Four-Year Outcomes From a Prospective Phase II Clinical Trial of Moderately Hypofractionated Proton Therapy for Localized Prostate CancerGrewal, A. S., Schonewolf, C., Min, E. J., Chao, H-H., Both, S., Lam, S., Mazzoni, S., Bekelman, J., Christodouleas, J. & Vapiwala, N., 15-Nov-2019, In : International Journal of Radiation Oncology Biology Physics. 105, 4, p. 713-722 10 p.
Research output: Contribution to journal › Article › Academic › peer-review
Purpose: Moderately hypofractionated radiation therapy represents an effective treatment for localized prostate cancer (PC). Although large randomized trials have reported the efficacy of photon-based hypofractionated therapy, hypofractionated proton therapy (HFPT) has not been extensively studied. This study was performed to determine the clinical and patient-reported outcomes for patients with PC treated with HFPT.
Methods and Materials: Between 2010 and 2017, 184 men were enrolled on a trial of 70 Gy in 28 fractions of HFPT for low- to intermediate-risk PC. Acute and late toxicity was evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Patient-reported outcomes were measured by International Prostate Symptom Score, International Index of Erectile Function Questionnaire, and Expanded Prostate Cancer Index Composite scores.
Results: Median follow-up was 49.2 months. Enrolled patients had low-risk (n = 18), favorable intermediate-risk (n = 78), and unfavorable intermediate-risk (n = 88) PC. Four-year rates of biochemical-clinical failure-free survival were 93.5% (95% confidence interval, 89%-98%), 94.4% (89%-100%), 92.5% (86%-100%), and 93.8% (88%-100%) in the overall group and the low-risk, favorable intermediate-risk, and unfavorable intermediate-risk cohorts, respectively (log-rank P > .4). The incidence of acute grade 2 or higher gastrointestinal (GI) and urologic toxicities were 3.8% and 12.5%, respectively. The 4-year incidence of late grade 2 or higher urologic and GI toxicity was 7.6% (4%-13%) and 13.6% (9%-20%), respectively. One late grade 3 GI toxicity was reported. All late toxicities were transient. Patient-reported International Prostate Symptom, International Index of Erectile Function, and Expanded Prostate Cancer Index Composite scores had no significant long-term changes after completion of HFPT (Supplementary Table 1, available at https://doi.org/10.1016/j.ijrobp.2019.05.069).
Conclusions: HFPT is associated with low rates of toxicity and does not appear to negatively affect 4-year patient reported urinary and bowel health. Further comparative analyses are warranted to better understand differences between proton and photon HFRT. (C) 2019 Elsevier Inc. All rights reserved.
|Number of pages||10|
|Journal||International Journal of Radiation Oncology Biology Physics|
|Publication status||Published - 15-Nov-2019|
- INTENSITY-MODULATED RADIOTHERAPY, PATIENT-REPORTED OUTCOMES, RADIATION-THERAPY, SERUM TESTOSTERONE, BEAM RADIOTHERAPY, RANDOMIZED-TRIAL, 5-YEAR OUTCOMES, TOXICITY, FRACTIONATION, ASSOCIATION