Non-randomised comparison of efficacy and side effects of bicalutamide compared with LHRH analogues in combination with radiotherapy in the xxxxxx trial.

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

Research output: Contribution to journalArticlepeer-review

Abstract

XXXXX is a randomised trial evaluating moderately hypofractionated radiotherapy for treatment of localised prostate cancer. 97% of participants had concurrent short course hormone therapy (HT), either Luteinising Hormone Releasing Hormone analogues (LHRHa) or bicalutamide 150mg daily. This exploratory analysis compares efficacy and side effects in a non-randomised comparison.

Methods: 2700 pts received LHRHa, 403 bicalutamide. The primary endpoint was biochemical/clinical failure (BCF). Groups were compared with Cox regression adjusted for various prognostic factors and stratified by radiotherapy dose. A key secondary endpoint was erectile dysfunction (ED) assessed by clinicians (LENT-SOM subjective erectile function for vaginal penetration) and patients (single items within UCLA-PCI and EPIC-50 questionnaires) at 2 years and compared between HT regimens by chi square trend test.

Results: Bicalutamide patients were significantly younger (median 67 vs 69 years LHRHa). Median follow-up is 9.3 years. There was no difference in BCF with adjusted hazard ratio 0.97 (95%CI 0.77-1.23; p=0.8). At 2 years, grade≥2 LENT-SOM ED was reported in significantly more LHRHa patients 313/590 (53%) versus 17/68 (25%) bicalutamide (p<0.0001). There were no differences in ED seen with UCLA-PCI and EPIC-50 questionnaires.

Conclusions: In this non-randomised 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 2 years but patient reported outcomes were similar between groups.
Original languageEnglish
JournalInternational Journal of Radiation: Oncology - Biology - Physics
Early online date10 Jan 2022
DOIs
Publication statusPublished - 10 Jan 2022

Research Beacons, Institutes and Platforms

  • Manchester Cancer Research Centre

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