RT Journal Article
T1 Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain - A GEICO study.
A1 Yubero, Alfonso
A1 Barquín, Aranzazu
A1 Estévez, Purificación
A1 Pajares, Bella
A1 Sánchez, Luisa
A1 Reche, Piedad
A1 Alarcón, Jesús
A1 Calzas, Julia
A1 Gaba, Lydia
A1 Fuentes, José
A1 Santaballa, Ana
A1 Salvador, Carmen
A1 Manso, Luis
A1 Herrero, Ana
A1 Taus, Álvaro
A1 Márquez, Raúl
A1 Madani, Julia
A1 Merino, María
A1 Marquina, Gloria
A1 Casado, Victoria
A1 Constenla, Manuel
A1 Gutiérrez, María
A1 Dosil, Alba
A1 González-Martín, Antonio
K1 Maintenance
K1 PARP inhibitor
K1 Recurrent ovarian cancer
K1 Rucaparib
K1 Treatment
AB Rucaparib is a poly(ADP-ribose) polymerase inhibitor approved in Europe as maintenance therapy for recurrent platinum-sensitive (Pt-S) ovarian cancer (OC). The Rucaparib Access Programme (RAP) was designed to provide early access to rucaparib for the above-mentioned indication, as well as for patients with BRCA-mutated Pt-S or platinum-resistant (Pt-R) OC and no therapeutic alternatives. In this observational, retrospective study we analysed the efficacy and safety of rucaparib within the RAP in Spain. Hospitals associated with the Spanish Ovarian Cancer Research Group (GEICO) recruited patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated with rucaparib 600 mg twice daily as maintenance or treatment (Pt-S/Pt-R) in the RAP. Baseline characteristics, efficacy, and safety data were collected. Between July 2020 and February 2021, 51 patients treated in 22 hospitals in the RAP were included in the study. Eighteen patients with a median of 3 (range, 1-6) prior treatment lines received rucaparib as maintenance; median progression-free survival (PFS) for this group was 9.1 months (95% confidence interval [CI], 4.2-11.6 months). Among 33 patients (median 5 [range, 1-9] prior treatment lines) who received rucaparib as treatment, 7 and 26 patients had Pt-S and Pt-R disease, respectively. Median PFS was 10.6 months (95% CI, 2.5 months-not reached) in the Pt-S group and 2.2 months (95% CI, 1.1-3.2 months) in the Pt-R group. Grade ≥ 3 treatment-emergent adverse events were reported in 39% of all patients, the most common being anaemia (12% and 15% in the maintenance and treatment groups, respectively). At data cut-off, 5 patients remained on treatment. Efficacy results in these heavily pre-treated patients were similar to those from previous trials. The safety profile of rucaparib in real life was predictable and manageable.
YR 2022
FD 2022-11-08
LK http://hdl.handle.net/10668/20283
UL http://hdl.handle.net/10668/20283
LA en
DS RISalud
RD Apr 7, 2025