NRG Oncology/RTOG 0415, Phase 3 Noninferiority Study Comparing 2 Fractionation Schedules in Patients With Low-Risk Prostate Cancer: Prostate-Specific Quality of Life Results International Journal of Radiation Oncology, Biology, Physics ORAL SCIENTIFIC SESSION| VOLUME 96, ISSUE 2, SUPPLEMENT , S2-S3, OCTOBER 01, 2016
Date
10/01/2016Abstract
Purpose/Objective(s)
To assess differences in health related quality of life (HRQOL) between hypofractionated (H) and conventional (C) schedule radiation therapy (RT) in men with low-risk prostate cancer.
Materials/Methods
Eligibility included: stage T1-2a, Gleason ≤6, PSA <10, randomized to a C schedule (3D/IMRT 73.8 Gy in 41 fractions [fx] over 8.2 wks) or an H schedule (3D/IMRT 70 Gy in 28 fxs over 5.6 wks). HRQOL was assessed with the Expanded Prostate Index Composite (EPIC) at baseline, 6, and 12 mos. EPIC assesses prostate cancer-specific HRQOL on a Likert scale with responses transformed to 0-100 (higher scores indicating better HRQOL; 0.5 SD change indicating clinical significance). EPIC has 4 domains: bowel, urinary, sexual, and hormonal. Each domain requires at least 80% of items to be completed. Change scores, calculated as follow-up – baseline, at 6 and 12 mos were compared between arms. Wilcoxon test was used to assess differences. A significance level of 0.0125 to adjust for multiple comparisons with respect to the 4 domain scores was used for an overall two-sided type I error of 0.05.
Results
Of 1092 pts analyzable for the primary endpoint, 962 consented to HRQOL (478 on 73.8 Gy arm; 448 on 70 Gy arm). Baseline characteristics were similar between treatment arms. Median age = 67 yrs; HRQOL compliance was 89.4% at baseline, 72.7% at 6 mos, and 65.9% at 1 yr. Compared to men without cancer1, most pts reported poor baseline EPIC sexual domain scores in both H and C arms, median 44.2 and 47.5, and only slightly lower than average bowel and urinary scores. No statistically significant differences with regard to any of the HRQOL baseline domains were measured between treatment arms. There were no differences in change score between arms of any domain scores at 6 mos. At 12 mos, those on the 70 Gy arm experienced a larger decline as compared to those on the 73.8 Gy arm in the bowel domain (median, 12 mo., scores 91.1 vs 94.6; median change scores from baseline -3.6 vs. -1.8, respectively, P = 0.0037), but not clinically significant.
Conclusion
Compared to a study of EPIC norms1 in men without cancer, baseline scores for bowel and urinary domains were about 5-6 points lower and sexual function was 15 points lower than norms. Men receiving either H or C fractionation schedules demonstrated 12 mo. bowel, urinary, and better sexual HRQOL comparable to the recent large European H study.2 EPIC scores exhibited only a small magnitude of decline at 1 yr follow-up from baseline. As compared with C fx, pts treated with H demonstrated a small statistically, but not clinically significant, larger decline in bowel HRQOL at 1 yr, thus late toxicity is comparable between arms, supporting value based care with H.
Author List
D. Watkins Bruner S.L. Pugh W.R. Lee J.J. Dignam D. Low G.P. Swanson A.B. Shah D.P. D'Souza J.M. Michalski I.S. Dayes S.A. Seaward P.L. Nguyen W.A. Hall T.M. Pisansky Y. Chen H.M. Sandler B. MovsasAuthor
William Adrian Hall MD Chair, Professor in the Radiation Oncology department at Medical College of WisconsinView Online
