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Rucaparib vs. Standard-of-Care Therapies in Metastatic, Castration-Resistant Prostate Cancer
Based on practice-changing evidence, many patients with metastatic, castration-sensitive prostate cancer receive androgen deprivation therapy (ADT) intensification with agents such as abiraterone acetate, apalutamide, enzalutamide and docetaxel. As a consequence of both the earlier integration of these agents in the treatment course and the lack of prospective evidence regarding drug sequencing, the management of patients with metastatic, castration-resistant prostate cancer (MCRPC) is increasingly challenging.
Investigators conducted an industry-sponsored phase 3 study comparing rucaparib to physician's choice of therapy (docetaxel, abiraterone acetate, or enzalutamide) in men with MCRPC with BRCA or ATM alterations. Eligible patients had disease progression after treatment with a second-generation androgen receptor pathway inhibitor (ARPI); previous treatment with a taxane chemotherapy was permitted. Crossover to rucaparib at time of progression was permitted. Of 405 patients who underwent randomization (2:1), approximately 75% had a BRCA alteration and 22% had received prior docetaxel.
At a median 62 months of follow-up, imaging-based progression-free survival (PFS) — the primary outcome — was significantly longer in the rucaparib arm than the standard-of-care arm both in the BRCA subgroup (median, 11.2 vs. 6.4 months; hazard ratio, 0.50; P<0.001) and in the intention-to-treat population (median, 10.2 vs. 6.4 months; HR 0.61; P<0.001). An exploratory analysis of patients with ATM alterations showed no statistical difference in PFS between treatment arms. Side effects from all treatments were consistent with previous reports.
These investigators are to be congratulated for the use of an active control arm, in contrast to many current trials that limit the control arm to the alternative ARPI, which is increasingly viewed as less than optimal. This study supports the use of rucaparib in patients with MCRPC with BRCA alterations who have disease progression following initial management with ADT/intensification.
Fizazi K et al.
Title: Rucaparib or physician's choice in metastatic prostate cancer.
Source: N Engl J Med 2023 Feb 16; [e-pub]. (Abstract/FREE Full Text)