Sabrina Chiara Cecere1, Gaia Giannone2, Vanda Salutari3, Laura Arenare4, Domenica Lorusso5, Graziana Ronzino6, Rossella Lauria7, Gennaro Cormio8, Claudia Carella9, Paolo Scollo10, Viola Ghizzoni3, Francesco Raspagliesi5, Marilena Di Napoli1, Enrica Mazzoni11, Claudia Marchetti12, Alice Bergamini13, Michele Orditura14, Giorgio Valabrega2, Giovanni Scambia3, Giuseppa Maltese5, Elisabetta De Matteis6, Cinzia Cardalesi7, Vera Loizzi8, Serena Boccia12, Emanuele Naglieri9, Giuseppa Scandurra10, Sandro Pignata15. 1. Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli, Italy. 2. Candiolo Cancer Institute, FPO - IRCCS - Str. Prov.le 142, km. 3,95 - Candiolo, TO, 10060, Italy; Department of Oncology, University of Turin, Italy. 3. Gynecologic Oncology Unit, Department of Woman, Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy. 4. Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy. 5. Gynecologic Oncology Unit, IRCCS National Cancer Institute Foundation, Milan, Italy. 6. Ospedale "Vito Fazzi" Lecce, Italy. 7. Division of Medical Oncology, Azienda Ospedaliera Universitaria Federico II, Naples, Italy. 8. University of Bari, Bari, Italy. 9. Gynecologic Oncology Unit, Istituto Oncologico Giovanni Paolo II, Bari, Italy. 10. Medical Oncology Unit, Cannizzaro Hospital, Catania, Italy. 11. Division of Medical Oncology, Ospedale "Senatore Antonio Perrino", Brindisi, Italy. 12. Division of Medical Oncology, "Umberto I" Hospital, "Sapienza" University of Rome, Rome, Italy. 13. Department of Obstetrics and Gynecology, IRCCS San Raffaele Hospital, Milan, Italy. 14. Oncoematology Unit, Università Degli Studi Della Campania "Luigi Vanvitelli", Napoli, Italy. 15. Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli, Italy. Electronic address: s.pignata@istitutotumori.na.it.
Abstract
OBJECTIVES: Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression. MATERIALS AD METHODS: In this non interventional, retrospective study, patients treated with olaparib in 13 centers, according to the label, have been collected and analyzed. Primary objectives of the study are to describe effectiveness and safety of olaparib in a real world setting with a focus on post progression treatments and response. RESULTS: 234 patients were analyzed. All patients were BRCA mutated and most of them had germline mutations. Around 50% of the patients received olaparib after 3 or more lines of platinum based chemotherapy achieving a radiologic complete (CR) or partial response. 12.4% patients with stable disease were also included. Median PFS was 14.7 months (95% CI:12.6-18), with statistically longer PFS in patients with normal serum Ca125 at baseline, a CR after last platinum based therapy and that received olaparib after second platinum based therapy. Median OS was not reached. Most frequent G3-G4 toxicity was anaemia (6%) with dose discontinuation and dose reduction in 11 (4.7%) and 49 (20.9%) of cases, respectively. Among 66 patients receiving further treatment after olaparib progression and evaluable for response, ORR was 22.2, 11.1% and 9.5% in patients with Platinum Free interval (PFI) of more than 12 months, between 6 and 12 months and less than 6 months, respectively. CONCLUSIONS: Olaparib is effective and safe in real world setting. Data on post-progression treatments seem to suggest cross resistance with chemotherapy and need to be confirmed in larger studies because of the potential importance in clinical practice decisions.
OBJECTIVES: Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression. MATERIALS AD METHODS: In this non interventional, retrospective study, patients treated with olaparib in 13 centers, according to the label, have been collected and analyzed. Primary objectives of the study are to describe effectiveness and safety of olaparib in a real world setting with a focus on post progression treatments and response. RESULTS: 234 patients were analyzed. All patients were BRCA mutated and most of them had germline mutations. Around 50% of the patients received olaparib after 3 or more lines of platinum based chemotherapy achieving a radiologic complete (CR) or partial response. 12.4% patients with stable disease were also included. Median PFS was 14.7 months (95% CI:12.6-18), with statistically longer PFS in patients with normal serum Ca125 at baseline, a CR after last platinum based therapy and that received olaparib after second platinum based therapy. Median OS was not reached. Most frequent G3-G4 toxicity was anaemia (6%) with dose discontinuation and dose reduction in 11 (4.7%) and 49 (20.9%) of cases, respectively. Among 66 patients receiving further treatment after olaparib progression and evaluable for response, ORR was 22.2, 11.1% and 9.5% in patients with Platinum Free interval (PFI) of more than 12 months, between 6 and 12 months and less than 6 months, respectively. CONCLUSIONS: Olaparib is effective and safe in real world setting. Data on post-progression treatments seem to suggest cross resistance with chemotherapy and need to be confirmed in larger studies because of the potential importance in clinical practice decisions.