Abstract 54P
Background
Maintenance monotherapy with the poly-(ADP-ribose)-polymerase inhibitor olaparib has previously shown good effectiveness and tolerability in patients with platinum-sensitive relapsed ovarian cancer (PSROC) who are in response to platinum-based chemotherapy (PBC) in the C-PATROL study. Cytoreductive surgery followed by PBC has the potential to improve survival in PSROC if a complete resection can be achieved.
Methods
The prospective German non-interventional study C-PATROL (NCT02503436) captured routine clinical data of patients with BRCA-mutated PSROC treated with PBC and receiving olaparib maintenance according to label. This predefined subgroup analysis compares patients based on surgery details for the current relapse and its outcome: patients who were macroscopic tumour-free (MTF) versus no surgery/non-MTF (non-MTF). Data were analysed by descriptive statistics.
Results
The study enrolled 277 patients between 10/2015 and 10/2019. Within the ITT set (study selection criteria fulfilled; N=267), 66 patients were included in the MTF vs 201 in the non-MTF subgroup (182 had no surgery and 19 were non-MTF). Median age was 59 vs 61 years, 58% vs 60% had an ECOG performance status of 0, 82% vs 63% were tumour-free after primary surgery, 27% vs 34% had ≥2 relapses, and 65% vs 20% had a complete response (CR) to the current PBC. Median follow-up was 42.8 (range: 0.3–80.5) vs 20.3 months (0.0–79.4). Median progression-free survival (PFS) was 43.2 (95% CI 21.9–nr) vs 12.1 months (10.7–14.1). Median overall survival (OS) was not reached (nr) (95% CI 60.8–nr) vs 27.4 months (24.4–33.6). Adverse events (AEs) were consistent with the known tolerability profile of olaparib (safety set: n=274; any AE: 96% vs 95%, AE of CTCAE grade ≥3: 34% vs 42%, olaparib discontinuation due to AE: 9% vs 12%).
Conclusions
Patients with PSROC for whom in the real-world a macroscopic complete (recurrence)tumour-resection was achieved before receiving PBC and olaparib maintenance, have a beneficial prognosis concerning PFS and OS.
Clinical trial identification
NCT02503436.
Editorial acknowledgment
This study is funded by AstraZeneca and is part of an alliance between AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Medical writing assistance provided by Dr. Yvonne Holighaus, Alcedis GmbH, Giessen, also funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
F. Marmé: Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK/Tesaro, Clovis, Pfizer, Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Novartis, Roche, Gilead/immunomedics, EISAI, PharmaMar, GenomicHealth, Myriad, Seagen; Financial Interests, Institutional, Invited Speaker: Seagen, Daiichi Sankyo, GSK, AstraZeneca, Stemline Menarini, Roche, AstraZeneca, Novartis, Roche, Eisai, Gilead/Immunomedics, MSD, German Breast Group, AGO Research GmbH, Vaccibody, GSK; Financial Interests, Institutional, Advisory Board: Roche, Immunicom; Financial Interests, Institutional, Funding: AstraZeneca, Lilly, Seagen. F. Hilpert: Financial Interests, Personal, Advisory Role: AstraZeneca, MSD; Financial Interests, Personal, Other, Honoraria: Novartis, AstraZeneca, MSD, GSK. M.K. Welslau: Financial Interests, Personal, Advisory Role: Amgen, Bristol Myers Squibb, Celgene, Gilead, HEXAL, Janssen, Lilly, Medac, Novartis, Roche, Sanofi; Financial Interests, Personal, Other, Honoraria: AMGEN, Astellas, AstraZeneca, Celgene, Hexal, Janssen, Gilead, Lilly, Novartis, Roche, Sanofi. J.P. Grabowski: Financial Interests, Personal, Other, Honoraria: AstraZeneca, GSK, MSD, Eisai, Esteve; Financial Interests, Personal, Advisory Role: AstraZeneca, MSD, GSK, Eisai, Esteve; Financial Interests, Institutional, Other, Research Funding: AstraZeneca, GSK, MSD, Esteve; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca, MSD, GSK, Eisai, Esteve. A. Schneeweiss: Financial Interests, Institutional, Research Grant: Celgene, Roche, AbbVie; Financial Interests, Personal, Other, Travel expenses: Celgene, Roche, AstraZeneca; Financial Interests, Personal, Other, Honoraria: Roche, Celgene, Pfizer, AstraZeneca, Novartis, Tesaro, MSD, Lilly, Seagen, Gilead, GSK, Bayer, Amgen, Pierre Fabre; Financial Interests, Personal, Other, Travel Expenses: Pfizer. A.D. Hartkopf: Financial Interests, Personal, Advisory Role: Roche, Novartis, MSD, AstraZeneca, GSK, ExactScience, Riemser, Teva, Onkowissen, Gilead, Menarini Stemline, Pfizer; Financial Interests, Personal, Speaker’s Bureau: Roche, Novartis, Lilly, MSD, AstraZeneca, Daiichi Sankyo, Seagen, GSK, ExactScience, Gilead, Menarini Stemline, Pfizer, Eisai. D. Bauerschlag: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Eisai, MSD, Roche, Novartis; Financial Interests, Personal, Advisory Role: AstraZeneca, Eisai, MSD, Roche, Novartis; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca, Eisai, MSD, Roche, Novartis. P.A. Fasching: Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Hexal, Lilly, Pierre Fabre, Seagen, Agendia, Sanofi Aventis, Medac, Menarini, Veracyte; Financial Interests, Personal, Invited Speaker: Novartis, Daiichi Sankyo, Eisai, Merck, Sharp & Dohme, AstraZeneca, Lilly, Seagen, Gilead, Mylan; Financial Interests, Personal, Other, Medical Writing Support: Roche; Financial Interests, Institutional, Invited Speaker: BionTech, Cepheid; Non-Financial Interests, Personal, Member: ASCO, Arbeitsgemeinschaft für Gynäkologische Onkologie e.V., Translational Research in Oncology, Deutsche Gesellschaft für Senologie e.v.. R.M. Glowik: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. J. Sehouli: Financial Interests, Personal, Advisory Board: Roche, GSK, AstraZeneca, MSD, Tesaro, ImmunoGen, Tubulis, Novocure, Incyte; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Institutional, Funding: Roche, GSK, AstraZeneca; Financial Interests, Institutional, Invited Speaker: Novocure; Non-Financial Interests, Institutional, Proprietary Information: ENGOT/NOGGO; Non-Financial Interests, Personal, Leadership Role, Council Member: ESGO; Non-Financial Interests, Personal, Leadership Role: North-Eastern German Society of Gynecological Oncology (NOGGO), Arbeitsgemeinschaft für Gynäkologische Onkologie (AGO), Pab-Arabian Research Society of Gynecological Oncology (PARSGO). All other authors have declared no conflicts of interest.