TY - JOUR
T1 - Olaparib as maintenance therapy in patients with BRCA 1-2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome.
T2 - Gynecologic oncology
AU - Cecere, Sabrina Chiara
AU - Giannone, Gaia
AU - Salutari, Vanda
AU - Arenare, Laura
AU - Lorusso, Domenica
AU - Ronzino, Graziana
AU - Lauria, Rossella
AU - Cormio, Gennaro
AU - Carella, Claudia
AU - Scollo, Paolo
AU - Ghizzoni, Viola
AU - Raspagliesi, Francesco
AU - Di Napoli, Marilena
AU - Mazzoni, Enrica
AU - Marchetti, Claudia
AU - Bergamini, Alice
AU - Orditura, Michele
AU - Valabrega, Giorgio
AU - Scambia, Giovanni
AU - Maltese, Giuseppa
AU - De Matteis, Elisabetta
AU - Cardalesi, Cinzia
AU - Loizzi, Vera
AU - Boccia, Serena
AU - Naglieri, Emanuele
AU - Scandurra, Giuseppa
AU - Pignata, Sandro
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - Female
KW - Humans
KW - Middle Aged
KW - Retrospective Studies
KW - Maintenance Chemotherapy
KW - Progression-Free Survival
KW - Genes, BRCA1
KW - Genes, BRCA2
KW - Maintenance
KW - Olaparib
KW - Ovarian cancer
KW - Post progression
KW - Real world
KW - Antineoplastic Agents/administration & dosage
KW - BRCA1 Protein/genetics
KW - BRCA2 Protein/genetics
KW - Germ-Line Mutation
KW - Neoplasm Recurrence, Local/drug therapy/genetics
KW - Organoplatinum Compounds/administration & dosage
KW - Ovarian Neoplasms/drug therapy/genetics
KW - Phthalazines/administration & dosage
KW - Piperazines/administration & dosage
U2 - 10.1016/j.ygyno.2019.10.023
DO - 10.1016/j.ygyno.2019.10.023
M3 - Article
VL - 156
SP - 38
EP - 44
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
IS - 1
ER -