Conditional Risk and Predictive Factors Associated With Late Toxicity in Patients With Prostate Cancer Treated With External Beam Radiation Therapy Alone in the Randomized Trial RTOG 0126.

PURPOSE: The objective of this study was to characterize the conditional risk of developing grade 2+ urinary or gastrointestinal (GI) toxicity for patients treated with external beam radiation therapy in Radiation Therapy Oncology Group 0126. A secondary objective was to analyze baseline patient and treatment characteristics and determine their relevance in predicting toxicity both at the time of trial enrollment and at later points of follow-up. METHODS AND MATERIALS: One thousand five hundred thirty-two patients with localized prostate cancer were enrolled between March 2002 and August 2008, of whom 1499 were eligible and included in data analysis with a median follow-up of 8.4 years (range, 0.02-13 years). Patients were treated with either 3-dimensional conformal radiation therapy or intensity-modulated radiation therapy according to institutional practice without the addition of androgen deprivation and randomized to receive either standard-dose radiation therapy of 70.2 Gy or dose-escalated radiation therapy of 79.2 Gy of radiation therapy to the prostate only with standard fractionation. Univariate and multivariate analyses were performed to determine whether initial factors were predictive of late toxicity at the time of treatment and at later time points. RESULTS: As patients proceed further from completion of radiation therapy without the development of toxicity, the subsequent risk of both grade 2+ genitourinary (GU) and GI toxicity decreases with time. At the time of enrollment, the risk of developing grade 2+ toxicity over the next 5 years was 9.57% and 17.89%, respectively. After 5 years of toxicity-free survival, the risk of developing grade 2+ GU or GI toxicity in the subsequent 5 years was 3.02% and 1.54%, respectively. Baseline treatment and patient-related factors predicted late toxicity both at trial enrollment and after 2 years of toxicity-free survivorship. Baseline urinary dysfunction and dose-escalated radiation therapy were associated with increased late GU toxicity. Acute GI toxicity and dose-escalated radiation therapy were associated with increased risk of late GI toxicity. Treatment with intensity-modulated radiation therapy was associated with reduced risk of either toxicity. CONCLUSIONS: The conditional risk of grade 2+ toxicities decreases as patients proceed further from treatment, with most toxicities occurring in the first few years after treatment completion. Baseline patient and treatment characteristics remain relevant at both enrollment and later time points.

Conditional Risks of Biochemical Failure and Prostate Cancer-Specific Death in Patients Undergoing External Beam Radiotherapy: A Secondary Analysis of 2 Randomized Clinical Trials.

Importance: As patients achieve years of survival after treatment for prostate cancer, the risk of biochemical failure (BF) or prostate cancer-specific death (PCSD) may evolve over time, with clinical relevance to both patients and clinicians. Objective: To determine conditional BF-free survival, PSCD, and overall survival estimates for patients with low- or intermediate-risk prostate cancer enrolled in the Radiation Therapy Oncology Group (RTOG) 0126 and RTOG 0415 clinical trials. A secondary objective was to determine whether prognostic factors at diagnosis remain relevant at later points in follow-up. Design, Setting, and Participants: A pooled secondary analysis of patients treated with external-beam radiotherapy alone and enrolled in the prospective randomized clinical trials RTOG 0126 and RTOG 0415 was performed. Patients included for analysis were enrolled between March 2002 and December 2009 with a median follow-up of 6.9 years. Overall survival was calculated using the Kaplan-Meier method at various survivorship time points. Cumulative incidence was used to calculate BF rates using the Phoenix definition, as well as PCSD. Risk factors such as Gleason score, tumor (T) stage, prostate-specific antigen level, and the equivalent dose in 2 Gy fractions of prescribed dose were analyzed at different time points using multivariable Cox proportional hazards modeling. Data were analyzed from November 2021 to February 2023. Main Outcomes and Measures: Conditional risks of BF and PCSD after completion of external-beam radiotherapy. Results: A total of 2591 patients (median [IQR] age, 69 [63-73] years) were included in the study with a mean (range) PSA level of 7.1 (4.7-8.9) ng/mL, 1334 patients (51.5%) with a Gleason score 6 disease, and 1706 patients (65.8%) with T1 disease. Rates of BF from time of treatment were 1.63% (95% CI, 1.20%-2.18%) at 1 year, 7.04% (95% CI, 6.09%-8.08%) at 3 years, 12.54% (95% CI, 11.28%-13.88%) at 5 years, and 22.32% (95% CI, 20.46%-24.24%) at 8 years. For patients surviving 1, 3, and 5 years without BF, the rates of BF in the next 5 years were 14.20% (95% CI, 12.80%-15.66%), 17.19% (95% CI, 15.34%-19.14%), and 18.85% (95% CI, 16.21%-21.64%), respectively. At the initial time point, the rate of PCSD in the next 5 years was 0.66% (95% CI, 0.39%-1.04%). For patients who achieved 1, 3, 5, and 8 years of survivorship, the rates of PCSD in the next 5 years were 1.16% (95% CI, 0.77-1.67) at 1 year, 2.42% (95% CI, 1.74%-3.27%) at 3 years, 2.88% (95% CI, 2.01%-3.99%) at 5 years, and 3.49% (95% CI, 0.98%-8.73%) at 8 years. Conclusions and Relevance: In this secondary analysis of 2 randomized clinical trials of patients undergoing external beam radiotherapy for prostate cancer, the conditional risks of BF and death from prostate cancer increased with time for patients with low- and intermediate-risk prostate cancer treated with radiotherapy alone. These results could inform optimal trial design and may be helpful information for patients evaluated in follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT00033631; NCT00331773.

Photobiomodulation During Chemoradiation for Head and Neck Cancer: Effect on Mucositis, Weight Loss, and Feeding Tube Dependence.

Purpose: The standard therapeutic approach in head and neck cancer (HNC) involves multimodality therapy, including surgery, radiation therapy (RT), or chemoradiation therapy (CRT). Treatment complications (mucositis, weight loss, and feeding tube dependence [FTD]) can result in treatment delays, incomplete treatment, and decreased quality of life. Studies on photobiomodulation (PBM) have shown promising reductions in mucositis severity but with little quantitative supporting data. We compared complications for patients with HNC receiving PBM with those in patients who did not, hypothesizing that PBM improves mucositis severity, weight loss, and FTD. Methods and Materials: Medical records of 44 patients with HNC treated with CRT or RT from 2015 to 2021 were reviewed (22 PBM, 22 controls; median age, 63.5 years; range, 45-83 years). Between-group outcomes of interest included maximum mucositis grade, weight loss, and FTD 100 days after initiation of treatment. Results: Median RT doses were 60 Gy (PBM) and 66 Gy (control). Eleven patients treated with PBM received CRT; 11 received RT alone (median of 22 PBM sessions [range, 6-32]). Sixteen control group patients received CRT; 6 received RT alone. Median maximal mucositis grades were 1 in the PBM group and 3 in the control group (P < .0001). The adjusted odds of higher mucositis grade were only 0.024% (P < .0001; 95% confidence interval, 0.004-0.135) in PBM compared with the control group. Conclusions: PBM may have a role in decreasing complications related to RT and CRT for HNC, mainly mucositis severity.

Compassion Inequities and Opioid Use Disorder: A Matched Case-Control Analysis Examining Inpatient Management of Cancer-Related Pain for Patients With Opioid Use Disorder.

CONTEXT: The opioid epidemic spurred guidelines intended to reduce inappropriate prescribing. Although acute cancer-related pain was excluded from these recommendations, studies demonstrate reduced opioid prescribing for patients hospitalized with advanced cancer. OBJECTIVES: We performed a matched case-control analysis to determine how a history of opioid use disorder (OUD) affects inpatient management of cancer pain. METHODS: Charts of patients with OUD admitted for cancer pain from 2015-2020 were retrospectively reviewed. Hospitalizations were matched 1:1 by patient age and sex. Home milligram-morphine equivalent per day (MME/day) was calculated from the home medication list. Admission MME/day was the average MME/day administered during hospitalization. RESULTS: A total of 80 hospitalizations (40:40) were matched for 25 patients with a history of OUD and 31 patients with no history of OUD. Cancer was metastatic/relapsed for 70% of admissions. The median overall survival was 2.3 months (95% CI 0-5.21, P = 0.13). Patients with OUD had a significantly lower change from Home to Admission MME/day (-3 vs. 37, P < 0.01) and were less likely to have any increase in Admission MME/day (OR 0.1, 95% CI 0.02-0.43, P < 0.01). When considering opioids administered after pain specialty consultation, there was no difference between groups. CONCLUSION: Our results suggest that patients with OUD receive lower quality inpatient management of cancer-related pain. Provider education and early involvement of pain specialists are crucial in delivering equitable and compassionate end-of-life care for patients with OUD.

Radiographic and Tumor Biomarker Response to Radiotherapy for Recurrent Granulosa Cell Tumor of the Ovary.

Granulosa cell tumors (GCTs) of the ovary are rare, comprising less than 5% of all malignant ovarian neoplasms. While generally considered indolent, GCTs have a tendency for metastasis and delayed relapse, with recurrence developing in 20%-50%. Recurrent or metastatic disease is associated with aggressive behavior and a poor prognosis, as nearly 70% of patients developing recurrence will eventually succumb to their disease. The optimal management of relapsed disease is controversial. Initial salvage therapy typically involves surgical debulking followed by cisplatin-based chemotherapy. Unfortunately, tumor responses are durable for less than half of patients treated with this regimen. Radiation therapy is an attractive option for providing rapid palliation and improving local control without the morbidity of additional surgery or chemotherapy. Here we describe a case of multiply recurrent, rapidly growing intraperitoneal GCT refractory to repeated surgical debulking and several lines of systemic therapy. The patient was treated with two courses of palliative radiotherapy and achieved rapid symptomatic relief, achieving over a 90% reduction in tumor volume. Serum concentration of inhibin B, often inappropriately elevated in patients with GCT, decreased by 98% following irradiation with no interim systemic therapy. At one-year follow-up, the patient has no evidence of radiographic or biochemical recurrence.