Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Case Reports
. 2023 May 24:48:101211.
doi: 10.1016/j.gore.2023.101211. eCollection 2023 Aug.

Rucaparib for PARP inhibitor-pretreated ovarian cancer: A GEICO retrospective subgroup analysis from the Spanish Rucaparib Access Program

Affiliations
Case Reports

Rucaparib for PARP inhibitor-pretreated ovarian cancer: A GEICO retrospective subgroup analysis from the Spanish Rucaparib Access Program

Alfonso Yubero et al. Gynecol Oncol Rep. .

Abstract

The poly(ADP-ribose) polymerase inhibitor (PARPi) rucaparib is approved as maintenance therapy for patients with platinum-sensitive recurrent high-grade ovarian cancer (HGOC). The efficacy and safety of rucaparib after PARPi therapy are largely unknown; therefore, we analyzed outcomes in the subgroup of PARPi-pretreated patients from Spanish hospitals participating in the Rucaparib Access Program. This post hoc subgroup analysis explored baseline characteristics, treatment exposure, safety, effectiveness, and subsequent therapy among women receiving rucaparib 600 mg twice daily after at least one prior PARPi for HGOC. Of 14 women eligible for the analysis, 11 (79%) had tumors harboring BRCA1/2 mutations. Patients had received a median of 5 (range 3-8) treatment lines before rucaparib. Twelve patients (86%) had previously received olaparib and two (14%) niraparib; 12 patients received rucaparib as treatment for platinum-resistant HGOC, one as treatment for platinum-sensitive HGOC, and one as maintenance therapy. Progression-free survival was 0.2-9.1 months. One of seven patients assessable for response by RECIST achieved stable disease. Adverse events occurred in 11 patients (79%; grade 3 in 29%), leading to treatment interruption in eight patients (57%), dose reduction in six (43%), but treatment discontinuation in only one (7%). No new safety signals were observed. This is one of the first reported series of real-world data on rucaparib after prior PARPi for HGOC. In this heavily pretreated population, rucaparib demonstrated meaningful activity in some patients and tolerability consistent with previous prospective trials. Future investigation should focus on identifying patients who may benefit from rucaparib after prior PARPi exposure.

Keywords: Ovarian cancer; PARP inhibitor; Real-world data; Rechallenge; Rucaparib.

PubMed Disclaimer

Conflict of interest statement

AY reports consulting/advisory roles for Clovis Oncology, GSK, AstraZeneca, MSD, PharmaMar, and Roche and receipt of travel/accommodation/expenses from MSD, GSK, and PharmaMar. PE reports consulting fees and honoraria for lectures, presentations, and speaker bureaus from MSD, GSK, AstraZeneca, Clovis Oncology, and PharmaMar. LS reports consulting/advisory roles for GSK–Tesaro, Clovis Oncology, AstraZeneca, MSD, and Roche, and travel/accommodation/expenses from GSK, MSD, and PharmaMar. AS reports consulting fees and honoraria for lectures, presentations, and speaker bureaus from MSD, GSK, AstraZeneca, Clovis Oncology, Pfizer, Lilly, and Novartis. BP reports consulting/advisory roles for Clovis Oncology, Novartis, and AstraZeneca, and travel/accommodation from AstraZeneca. CS reports consulting/advisory roles for PharmaMar and travel/accommodation/expenses from GSK, MSD, Pfizer, and AstraZeneca. LM reports consulting/advisory roles for Roche/Genentech, AstraZeneca, Novartis, Pfizer, Tesaro, Eisai, Lilly, Clovis Oncology, Pierre Fabre, and GlaxoSmithKline, speakers’ bureaus for Roche/Genentech, Novartis, Pfizer, AstraZeneca, and Lilly, and research funding from Tesaro. AGM reports advisory/consultancy roles for Alkermes, Amgen, AstraZeneca, Clovis Oncology, Genmab, GSK, ImmunoGen, Merck Sharp & Dohme, MacroGenics, Novartis, Oncoinvent, Pfizer/Merck, PharmaMar, Roche, Sotio Biotech, and Sutro Biopharma, speaker bureaus for AstraZeneca, PharmaMar, Roche, GSK, and Clovis Oncology, research grant/funding from Roche and Tesaro/GSK, and travel/accommodation/expenses from AstraZeneca, PharmaMar, Roche, and Tesaro/GSK. AB, PR, and RM declare no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Rucaparib treatment exposure following PARPi. MNT: maintenance. PARP: poly(ADP-ribose) polymerase inhibitor. Tx Pt-R: treatment for platinum-resistant disease. Tx Pt-S: treatment for platinum-sensitive disease.

References

    1. Baert T., Ferrero A., Sehouli J., O'Donnell D.M., Gonzalez-Martin A., Joly F., van der Velden J., Blecharz P., Tan D.S.P., Querleu D., et al. The systemic treatment of recurrent ovarian cancer revisited. Ann Oncol. 2021;32(6):710–725. - PubMed
    1. Coleman R.L., Oza A.M., Lorusso D., Aghajanian C., Oaknin A., Dean A., Colombo N., Weberpals J.I., Clamp A., Scambia G., et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;390(10106):1949–1961. - PMC - PubMed
    1. Essel K.G., Behbakht K., Lai T., Hand L., Evans E., Dvorak J., Ding K., Konecny G., Moore K.N. PARPi after PARPi in epithelial ovarian cancer. Gynecol. Oncol. Rep. 2021;35 - PMC - PubMed
    1. Kristeleit R., Lisyanskaya A., Fedenko A., Dvorkin M., de Melo A.C., Shparyk Y., Rakhmatullina I., Bondarenko I., Colombo N., Svintsitskiy V., et al. Rucaparib versus standard-of-care chemotherapy in patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation (ARIEL4): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2022;23(4):465–478. - PubMed
    1. Lynparza (olaparib) Prescribing Information. <https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s024lbl.pdf> (Accessed 30 May 2023).

Publication types

LinkOut - more resources