5-year patient-reported outcomes of bowel and urinary bother in the CHHiP trial (CRUK/06/016)


Background: Hypofractionated radiotherapy (hRT) has been shown to be non-inferior to conventional fractionation (cRT) in the CHHiP trial. Clinician reported toxicity was low across all fractionation schedules at 5 years (y), as were patient reported outcomes (PRO) to 2y. Here we aim to confirm these findings with PRO data at 5y. Methods: The CHHiP trial randomised patients (pts) in a 1:1:1 ratio to cRT: 74Gy/37 fractions (f) or hRT: 60Gy/20f or 57Gy/19f. Overall bowel bother (BB) and urinary bother (UB) were assessed as single items of the UCLA-PCI and EPIC-50 instruments. PRO were completed before hormone therapy and RT (pRT). Late symptoms were assessed 6 monthly from 6-24 months and yearly to 5y. Differences in the distribution of scores were assessed using a chi2 trend test. Odds of an increase in bother were modelled using ordered logistic regression. Kaplan-Meier methods were used to estimate time to “small” or worse bother, with RT schedules compared using the log-rank test. Results: Between Oct, 2002 and Nov, 2009 2100 pts were recruited into the PRO sub-study (696 74Gy, 698 60Gy and 706 57Gy). Return rates at 5y were 355 (51%), 388 (56%) and 402 (57%) for the 74, 60 and 57Gy schedules respectively. Cross-sectional analyses at 5y showed no difference between groups (Table 1). The odds of an increase in BB from pRT to 5y for hRT compared to cRT were (Odds Ratio (OR) (99% CI), p-value): 60Gy: 0.78 (0.52-1.18), 0.12; 57Gy: 0.75 (0.50-1.12), 0.06, and for UB were: 60Gy: 1.00 (0.67-1.50), 1.00; 57Gy: 1.08 (0.72-1.61), 0.62. Time to first late “small” or worse BB was also similar across groups (Hazard ratio (HR) (99% CI), p-value): 60Gy: 1.08 (0.85-1.37), 0.42; 57Gy: 0.92 (0.71-1.18), 0.36 or UB: 60Gy: 0.93 (0.73-1.20), 0.48; 57Gy: 0.91 (0.71, 1.17), 0.34. Conclusions: After 5 years follow-up, cRT and hRT showed a similar low level of patient reported BB and UB. Clinical trial information: ISRCTN97182923.

Journal of Clinical Oncology 2017; 35(Suppl 6):23