Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain – A GEICO study
Abstract 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,...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12885-022-10191-5 |
| _version_ | 1797988480901447680 |
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| author | Alfonso Yubero Aranzazu Barquín Purificación Estévez Bella Pajares Luisa Sánchez Piedad Reche Jesús Alarcón Julia Calzas Lydia Gaba José Fuentes Ana Santaballa Carmen Salvador Luis Manso Ana Herrero Álvaro Taus Raúl Márquez Julia Madani María Merino Gloria Marquina Victoria Casado Manuel Constenla María Gutiérrez Alba Dosil Antonio González-Martín |
| author_facet | Alfonso Yubero Aranzazu Barquín Purificación Estévez Bella Pajares Luisa Sánchez Piedad Reche Jesús Alarcón Julia Calzas Lydia Gaba José Fuentes Ana Santaballa Carmen Salvador Luis Manso Ana Herrero Álvaro Taus Raúl Márquez Julia Madani María Merino Gloria Marquina Victoria Casado Manuel Constenla María Gutiérrez Alba Dosil Antonio González-Martín |
| author_sort | Alfonso Yubero |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-11T08:03:33Z |
| format | Article |
| id | doaj.art-535064772afa48388b62acdd5418de2a |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-11T08:03:33Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-535064772afa48388b62acdd5418de2a2022-12-22T04:35:37ZengBMCBMC Cancer1471-24072022-11-0122111010.1186/s12885-022-10191-5Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain – A GEICO studyAlfonso Yubero0Aranzazu Barquín1Purificación Estévez2Bella Pajares3Luisa Sánchez4Piedad Reche5Jesús Alarcón6Julia Calzas7Lydia Gaba8José Fuentes9Ana Santaballa10Carmen Salvador11Luis Manso12Ana Herrero13Álvaro Taus14Raúl Márquez15Julia Madani16María Merino17Gloria Marquina18Victoria Casado19Manuel Constenla20María Gutiérrez21Alba Dosil22Antonio González-Martín23Medical Oncology, Hospital Clínico Universitario Lozano BlesaMedical Oncology, Centro Integral Oncológico Clara CampalMedical Oncology, Hospital Universitario Virgen del RocíoMedical Oncology, Hospital Universitario Virgen de la VictoriaMedical Oncology, Clínica Universidad de NavarraMedical Oncology, Hospital Universitario TorrecárdenasMedical Oncology, Hospital Universitario Son EspasesMedical Oncology, Hospital Universitario de FuenlabradaDepartment of Medical Oncology, Translational Genomics and Targeted Therapeutics in Solid Tumors, Hospital Clínic de Barcelona, Institut D’Investigacions Biomèdiques August Pi I Sunyer (Idibaps)Medical Oncology, Hospital Universitario Virgen de ValmeMedical Oncology, Hospital Universitario i Politècnic la FeMedical Oncology, Hospital Lluís Alcanyís de XàtivaMedical Oncology, Hospital Universitario 12 de OctubreMedical Oncology, Hospital Universitario Miguel ServetMedical Oncology, Hospital del MarMedical Oncology, MD Anderson Cancer CenterMedical Oncology, Hospital Universitario San JorgeMedical Oncology, Hospital Universitario Infanta SofíaMedical Oncology, Hospital Clínico San CarlosMedical Oncology, Fundación Jiménez DíazMedical Oncology, Complejo Hospitalario Universitario de PontevedraMedical Oncology, Hospital Universitario TxagorritxuClovis OncologyMedical Oncology, Clínica Universidad de NavarraAbstract 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.https://doi.org/10.1186/s12885-022-10191-5RucaparibRecurrent ovarian cancerMaintenanceTreatmentPARP inhibitor |
| spellingShingle | Alfonso Yubero Aranzazu Barquín Purificación Estévez Bella Pajares Luisa Sánchez Piedad Reche Jesús Alarcón Julia Calzas Lydia Gaba José Fuentes Ana Santaballa Carmen Salvador Luis Manso Ana Herrero Álvaro Taus Raúl Márquez Julia Madani María Merino Gloria Marquina Victoria Casado Manuel Constenla María Gutiérrez Alba Dosil Antonio González-Martín Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain – A GEICO study BMC Cancer Rucaparib Recurrent ovarian cancer Maintenance Treatment PARP inhibitor |
| title | Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain – A GEICO study |
| title_full | Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain – A GEICO study |
| title_fullStr | Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain – A GEICO study |
| title_full_unstemmed | Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain – A GEICO study |
| title_short | Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain – A GEICO study |
| title_sort | rucaparib in recurrent ovarian cancer real world experience from the rucaparib early access programme in spain a geico study |
| topic | Rucaparib Recurrent ovarian cancer Maintenance Treatment PARP inhibitor |
| url | https://doi.org/10.1186/s12885-022-10191-5 |
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