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

• Type of Material: Article
• Authors: Himanshu R. Lukka, Juravinski Cancer Centre at Hamilton Health Sciences; Stephanie L.. Pugh, NRGOncologyStat & Data Management Ctr; Deborah Bruner, Emory University; Jean-Paul Bahary, Centre Hospitalier de l’Université de Montréal; Colleen A.F. Lawton, Froedtert; Jason A. Efstathiou, Massachusetts General Hospital; Rajat J. Kudchadker, University of Texas MD Anderson Cancer Center; Lee E. Ponsky, Case Western Reserve University; Samantha A. Seaward, Kaiser Permanente Northern California; Ian S. Dayes, Juravinski Cancer Centre at Hamilton Health Sciences; Darindra D. Gopaul, Grand River Hospital; Jeff M. Michalski, Washington University; Guila Delouya, Centre Hospitalier de l’Université de Montréal; Irving D. Kaplan, Dana Farber Cancer Institute; Eric M. Horwitz, Fox Chase Cancer Center; Mack Roach, University of California San Francisco; Wayne H. Pinover, Abington Memorial Hospital; David C. Beyer, Arizona Oncology Services Foundation; John O. Amanie, Cross Cancer Institute; Howard M. Sandler, Cedars Sinai Medical Center; Lisa A. Kachnic, Vanderbilt University
• Language: English
• Date: 2018-10-01
• Publisher: Elsevier Science Inc.
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2018 Elsevier Inc.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.ijrobp.2018.06.008
• Title of Journal or Parent Work: International Journal of Radiation Oncology Biology Physiology
• Volume: 102
• Issue: 2
• Start Page: 287
• End Page: 295
• Grant/Funding Information: This project was supported by the National Cancer Institute, grant nos. UG1CA189867 (National Cancer Institute Community Oncology Research Program), U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology Statistics and Data Management Center), and U24CA180803 (Imaging and Radiation Oncology Core).
• Keywords: ALPHA/BETA-RATIO; BRACHYTHERAPY; Science & Technology; Oncology; Radiology, Nuclear Medicine & Medical Imaging; Life Sciences & Biomedicine; STEREOTACTIC BODY RADIOTHERAPY; TRIAL; FRACTIONATION; SBRT; RADIATION-THERAPY; PHASE I/II; QUALITY-OF-LIFE
• Research Categories: Health Sciences, Oncology

Abstract

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.