ANALYSIS OF THE CLINICAL EXPERIENCE WITHIN RUCAPARIB'S EARLY ACCESS PROGRAM IN SPAIN - A GEICO STUDY

Introduction/Background* Rucaparib is a PARP-1/2/3 inhibitor approved for the treatment of high-grade ovarian cancer (HGOC). In ARIEL3, rucaparib improved PFS as maintenance therapy for platinum (Pt)-sensitive recurrent OC. Study 10, ARIEL2, and ARIEL4 showed rucaparib’s benefit as treatment. An observational study was performed in HGOC pts treated within the rucaparib access program (RAP) in Spain. The aim was to better understand rucaparib’s management in real-life setting, to optimize future use, considering Pt-sensitive and Pt-resistant BRCAmut treatment and maintenance patients. Methodology A retrospective study was performed at 22 GEICO hospitals in Spain that treated pts within RAP (600 mg BID) since September 2018. Adult women with high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer, with medical record available, were included. Patient characteristics, medical history, safety, efficacy, and dosing data were collected. Result(s)* Between July 2020 and February 2021, 51 pts were recruited with median age 63 years (36-86). At diagnosis, 45.1% of patients harbored gBRCA mutations, 19.6% sBRCA mutations, and 31.4% were BRCAwt. Before rucaparib, pts had ECOG PS 0, 1, or 2 (37.3%, 49.0%, and 5.9%) and 72.5% had measurable disease. The median number of previous lines was 4 (1-9), 51.0% of pts received prior bevacizumab, and notably 25.5% of pts had received a prior PARPi. Rucaparib was given as maintenance, Pt-resistant, and Pt-sensitive treatment in 35.3%, 51.0%, and 13.7% of pts respectively (median dose 557.7 mg [300-600]). 82.4% of pts received rucaparib for ≤12 mo and 17.6% >12 mo. 50.0% had at least one dose reduction and 60.0% at least one dose interruption. 9.8% discontinued due to rucaparib toxicity and 5 pts remained on treatment upon analysis. Median PFS was 6.0 mo (95% CI 2.5-7.8). For treatment group (19 radiologically-evaluable pts), the disease control rate was 42.0% (21.0% PR and 21.0% SD). Overall, 86.3% of pts had rucaparib-related toxicities, while most common G3-4 hematological events were anemia (13.7%), neutropenia (5.9%), and thrombocytopenia (5.9%). Conclusion* Rucaparib’s safety profile in real-life setting is manageable and efficacy results, even considering heavily pre-treated pts, are comparable to those of previous trials. The RAP in Spain showed a consolidated management of rucaparib and, consequently, an improved safety profile.