Five-Year Patient-Reported Outcomes in NRG Oncology RTOG 0938, Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer.

PURPOSE: There is considerable interest in very short (ultrahypofractionated) radiation therapy regimens to treat prostate cancer based on potential radiobiological advantages, patient convenience, and resource allocation benefits. Our objective is to demonstrate that detectable changes in health-related quality of life measured by the bowel and urinary domains of the Expanded Prostate Cancer Index Composite (EPIC-50) were not substantially worse than baseline scores. METHODS AND MATERIALS: NRG Oncology's RTOG 0938 is a nonblinded randomized phase 2 study of National Comprehensive Cancer Network low-risk prostate cancer in which each arm is compared with a historical control. Patients were randomized to 5 fractions (7.25 Gy in 2 week and a day [twice a week]) or 12 fractions (4.3Gy in 2.5 weeks [5 times a week]). Secondary objectives assessed patient-reported toxicity at 5 years using the EPIC. Chi-square tests were used to assess the proportion of patients with a deterioration from baseline of >5 points for bowel, >2 points for urinary, and >11 points for sexual score. RESULTS: The study enrolled 127 patients to 5 fractions (121 eligible) and 128 patients to 12 fractions (125 eligible). The median follow-up for all patients at the time of analysis was 5.38 years. The 5-year frequency for >5 point change in bowel score were 38.4% (P = .27) and 23.4% (P = 0.98) for 5 and 12 fractions, respectively. The 5-year frequencies for >2 point change in urinary score were 46.6% (P = .15) and 36.4% (P = .70) for 5 and 12 fractions, respectively. For 5 fractions, 49.3% (P = .007) of patients had a drop in 5-year EPIC-50 sexual score of ≥11 points; for 12 fractions, 54% (P < .001) of patients had a drop in 5-year EPIC-50 sexual score of ≥11 points. Disease-free survival at 5 years is 89.6% (95% CI: 84.0-95.2) in the 5-fraction arm and 92.3% (95% CI: 87.4-97.1) in the 12-fraction arm. There was no late grade 4 or 5 treatment-related urinary or bowel toxicity. CONCLUSIONS: This study confirms that, based on long-term changes in bowel and urinary domains and toxicity, the 5- and 12-fraction regimens are well tolerated. These ultrahypofractionated approaches need to be compared with current standard radiation therapy regimens.

Patient Reported Outcomes in NRG Oncology RTOG 0938, Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer.

PURPOSE: There is considerable interest in very short (ultrahypofractionated) radiation therapy regimens to treat prostate cancer based on potential radiobiological advantages, patient convenience, and resource allocation benefits. Our objective is to demonstrate that detectable changes in health-related quality of life measured by the bowel and urinary domains of the Expanded Prostate Cancer Index Composite (EPIC-50) were not substantially worse than baseline scores. METHODS AND MATERIALS: NRG Oncology's RTOG 0938 is a nonblinded randomized phase 2 study of National Comprehensive Cancer Network low-risk prostate cancer in which each arm is compared with a historical control. Patients were randomized to 5 fractions (7.25 Gy in 2 weeks) or 12 fractions (4.3 Gy in 2.5 weeks). The co-primary endpoints were the proportion of patients with a change in EPIC-50 bowel score at 1 year (baseline to 1 year) >5 points and in EPIC-50 urinary score >2 points tested with a 1-sample binomial test. RESULTS: The study enrolled 127 patients to 5 fractions (121 analyzed) and 128 patients to 12 fractions (125 analyzed). Median follow-up for all patients at the time of analysis was 3.8 years. The 1-year frequency for >5 point change in bowel score were 29.8% (P < .001) and 28.4% (P < .001) for 5 and 12 fractions, respectively. The 1-year frequencies for >2 point change in urinary score were 45.7% (P < .001) and 42.2% (P < .001) for 5 and 12 fractions, respectively. For 5 fractions, 32.9% of patients had a drop in 1-year EPIC-50 sexual score of ≥11 points (P = .34); for 12 fractions, 30.9% of patients had a drop in 1-year EPIC-50 sexual score of ≥ 11 points (P = .20). Disease-free survival at 2 years is 99.2% (95% confidence interval: 97.5-100) in the 5-fraction arm and 97.5% (95% confidence interval: 94.6-100) in the 12-fraction arm. There was no late grade 4 or 5 treatment-related urinary or bowel toxicity. CONCLUSIONS: This study confirms that, based on changes in bowel and urinary domains and toxicity (acute and late), the 5- and 12-fraction regimens are well tolerated. These ultrahypofractionated approaches need to be compared with current standard radiation therapy regimens.

Spirituality and Quality of Life in Black Patients With Cancer Pain.

PURPOSE: The objective of this study was to examine the associations between spirituality and overall quality of life (QOL) and individual QOL domains in black patients with cancer pain. METHODS: A secondary data analysis of a parent study exploring pain medication adherence in black patients receiving around-the-clock opioids with cancer pain was performed. All the participating patients completed Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (spirituality), Brief Pain Inventory (pain severity and interference), Edmonton Symptom Assessment Scale (symptoms), and Functional Assessment of Cancer Therapy-General (QOL). Pearson correlation and multiple linear regression analyses were conducted to examine the associations between spirituality and overall QOL and QOL domains and to identify the predictors of overall QOL and QOL domains. RESULTS: Black patients treated for cancer pain (n = 102) completed the study. Pearson correlation showed significant positive associations between spirituality and overall QOL (P < 0.001) and individual QOL domains (physical, social, emotional, and functional). Higher spirituality was associated with lower pain severity (P = 0.01), pain interference (P = 0.001), and total symptoms score (P < 0.001). In multiple regression analysis, the best model for the overall QOL explained 67% of the variance (P < 0.001) and included total symptoms score, pain interference, spirituality, and age. Spirituality significantly predicted QOL domains of social (P < 0.0001), emotional (P = 0.002), and functional well-being (P = 0.001) rather than physical well-being. CONCLUSIONS: Spirituality is associated with decreased pain and lower symptom burden and may serve as a protective factor against diminished overall QOL, specifically social, emotional, and functional domains in black patients with cancer pain. There is a need to develop spirituality-based interventions along with symptom management interventions to improve QOL for this population.

Feasibility trial of electroacupuncture for aromatase inhibitor--related arthralgia in breast cancer survivors.

BACKGROUND: Arthralgia affects postmenopausal women receiving aromatase inhibitors (AIs) for breast cancer. Given the existing evidence for electroacupuncture (EA) for treatment of osteoarthritis in the general population, this study aims to establish the feasibility of studying EA for treating AI-related arthralgia. PATIENTS AND METHODS: Postmenopausal women with stage I-III breast cancer who reported AI-related arthralgia were enrolled in a single-arm feasibility trial. EA was provided twice a week for 2 weeks followed by 6 weekly treatments. The protocol was based on Chinese medicine diagnosis of "Bi" syndrome with electrostimulation of needles around the painful joint(s). Pain severity of the modified Brief Pain Inventory was used as the primary outcome. Joint stiffness, joint interference, and Patient Global Impression of Change (PGIC) were secondary outcomes. Paired t tests were used for analysis. RESULTS: Twelve women were enrolled and all provided data for analysis. From baseline to the end of intervention, patients reported reduction in pain severity (from 5.3 to 1.9), stiffness (from 6.9 to 2.4), and joint symptom interference (from 4.7 to 0.8), all P < .001; 11/12 considered joint symptoms "very much better" based on the PGIC. Subjects also reported significant decrease in fatigue (from 4.4 to 1.9, P = .005) and anxiety (from 7.1 to 4.8, P = .01). No infection or development or worsening of lymphedema was observed. CONCLUSION: Preliminary data establish the feasibility of recruitment and acceptance as well as promising preliminary safety and effectiveness. A randomized controlled trial is warranted to establish the efficacy of EA for AI-related arthralgia in breast cancer survivors.

Prevalence and correlates of vitamin D status in African American men.

BACKGROUND: Few studies have examined vitamin D insufficiency in African American men although they are at very high risk. We examined the prevalence and correlates of vitamin D insufficiency among African American men in Philadelphia. METHODS: Participants in this cross-sectional analysis were 194 African American men in the Philadelphia region who were enrolled in a risk assessment program for prostate cancer from 10/96-10/07. All participants completed diet and health history questionnaires and provided plasma samples, which were assessed for 25-hydroxyvitamin D (25(OH)D) concentrations. We used linear regression models to examine associations with 25(OH)D concentrations and logistic regression to estimate odds ratios (OR) for having 25(OH)D >or= 15 ng/mL. RESULTS: Mean 25(OH)D was 13.7 ng/mL, and 61% of men were classified as having vitamin D insufficiency (25(OH)D <15 ng/mL). Even among men with vitamin D intake >or= 400 IU/day, 55% had 25(OH)D concentrations <15 ng/mL. In multivariate models, 25(OH)D concentrations were significantly associated with supplemental vitamin D intake (OR 4.3, 95% confidence interval (CI) 1.5, 12.4) for >400 vs. 0 IU/day), milk consumption (OR 5.9, 95% CI 2.2, 16.0 for >or= 3.5 vs. <1 time per week), and blood collection in the summer. Additionally, 25(OH)D concentrations increased with more recreational physical activity (OR 1.3, 95% CI 1.1, 1.6 per hour). A significant inverse association of body mass index with 25(OH)D concentrations in bivariate analyses was attenuated with adjustment for season of blood collection. CONCLUSION: The problem of low vitamin D status in African American men may be more severe than previously reported. Future efforts to increase vitamin D recommendations and intake, such as through supplementation, are warranted to improve vitamin D status in this particularly vulnerable population.