Patient-Reported Outcomes in the Acute Phase of the Randomized Hypofractionated Irradiation for Prostate Cancer (HYPRO) Trial

Purpose: Many patients experience bowel and bladder toxicity during the acute phase of radiation therapy for prostate cancer. Recent literature indicates that hypofractionation (HF) might increase this acute response but little is known on patient-reported outcome during this phase with HF. We evaluated the course of patient-reported acute symptoms during HF versus standard fractionated (SF) radiation therapy within the hypofractionated irradiation for prostate cancer (HYPRO) trial. Methods and Materials: In the HYPRO trial patients were treated with either 64.4 Gy (HF) in 19 fractions (3 times per week) or 78 Gy (SF) in 39 fractions (5 times per week). Normalized total dose for 2 Gy/fractions (NTD2Gy)for acute toxicity (alpha/beta ratio of 10) for HF was 72.1 Gy with a similar dose rate of 10.2 Gy per week. Among the 794 patients who were previously eligible for acute grade >= 2 toxicity assessment, 717 had filled out >= 1 symptom questionnaires. For each maximum symptom, we scored any complaint and moderate-severe complaint. Differences were tested by chi(2) test, and associations with clinical factors were tested using logistic regression. Significance was set at P <=.008 to adjust for multiple testing. Results: We observed significantly higher rates of moderate-severe painful defecation (HF 10.8%, SF 5.3%), any mucus discharge (HF 47.1%, SF 37.4%), any rectal blood loss (HF 16.1%, SF 9.3%), increased daily stool frequency >= 4 and >= 6 (HF 34.6%/13.8%, SF 25.6%/7.0%), and any urinary straining (HF 69.9%, SF 58.0%). At 3 months postradiation therapy, rates dropped considerably with similar levels for HF and SF. Hormonal treatment was associated with less acute gastrointestinal symptoms. Conclusion: The increased patient-reported acute rectal symptoms with HF confirmed the previously reported results on acute grade >= 2 rectal toxicity. The increase in bladder symptoms with HF was not identified previously. These observations contradict the NTD2Gy calculations. We observed no patterns of persisting complaints with HF after the acute period; therefore, HF is well tolerated and only associated with a temporary increase of symptoms. (C) 2021 Elsevier Inc. All rights reserved.

Automated summary

This study evaluated patient-reported acute symptoms during hypofractionation (HF) versus standard fractionated (SF) radiation therapy for prostate cancer. The results showed that patients experienced more severe rectal symptoms and an increase in bladder symptoms during HF compared to SF. However, the symptoms decreased significantly after the acute phase, indicating that HF was well tolerated.