this phase 2 trial of iberdomide in patients with SLE suggest that a greater proportion of patients with subacute or chronic CLE who received the higher dose of 0.45 mg iberdomide achieved CLASI-50 vs placebo. For the overall population, CLASI-50 response was not significantly different between treatment groups at week 24, partly due to a high placebo response that may have been driven by patients with acute CLE,” the authors wrote.
SOURCE:
The study was led by Victoria P. Werth, MD, of the University of Pennsylvania and the Veteran’s Administration Medical Center, both in Philadelphia, and was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study included small patient subgroups for different CLE subtypes, which may affect the generalizability of the findings. CLE subtype was determined by the investigator without additional photographic adjudication. Additionally, the use of background lupus medications could have influenced the placebo group’s response, limiting the ability to observe the treatment effect of iberdomide monotherapy.
DISCLOSURES:
The study was funded by Bristol-Myers Squibb. Six authors reported being employed by Bristol-Myers Squibb, and several others reported consultancy and research support from various sources including Bristol-Myers Squibb.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
particularly in subacute and chronic cases.
METHODOLOGY:
- Researchers conducted a randomized phase 2 trial to evaluate the efficacy and safety of iberdomide in 288 patients with CLE (mean age, 45 years; 97% women). Iberdomide is a cereblon modulator, which results in degradation of two transcription factors of immune cell development and homeostasis — Ikaros and Aiolos — that have been implicated in the genetic predisposition of systemic lupus.
- CLE Disease Area and Severity Index Activity (CLASI-A) endpoints included mean percent change from baseline and ≥ 50% reduction from baseline (CLASI-50), which were evaluated in all patients with baseline CLASI-A scores ≥ 8 and by CLE subtypes (acute, subacute, and chronic).
- At baseline, 56% of patients had acute CLE, 29% had chronic CLE, and 16% had subacute CLE; 28% of patients had a baseline CLASI-A score ≥ 8.
- Patients were randomly assigned to receive oral iberdomide (0.45 mg, 0.30 mg, 0.15 mg, or placebo daily) for 24 weeks while continuing standard lupus medications. At week 24, patients on placebo were rerandomized to iberdomide 0.45 mg or 0.30 mg once a day, while those on iberdomide continued their assigned dose through week 52.
TAKEAWAY:
- Among patients with baseline CLASI-A ≥ 8, the mean change in CLASI-A score from baseline at week 24 was −66.7% for those on iberdomide 0.45 mg vs −54.2% for placebo (P = .295).
- At week 24, patients with subacute CLE showed a significantly greater mean percent change from baseline in CLASI-A with iberdomide 0.45 mg vs placebo (−90.5% vs −51.2%; P = .007), while no significant differences were observed with the 0.45-mg dose vs placebo in patients with chronic or acute CLE.
- Overall, CLASI-50 responses were not significantly different among those on 0.45 mg vs placebo (55.6% vs 44.6%). The proportions of patients achieving CLASI-50 at week 24 were significantly greater for iberdomide 0.45 mg vs placebo for those with subacute CLE (91.7% vs 52.9%; P = .035) and chronic CLE (62.1% vs 27.8%; P = .029), but not for those with baseline CLASI-A ≥ 8 (66.7% vs 50%).
- More than 80% of patients had treatment-emergent adverse events (TEAEs), which were mostly mild to moderate. Over 2 years, the most common were urinary tract infections, upper respiratory tract infections, neutropenia, and nasopharyngitis. TEAEs leading to iberdomide discontinuation in one or more patients were neutropenia (n = 7), rash (n = 7), increased hepatic enzymes (n = 4), and deep vein thrombosis (n = 3).
IN PRACTICE:
“Data from this phase 2 trial of iberdomide in patients with SLE suggest that a greater proportion of patients with subacute or chronic CLE who received the higher dose of 0.45 mg iberdomide achieved CLASI-50 vs placebo. For the overall population, CLASI-50 response was not significantly different between treatment groups at week 24, partly due to a high placebo response that may have been driven by patients with acute CLE,” the authors wrote.
SOURCE:
The study was led by Victoria P. Werth, MD, of the University of Pennsylvania and the Veteran’s Administration Medical Center, both in Philadelphia, and was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study included small patient subgroups for different CLE subtypes, which may affect the generalizability of the findings. CLE subtype was determined by the investigator without additional photographic adjudication. Additionally, the use of background lupus medications could have influenced the placebo group’s response, limiting the ability to observe the treatment effect of iberdomide monotherapy.
DISCLOSURES:
The study was funded by Bristol-Myers Squibb. Six authors reported being employed by Bristol-Myers Squibb, and several others reported consultancy and research support from various sources including Bristol-Myers Squibb.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
particularly in subacute and chronic cases.
METHODOLOGY:
- Researchers conducted a randomized phase 2 trial to evaluate the efficacy and safety of iberdomide in 288 patients with CLE (mean age, 45 years; 97% women). Iberdomide is a cereblon modulator, which results in degradation of two transcription factors of immune cell development and homeostasis — Ikaros and Aiolos — that have been implicated in the genetic predisposition of systemic lupus.
- CLE Disease Area and Severity Index Activity (CLASI-A) endpoints included mean percent change from baseline and ≥ 50% reduction from baseline (CLASI-50), which were evaluated in all patients with baseline CLASI-A scores ≥ 8 and by CLE subtypes (acute, subacute, and chronic).
- At baseline, 56% of patients had acute CLE, 29% had chronic CLE, and 16% had subacute CLE; 28% of patients had a baseline CLASI-A score ≥ 8.
- Patients were randomly assigned to receive oral iberdomide (0.45 mg, 0.30 mg, 0.15 mg, or placebo daily) for 24 weeks while continuing standard lupus medications. At week 24, patients on placebo were rerandomized to iberdomide 0.45 mg or 0.30 mg once a day, while those on iberdomide continued their assigned dose through week 52.
TAKEAWAY:
- Among patients with baseline CLASI-A ≥ 8, the mean change in CLASI-A score from baseline at week 24 was −66.7% for those on iberdomide 0.45 mg vs −54.2% for placebo (P = .295).
- At week 24, patients with subacute CLE showed a significantly greater mean percent change from baseline in CLASI-A with iberdomide 0.45 mg vs placebo (−90.5% vs −51.2%; P = .007), while no significant differences were observed with the 0.45-mg dose vs placebo in patients with chronic or acute CLE.
- Overall, CLASI-50 responses were not significantly different among those on 0.45 mg vs placebo (55.6% vs 44.6%). The proportions of patients achieving CLASI-50 at week 24 were significantly greater for iberdomide 0.45 mg vs placebo for those with subacute CLE (91.7% vs 52.9%; P = .035) and chronic CLE (62.1% vs 27.8%; P = .029), but not for those with baseline CLASI-A ≥ 8 (66.7% vs 50%).
- More than 80% of patients had treatment-emergent adverse events (TEAEs), which were mostly mild to moderate. Over 2 years, the most common were urinary tract infections, upper respiratory tract infections, neutropenia, and nasopharyngitis. TEAEs leading to iberdomide discontinuation in one or more patients were neutropenia (n = 7), rash (n = 7), increased hepatic enzymes (n = 4), and deep vein thrombosis (n = 3).
IN PRACTICE:
“Data from this phase 2 trial of iberdomide in patients with SLE suggest that a greater proportion of patients with subacute or chronic CLE who received the higher dose of 0.45 mg iberdomide achieved CLASI-50 vs placebo. For the overall population, CLASI-50 response was not significantly different between treatment groups at week 24, partly due to a high placebo response that may have been driven by patients with acute CLE,” the authors wrote.
SOURCE:
The study was led by Victoria P. Werth, MD, of the University of Pennsylvania and the Veteran’s Administration Medical Center, both in Philadelphia, and was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study included small patient subgroups for different CLE subtypes, which may affect the generalizability of the findings. CLE subtype was determined by the investigator without additional photographic adjudication. Additionally, the use of background lupus medications could have influenced the placebo group’s response, limiting the ability to observe the treatment effect of iberdomide monotherapy.
DISCLOSURES:
The study was funded by Bristol-Myers Squibb. Six authors reported being employed by Bristol-Myers Squibb, and several others reported consultancy and research support from various sources including Bristol-Myers Squibb.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Air Pollution Exposure Linked to Higher Breast Cancer Risk
TOPLINE:
A recent study found that long-term exposure to fine particulate matter ≤ 2.5 μm (PM2.5) is associated with an increased risk for breast cancer, with the highest risk observed among White women.
METHODOLOGY:
- Studies have suggested that exposure to air pollution — specifically PM2.5 — may increase the risk for breast cancer, but data are largely in populations of White women.
- The current analysis explored the potential risk among a more racially and ethnically diverse group.
- The study included 58,358 women (median age, 60.4 years at enrollment) from the California Cancer Registry, followed over an average of 19.3 years. Overall, 35% were African American, 39% were Latino, 15% were White, and 10% were Japanese American.
- Researchers measured PM2.5 exposure using satellite-based data and geocoded addresses. Other pollutants, such as PM10, NO2, NOX, and CO, were also tracked using Environmental Protection Agency data.
TAKEAWAY:
- A total of 3524 invasive breast cancer cases were diagnosed over an average follow-up period of 19.3 years. PM2.5 exposure was associated with a 28% increased risk for breast cancer overall (hazard ratio [HR], 1.28; 95% CI, 1.08-1.51).
- When looking at risk by racial/ethnic group, the association between PM2.5 exposure and breast cancer risk was strongest among White women (HR, 1.67). PM2.5 exposure was also associated with a higher risk for breast cancer among African American women (HR, 1.14; 95% CI, 0.89-1.46) and Latino women (HR, 1.34; 95% CI, 0.94-1.92), but the associations were not significant.
- Overall breast cancer incidence was also positively associated with exposure to NO2, NOX, and CO (HRs, 1.09-1.11), but the associations were not significant. A meta-analysis of this study and ten other cohorts estimated a 5% increased breast cancer incidence per 10-unit increase in PM2.5 (HR, 1.05).
IN PRACTICE:
“Collective findings suggest that PM2.5 exposure should be considered a risk factor for breast cancer, and curtailing air pollution exposures at the population level using regulatory strategies should be a priority,” the authors concluded.
SOURCE:
The study, led by Anna H. Wu, PhD, MPH, Keck School of Medicine, University of Southern California, Los Angeles, was published online in the Journal of Clinical Oncology.
LIMITATIONS:
The study did not include data on nonresidential exposures or residential history before cohort entry, which limited the assessment of earlier exposures. The study also lacked information on specific sources of PM emissions, as well as an explanation for why White women had the highest breast cancer risk compared with other racial/ethnic groups.
DISCLOSURES:
The study was supported by grants from the Health Effects Air Pollution Foundation, the National Cancer Institute, USC Environmental Exposures, Host Factors, and Human Disease, and the California Air Resource Board. One author disclosed being an associate editor for the Journal of Clinical Oncology. No other potential conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A recent study found that long-term exposure to fine particulate matter ≤ 2.5 μm (PM2.5) is associated with an increased risk for breast cancer, with the highest risk observed among White women.
METHODOLOGY:
- Studies have suggested that exposure to air pollution — specifically PM2.5 — may increase the risk for breast cancer, but data are largely in populations of White women.
- The current analysis explored the potential risk among a more racially and ethnically diverse group.
- The study included 58,358 women (median age, 60.4 years at enrollment) from the California Cancer Registry, followed over an average of 19.3 years. Overall, 35% were African American, 39% were Latino, 15% were White, and 10% were Japanese American.
- Researchers measured PM2.5 exposure using satellite-based data and geocoded addresses. Other pollutants, such as PM10, NO2, NOX, and CO, were also tracked using Environmental Protection Agency data.
TAKEAWAY:
- A total of 3524 invasive breast cancer cases were diagnosed over an average follow-up period of 19.3 years. PM2.5 exposure was associated with a 28% increased risk for breast cancer overall (hazard ratio [HR], 1.28; 95% CI, 1.08-1.51).
- When looking at risk by racial/ethnic group, the association between PM2.5 exposure and breast cancer risk was strongest among White women (HR, 1.67). PM2.5 exposure was also associated with a higher risk for breast cancer among African American women (HR, 1.14; 95% CI, 0.89-1.46) and Latino women (HR, 1.34; 95% CI, 0.94-1.92), but the associations were not significant.
- Overall breast cancer incidence was also positively associated with exposure to NO2, NOX, and CO (HRs, 1.09-1.11), but the associations were not significant. A meta-analysis of this study and ten other cohorts estimated a 5% increased breast cancer incidence per 10-unit increase in PM2.5 (HR, 1.05).
IN PRACTICE:
“Collective findings suggest that PM2.5 exposure should be considered a risk factor for breast cancer, and curtailing air pollution exposures at the population level using regulatory strategies should be a priority,” the authors concluded.
SOURCE:
The study, led by Anna H. Wu, PhD, MPH, Keck School of Medicine, University of Southern California, Los Angeles, was published online in the Journal of Clinical Oncology.
LIMITATIONS:
The study did not include data on nonresidential exposures or residential history before cohort entry, which limited the assessment of earlier exposures. The study also lacked information on specific sources of PM emissions, as well as an explanation for why White women had the highest breast cancer risk compared with other racial/ethnic groups.
DISCLOSURES:
The study was supported by grants from the Health Effects Air Pollution Foundation, the National Cancer Institute, USC Environmental Exposures, Host Factors, and Human Disease, and the California Air Resource Board. One author disclosed being an associate editor for the Journal of Clinical Oncology. No other potential conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A recent study found that long-term exposure to fine particulate matter ≤ 2.5 μm (PM2.5) is associated with an increased risk for breast cancer, with the highest risk observed among White women.
METHODOLOGY:
- Studies have suggested that exposure to air pollution — specifically PM2.5 — may increase the risk for breast cancer, but data are largely in populations of White women.
- The current analysis explored the potential risk among a more racially and ethnically diverse group.
- The study included 58,358 women (median age, 60.4 years at enrollment) from the California Cancer Registry, followed over an average of 19.3 years. Overall, 35% were African American, 39% were Latino, 15% were White, and 10% were Japanese American.
- Researchers measured PM2.5 exposure using satellite-based data and geocoded addresses. Other pollutants, such as PM10, NO2, NOX, and CO, were also tracked using Environmental Protection Agency data.
TAKEAWAY:
- A total of 3524 invasive breast cancer cases were diagnosed over an average follow-up period of 19.3 years. PM2.5 exposure was associated with a 28% increased risk for breast cancer overall (hazard ratio [HR], 1.28; 95% CI, 1.08-1.51).
- When looking at risk by racial/ethnic group, the association between PM2.5 exposure and breast cancer risk was strongest among White women (HR, 1.67). PM2.5 exposure was also associated with a higher risk for breast cancer among African American women (HR, 1.14; 95% CI, 0.89-1.46) and Latino women (HR, 1.34; 95% CI, 0.94-1.92), but the associations were not significant.
- Overall breast cancer incidence was also positively associated with exposure to NO2, NOX, and CO (HRs, 1.09-1.11), but the associations were not significant. A meta-analysis of this study and ten other cohorts estimated a 5% increased breast cancer incidence per 10-unit increase in PM2.5 (HR, 1.05).
IN PRACTICE:
“Collective findings suggest that PM2.5 exposure should be considered a risk factor for breast cancer, and curtailing air pollution exposures at the population level using regulatory strategies should be a priority,” the authors concluded.
SOURCE:
The study, led by Anna H. Wu, PhD, MPH, Keck School of Medicine, University of Southern California, Los Angeles, was published online in the Journal of Clinical Oncology.
LIMITATIONS:
The study did not include data on nonresidential exposures or residential history before cohort entry, which limited the assessment of earlier exposures. The study also lacked information on specific sources of PM emissions, as well as an explanation for why White women had the highest breast cancer risk compared with other racial/ethnic groups.
DISCLOSURES:
The study was supported by grants from the Health Effects Air Pollution Foundation, the National Cancer Institute, USC Environmental Exposures, Host Factors, and Human Disease, and the California Air Resource Board. One author disclosed being an associate editor for the Journal of Clinical Oncology. No other potential conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Risk Assessment Tool Can Help Predict Fractures in Cancer
TOPLINE:
METHODOLOGY:
- Cancer-specific guidelines recommend using FRAX to assess fracture risk, but its applicability in patients with cancer remains unclear.
- This retrospective cohort study included 9877 patients with cancer (mean age, 67.1 years) and 45,875 matched control individuals without cancer (mean age, 66.2 years). All participants had dual-energy x-ray absorptiometry (DXA) scans.
- Researchers collected data on bone mineral density and fractures. The 10-year probabilities of major osteoporotic fractures and hip fractures were calculated using FRAX, and the observed 10-year probabilities of these fractures were compared with FRAX-derived probabilities.
- Compared with individuals without cancer, patients with cancer had a shorter mean follow-up duration (8.5 vs 7.6 years), a slightly higher mean body mass index, and a higher percentage of parental hip fractures (7.0% vs 8.2%); additionally, patients with cancer were more likely to have secondary causes of osteoporosis (10% vs 38.4%) and less likely to receive osteoporosis medication (9.9% vs 4.2%).
TAKEAWAY:
- Compared with individuals without cancer, patients with cancer had a significantly higher incidence rate of major fractures (12.9 vs 14.5 per 1000 person-years) and hip fractures (3.5 vs 4.2 per 1000 person-years).
- FRAX with bone mineral density exhibited excellent calibration for predicting major osteoporotic fractures (slope, 1.03) and hip fractures (0.97) in patients with cancer, regardless of the site of cancer diagnosis. FRAX without bone mineral density, however, underestimated the risk for both major (0.87) and hip fractures (0.72).
- In patients with cancer, FRAX with bone mineral density findings were associated with incident major osteoporotic fractures (hazard ratio [HR] per SD, 1.84) and hip fractures (HR per SD, 3.61).
- When models were adjusted for FRAX with bone mineral density, patients with cancer had an increased risk for both major osteoporotic fractures (HR, 1.17) and hip fractures (HR, 1.30). No difference was found in the risk for fracture between patients with and individuals without cancer when the models were adjusted for FRAX without bone mineral density, even when considering osteoporosis medication use.
IN PRACTICE:
“This retrospective cohort study demonstrates that individuals with cancer are at higher risk of fracture than individuals without cancer and that FRAX, particularly with BMD [bone mineral density], may accurately predict fracture risk in this population. These results, along with the known mortality risk of osteoporotic fractures among cancer survivors, further emphasize the clinical importance of closing the current osteoporosis care gap among cancer survivors,” the authors wrote.
SOURCE:
This study, led by Carrie Ye, MD, MPH, University of Alberta, Edmonton, Alberta, Canada, was published online in JAMA Oncology.
LIMITATIONS:
This study cohort included a selected group of cancer survivors who were referred for DXA scans and may not represent the general cancer population. The cohort consisted predominantly of women, limiting the generalizability to men with cancer. Given the heterogeneity of the population, the findings may not be applicable to all cancer subgroups. Information on cancer stage or the presence of bone metastases at the time of fracture risk assessment was lacking, which could have affected the findings.
DISCLOSURES:
This study was funded by the CancerCare Manitoba Foundation. Three authors reported having ties with various sources, including two who received grants from various organizations.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Cancer-specific guidelines recommend using FRAX to assess fracture risk, but its applicability in patients with cancer remains unclear.
- This retrospective cohort study included 9877 patients with cancer (mean age, 67.1 years) and 45,875 matched control individuals without cancer (mean age, 66.2 years). All participants had dual-energy x-ray absorptiometry (DXA) scans.
- Researchers collected data on bone mineral density and fractures. The 10-year probabilities of major osteoporotic fractures and hip fractures were calculated using FRAX, and the observed 10-year probabilities of these fractures were compared with FRAX-derived probabilities.
- Compared with individuals without cancer, patients with cancer had a shorter mean follow-up duration (8.5 vs 7.6 years), a slightly higher mean body mass index, and a higher percentage of parental hip fractures (7.0% vs 8.2%); additionally, patients with cancer were more likely to have secondary causes of osteoporosis (10% vs 38.4%) and less likely to receive osteoporosis medication (9.9% vs 4.2%).
TAKEAWAY:
- Compared with individuals without cancer, patients with cancer had a significantly higher incidence rate of major fractures (12.9 vs 14.5 per 1000 person-years) and hip fractures (3.5 vs 4.2 per 1000 person-years).
- FRAX with bone mineral density exhibited excellent calibration for predicting major osteoporotic fractures (slope, 1.03) and hip fractures (0.97) in patients with cancer, regardless of the site of cancer diagnosis. FRAX without bone mineral density, however, underestimated the risk for both major (0.87) and hip fractures (0.72).
- In patients with cancer, FRAX with bone mineral density findings were associated with incident major osteoporotic fractures (hazard ratio [HR] per SD, 1.84) and hip fractures (HR per SD, 3.61).
- When models were adjusted for FRAX with bone mineral density, patients with cancer had an increased risk for both major osteoporotic fractures (HR, 1.17) and hip fractures (HR, 1.30). No difference was found in the risk for fracture between patients with and individuals without cancer when the models were adjusted for FRAX without bone mineral density, even when considering osteoporosis medication use.
IN PRACTICE:
“This retrospective cohort study demonstrates that individuals with cancer are at higher risk of fracture than individuals without cancer and that FRAX, particularly with BMD [bone mineral density], may accurately predict fracture risk in this population. These results, along with the known mortality risk of osteoporotic fractures among cancer survivors, further emphasize the clinical importance of closing the current osteoporosis care gap among cancer survivors,” the authors wrote.
SOURCE:
This study, led by Carrie Ye, MD, MPH, University of Alberta, Edmonton, Alberta, Canada, was published online in JAMA Oncology.
LIMITATIONS:
This study cohort included a selected group of cancer survivors who were referred for DXA scans and may not represent the general cancer population. The cohort consisted predominantly of women, limiting the generalizability to men with cancer. Given the heterogeneity of the population, the findings may not be applicable to all cancer subgroups. Information on cancer stage or the presence of bone metastases at the time of fracture risk assessment was lacking, which could have affected the findings.
DISCLOSURES:
This study was funded by the CancerCare Manitoba Foundation. Three authors reported having ties with various sources, including two who received grants from various organizations.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Cancer-specific guidelines recommend using FRAX to assess fracture risk, but its applicability in patients with cancer remains unclear.
- This retrospective cohort study included 9877 patients with cancer (mean age, 67.1 years) and 45,875 matched control individuals without cancer (mean age, 66.2 years). All participants had dual-energy x-ray absorptiometry (DXA) scans.
- Researchers collected data on bone mineral density and fractures. The 10-year probabilities of major osteoporotic fractures and hip fractures were calculated using FRAX, and the observed 10-year probabilities of these fractures were compared with FRAX-derived probabilities.
- Compared with individuals without cancer, patients with cancer had a shorter mean follow-up duration (8.5 vs 7.6 years), a slightly higher mean body mass index, and a higher percentage of parental hip fractures (7.0% vs 8.2%); additionally, patients with cancer were more likely to have secondary causes of osteoporosis (10% vs 38.4%) and less likely to receive osteoporosis medication (9.9% vs 4.2%).
TAKEAWAY:
- Compared with individuals without cancer, patients with cancer had a significantly higher incidence rate of major fractures (12.9 vs 14.5 per 1000 person-years) and hip fractures (3.5 vs 4.2 per 1000 person-years).
- FRAX with bone mineral density exhibited excellent calibration for predicting major osteoporotic fractures (slope, 1.03) and hip fractures (0.97) in patients with cancer, regardless of the site of cancer diagnosis. FRAX without bone mineral density, however, underestimated the risk for both major (0.87) and hip fractures (0.72).
- In patients with cancer, FRAX with bone mineral density findings were associated with incident major osteoporotic fractures (hazard ratio [HR] per SD, 1.84) and hip fractures (HR per SD, 3.61).
- When models were adjusted for FRAX with bone mineral density, patients with cancer had an increased risk for both major osteoporotic fractures (HR, 1.17) and hip fractures (HR, 1.30). No difference was found in the risk for fracture between patients with and individuals without cancer when the models were adjusted for FRAX without bone mineral density, even when considering osteoporosis medication use.
IN PRACTICE:
“This retrospective cohort study demonstrates that individuals with cancer are at higher risk of fracture than individuals without cancer and that FRAX, particularly with BMD [bone mineral density], may accurately predict fracture risk in this population. These results, along with the known mortality risk of osteoporotic fractures among cancer survivors, further emphasize the clinical importance of closing the current osteoporosis care gap among cancer survivors,” the authors wrote.
SOURCE:
This study, led by Carrie Ye, MD, MPH, University of Alberta, Edmonton, Alberta, Canada, was published online in JAMA Oncology.
LIMITATIONS:
This study cohort included a selected group of cancer survivors who were referred for DXA scans and may not represent the general cancer population. The cohort consisted predominantly of women, limiting the generalizability to men with cancer. Given the heterogeneity of the population, the findings may not be applicable to all cancer subgroups. Information on cancer stage or the presence of bone metastases at the time of fracture risk assessment was lacking, which could have affected the findings.
DISCLOSURES:
This study was funded by the CancerCare Manitoba Foundation. Three authors reported having ties with various sources, including two who received grants from various organizations.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
SBRT or Prostatectomy for Localized Prostate Cancer: Is One Better?
TOPLINE:
according to a phase 3, open-label, randomized trial evaluating quality-of-life outcomes.
METHODOLOGY:
- Compared with prostatectomy, radiotherapy may offer better urinary and sexual outcomes but a higher risk for bowel toxicity in patients with localized prostate cancer. However, a comparison has not been performed in a randomized trial using more modern treatment options, such as SBRT.
- Researchers conducted the multicenter PACE-A trial to compare and evaluate quality-of-life outcomes among 123 patients (median age, 65.5 years) with low- to intermediate-risk localized prostate cancer who were randomly assigned to undergo either SBRT (n = 63) or radical prostatectomy (n = 60).
- Of the 123 patients, 97 (79%) had a Gleason score of 3+4 and 116 (94%) had National Comprehensive Cancer Network intermediate risk. The median follow-up was 60.7 months.
- The co–primary endpoints were urinary continence, measured by the number of absorbent urinary pads required per day, and bowel function, assessed using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26).
- Secondary endpoints included erectile function (measured using the International Index of Erectile Function 5 questionnaire) , clinician-reported genitourinary and gastrointestinal toxicity, and International Prostate Symptom Score. Other patient-reported outcomes included EPIC-26 domain scores for urinary irritative/obstructive symptoms, and overall urinary, bowel, and sexual issues.
TAKEAWAY:
- At 2 years, only 6.5% (three of 46) of patients who ultimately received SBRT used one or more urinary pads daily compared with 50% (16 of 32) of patients who underwent prostatectomy (P < .001). Patients in the prostatectomy group reported worse EPIC-26 urinary incontinence domain scores (median, 77.3 vs 100; P = .003).
- Patients who underwent prostatectomy also had significantly worse sexual function scores (median, 18 vs 62.5 with SBRT; P < .001). Erectile dysfunction events of grade 2 or higher were significantly more common in patients who underwent prostatectomy (63% vs 18%).
- However, at 2 years, the bowel domain scores in the prostatectomy group were significantly higher than in the SBRT group (median, 100 vs 87.5), with a mean difference of 8.9.
- Overall, clinician-reported genitourinary and gastrointestinal toxicities were low in both treatment groups.
IN PRACTICE:
“PACE-A provides level 1 evidence of better outcomes of urinary continence and sexual function with worse bowel bother for SBRT, compared with prostatectomy,” the authors wrote, adding that the trial “provides contemporary toxicity estimates to optimize treatment decisions and maximize individual quality of life.”
SOURCE:
The study, led by Nicholas van As, of The Royal Marsden Hospital and The Institute of Cancer Research in London, was published online in European Urology.
LIMITATIONS:
The small sample size and differential dropout from allocated treatment could have introduced bias. Data completeness was another limitation.
DISCLOSURES:
The study was supported by grants from the Royal Marsden NHS Foundation Trust. Several authors reported having various ties with various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
according to a phase 3, open-label, randomized trial evaluating quality-of-life outcomes.
METHODOLOGY:
- Compared with prostatectomy, radiotherapy may offer better urinary and sexual outcomes but a higher risk for bowel toxicity in patients with localized prostate cancer. However, a comparison has not been performed in a randomized trial using more modern treatment options, such as SBRT.
- Researchers conducted the multicenter PACE-A trial to compare and evaluate quality-of-life outcomes among 123 patients (median age, 65.5 years) with low- to intermediate-risk localized prostate cancer who were randomly assigned to undergo either SBRT (n = 63) or radical prostatectomy (n = 60).
- Of the 123 patients, 97 (79%) had a Gleason score of 3+4 and 116 (94%) had National Comprehensive Cancer Network intermediate risk. The median follow-up was 60.7 months.
- The co–primary endpoints were urinary continence, measured by the number of absorbent urinary pads required per day, and bowel function, assessed using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26).
- Secondary endpoints included erectile function (measured using the International Index of Erectile Function 5 questionnaire) , clinician-reported genitourinary and gastrointestinal toxicity, and International Prostate Symptom Score. Other patient-reported outcomes included EPIC-26 domain scores for urinary irritative/obstructive symptoms, and overall urinary, bowel, and sexual issues.
TAKEAWAY:
- At 2 years, only 6.5% (three of 46) of patients who ultimately received SBRT used one or more urinary pads daily compared with 50% (16 of 32) of patients who underwent prostatectomy (P < .001). Patients in the prostatectomy group reported worse EPIC-26 urinary incontinence domain scores (median, 77.3 vs 100; P = .003).
- Patients who underwent prostatectomy also had significantly worse sexual function scores (median, 18 vs 62.5 with SBRT; P < .001). Erectile dysfunction events of grade 2 or higher were significantly more common in patients who underwent prostatectomy (63% vs 18%).
- However, at 2 years, the bowel domain scores in the prostatectomy group were significantly higher than in the SBRT group (median, 100 vs 87.5), with a mean difference of 8.9.
- Overall, clinician-reported genitourinary and gastrointestinal toxicities were low in both treatment groups.
IN PRACTICE:
“PACE-A provides level 1 evidence of better outcomes of urinary continence and sexual function with worse bowel bother for SBRT, compared with prostatectomy,” the authors wrote, adding that the trial “provides contemporary toxicity estimates to optimize treatment decisions and maximize individual quality of life.”
SOURCE:
The study, led by Nicholas van As, of The Royal Marsden Hospital and The Institute of Cancer Research in London, was published online in European Urology.
LIMITATIONS:
The small sample size and differential dropout from allocated treatment could have introduced bias. Data completeness was another limitation.
DISCLOSURES:
The study was supported by grants from the Royal Marsden NHS Foundation Trust. Several authors reported having various ties with various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
according to a phase 3, open-label, randomized trial evaluating quality-of-life outcomes.
METHODOLOGY:
- Compared with prostatectomy, radiotherapy may offer better urinary and sexual outcomes but a higher risk for bowel toxicity in patients with localized prostate cancer. However, a comparison has not been performed in a randomized trial using more modern treatment options, such as SBRT.
- Researchers conducted the multicenter PACE-A trial to compare and evaluate quality-of-life outcomes among 123 patients (median age, 65.5 years) with low- to intermediate-risk localized prostate cancer who were randomly assigned to undergo either SBRT (n = 63) or radical prostatectomy (n = 60).
- Of the 123 patients, 97 (79%) had a Gleason score of 3+4 and 116 (94%) had National Comprehensive Cancer Network intermediate risk. The median follow-up was 60.7 months.
- The co–primary endpoints were urinary continence, measured by the number of absorbent urinary pads required per day, and bowel function, assessed using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26).
- Secondary endpoints included erectile function (measured using the International Index of Erectile Function 5 questionnaire) , clinician-reported genitourinary and gastrointestinal toxicity, and International Prostate Symptom Score. Other patient-reported outcomes included EPIC-26 domain scores for urinary irritative/obstructive symptoms, and overall urinary, bowel, and sexual issues.
TAKEAWAY:
- At 2 years, only 6.5% (three of 46) of patients who ultimately received SBRT used one or more urinary pads daily compared with 50% (16 of 32) of patients who underwent prostatectomy (P < .001). Patients in the prostatectomy group reported worse EPIC-26 urinary incontinence domain scores (median, 77.3 vs 100; P = .003).
- Patients who underwent prostatectomy also had significantly worse sexual function scores (median, 18 vs 62.5 with SBRT; P < .001). Erectile dysfunction events of grade 2 or higher were significantly more common in patients who underwent prostatectomy (63% vs 18%).
- However, at 2 years, the bowel domain scores in the prostatectomy group were significantly higher than in the SBRT group (median, 100 vs 87.5), with a mean difference of 8.9.
- Overall, clinician-reported genitourinary and gastrointestinal toxicities were low in both treatment groups.
IN PRACTICE:
“PACE-A provides level 1 evidence of better outcomes of urinary continence and sexual function with worse bowel bother for SBRT, compared with prostatectomy,” the authors wrote, adding that the trial “provides contemporary toxicity estimates to optimize treatment decisions and maximize individual quality of life.”
SOURCE:
The study, led by Nicholas van As, of The Royal Marsden Hospital and The Institute of Cancer Research in London, was published online in European Urology.
LIMITATIONS:
The small sample size and differential dropout from allocated treatment could have introduced bias. Data completeness was another limitation.
DISCLOSURES:
The study was supported by grants from the Royal Marsden NHS Foundation Trust. Several authors reported having various ties with various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Fear of Cancer Recurrence Can Persist for Childhood Survivors
TOPLINE:
About one third of adult survivors of childhood cancer experience a clinically significant or high fear that their primary cancer may recur or that they will develop a subsequent malignancy, according to a recent analysis. The study finds that several factors are associated with a higher risk of experiencing a clinically significant fear of recurrence, including being unemployed or having elevated anxiety or depression.
METHODOLOGY:
- Adult survivors of childhood cancer face a high risk of developing subsequent malignant neoplasms — about a sixfold greater risk than in the general population — and studies indicate that these cancer survivors also fear their cancer will recur. However, data on the prevalence of and risk factors associated with clinically significant fear of recurrence in this population remain limited.
- This cross-sectional study included 229 adult survivors of childhood cancer (mean age at study completion, 39.6 years), recruited from the Childhood Cancer Survivor Study, who completed online surveys between October 2018 and April 2019.
- Fear of cancer recurrence was assessed using the 9-item Fear of Cancer Recurrence Inventory–Short Form, which defines recurrence as the possibility that cancer might return to the same or a different part of the body.
- Chronic pain, symptoms of depression and anxiety, self-perceived health, and intolerance of uncertainty were also evaluated.
- Among the participants, 21 experienced a recurrence of their primary cancer and 17 were diagnosed with a subsequent malignant neoplasm.
TAKEAWAY:
- Overall, 38 (16.6%) adult survivors of childhood cancer reported clinically significant fear that their cancer would recur, and an additional 36 (15.7%) survivors experienced high levels of fear; the remaining 67.7% of participants reported minimal levels of fear.
- Survivors who were unemployed (prevalence ratio [PR], 2.5) were more likely to experience a clinically significant fear of recurrence, as were survivors who had undergone pelvic radiation (PR, 2.9) or limb-sparing or amputation surgery (PR, 2.4).
- Survivors who had elevated anxiety or depression (PR, 2.6) or both (PR, 3.2) were more likely to experience a clinically significant fear of recurrence, as were survivors who had a chronic neurologic health condition (PR, 3.3) or who perceived their health status to be poor or fair vs good to excellent (PR, 3.0).
- Among 94 participants with chronic pain, 25.5% reported clinically significant fear and 13.8% reported high levels of fear. But chronic pain (PR, 1.2; 95% CI, 0.6-2.4) was not significantly associated with a clinically significant fear of recurrence in a multivariable model.
IN PRACTICE:
“These findings underscore the substantial psychological and functional burden of FCR [fear of cancer recurrence] and suggest healthcare professionals should routinely assess FCR as a part of providing comprehensive care to long-term survivors,” the authors wrote.
SOURCE:
The study, led by Alex Pizzo, MSc, Concordia University, Montréal, Québec, Canada, was published online in JAMA Network Open.
LIMITATIONS:
The cross-sectional design limited causal inference. Self-perceived health was assessed with a single item, limiting its measurement. Internet and smartphone access eligibility could have introduced bias. The study also lacked racial and ethnic diversity.
DISCLOSURES:
The study was supported by the Childhood Cancer Survivor Study Career Development Award and a grant from the National Cancer Institute. Additional funding was provided by the Canada Research Chairs Program. Three authors reported receiving grants from various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
About one third of adult survivors of childhood cancer experience a clinically significant or high fear that their primary cancer may recur or that they will develop a subsequent malignancy, according to a recent analysis. The study finds that several factors are associated with a higher risk of experiencing a clinically significant fear of recurrence, including being unemployed or having elevated anxiety or depression.
METHODOLOGY:
- Adult survivors of childhood cancer face a high risk of developing subsequent malignant neoplasms — about a sixfold greater risk than in the general population — and studies indicate that these cancer survivors also fear their cancer will recur. However, data on the prevalence of and risk factors associated with clinically significant fear of recurrence in this population remain limited.
- This cross-sectional study included 229 adult survivors of childhood cancer (mean age at study completion, 39.6 years), recruited from the Childhood Cancer Survivor Study, who completed online surveys between October 2018 and April 2019.
- Fear of cancer recurrence was assessed using the 9-item Fear of Cancer Recurrence Inventory–Short Form, which defines recurrence as the possibility that cancer might return to the same or a different part of the body.
- Chronic pain, symptoms of depression and anxiety, self-perceived health, and intolerance of uncertainty were also evaluated.
- Among the participants, 21 experienced a recurrence of their primary cancer and 17 were diagnosed with a subsequent malignant neoplasm.
TAKEAWAY:
- Overall, 38 (16.6%) adult survivors of childhood cancer reported clinically significant fear that their cancer would recur, and an additional 36 (15.7%) survivors experienced high levels of fear; the remaining 67.7% of participants reported minimal levels of fear.
- Survivors who were unemployed (prevalence ratio [PR], 2.5) were more likely to experience a clinically significant fear of recurrence, as were survivors who had undergone pelvic radiation (PR, 2.9) or limb-sparing or amputation surgery (PR, 2.4).
- Survivors who had elevated anxiety or depression (PR, 2.6) or both (PR, 3.2) were more likely to experience a clinically significant fear of recurrence, as were survivors who had a chronic neurologic health condition (PR, 3.3) or who perceived their health status to be poor or fair vs good to excellent (PR, 3.0).
- Among 94 participants with chronic pain, 25.5% reported clinically significant fear and 13.8% reported high levels of fear. But chronic pain (PR, 1.2; 95% CI, 0.6-2.4) was not significantly associated with a clinically significant fear of recurrence in a multivariable model.
IN PRACTICE:
“These findings underscore the substantial psychological and functional burden of FCR [fear of cancer recurrence] and suggest healthcare professionals should routinely assess FCR as a part of providing comprehensive care to long-term survivors,” the authors wrote.
SOURCE:
The study, led by Alex Pizzo, MSc, Concordia University, Montréal, Québec, Canada, was published online in JAMA Network Open.
LIMITATIONS:
The cross-sectional design limited causal inference. Self-perceived health was assessed with a single item, limiting its measurement. Internet and smartphone access eligibility could have introduced bias. The study also lacked racial and ethnic diversity.
DISCLOSURES:
The study was supported by the Childhood Cancer Survivor Study Career Development Award and a grant from the National Cancer Institute. Additional funding was provided by the Canada Research Chairs Program. Three authors reported receiving grants from various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
About one third of adult survivors of childhood cancer experience a clinically significant or high fear that their primary cancer may recur or that they will develop a subsequent malignancy, according to a recent analysis. The study finds that several factors are associated with a higher risk of experiencing a clinically significant fear of recurrence, including being unemployed or having elevated anxiety or depression.
METHODOLOGY:
- Adult survivors of childhood cancer face a high risk of developing subsequent malignant neoplasms — about a sixfold greater risk than in the general population — and studies indicate that these cancer survivors also fear their cancer will recur. However, data on the prevalence of and risk factors associated with clinically significant fear of recurrence in this population remain limited.
- This cross-sectional study included 229 adult survivors of childhood cancer (mean age at study completion, 39.6 years), recruited from the Childhood Cancer Survivor Study, who completed online surveys between October 2018 and April 2019.
- Fear of cancer recurrence was assessed using the 9-item Fear of Cancer Recurrence Inventory–Short Form, which defines recurrence as the possibility that cancer might return to the same or a different part of the body.
- Chronic pain, symptoms of depression and anxiety, self-perceived health, and intolerance of uncertainty were also evaluated.
- Among the participants, 21 experienced a recurrence of their primary cancer and 17 were diagnosed with a subsequent malignant neoplasm.
TAKEAWAY:
- Overall, 38 (16.6%) adult survivors of childhood cancer reported clinically significant fear that their cancer would recur, and an additional 36 (15.7%) survivors experienced high levels of fear; the remaining 67.7% of participants reported minimal levels of fear.
- Survivors who were unemployed (prevalence ratio [PR], 2.5) were more likely to experience a clinically significant fear of recurrence, as were survivors who had undergone pelvic radiation (PR, 2.9) or limb-sparing or amputation surgery (PR, 2.4).
- Survivors who had elevated anxiety or depression (PR, 2.6) or both (PR, 3.2) were more likely to experience a clinically significant fear of recurrence, as were survivors who had a chronic neurologic health condition (PR, 3.3) or who perceived their health status to be poor or fair vs good to excellent (PR, 3.0).
- Among 94 participants with chronic pain, 25.5% reported clinically significant fear and 13.8% reported high levels of fear. But chronic pain (PR, 1.2; 95% CI, 0.6-2.4) was not significantly associated with a clinically significant fear of recurrence in a multivariable model.
IN PRACTICE:
“These findings underscore the substantial psychological and functional burden of FCR [fear of cancer recurrence] and suggest healthcare professionals should routinely assess FCR as a part of providing comprehensive care to long-term survivors,” the authors wrote.
SOURCE:
The study, led by Alex Pizzo, MSc, Concordia University, Montréal, Québec, Canada, was published online in JAMA Network Open.
LIMITATIONS:
The cross-sectional design limited causal inference. Self-perceived health was assessed with a single item, limiting its measurement. Internet and smartphone access eligibility could have introduced bias. The study also lacked racial and ethnic diversity.
DISCLOSURES:
The study was supported by the Childhood Cancer Survivor Study Career Development Award and a grant from the National Cancer Institute. Additional funding was provided by the Canada Research Chairs Program. Three authors reported receiving grants from various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Excess Body Weight Tied to Increased Risk for Second Cancers
TOPLINE:
Cancer survivors who had overweight or obesity at the time of their initial cancer diagnosis have a higher risk for a second primary cancer, particularly an obesity-related cancer, a new analysis found.
METHODOLOGY:
- Cancer survivors have an increased risk for another primary cancer. Studies suggest that lifestyle factors, such as excess body weight, may contribute to the risk for a second cancer; however, prospective long-term data on this association remain limited.
- Researchers evaluated 26,894 participants (mean age at first cancer diagnosis, 72.2 years; 97.6% White) from the Cancer Prevention Study II Nutrition cohort, who were diagnosed with a first nonmetastatic primary cancer between 1992 and 2015.
- Body mass index (BMI) was calculated from self-reported data at the time of the first primary cancer diagnosis; 10,713 participants had a normal BMI (18.5 to < 25.0), 11,497 had overweight (25.0 to < 30.0), and 4684 had obesity (≥ 30.0). Participants were followed through 2017.
- The study outcomes were the incidences of any second primary cancer and obesity-related second cancers.
- The most common first primary cancers were prostate (35.0%), breast (19.1%), and colorectal (9.5%) cancers; almost 40% of all first primary cancers were related to obesity.
TAKEAWAY:
- Overall, 13.9% participants (3749 of 26,894) were diagnosed with a second cancer over a median of 7.9 years; 33.2% of these cancers were related to obesity.
- Compared with participants with a normal BMI, those who had overweight had a 15% higher risk for any second cancer (adjusted hazard ratio [aHR], 1.15) and a 40% higher risk for an obesity-related second cancer (aHR, 1.40). Additionally, those with obesity had a 34% higher risk for any second cancer and a 78% higher risk for an obesity-related second cancer.
- For every 5-unit increase in BMI, the risk for an obesity-related cancer (aHR, 1.28) was considerably higher than the risk for any second cancer (aHR, 1.13).
- Among all survivors, every 5-unit increase in BMI was associated with a 42% increased risk for colorectal cancer as a second cancer (aHR, 1.42) and a 70% higher risk for kidney cancer as a second cancer (aHR, 1.70).
IN PRACTICE:
“In this cohort study of older survivors of nonmetastatic cancer, those who had overweight or obesity at the time of their first cancer diagnosis were at higher risk of developing a second cancer, especially obesity-related cancers,” the authors wrote. “These findings have important public health implications and may inform evidence-based survivorship guidelines to reduce the risk of second primary cancers among cancer survivors.”
SOURCE:
This study, led by Clara Bodelon, PhD, MS, American Cancer Society, Atlanta, was published online in JAMA Network Open.
LIMITATIONS:
The exclusion of multiple primary cancers in the same site could have underestimated the magnitude of the association of excess body weight with the risk for second primary cancers. BMI was used as a measure of excess body fat in this study, which does not differentiate between fat and lean mass. Unmeasured or residual confounding factors might be present.
DISCLOSURES:
The study was supported by grants from the Centers for Disease Control and Prevention’s National Program of Cancer Registries and cancer registries supported by the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program. No relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Cancer survivors who had overweight or obesity at the time of their initial cancer diagnosis have a higher risk for a second primary cancer, particularly an obesity-related cancer, a new analysis found.
METHODOLOGY:
- Cancer survivors have an increased risk for another primary cancer. Studies suggest that lifestyle factors, such as excess body weight, may contribute to the risk for a second cancer; however, prospective long-term data on this association remain limited.
- Researchers evaluated 26,894 participants (mean age at first cancer diagnosis, 72.2 years; 97.6% White) from the Cancer Prevention Study II Nutrition cohort, who were diagnosed with a first nonmetastatic primary cancer between 1992 and 2015.
- Body mass index (BMI) was calculated from self-reported data at the time of the first primary cancer diagnosis; 10,713 participants had a normal BMI (18.5 to < 25.0), 11,497 had overweight (25.0 to < 30.0), and 4684 had obesity (≥ 30.0). Participants were followed through 2017.
- The study outcomes were the incidences of any second primary cancer and obesity-related second cancers.
- The most common first primary cancers were prostate (35.0%), breast (19.1%), and colorectal (9.5%) cancers; almost 40% of all first primary cancers were related to obesity.
TAKEAWAY:
- Overall, 13.9% participants (3749 of 26,894) were diagnosed with a second cancer over a median of 7.9 years; 33.2% of these cancers were related to obesity.
- Compared with participants with a normal BMI, those who had overweight had a 15% higher risk for any second cancer (adjusted hazard ratio [aHR], 1.15) and a 40% higher risk for an obesity-related second cancer (aHR, 1.40). Additionally, those with obesity had a 34% higher risk for any second cancer and a 78% higher risk for an obesity-related second cancer.
- For every 5-unit increase in BMI, the risk for an obesity-related cancer (aHR, 1.28) was considerably higher than the risk for any second cancer (aHR, 1.13).
- Among all survivors, every 5-unit increase in BMI was associated with a 42% increased risk for colorectal cancer as a second cancer (aHR, 1.42) and a 70% higher risk for kidney cancer as a second cancer (aHR, 1.70).
IN PRACTICE:
“In this cohort study of older survivors of nonmetastatic cancer, those who had overweight or obesity at the time of their first cancer diagnosis were at higher risk of developing a second cancer, especially obesity-related cancers,” the authors wrote. “These findings have important public health implications and may inform evidence-based survivorship guidelines to reduce the risk of second primary cancers among cancer survivors.”
SOURCE:
This study, led by Clara Bodelon, PhD, MS, American Cancer Society, Atlanta, was published online in JAMA Network Open.
LIMITATIONS:
The exclusion of multiple primary cancers in the same site could have underestimated the magnitude of the association of excess body weight with the risk for second primary cancers. BMI was used as a measure of excess body fat in this study, which does not differentiate between fat and lean mass. Unmeasured or residual confounding factors might be present.
DISCLOSURES:
The study was supported by grants from the Centers for Disease Control and Prevention’s National Program of Cancer Registries and cancer registries supported by the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program. No relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Cancer survivors who had overweight or obesity at the time of their initial cancer diagnosis have a higher risk for a second primary cancer, particularly an obesity-related cancer, a new analysis found.
METHODOLOGY:
- Cancer survivors have an increased risk for another primary cancer. Studies suggest that lifestyle factors, such as excess body weight, may contribute to the risk for a second cancer; however, prospective long-term data on this association remain limited.
- Researchers evaluated 26,894 participants (mean age at first cancer diagnosis, 72.2 years; 97.6% White) from the Cancer Prevention Study II Nutrition cohort, who were diagnosed with a first nonmetastatic primary cancer between 1992 and 2015.
- Body mass index (BMI) was calculated from self-reported data at the time of the first primary cancer diagnosis; 10,713 participants had a normal BMI (18.5 to < 25.0), 11,497 had overweight (25.0 to < 30.0), and 4684 had obesity (≥ 30.0). Participants were followed through 2017.
- The study outcomes were the incidences of any second primary cancer and obesity-related second cancers.
- The most common first primary cancers were prostate (35.0%), breast (19.1%), and colorectal (9.5%) cancers; almost 40% of all first primary cancers were related to obesity.
TAKEAWAY:
- Overall, 13.9% participants (3749 of 26,894) were diagnosed with a second cancer over a median of 7.9 years; 33.2% of these cancers were related to obesity.
- Compared with participants with a normal BMI, those who had overweight had a 15% higher risk for any second cancer (adjusted hazard ratio [aHR], 1.15) and a 40% higher risk for an obesity-related second cancer (aHR, 1.40). Additionally, those with obesity had a 34% higher risk for any second cancer and a 78% higher risk for an obesity-related second cancer.
- For every 5-unit increase in BMI, the risk for an obesity-related cancer (aHR, 1.28) was considerably higher than the risk for any second cancer (aHR, 1.13).
- Among all survivors, every 5-unit increase in BMI was associated with a 42% increased risk for colorectal cancer as a second cancer (aHR, 1.42) and a 70% higher risk for kidney cancer as a second cancer (aHR, 1.70).
IN PRACTICE:
“In this cohort study of older survivors of nonmetastatic cancer, those who had overweight or obesity at the time of their first cancer diagnosis were at higher risk of developing a second cancer, especially obesity-related cancers,” the authors wrote. “These findings have important public health implications and may inform evidence-based survivorship guidelines to reduce the risk of second primary cancers among cancer survivors.”
SOURCE:
This study, led by Clara Bodelon, PhD, MS, American Cancer Society, Atlanta, was published online in JAMA Network Open.
LIMITATIONS:
The exclusion of multiple primary cancers in the same site could have underestimated the magnitude of the association of excess body weight with the risk for second primary cancers. BMI was used as a measure of excess body fat in this study, which does not differentiate between fat and lean mass. Unmeasured or residual confounding factors might be present.
DISCLOSURES:
The study was supported by grants from the Centers for Disease Control and Prevention’s National Program of Cancer Registries and cancer registries supported by the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program. No relevant conflicts of interest were disclosed by the authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
MMR/MSI Testing for CRC Climbs, But Variations Persist
TOPLINE:
with testing rates differing by cancer stage, individual hospital, patient sex, race, and insurance status.
METHODOLOGY:
- In 2017, the National Comprehensive Cancer Network (NCCN) recommended universal testing for MMR and MSI among patients with CRC, but studies suggest that testing may still be underused.
- To assess trends and factors associated with MMR/MSI testing in the United States, researchers evaluated 834,797 patients diagnosed with stage I-IV CRC between 2012 and 2021 across 1366 Commission on Cancer–accredited hospitals in the National Cancer Database.
- The variability in MMR/MSI testing was assessed in relation to both patient and hospital-level factors.
- Overall, 70.7% patients had colon cancer, 7.3% had rectosigmoid cancer, and 22.0% had rectal cancer. The median patient age was 66 years; just over half (53%) were men, 81.8% were White, and 11.9% were Black.
TAKEAWAY:
- Overall, 43.9% patients underwent MMR/MSI testing, but testing rates increased more than threefold between 2012 and 2021 — from 22.7% to 71.5%. Still, testing rates varied depending on a range of factors.
- About 22% variability in MMR/MSI testing was attributed to hospital-level variations, with the best vs worst performing hospitals reporting testing rates of 90% vs 2%. This hospital-level variation may be caused by testing protocol differences at individual institutions, the authors said.
- The likelihood of undergoing MMR/MSI testing was lower in patients with stage IV vs stage I disease (adjusted odds ratio [aOR], 0.78) but higher in those with stage II (aOR, 1.53) and III (aOR, 1.40) disease.
- The likelihood of undergoing MMR/MSI testing was slightly lower for men than for women (aOR, 0.98) and for Black patients than for White patients (aOR, 0.97). Having a lower household income, public or no insurance (vs private insurance), or living a longer distance (more than 5 miles) from the treatment facility was also associated with lower odds of testing.
IN PRACTICE:
“This cohort study indicated that MMR/MSI testing increased markedly, suggesting increased NCCN guideline adherence,” the authors said. However, variations still exist by cancer stage, hospital, and patient factors. Implementing “widespread institution-level reflexive testing for every initial diagnostic biopsy” can improve testing rates and reduce disparities, the authors suggested.
SOURCE:
This study, led by Totadri Dhimal, MD, University of Rochester Medical Center in New York, was published online in JAMA Oncology.
LIMITATIONS:
The study lacked clinical granularity, and potential coding inaccuracies and incomplete data could have affected the interpretation and generalizability of the findings.
DISCLOSURES:
No funding information was provided for the study. One author reported receiving author royalties from UpToDate outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
with testing rates differing by cancer stage, individual hospital, patient sex, race, and insurance status.
METHODOLOGY:
- In 2017, the National Comprehensive Cancer Network (NCCN) recommended universal testing for MMR and MSI among patients with CRC, but studies suggest that testing may still be underused.
- To assess trends and factors associated with MMR/MSI testing in the United States, researchers evaluated 834,797 patients diagnosed with stage I-IV CRC between 2012 and 2021 across 1366 Commission on Cancer–accredited hospitals in the National Cancer Database.
- The variability in MMR/MSI testing was assessed in relation to both patient and hospital-level factors.
- Overall, 70.7% patients had colon cancer, 7.3% had rectosigmoid cancer, and 22.0% had rectal cancer. The median patient age was 66 years; just over half (53%) were men, 81.8% were White, and 11.9% were Black.
TAKEAWAY:
- Overall, 43.9% patients underwent MMR/MSI testing, but testing rates increased more than threefold between 2012 and 2021 — from 22.7% to 71.5%. Still, testing rates varied depending on a range of factors.
- About 22% variability in MMR/MSI testing was attributed to hospital-level variations, with the best vs worst performing hospitals reporting testing rates of 90% vs 2%. This hospital-level variation may be caused by testing protocol differences at individual institutions, the authors said.
- The likelihood of undergoing MMR/MSI testing was lower in patients with stage IV vs stage I disease (adjusted odds ratio [aOR], 0.78) but higher in those with stage II (aOR, 1.53) and III (aOR, 1.40) disease.
- The likelihood of undergoing MMR/MSI testing was slightly lower for men than for women (aOR, 0.98) and for Black patients than for White patients (aOR, 0.97). Having a lower household income, public or no insurance (vs private insurance), or living a longer distance (more than 5 miles) from the treatment facility was also associated with lower odds of testing.
IN PRACTICE:
“This cohort study indicated that MMR/MSI testing increased markedly, suggesting increased NCCN guideline adherence,” the authors said. However, variations still exist by cancer stage, hospital, and patient factors. Implementing “widespread institution-level reflexive testing for every initial diagnostic biopsy” can improve testing rates and reduce disparities, the authors suggested.
SOURCE:
This study, led by Totadri Dhimal, MD, University of Rochester Medical Center in New York, was published online in JAMA Oncology.
LIMITATIONS:
The study lacked clinical granularity, and potential coding inaccuracies and incomplete data could have affected the interpretation and generalizability of the findings.
DISCLOSURES:
No funding information was provided for the study. One author reported receiving author royalties from UpToDate outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
with testing rates differing by cancer stage, individual hospital, patient sex, race, and insurance status.
METHODOLOGY:
- In 2017, the National Comprehensive Cancer Network (NCCN) recommended universal testing for MMR and MSI among patients with CRC, but studies suggest that testing may still be underused.
- To assess trends and factors associated with MMR/MSI testing in the United States, researchers evaluated 834,797 patients diagnosed with stage I-IV CRC between 2012 and 2021 across 1366 Commission on Cancer–accredited hospitals in the National Cancer Database.
- The variability in MMR/MSI testing was assessed in relation to both patient and hospital-level factors.
- Overall, 70.7% patients had colon cancer, 7.3% had rectosigmoid cancer, and 22.0% had rectal cancer. The median patient age was 66 years; just over half (53%) were men, 81.8% were White, and 11.9% were Black.
TAKEAWAY:
- Overall, 43.9% patients underwent MMR/MSI testing, but testing rates increased more than threefold between 2012 and 2021 — from 22.7% to 71.5%. Still, testing rates varied depending on a range of factors.
- About 22% variability in MMR/MSI testing was attributed to hospital-level variations, with the best vs worst performing hospitals reporting testing rates of 90% vs 2%. This hospital-level variation may be caused by testing protocol differences at individual institutions, the authors said.
- The likelihood of undergoing MMR/MSI testing was lower in patients with stage IV vs stage I disease (adjusted odds ratio [aOR], 0.78) but higher in those with stage II (aOR, 1.53) and III (aOR, 1.40) disease.
- The likelihood of undergoing MMR/MSI testing was slightly lower for men than for women (aOR, 0.98) and for Black patients than for White patients (aOR, 0.97). Having a lower household income, public or no insurance (vs private insurance), or living a longer distance (more than 5 miles) from the treatment facility was also associated with lower odds of testing.
IN PRACTICE:
“This cohort study indicated that MMR/MSI testing increased markedly, suggesting increased NCCN guideline adherence,” the authors said. However, variations still exist by cancer stage, hospital, and patient factors. Implementing “widespread institution-level reflexive testing for every initial diagnostic biopsy” can improve testing rates and reduce disparities, the authors suggested.
SOURCE:
This study, led by Totadri Dhimal, MD, University of Rochester Medical Center in New York, was published online in JAMA Oncology.
LIMITATIONS:
The study lacked clinical granularity, and potential coding inaccuracies and incomplete data could have affected the interpretation and generalizability of the findings.
DISCLOSURES:
No funding information was provided for the study. One author reported receiving author royalties from UpToDate outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Crisugabalin Alleviates Postherpetic Neuralgia Symptoms in Phase 3 Study
TOPLINE:
METHODOLOGY:
- Researchers conducted a phase 3 multicenter, double-blind study involving 366 patients in China (median age, 63 years; 52.7% men) with PHN with an average daily pain score (ADPS) of 4 or greater on the numeric pain rating scale who were randomly assigned to receive either crisugabalin 40 mg/d (n = 121), 80 mg/d (n = 121), or placebo (n = 124) for 12 weeks.
- Patients who did not experience any serious toxic effects in these 12 weeks entered a 14-week open-label extension phase and received crisugabalin 40 mg twice daily.
- The primary efficacy endpoint was the change in ADPS from baseline at week 12.
- Secondary efficacy endpoints included the proportion of patients achieving at least 30% and 50% reduction in ADPS at week 12; changes in the Short-Form McGill Pain Questionnaire (SF-MPQ), Visual Analog Scale, and Average Daily Sleep Interference Scale scores at week 12; and change in the SF-MPQ Present Pain Intensity scores at weeks 12 and 26.
TAKEAWAY:
- At week 12, among those on crisugabalin 40 mg/d and 80 mg/d, there were significant reductions in ADPS compared with placebo (least squares mean [LSM] change from baseline, −2.2 and −2.6 vs −1.1, respectively; P < .001).
- A greater proportion of patients on crisugabalin 40 mg/d (61.2%) and 80 mg/d (54.5%) achieved 30% or greater reduction in ADPS (P < .001) than patients who received placebo (35.5%). Similarly, a 50% or greater reduction in ADPS was achieved by 37.2% of patients on crisugabalin 40 mg/d (P = .002) and 38% on 80 mg/d (P < .001), compared with 20.2% for placebo.
- Crisugabalin 40 mg/d and crisugabalin 80 mg/d were associated with greater reductions in the pain intensity at week 12 than placebo (LSM, −1.0 and −1.2 vs −0.5, respectively; P < .001). Similar patterns were noted for other pain-related measures at weeks 12 and 26.
- Serious treatment-emergent adverse events occurred in four patients in each group; only 2.4% of those on 40 mg/d and 1.6% on 80 mg/d discontinued treatment because of side effects.
IN PRACTICE:
“Crisugabalin 40 mg/d or crisugabalin 80 mg/d was well-tolerated and significantly improved ADPS compared to placebo,” the authors wrote, adding that “crisugabalin can be flexibly selected depending on individual patient response and tolerability at 40 mg/d or 80 mg/d.”
SOURCE:
The study was led by Daying Zhang, PhD, of the Department of Pain Medicine at The First Affiliated Hospital of Nanchang University, Nanchang, China. It was published online in JAMA Dermatology.
LIMITATIONS:
The findings may not be generalizable to the global population as the study population was limited to Chinese patients. The study only provided short-term efficacy and safety data on crisugabalin, lacked an active comparator, and did not reflect the standard of care observed in the United States or Europe, where oral tricyclic antidepressants, pregabalin, and the lidocaine patch are recommended as first-line therapies.
DISCLOSURES:
The study was sponsored and funded by Haisco Pharmaceutical. Dr. Zhang and another author reported receiving support from Haisco. Two authors are company employees.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a phase 3 multicenter, double-blind study involving 366 patients in China (median age, 63 years; 52.7% men) with PHN with an average daily pain score (ADPS) of 4 or greater on the numeric pain rating scale who were randomly assigned to receive either crisugabalin 40 mg/d (n = 121), 80 mg/d (n = 121), or placebo (n = 124) for 12 weeks.
- Patients who did not experience any serious toxic effects in these 12 weeks entered a 14-week open-label extension phase and received crisugabalin 40 mg twice daily.
- The primary efficacy endpoint was the change in ADPS from baseline at week 12.
- Secondary efficacy endpoints included the proportion of patients achieving at least 30% and 50% reduction in ADPS at week 12; changes in the Short-Form McGill Pain Questionnaire (SF-MPQ), Visual Analog Scale, and Average Daily Sleep Interference Scale scores at week 12; and change in the SF-MPQ Present Pain Intensity scores at weeks 12 and 26.
TAKEAWAY:
- At week 12, among those on crisugabalin 40 mg/d and 80 mg/d, there were significant reductions in ADPS compared with placebo (least squares mean [LSM] change from baseline, −2.2 and −2.6 vs −1.1, respectively; P < .001).
- A greater proportion of patients on crisugabalin 40 mg/d (61.2%) and 80 mg/d (54.5%) achieved 30% or greater reduction in ADPS (P < .001) than patients who received placebo (35.5%). Similarly, a 50% or greater reduction in ADPS was achieved by 37.2% of patients on crisugabalin 40 mg/d (P = .002) and 38% on 80 mg/d (P < .001), compared with 20.2% for placebo.
- Crisugabalin 40 mg/d and crisugabalin 80 mg/d were associated with greater reductions in the pain intensity at week 12 than placebo (LSM, −1.0 and −1.2 vs −0.5, respectively; P < .001). Similar patterns were noted for other pain-related measures at weeks 12 and 26.
- Serious treatment-emergent adverse events occurred in four patients in each group; only 2.4% of those on 40 mg/d and 1.6% on 80 mg/d discontinued treatment because of side effects.
IN PRACTICE:
“Crisugabalin 40 mg/d or crisugabalin 80 mg/d was well-tolerated and significantly improved ADPS compared to placebo,” the authors wrote, adding that “crisugabalin can be flexibly selected depending on individual patient response and tolerability at 40 mg/d or 80 mg/d.”
SOURCE:
The study was led by Daying Zhang, PhD, of the Department of Pain Medicine at The First Affiliated Hospital of Nanchang University, Nanchang, China. It was published online in JAMA Dermatology.
LIMITATIONS:
The findings may not be generalizable to the global population as the study population was limited to Chinese patients. The study only provided short-term efficacy and safety data on crisugabalin, lacked an active comparator, and did not reflect the standard of care observed in the United States or Europe, where oral tricyclic antidepressants, pregabalin, and the lidocaine patch are recommended as first-line therapies.
DISCLOSURES:
The study was sponsored and funded by Haisco Pharmaceutical. Dr. Zhang and another author reported receiving support from Haisco. Two authors are company employees.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a phase 3 multicenter, double-blind study involving 366 patients in China (median age, 63 years; 52.7% men) with PHN with an average daily pain score (ADPS) of 4 or greater on the numeric pain rating scale who were randomly assigned to receive either crisugabalin 40 mg/d (n = 121), 80 mg/d (n = 121), or placebo (n = 124) for 12 weeks.
- Patients who did not experience any serious toxic effects in these 12 weeks entered a 14-week open-label extension phase and received crisugabalin 40 mg twice daily.
- The primary efficacy endpoint was the change in ADPS from baseline at week 12.
- Secondary efficacy endpoints included the proportion of patients achieving at least 30% and 50% reduction in ADPS at week 12; changes in the Short-Form McGill Pain Questionnaire (SF-MPQ), Visual Analog Scale, and Average Daily Sleep Interference Scale scores at week 12; and change in the SF-MPQ Present Pain Intensity scores at weeks 12 and 26.
TAKEAWAY:
- At week 12, among those on crisugabalin 40 mg/d and 80 mg/d, there were significant reductions in ADPS compared with placebo (least squares mean [LSM] change from baseline, −2.2 and −2.6 vs −1.1, respectively; P < .001).
- A greater proportion of patients on crisugabalin 40 mg/d (61.2%) and 80 mg/d (54.5%) achieved 30% or greater reduction in ADPS (P < .001) than patients who received placebo (35.5%). Similarly, a 50% or greater reduction in ADPS was achieved by 37.2% of patients on crisugabalin 40 mg/d (P = .002) and 38% on 80 mg/d (P < .001), compared with 20.2% for placebo.
- Crisugabalin 40 mg/d and crisugabalin 80 mg/d were associated with greater reductions in the pain intensity at week 12 than placebo (LSM, −1.0 and −1.2 vs −0.5, respectively; P < .001). Similar patterns were noted for other pain-related measures at weeks 12 and 26.
- Serious treatment-emergent adverse events occurred in four patients in each group; only 2.4% of those on 40 mg/d and 1.6% on 80 mg/d discontinued treatment because of side effects.
IN PRACTICE:
“Crisugabalin 40 mg/d or crisugabalin 80 mg/d was well-tolerated and significantly improved ADPS compared to placebo,” the authors wrote, adding that “crisugabalin can be flexibly selected depending on individual patient response and tolerability at 40 mg/d or 80 mg/d.”
SOURCE:
The study was led by Daying Zhang, PhD, of the Department of Pain Medicine at The First Affiliated Hospital of Nanchang University, Nanchang, China. It was published online in JAMA Dermatology.
LIMITATIONS:
The findings may not be generalizable to the global population as the study population was limited to Chinese patients. The study only provided short-term efficacy and safety data on crisugabalin, lacked an active comparator, and did not reflect the standard of care observed in the United States or Europe, where oral tricyclic antidepressants, pregabalin, and the lidocaine patch are recommended as first-line therapies.
DISCLOSURES:
The study was sponsored and funded by Haisco Pharmaceutical. Dr. Zhang and another author reported receiving support from Haisco. Two authors are company employees.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Phase3 Data: Atopic Dermatitis Symptoms Improved with Topical Roflumilast
TOPLINE:
(AD) in two phase 3 trials.
METHODOLOGY:
- Two randomized, parallel-group, double-blind, vehicle-controlled phase 3 trials, INTEGUMENT-1 (n = 654) and INTEGUMENT-2 (n = 683), enrolled patients aged ≥ 6 years with mild to moderate AD who were randomly assigned in a 2:1 ratio to roflumilast cream 0.15%, a phosphodiesterase 4 inhibitor, or vehicle cream once daily for 4 weeks.
- The primary efficacy endpoint was the Validated Investigator Global Assessment for AD (vIGA-AD) success at week 4, defined as a score of 0 (clear) or 1 (almost clear) plus improvement of at least two grades from baseline.
- Secondary endpoints included vIGA-AD success at week 4 in patients with a baseline score of 3, at least a four-point reduction in the Worst Itch Numeric Rating Scale (WI-NRS), and at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at weeks 1, 2, and 4.
TAKEAWAY:
- Significantly more patients receiving roflumilast achieved vIGA-AD success at week 4 vs those in the vehicle group in INTEGUMENT-1 (32.0% vs 15.2%; P < .001) and INTEGUMENT-2 (28.9% vs 12.0%; P < .001), which was consistent across all age groups and in those with a baseline score of 3.
- Similarly, a greater proportion of patients treated with roflumilast vs vehicle achieved at least a four-point reduction in WI-NRS at weeks 1, 2, and 4, with improvements noted as early as 24 hours after the first application (P < .05 at all subsequent timepoints).
- The number of patients achieving EASI-75 and vIGA-AD scores of 0 or 1 was significantly higher with roflumilast than with vehicle at weeks 1, 2, and 4.
- Most treatment-emergent adverse events (TEAEs) were mild to moderate, with only 0.9% of the patients experiencing serious TEAEs in each trial. More than 95% of the patients showed no signs of irritation, and over 90% reported no or mild sensation at the application site.
IN PRACTICE:
The two phase 3 randomized clinical trials of patients with AD treated with roflumilast cream 0.15% “demonstrated improvement across multiple efficacy endpoints, including reducing pruritus within 24 hours after application, with favorable safety and tolerability,” the authors wrote. “Additional research, including subgroup analyses, will provide more data regarding the efficacy and safety of roflumilast cream 0.15%, in patients with AD,” they added.
SOURCE:
The study was led by Eric L. Simpson, MD, of the Department of Dermatology, Oregon Health & Science University, Portland, Oregon, and was published online on September 18 in JAMA Dermatology.
LIMITATIONS:
A short duration, a minimum age limit of 6 years, and the lack of an active comparator may influence the interpretation and generalizability of the results.
DISCLOSURES:
The study was sponsored by Arcutis Biotherapeutics. Simpson received grants and personal fees from Arcutis during this study. Three authors reported being employees and/or stockholders of Arcutis, two other authors reported patents for Arcutis, and several authors declared having various ties with various sources, including Arcutis.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
(AD) in two phase 3 trials.
METHODOLOGY:
- Two randomized, parallel-group, double-blind, vehicle-controlled phase 3 trials, INTEGUMENT-1 (n = 654) and INTEGUMENT-2 (n = 683), enrolled patients aged ≥ 6 years with mild to moderate AD who were randomly assigned in a 2:1 ratio to roflumilast cream 0.15%, a phosphodiesterase 4 inhibitor, or vehicle cream once daily for 4 weeks.
- The primary efficacy endpoint was the Validated Investigator Global Assessment for AD (vIGA-AD) success at week 4, defined as a score of 0 (clear) or 1 (almost clear) plus improvement of at least two grades from baseline.
- Secondary endpoints included vIGA-AD success at week 4 in patients with a baseline score of 3, at least a four-point reduction in the Worst Itch Numeric Rating Scale (WI-NRS), and at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at weeks 1, 2, and 4.
TAKEAWAY:
- Significantly more patients receiving roflumilast achieved vIGA-AD success at week 4 vs those in the vehicle group in INTEGUMENT-1 (32.0% vs 15.2%; P < .001) and INTEGUMENT-2 (28.9% vs 12.0%; P < .001), which was consistent across all age groups and in those with a baseline score of 3.
- Similarly, a greater proportion of patients treated with roflumilast vs vehicle achieved at least a four-point reduction in WI-NRS at weeks 1, 2, and 4, with improvements noted as early as 24 hours after the first application (P < .05 at all subsequent timepoints).
- The number of patients achieving EASI-75 and vIGA-AD scores of 0 or 1 was significantly higher with roflumilast than with vehicle at weeks 1, 2, and 4.
- Most treatment-emergent adverse events (TEAEs) were mild to moderate, with only 0.9% of the patients experiencing serious TEAEs in each trial. More than 95% of the patients showed no signs of irritation, and over 90% reported no or mild sensation at the application site.
IN PRACTICE:
The two phase 3 randomized clinical trials of patients with AD treated with roflumilast cream 0.15% “demonstrated improvement across multiple efficacy endpoints, including reducing pruritus within 24 hours after application, with favorable safety and tolerability,” the authors wrote. “Additional research, including subgroup analyses, will provide more data regarding the efficacy and safety of roflumilast cream 0.15%, in patients with AD,” they added.
SOURCE:
The study was led by Eric L. Simpson, MD, of the Department of Dermatology, Oregon Health & Science University, Portland, Oregon, and was published online on September 18 in JAMA Dermatology.
LIMITATIONS:
A short duration, a minimum age limit of 6 years, and the lack of an active comparator may influence the interpretation and generalizability of the results.
DISCLOSURES:
The study was sponsored by Arcutis Biotherapeutics. Simpson received grants and personal fees from Arcutis during this study. Three authors reported being employees and/or stockholders of Arcutis, two other authors reported patents for Arcutis, and several authors declared having various ties with various sources, including Arcutis.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
(AD) in two phase 3 trials.
METHODOLOGY:
- Two randomized, parallel-group, double-blind, vehicle-controlled phase 3 trials, INTEGUMENT-1 (n = 654) and INTEGUMENT-2 (n = 683), enrolled patients aged ≥ 6 years with mild to moderate AD who were randomly assigned in a 2:1 ratio to roflumilast cream 0.15%, a phosphodiesterase 4 inhibitor, or vehicle cream once daily for 4 weeks.
- The primary efficacy endpoint was the Validated Investigator Global Assessment for AD (vIGA-AD) success at week 4, defined as a score of 0 (clear) or 1 (almost clear) plus improvement of at least two grades from baseline.
- Secondary endpoints included vIGA-AD success at week 4 in patients with a baseline score of 3, at least a four-point reduction in the Worst Itch Numeric Rating Scale (WI-NRS), and at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) at weeks 1, 2, and 4.
TAKEAWAY:
- Significantly more patients receiving roflumilast achieved vIGA-AD success at week 4 vs those in the vehicle group in INTEGUMENT-1 (32.0% vs 15.2%; P < .001) and INTEGUMENT-2 (28.9% vs 12.0%; P < .001), which was consistent across all age groups and in those with a baseline score of 3.
- Similarly, a greater proportion of patients treated with roflumilast vs vehicle achieved at least a four-point reduction in WI-NRS at weeks 1, 2, and 4, with improvements noted as early as 24 hours after the first application (P < .05 at all subsequent timepoints).
- The number of patients achieving EASI-75 and vIGA-AD scores of 0 or 1 was significantly higher with roflumilast than with vehicle at weeks 1, 2, and 4.
- Most treatment-emergent adverse events (TEAEs) were mild to moderate, with only 0.9% of the patients experiencing serious TEAEs in each trial. More than 95% of the patients showed no signs of irritation, and over 90% reported no or mild sensation at the application site.
IN PRACTICE:
The two phase 3 randomized clinical trials of patients with AD treated with roflumilast cream 0.15% “demonstrated improvement across multiple efficacy endpoints, including reducing pruritus within 24 hours after application, with favorable safety and tolerability,” the authors wrote. “Additional research, including subgroup analyses, will provide more data regarding the efficacy and safety of roflumilast cream 0.15%, in patients with AD,” they added.
SOURCE:
The study was led by Eric L. Simpson, MD, of the Department of Dermatology, Oregon Health & Science University, Portland, Oregon, and was published online on September 18 in JAMA Dermatology.
LIMITATIONS:
A short duration, a minimum age limit of 6 years, and the lack of an active comparator may influence the interpretation and generalizability of the results.
DISCLOSURES:
The study was sponsored by Arcutis Biotherapeutics. Simpson received grants and personal fees from Arcutis during this study. Three authors reported being employees and/or stockholders of Arcutis, two other authors reported patents for Arcutis, and several authors declared having various ties with various sources, including Arcutis.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Biomarkers in Cord Blood May Predict AD Onset in Newborns, Study Suggests
TOPLINE:
and interleukin (IL) 31.
METHODOLOGY:
- Researchers conducted a prospective study to evaluate the predictive role of serologic biomarkers and cutaneous markers and the development of AD in 40 full-term newborns from a university hospital in Italy.
- Cord blood was collected at birth and analyzed for serum biomarkers such as CCL17/TARC and IL-31.
- TEWL and skin hydration rates were measured at 1, 6, and 12 months, and dermatological features such as dryness, cradle cap, and eczematous lesions were also monitored during visits.
TAKEAWAY:
- At 6 months, 16 infants had symptoms of AD, which included dry skin, pruritus, and keratosis pilaris, which persisted at 12 months. Their mean Eczema Area and Severity Index score was 6.6 at 6 months and 2.9 at 12 months.
- Infants with signs of AD had significantly higher TEWL levels at the anterior cubital fossa at 1, 6, and 12 months than those without AD.
- Cord blood levels of CCL17/TARC and IL-31 were significantly higher in infants with AD.
- A correlation was found between TEWL values and CCL17 levels at 1, 6, and 12 months.
IN PRACTICE:
“,” the authors wrote. “Stratified interventions based on these variables, family history, FLG [filaggrin] variations, and other biomarkers could offer more targeted approaches to AD prevention and management, especially during the first year of life,” they added.
SOURCE:
The study was led by Angelo Massimiliano D’Erme, MD, PhD, of the Dermatology Unit, in the Department of Medical and Oncology, University of Pisa, Pisa, Italy, and was published online in JAMA Dermatology.
LIMITATIONS:
The limitations included the observational design and small sample size, and it was a single-center study.
DISCLOSURES:
The authors did not disclose any funding information. One author disclosed receiving personal fees from various pharmaceutical companies and serving as a founder and chairman of a nonprofit organization.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article appeared on Medscape.com.
TOPLINE:
and interleukin (IL) 31.
METHODOLOGY:
- Researchers conducted a prospective study to evaluate the predictive role of serologic biomarkers and cutaneous markers and the development of AD in 40 full-term newborns from a university hospital in Italy.
- Cord blood was collected at birth and analyzed for serum biomarkers such as CCL17/TARC and IL-31.
- TEWL and skin hydration rates were measured at 1, 6, and 12 months, and dermatological features such as dryness, cradle cap, and eczematous lesions were also monitored during visits.
TAKEAWAY:
- At 6 months, 16 infants had symptoms of AD, which included dry skin, pruritus, and keratosis pilaris, which persisted at 12 months. Their mean Eczema Area and Severity Index score was 6.6 at 6 months and 2.9 at 12 months.
- Infants with signs of AD had significantly higher TEWL levels at the anterior cubital fossa at 1, 6, and 12 months than those without AD.
- Cord blood levels of CCL17/TARC and IL-31 were significantly higher in infants with AD.
- A correlation was found between TEWL values and CCL17 levels at 1, 6, and 12 months.
IN PRACTICE:
“,” the authors wrote. “Stratified interventions based on these variables, family history, FLG [filaggrin] variations, and other biomarkers could offer more targeted approaches to AD prevention and management, especially during the first year of life,” they added.
SOURCE:
The study was led by Angelo Massimiliano D’Erme, MD, PhD, of the Dermatology Unit, in the Department of Medical and Oncology, University of Pisa, Pisa, Italy, and was published online in JAMA Dermatology.
LIMITATIONS:
The limitations included the observational design and small sample size, and it was a single-center study.
DISCLOSURES:
The authors did not disclose any funding information. One author disclosed receiving personal fees from various pharmaceutical companies and serving as a founder and chairman of a nonprofit organization.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article appeared on Medscape.com.
TOPLINE:
and interleukin (IL) 31.
METHODOLOGY:
- Researchers conducted a prospective study to evaluate the predictive role of serologic biomarkers and cutaneous markers and the development of AD in 40 full-term newborns from a university hospital in Italy.
- Cord blood was collected at birth and analyzed for serum biomarkers such as CCL17/TARC and IL-31.
- TEWL and skin hydration rates were measured at 1, 6, and 12 months, and dermatological features such as dryness, cradle cap, and eczematous lesions were also monitored during visits.
TAKEAWAY:
- At 6 months, 16 infants had symptoms of AD, which included dry skin, pruritus, and keratosis pilaris, which persisted at 12 months. Their mean Eczema Area and Severity Index score was 6.6 at 6 months and 2.9 at 12 months.
- Infants with signs of AD had significantly higher TEWL levels at the anterior cubital fossa at 1, 6, and 12 months than those without AD.
- Cord blood levels of CCL17/TARC and IL-31 were significantly higher in infants with AD.
- A correlation was found between TEWL values and CCL17 levels at 1, 6, and 12 months.
IN PRACTICE:
“,” the authors wrote. “Stratified interventions based on these variables, family history, FLG [filaggrin] variations, and other biomarkers could offer more targeted approaches to AD prevention and management, especially during the first year of life,” they added.
SOURCE:
The study was led by Angelo Massimiliano D’Erme, MD, PhD, of the Dermatology Unit, in the Department of Medical and Oncology, University of Pisa, Pisa, Italy, and was published online in JAMA Dermatology.
LIMITATIONS:
The limitations included the observational design and small sample size, and it was a single-center study.
DISCLOSURES:
The authors did not disclose any funding information. One author disclosed receiving personal fees from various pharmaceutical companies and serving as a founder and chairman of a nonprofit organization.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article appeared on Medscape.com.