Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain - A GEICO study.

Autor: Yubero A; Medical Oncology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain. ayuberoe@salud.aragon.es., Barquín A; Medical Oncology, Centro Integral Oncológico Clara Campal, Madrid, Spain., Estévez P; Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain., Pajares B; Medical Oncology, Hospital Universitario Virgen de la Victoria, Málaga, Spain., Sánchez L; Medical Oncology, Clínica Universidad de Navarra, Madrid, Spain., Reche P; Medical Oncology, Hospital Universitario Torrecárdenas, Almería, Spain., Alarcón J; Medical Oncology, Hospital Universitario Son Espases, Mallorca, Spain., Calzas J; Medical Oncology, Hospital Universitario de Fuenlabrada, Madrid, Spain., Gaba L; Department of Medical Oncology, Translational Genomics and Targeted Therapeutics in Solid Tumors, Hospital Clínic de Barcelona, Institut D'Investigacions Biomèdiques August Pi I Sunyer (Idibaps), Barcelona, Spain., Fuentes J; Medical Oncology, Hospital Universitario Virgen de Valme, Sevilla, Spain., Santaballa A; Medical Oncology, Hospital Universitario i Politècnic la Fe, Valencia, Spain., Salvador C; Medical Oncology, Hospital Lluís Alcanyís de Xàtiva, Xátiva, Spain., Manso L; Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain., Herrero A; Medical Oncology, Hospital Universitario Miguel Servet, Zaragoza, Spain., Taus Á; Medical Oncology, Hospital del Mar, Barcelona, Spain., Márquez R; Medical Oncology, MD Anderson Cancer Center, Madrid, Spain., Madani J; Medical Oncology, Hospital Universitario San Jorge, Huesca, Spain., Merino M; Medical Oncology, Hospital Universitario Infanta Sofía, Madrid, Spain., Marquina G; Medical Oncology, Hospital Clínico San Carlos, Madrid, Spain., Casado V; Medical Oncology, Fundación Jiménez Díaz, Madrid, Spain., Constenla M; Medical Oncology, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain., Gutiérrez M; Medical Oncology, Hospital Universitario Txagorritxu, Araba, Spain., Dosil A; Clovis Oncology , Madrid, Spain., González-Martín A; Medical Oncology, Clínica Universidad de Navarra, Madrid, Spain.; Centre for Applied Medical Research, Pamplona, Spain.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2022 Nov 08; Vol. 22 (1), pp. 1150. Date of Electronic Publication: 2022 Nov 08.
DOI: 10.1186/s12885-022-10191-5
Abstrakt: Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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