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

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Abstract

Background
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 date08 Jan 2022
DOIs
Publication statusEarly online date - 08 Jan 2022

Keywords

  • erectile dysfunction
  • radiotherapy
  • Prostate cancer
  • androgen suppression

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