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

Abstract

Purpose NRG Oncology/RTOG 1203 was designed to compare patient-reported acute toxicity and health-related 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.

Trial registration: ClinicalTrials.gov NCT01672892.

Fig 1.

CONSORT diagram. The number of participants in the primary end point analysis equals the number of participants assigned to the treatment group minus ineligible patients and the number excluded from the analysis. IMRT, intensity-modulated radiation therapy.

Fig 2.

Expanded Prostate Cancer Index Composite (EPIC) assessment of toxicity. Changes in EPIC (A) bowel, and (B) urinary summary scores between baseline and week 3 of radiation therapy (RT), week 5 of RT, and 4 to 6 weeks after completion of RT. Higher scores reflect better function so that greater declines are seen in patients with increased burden of symptoms. Error bars represent 95% CIs. (*) Statistically significant difference. IMRT, intensity-modulated radiation therapy.

Fig 3.

Patient-Reported Outcomes–Common Terminology Criteria for Adverse Events scores after 5 weeks of radiation treatment. High toxicity scores were considered as selection of level 4 or 5 responses with each question on a 5-point scale. These level 5 and 5 responses for each question were the following: [1] frequently or almost constantly; [2] quite a bit or very much; [3] severe or very severe. (*) Statistically significant difference. IMRT, intensity-modulated radiation therapy; RT, radiation therapy.