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.
Bibliographical noteFunding Information:
The human investigations were performed after approval by a local Human Investigations Committee and in accordance with an assurance filed with and approved by the Department of Health and Human Services. Supported by National Cancer Institute Grants No. U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology Statistics and Data Management Center), and UG1CA189867 (National Cancer Institute Community Oncology Research Program).
© 2018 American Society of Clinical Oncology. All rights reserved.
All Science Journal Classification (ASJC) codes
- Cancer Research