Patient-Reported Toxicity During Pelvic Intensity-Modulated Radiation Therapy: NRG Oncology-RTOG 1203

• Authors: Ann H. Klopp, MD Anderson Cancer Center; Anamaria R. Yeung, University of Florida; Snehal Deshmukh, NRG Oncology Statistics and Data Management Center; Karen M. Gil, Summa Health System; Lari Wenzel, University of California, Irvine; Shannon N. Westin, MD Anderson Cancer Center; Kent Gifford, MD Anderson Cancer Center; David K. Gaffney, University of Utah; William Small, Emory University; Spencer Thompson, University of Oklahoma; Desiree E. Doncals, Summa Akron City Hospital; Guilherme H. C. Cantuaria, Northside Hospital; Brian P. Yaremko, London Regional Cancer Program; Amy Chang, Pamela Youde Nethersole Eastern Hospital; Vijayananda Kundapur, Saskatoon Cancer Centre; Dasarahally S. Mohan, Kaiser Permanente Cancer Treatment Center; Michael L. Haas, Reading Hospital; Yong Bae Kim, Yonsei University Health System; Catherine L. Ferguson, Georgia Regents University; Stephanie L. Pugh, NRG Oncology Statistics and Data Management Centertr; Lisa A. Kachnic, Vanderbilt University; Deborah W. Bruner, Emory University
• Journal Title: Journal of Clinical Oncology
• Volume: Volume 36, Number 24
• Publisher: American Society of Clinical Oncology | 2018-08-20, Pages 2538-+
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1200/JCO.2017.77.4273
• Subjects: Health Sciences, Oncology; Physics, Radiation; Health Sciences, Epidemiology
• Keywords: Science & Technology; Life Sciences & Biomedicine; Oncology; QUALITY-OF-LIFE; 3-DIMENSIONAL CONFORMAL RADIOTHERAPY; RANDOMIZED CONTROLLED-TRIAL; PROSTATE-CANCER; CLINICAL-TRIALS; PORTEC-2 TRIAL; CARCINOMA; CERVIX; VALIDATION; OUTCOMES

Abstract

Purpose: NRG Oncology/RTOG 1203 was designed to compare patient-reported acute toxicity and healthrelated quality of life during treatment with standard pelvic radiation or intensity-modulated radiation therapy (IMRT) in women with cervical and endometrial cancer. Methods: Patients were randomly assigned to standard four-field radiation therapy (RT) or IMRT radiation treatment. The primary end point was change in patient-reported acute GI toxicity from baseline to the end of RT, measured with the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC). Secondary end points included change in patient-reported urinary toxicity, change in GI toxicity measured with the Patient-Reported Outcome Common Terminology Criteria for Adverse Events, and quality of life measured with the Trial Outcome Index. Results: From 2012 to 2015, 289 patients were enrolled, of whom 278 were eligible. Between baseline and end of RT, the mean EPIC bowel score declined 23.6 points in the standard RT group and 18.6 points in the IMRT group (P = .048), the mean EPIC urinary score declined 10.4 points in the standard RT group and 5.6 points in the IMRT group (P = .03), and the mean Trial Outcome Index score declined 12.8 points in the standard RT group and 8.8 points in the IMRT group (P = .06). At the end of RT, 51.9% of women who received standard RT and 33.7% who received IMRT reported frequent or almost constant diarrhea (P = .01), and more patients who received standard RT were taking antidiarrheal medications four or more times daily (20.4% v 7.8%; P = .04). Conclusion: Pelvic IMRT was associated with significantly less GI and urinary toxicity than standard RT from the patient's perspective.