Coleman RL, et al. — Rucaparib has been shown to have anticancer activity in recurrent ovarian carcinoma. In the current study, the efficacy of rucaparib was evaluated after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma. Rucaparib was shown to significantly improve progression-free survival in patients with platinum-sensitive ovarian cancer who had achieved a response to platinum-based chemotherapy.

Methods

• Eligibility criteria were as follows: greater than or equal to 18 years of age; platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma; received at least two previous platinum-based chemotherapy regimens; had achieved complete or partial response to the last platinum-based regimen; CA-125 concentration less than the upper limit of normal; PS = 0–1; and adequate organ function.
• Ineligibility criteria were as follows: symptomatic or untreated central nervous system metastases; anticancer therapy 14 days or less before starting the study; or received previous treatment with a poly(ADP-ribose) polymerase inhibitor.
• Patients received oral rucaparib (600 mg twice daily) or placebo in 28 day cycles.

Results

• 564 patients were enrolled.
• The median PFS in patients with aBRCA-mutant carcinoma was 16.6 months in the rucaparib group versus 5.4 months in the placebo group.
• In patients with a homologous recombination deficient carcinoma, the median PFS was 13.6 months versus 5.4 months, respectively.