Nonrandomised Comparison of Efficacy and Side Effects of Bicalutamide Compared With Luteinizing Hormone-Releasing Hormone (LHRH) Analogs in Combination With Radiation Therapy in the CHHiP Trial - PDF Version
Alison Tree, Clare Griffin, Isabel Syndikus, Alison Birtle, Ananya Choudhury, John Graham, Catherine Ferguson, Vincent Khoo, Zafar Malik, Joe O'Sullivan, Miguel Panades, Chris Parker, Yvonne Rimmer, Christopher Scrase, John Staffurth, David Dearnaley, Emma Hall, CHHiP investigators
Int J Radiat Oncol Biol Phys. 2022 Jan 10;S0360-3016(21)03433-7.
CHHiP is a randomised trial evaluating moderately hypofractionated radiation therapy for treatment of localised prostate cancer. Of all participants, 97% of them had concurrent short-course hormone therapy (HT), either luteinising hormone-releasing hormone analog (LHRHa) or 150 mg of bicalutamide daily. This exploratory analysis compares efficacy and side effects in a nonrandomised comparison.
METHODS AND MATERIALS
In our study, 2700 patients received LHRHa and 403 received bicalutamide. The primary endpoint was biochemical/clinical failure. Groups were compared with Cox regression adjusted for various prognostic factors and stratified by radiation therapy dose. A key secondary endpoint was erectile dysfunction (ED) assessed by clinicians (using scores from Late Effects on Normal Tissues: Subjective/Objective/Management [LENT-SOM] subjective erectile function for vaginal penetration) and patients (single items within the University of California-Los Angeles Prostate Cancer Index [UCLA PCI] and Expanded Prostate Cancer Index Composite [EPIC]-50 questionnaires) at two years and compared between HT regimens by χ2 trend test.
Bicalutamide patients were significantly younger (median 67 vs 69 years LHRHa). Median follow-up was 9.3 years. There was no difference in biochemical or clinical failure with an adjusted hazard ratio or 0.97 (95% confidence interval, 0.77-1.23; P =0.8). At two years, grade ≥2 LENT-SOM ED was reported in significantly more LHRHa patients (313 out of 590; 53%) versus bicalutamide (17 out of 68; 25%) (P < .0001). There were no differences in ED seen with UCLA-PCI and EPIC-50 questionnaires.
In this nonrandomised comparison, there was no evidence of a difference in efficacy according to type of HT received. Bicalutamide preserved clinician assessed (LENT-SOM) erectile function at two years but patient-reported outcomes were similar between groups.