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Clinical Trial
. 2017 Nov;147(2):267-275.
doi: 10.1016/j.ygyno.2017.08.022. Epub 2017 Sep 4.

Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10 and ARIEL2

Amit M Oza  1 , Anna V Tinker  2 , Ana Oaknin  3 , Ronnie Shapira-Frommer  4 , Iain A McNeish  5 , Elizabeth M Swisher  6 , Isabelle Ray-Coquard  7 , Katherine Bell-McGuinn  8 , Robert L Coleman  9 , David M O'Malley  10 , Alexandra Leary  11 , Lee-May Chen  12 , Diane Provencher  13 , Ling Ma  14 , James D Brenton  15 , Gottfried E Konecny  16 , Cesar M Castro  17 , Heidi Giordano  18 , Lara Maloney  18 , Sandra Goble  18 , Kevin K Lin  18 , James Sun  19 , Mitch Raponi  18 , Lindsey Rolfe  18 , Rebecca S Kristeleit  20
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Free article
Clinical Trial

Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10 and ARIEL2

Amit M Oza et al. Gynecol Oncol. 2017 Nov.
Free article

Abstract

Objective: An integrated analysis was undertaken to characterize the antitumor activity and safety profile of the oral poly(ADP-ribose) polymerase inhibitor rucaparib in patients with relapsed high-grade ovarian carcinoma (HGOC).

Methods: Eligible patients from Study 10 (NCT01482715) and ARIEL2 (NCT01891344) who received a starting dose of oral rucaparib 600mg twice daily (BID) with or without food were included in these analyses. The integrated efficacy population included patients with HGOC and a deleterious germline or somatic BRCA1 or BRCA2 (BRCA1/2) mutation who received at least two prior chemotherapies and were sensitive, resistant, or refractory to platinum-based chemotherapy. The primary endpoint was investigator-assessed confirmed objective response rate (ORR). Secondary endpoints included duration of response (DOR) and progression-free survival (PFS). The integrated safety population included patients with HGOC who received at least one dose of rucaparib 600mg BID, irrespective of BRCA1/2 mutation status and prior treatments.

Results: In the efficacy population (n=106), ORR was 53.8% (95% confidence interval [CI], 43.8-63.5); 8.5% and 45.3% of patients achieved complete and partial responses, respectively. Median DOR was 9.2months (95% CI, 6.6-11.6). In the safety population (n=377), the most frequent treatment-emergent adverse events (AEs) were nausea, asthenia/fatigue, vomiting, and anemia/hemoglobin decreased. The most common grade ≥3 treatment-emergent AE was anemia/hemoglobin decreased. Treatment-emergent AEs led to treatment interruption, dose reduction, and treatment discontinuation in 58.6%, 45.9%, and 9.8% of patients, respectively. No treatment-related deaths occurred.

Conclusions: Rucaparib has antitumor activity in advanced BRCA1/2-mutated HGOC and a manageable safety profile.

Keywords: Ovarian carcinoma; PARP inhibitor; Rucaparib; Somatic, germline BRCA mutation.

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