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Spinal Cord Stimulation Promising for Chronic Back, Leg Pain
TOPLINE:
Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.
METHODOLOGY:
- Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
- More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
- Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
- Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
- The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.
TAKEAWAY:
- Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
- Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
- Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
- Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.
IN PRACTICE:
“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.
SOURCE:
The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.
LIMITATIONS:
The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.
DISCLOSURES:
This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.
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:
Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.
METHODOLOGY:
- Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
- More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
- Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
- Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
- The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.
TAKEAWAY:
- Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
- Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
- Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
- Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.
IN PRACTICE:
“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.
SOURCE:
The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.
LIMITATIONS:
The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.
DISCLOSURES:
This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.
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:
Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.
METHODOLOGY:
- Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
- More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
- Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
- Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
- The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.
TAKEAWAY:
- Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
- Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
- Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
- Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.
IN PRACTICE:
“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.
SOURCE:
The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.
LIMITATIONS:
The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.
DISCLOSURES:
This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.
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.
Which Breast Cancer Patients Can Skip Postop Radiotherapy?
TOPLINE:
Overall, patients with a high POLAR score derived a significant benefit from adjuvant radiotherapy, while those with a low score did not and might consider forgoing radiotherapy.
METHODOLOGY:
- Radiation therapy after breast-conserving surgery has been shown to reduce the risk for locoregional recurrence and is a standard approach to manage early breast cancer. However, certain patients with low locoregional recurrence risks may not necessarily benefit from adjuvant radiation, but there has not been a commercially available molecular test to help identify which patients that might be.
- In the current analysis, researchers assessed whether the POLAR biomarker test could reliably predict locoregional recurrence as well as identify patients who would not benefit from radiotherapy.
- The meta-analysis used data from three randomized trials — Scottish Conservation Trial, SweBCG91-RT, and Princess Margaret RT trial — to validate the POLAR biomarker test in patients with low-risk, HR-positive, HER2-negative, node-negative breast cancer.
- The analysis included 623 patients (ages 50-76), of whom 429 (69%) had high POLAR scores and 194 (31%) had low POLAR scores.
- The primary endpoint was the time to locoregional recurrence, and secondary endpoints included evaluating POLAR as a prognostic factor for locoregional recurrence in patients without radiotherapy and effect of radiotherapy in patients with low and high POLAR scores.
TAKEAWAY:
- Patients with high POLAR scores demonstrated a significant benefit from radiotherapy. The 10-year locoregional recurrence rate was 7% with radiotherapy vs 20% without radiotherapy (hazard ratio [HR], 0.37; P < .001).
- Patients with low POLAR scores, however, did not experience a significant benefit from radiotherapy. In this group, the 10-year locoregional recurrence rates were similar with and without radiotherapy (7% vs 5%, respectively; HR, 0.92; P = .832), indicating that radiotherapy could potentially be omitted for these patients.
- Among patients who did not receive radiotherapy (n = 309), higher POLAR scores predicted a greater risk for recurrence, suggesting the genomic signature has prognostic value. There is no evidence, however, that POLAR predicts radiotherapy benefit or predicts patients’ risk for distant metastases or mortality.
IN PRACTICE:
“This meta-analysis from three randomized controlled trials clearly demonstrates the clinical potential for POLAR to be used in smaller estrogen receptor positive node negative breast cancer patients to identify those women who do not appear to benefit from the use of post-operative adjuvant radiotherapy,” the authors wrote. “ This classifier is an important step towards molecularly-stratified targeting of the use of radiotherapy.”
SOURCE:
The study, led by Per Karlsson, MD, PhD, University of Gothenburg, Sweden, was published online in the Journal of the National Cancer Institute.
LIMITATIONS:
One cohort (SweBCG) had limited use of adjuvant systemic therapy, which could affect generalizability. Additionally, low numbers of patients with low POLAR scores in two trials could affect the observed benefit of radiotherapy.
DISCLOSURES:
This study was supported by the Breast Cancer Institute Fund (Edinburgh and Lothians Health Foundation), Canadian Institutes of Health Research, Exact Sciences Corporation, PFS Genomics, Swedish Cancer Society, and Swedish Research Council. One author reported being an employee and owning stock or stock options or patents with Exact Sciences. Several authors reported having various ties with various sources including Exact Sciences.
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:
Overall, patients with a high POLAR score derived a significant benefit from adjuvant radiotherapy, while those with a low score did not and might consider forgoing radiotherapy.
METHODOLOGY:
- Radiation therapy after breast-conserving surgery has been shown to reduce the risk for locoregional recurrence and is a standard approach to manage early breast cancer. However, certain patients with low locoregional recurrence risks may not necessarily benefit from adjuvant radiation, but there has not been a commercially available molecular test to help identify which patients that might be.
- In the current analysis, researchers assessed whether the POLAR biomarker test could reliably predict locoregional recurrence as well as identify patients who would not benefit from radiotherapy.
- The meta-analysis used data from three randomized trials — Scottish Conservation Trial, SweBCG91-RT, and Princess Margaret RT trial — to validate the POLAR biomarker test in patients with low-risk, HR-positive, HER2-negative, node-negative breast cancer.
- The analysis included 623 patients (ages 50-76), of whom 429 (69%) had high POLAR scores and 194 (31%) had low POLAR scores.
- The primary endpoint was the time to locoregional recurrence, and secondary endpoints included evaluating POLAR as a prognostic factor for locoregional recurrence in patients without radiotherapy and effect of radiotherapy in patients with low and high POLAR scores.
TAKEAWAY:
- Patients with high POLAR scores demonstrated a significant benefit from radiotherapy. The 10-year locoregional recurrence rate was 7% with radiotherapy vs 20% without radiotherapy (hazard ratio [HR], 0.37; P < .001).
- Patients with low POLAR scores, however, did not experience a significant benefit from radiotherapy. In this group, the 10-year locoregional recurrence rates were similar with and without radiotherapy (7% vs 5%, respectively; HR, 0.92; P = .832), indicating that radiotherapy could potentially be omitted for these patients.
- Among patients who did not receive radiotherapy (n = 309), higher POLAR scores predicted a greater risk for recurrence, suggesting the genomic signature has prognostic value. There is no evidence, however, that POLAR predicts radiotherapy benefit or predicts patients’ risk for distant metastases or mortality.
IN PRACTICE:
“This meta-analysis from three randomized controlled trials clearly demonstrates the clinical potential for POLAR to be used in smaller estrogen receptor positive node negative breast cancer patients to identify those women who do not appear to benefit from the use of post-operative adjuvant radiotherapy,” the authors wrote. “ This classifier is an important step towards molecularly-stratified targeting of the use of radiotherapy.”
SOURCE:
The study, led by Per Karlsson, MD, PhD, University of Gothenburg, Sweden, was published online in the Journal of the National Cancer Institute.
LIMITATIONS:
One cohort (SweBCG) had limited use of adjuvant systemic therapy, which could affect generalizability. Additionally, low numbers of patients with low POLAR scores in two trials could affect the observed benefit of radiotherapy.
DISCLOSURES:
This study was supported by the Breast Cancer Institute Fund (Edinburgh and Lothians Health Foundation), Canadian Institutes of Health Research, Exact Sciences Corporation, PFS Genomics, Swedish Cancer Society, and Swedish Research Council. One author reported being an employee and owning stock or stock options or patents with Exact Sciences. Several authors reported having various ties with various sources including Exact Sciences.
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:
Overall, patients with a high POLAR score derived a significant benefit from adjuvant radiotherapy, while those with a low score did not and might consider forgoing radiotherapy.
METHODOLOGY:
- Radiation therapy after breast-conserving surgery has been shown to reduce the risk for locoregional recurrence and is a standard approach to manage early breast cancer. However, certain patients with low locoregional recurrence risks may not necessarily benefit from adjuvant radiation, but there has not been a commercially available molecular test to help identify which patients that might be.
- In the current analysis, researchers assessed whether the POLAR biomarker test could reliably predict locoregional recurrence as well as identify patients who would not benefit from radiotherapy.
- The meta-analysis used data from three randomized trials — Scottish Conservation Trial, SweBCG91-RT, and Princess Margaret RT trial — to validate the POLAR biomarker test in patients with low-risk, HR-positive, HER2-negative, node-negative breast cancer.
- The analysis included 623 patients (ages 50-76), of whom 429 (69%) had high POLAR scores and 194 (31%) had low POLAR scores.
- The primary endpoint was the time to locoregional recurrence, and secondary endpoints included evaluating POLAR as a prognostic factor for locoregional recurrence in patients without radiotherapy and effect of radiotherapy in patients with low and high POLAR scores.
TAKEAWAY:
- Patients with high POLAR scores demonstrated a significant benefit from radiotherapy. The 10-year locoregional recurrence rate was 7% with radiotherapy vs 20% without radiotherapy (hazard ratio [HR], 0.37; P < .001).
- Patients with low POLAR scores, however, did not experience a significant benefit from radiotherapy. In this group, the 10-year locoregional recurrence rates were similar with and without radiotherapy (7% vs 5%, respectively; HR, 0.92; P = .832), indicating that radiotherapy could potentially be omitted for these patients.
- Among patients who did not receive radiotherapy (n = 309), higher POLAR scores predicted a greater risk for recurrence, suggesting the genomic signature has prognostic value. There is no evidence, however, that POLAR predicts radiotherapy benefit or predicts patients’ risk for distant metastases or mortality.
IN PRACTICE:
“This meta-analysis from three randomized controlled trials clearly demonstrates the clinical potential for POLAR to be used in smaller estrogen receptor positive node negative breast cancer patients to identify those women who do not appear to benefit from the use of post-operative adjuvant radiotherapy,” the authors wrote. “ This classifier is an important step towards molecularly-stratified targeting of the use of radiotherapy.”
SOURCE:
The study, led by Per Karlsson, MD, PhD, University of Gothenburg, Sweden, was published online in the Journal of the National Cancer Institute.
LIMITATIONS:
One cohort (SweBCG) had limited use of adjuvant systemic therapy, which could affect generalizability. Additionally, low numbers of patients with low POLAR scores in two trials could affect the observed benefit of radiotherapy.
DISCLOSURES:
This study was supported by the Breast Cancer Institute Fund (Edinburgh and Lothians Health Foundation), Canadian Institutes of Health Research, Exact Sciences Corporation, PFS Genomics, Swedish Cancer Society, and Swedish Research Council. One author reported being an employee and owning stock or stock options or patents with Exact Sciences. Several authors reported having various ties with various sources including Exact Sciences.
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.
Two Brain Stim Methods Better Than One for Depression?
TOPLINE:
a new study showed.
METHODOLOGY:
- Researchers conducted a double-blind, sham-controlled randomized clinical trial from 2021 to 2023 at three hospitals in China with 240 participants with MDD (mean age, 32.5 years; 58% women).
- Participants received active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, or sham tDCS + sham rTMS with treatments administered five times per week for 2 weeks.
- tDCS was administered in 20-minute sessions using a 2-mA direct current stimulator, whereas rTMS involved 1600 pulses of 10-Hz stimulation targeting the left dorsolateral prefrontal cortex. Sham treatments used a pseudostimulation coil and only emitted sound.
- The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HDRS-24) total score from baseline to week 2.
- Secondary outcomes included HDRS-24 total score change at week 4, remission rate (HDRS-24 total score ≤ 9), response rate (≥ 50% reduction in HDRS-24 total score), and adverse events.
TAKEAWAY:
- The active tDCS + active rTMS group demonstrated the greatest reduction in mean HDRS-24 score (18.33 ± 5.39) at week 2 compared with sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS (P < .001).
- Response rates at week 2 were notably higher in the active tDCS + active rTMS group (85%) than in the active tDCS + sham rTMS (30%) and sham tDCS + sham rTMS groups (32%).
- The remission rate at week 4 reached 83% in the active tDCS + active rTMS group, which was significantly higher than the remission rates with the other interventions (P < .001).
- The treatments were well tolerated, with no serious adverse events, seizures, or manic symptoms reported across all intervention groups.
IN PRACTICE:
This trial “was the first to evaluate the safety, feasibility, and efficacy of combining tDCS and rTMS in treating depression. Future studies should focus on investigating the mechanism of this synergistic effect and improving the stimulation parameters to optimize the therapeutic effect,” the investigators wrote.
SOURCE:
This study was led by Dongsheng Zhou, MD, Ningbo Kangning Hospital, Ningbo, China. It was published online in JAMA Network Open.
LIMITATIONS:
The brief treatment duration involving 10 sessions may have been insufficient for tDCS and rTMS to demonstrate their full antidepressant potential. The inability to regulate participants’ antidepressant medications throughout the study period presented another limitation. Additionally, the lack of stratified randomization and adjustment for center effects may have introduced variability in the results.
DISCLOSURES:
This study received support from multiple grants, including from the Natural Science Foundation of Zhejiang Province, Basic Public Welfare Research Project of Zhejiang Province, Ningbo Medical and Health Brand Discipline, Ningbo Clinical Medical Research Centre for Mental Health, Ningbo Top Medical and Health Research Program, and the Zhejiang Medical and Health Science and Technology Plan Project. The authors reported no conflicts of interest.
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:
a new study showed.
METHODOLOGY:
- Researchers conducted a double-blind, sham-controlled randomized clinical trial from 2021 to 2023 at three hospitals in China with 240 participants with MDD (mean age, 32.5 years; 58% women).
- Participants received active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, or sham tDCS + sham rTMS with treatments administered five times per week for 2 weeks.
- tDCS was administered in 20-minute sessions using a 2-mA direct current stimulator, whereas rTMS involved 1600 pulses of 10-Hz stimulation targeting the left dorsolateral prefrontal cortex. Sham treatments used a pseudostimulation coil and only emitted sound.
- The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HDRS-24) total score from baseline to week 2.
- Secondary outcomes included HDRS-24 total score change at week 4, remission rate (HDRS-24 total score ≤ 9), response rate (≥ 50% reduction in HDRS-24 total score), and adverse events.
TAKEAWAY:
- The active tDCS + active rTMS group demonstrated the greatest reduction in mean HDRS-24 score (18.33 ± 5.39) at week 2 compared with sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS (P < .001).
- Response rates at week 2 were notably higher in the active tDCS + active rTMS group (85%) than in the active tDCS + sham rTMS (30%) and sham tDCS + sham rTMS groups (32%).
- The remission rate at week 4 reached 83% in the active tDCS + active rTMS group, which was significantly higher than the remission rates with the other interventions (P < .001).
- The treatments were well tolerated, with no serious adverse events, seizures, or manic symptoms reported across all intervention groups.
IN PRACTICE:
This trial “was the first to evaluate the safety, feasibility, and efficacy of combining tDCS and rTMS in treating depression. Future studies should focus on investigating the mechanism of this synergistic effect and improving the stimulation parameters to optimize the therapeutic effect,” the investigators wrote.
SOURCE:
This study was led by Dongsheng Zhou, MD, Ningbo Kangning Hospital, Ningbo, China. It was published online in JAMA Network Open.
LIMITATIONS:
The brief treatment duration involving 10 sessions may have been insufficient for tDCS and rTMS to demonstrate their full antidepressant potential. The inability to regulate participants’ antidepressant medications throughout the study period presented another limitation. Additionally, the lack of stratified randomization and adjustment for center effects may have introduced variability in the results.
DISCLOSURES:
This study received support from multiple grants, including from the Natural Science Foundation of Zhejiang Province, Basic Public Welfare Research Project of Zhejiang Province, Ningbo Medical and Health Brand Discipline, Ningbo Clinical Medical Research Centre for Mental Health, Ningbo Top Medical and Health Research Program, and the Zhejiang Medical and Health Science and Technology Plan Project. The authors reported no conflicts of interest.
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:
a new study showed.
METHODOLOGY:
- Researchers conducted a double-blind, sham-controlled randomized clinical trial from 2021 to 2023 at three hospitals in China with 240 participants with MDD (mean age, 32.5 years; 58% women).
- Participants received active tDCS + active rTMS, sham tDCS + active rTMS, active tDCS + sham rTMS, or sham tDCS + sham rTMS with treatments administered five times per week for 2 weeks.
- tDCS was administered in 20-minute sessions using a 2-mA direct current stimulator, whereas rTMS involved 1600 pulses of 10-Hz stimulation targeting the left dorsolateral prefrontal cortex. Sham treatments used a pseudostimulation coil and only emitted sound.
- The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HDRS-24) total score from baseline to week 2.
- Secondary outcomes included HDRS-24 total score change at week 4, remission rate (HDRS-24 total score ≤ 9), response rate (≥ 50% reduction in HDRS-24 total score), and adverse events.
TAKEAWAY:
- The active tDCS + active rTMS group demonstrated the greatest reduction in mean HDRS-24 score (18.33 ± 5.39) at week 2 compared with sham tDCS + active rTMS, active tDCS + sham rTMS, and sham tDCS + sham rTMS (P < .001).
- Response rates at week 2 were notably higher in the active tDCS + active rTMS group (85%) than in the active tDCS + sham rTMS (30%) and sham tDCS + sham rTMS groups (32%).
- The remission rate at week 4 reached 83% in the active tDCS + active rTMS group, which was significantly higher than the remission rates with the other interventions (P < .001).
- The treatments were well tolerated, with no serious adverse events, seizures, or manic symptoms reported across all intervention groups.
IN PRACTICE:
This trial “was the first to evaluate the safety, feasibility, and efficacy of combining tDCS and rTMS in treating depression. Future studies should focus on investigating the mechanism of this synergistic effect and improving the stimulation parameters to optimize the therapeutic effect,” the investigators wrote.
SOURCE:
This study was led by Dongsheng Zhou, MD, Ningbo Kangning Hospital, Ningbo, China. It was published online in JAMA Network Open.
LIMITATIONS:
The brief treatment duration involving 10 sessions may have been insufficient for tDCS and rTMS to demonstrate their full antidepressant potential. The inability to regulate participants’ antidepressant medications throughout the study period presented another limitation. Additionally, the lack of stratified randomization and adjustment for center effects may have introduced variability in the results.
DISCLOSURES:
This study received support from multiple grants, including from the Natural Science Foundation of Zhejiang Province, Basic Public Welfare Research Project of Zhejiang Province, Ningbo Medical and Health Brand Discipline, Ningbo Clinical Medical Research Centre for Mental Health, Ningbo Top Medical and Health Research Program, and the Zhejiang Medical and Health Science and Technology Plan Project. The authors reported no conflicts of interest.
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.
Does Radiation Timing Affect QOL After Prostate Surgery?
TOPLINE:
METHODOLOGY:
- Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
- Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
- Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
- Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
- The median follow-up duration was 85.6 months.
TAKEAWAY:
- Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
- Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
- In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
- Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.
IN PRACTICE:
“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”
SOURCE:
The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.
LIMITATIONS:
The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.
DISCLOSURES:
This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
- Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
- Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
- Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
- The median follow-up duration was 85.6 months.
TAKEAWAY:
- Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
- Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
- In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
- Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.
IN PRACTICE:
“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”
SOURCE:
The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.
LIMITATIONS:
The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.
DISCLOSURES:
This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Delaying radiotherapy after prostatectomy can help avoid overtreatment and mitigate genitourinary and erectile toxic effects. However, few studies have compared long-term patient-reported health-related quality-of-life outcomes on the basis of the timing of postprostatectomy radiotherapy.
- Researchers evaluated 1203 men (median age, 60.5 years; 92% were White and 6.8% were Black) with localized prostate cancer who underwent radical prostatectomy from the PROST-QA (2003-2006) and RP2 Consortium (2010-2013). Among these patients, 1082 underwent surgery only, 57 received early radiotherapy (within 12 months of surgery), and 64 underwent late radiotherapy (12 months or more after surgery).
- Patients who received early radiotherapy were more likely to receive androgen deprivation therapy than those who underwent late radiotherapy (40.4% vs 12.5%; P < .001).
- Primary outcome was health-related quality of life measured using the Expanded Prostate Cancer Index Composite at baseline, 2, 6, and 12 months, and annually after that. Health-related quality-of-life measures included sexual function, urinary incontinence, urinary irritation and/or obstruction, and bowel or rectal function.
- The median follow-up duration was 85.6 months.
TAKEAWAY:
- Postprostatectomy radiotherapy was associated with a significantly greater decline in health-related quality of life across all domains, including sexual function and urinary incontinence.
- Patients who received early radiation initially experienced worse urinary incontinence and sexual health, compared with patients in the late group, but the early group also had higher-risk disease and were more likely to receive concurrent androgen deprivation therapy.
- In the long term, the early radiotherapy group experienced more pronounced recovery of sexual function, urinary irritation, and urinary incontinence than the late radiotherapy group.
- Ultimately, patients in the early radiotherapy group had similar, potentially better, long-term health-related quality-of-life domain scores than those in the late group over the long term. For instance, the likelihood of being pad free increased for patients treated early with radiation, while it decreased for those treated late. In patients who received early radiation, the rate of freedom from pad use increased from 39% before radiation to 67% at the sixth follow-up visit after radiation, while it decreased from 73% to 48% in those who received late radiation.
IN PRACTICE:
“Long-term patient-reported sexual, incontinence, and urinary irritative outcomes did not significantly differ between early vs late postprostatectomy [radiotherapy],” the authors said. In fact, “men receiving early [radiation] experienced greater recovery of these toxicity domains and achieved similar, and possibly better, domain scores as those receiving late [radiation] at long-term follow-up.” Overall, “these results may help guide treatment counseling and support consideration of early [radiotherapy] after prostatectomy for men at particularly high risk of recurrence and metastasis.”
SOURCE:
The study, led by Sagar A. Patel, MD, MSc, Emory University in Atlanta, was published online in JAMA Network Open.
LIMITATIONS:
The early and late postprostatectomy radiotherapy groups were relatively small and underpowered to detect statistically significant differences between groups. The study has a nonrandomized design, which may introduce unaccounted for imbalances among the different groups. The study did not directly compare health-related quality of life between patients receiving adjuvant vs salvage radiotherapy.
DISCLOSURES:
This study received funding from National Institutes of Health grants and the Paul Calabresi Career Development Award for Clinical Oncology. Several authors reported receiving personal fees, grants, and having other ties with various sources. Additional disclosures are noted in the original article.
A version of this article appeared on Medscape.com.
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.