For patients with metastatic castration-resistant prostate cancer, treatment with rucaparib is associated with significantly longer duration of imaging-based progression-free survival compared with a control medication, according to a study published online Feb. 16 in the New England Journal of Medicine to coincide with the American Society of Clinical Oncology annual Genitourinary Cancers Symposium, held from Feb. 16 to 18 in San Francisco.
Karim Fizazi, M.D., Ph.D., from Paris-Saclay University, and colleagues enrolled patients with metastatic, castration-resistant prostate cancer with a BRCA1, BRCA2, or ATM mutation and disease progression after treatment with a second-generation androgen-receptor pathway inhibitor (ARPI). Patients were randomly assigned to receive oral rucaparib or a physician’s choice control (docetaxel or a second-generation ARPI; 270 and 135 patients, respectively [intention-to-treat population]). Overall, 201 and 101 patients, respectively, had a BRCA mutation.
The researchers found that the duration of imaging-based progression-free survival was significantly longer in the rucaparib versus control group at 62 months, both in the BRCA mutation group (median, 11.2 and 6.4 months, respectively; hazard ratio, 0.50) and in the intention-to-treat group (median, 10.2 versus 6.4 months; hazard ratio, 0.61). The median duration of imaging-based progression-free survival did not differ significantly in the rucaparib and control groups in an exploratory analysis in the ATM subgroup (8.1 and 6.8 months, respectively). Fatigue and nausea were the most common adverse events reported with rucaparib.
“The benefit with respect to imaging-based progression-free survival in the rucaparib group was reported both in the BRCA subgroup and in the intention-to-treat population, with the greatest benefit in the BRCA subgroup,” the authors write.
Karim Fizazi et al, Rucaparib or Physician’s Choice in Metastatic Prostate Cancer, New England Journal of Medicine (2023). DOI: 10.1056/NEJMoa2214676
New England Journal of Medicine
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