Long-term efficacy, tolerability and overall survival in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer treated with maintenance olaparib capsules following response to chemotherapy

Friedlander, M; Matulonis, U; Gourley, C; du Bois, A; Vergote, I; Rustin, G; Scott, C; Meier, W; Shapira-Frommer, R; Safra, T; Matei, D; Shirinkin, V; Selle, F; Fielding, A; Lowe, ES; McMurtry, EL; Spencer, S; Rowe, P; Mann, H; Parry, D; Ledermann, J

Author(s): Friedlander, M; Matulonis, U; Gourley, C; du Bois, A; Vergote, I; Rustin, G; Scott, C; Meier, W; Shapira-Frommer, R; Safra, T; Matei, D; Shirinkin, V; Selle, F; Fielding, A; Lowe, ES; McMurtry, EL; Spencer, S; Rowe, P; Mann, H; Parry, D; Ledermann, J;
Details: Publication Year 2018-10,Volume 119,Issue #9,Page 1075-1085
Journal Title: British Journal of Cancer
Publication Type: Journal Article
Abstract: BACKGROUND: In Study 19, maintenance monotherapy with olaparib significantly prolonged progression-free survival vs placebo in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer. METHODS: Study 19 was a randomised, placebo-controlled, Phase II trial enrolling 265 patients who had received at least two platinum-based chemotherapy regimens and were in complete or partial response to their most recent regimen. Patients were randomised to olaparib (capsules; 400 mg bid) or placebo. We present long-term safety and final mature overall survival (OS; 79% maturity) data, from the last data cut-off (9 May 2016). RESULTS: Thirty-two patients (24%) received maintenance olaparib for over 2 years; 15 (11%) did so for over 6 years. No new tolerability signals were identified with long-term treatment and adverse events were generally low grade. The incidence of discontinuations due to adverse events was low (6%). An apparent OS advantage was observed with olaparib vs placebo (hazard ratio 0.73, 95% confidence interval 0.550.95, P = 0.02138) irrespective of BRCA1/2 mutation status, although the predefined threshold for statistical significance was not met. CONCLUSIONS: Study 19 showed a favourable final OS result irrespective of BRCA1/2 mutation status and unprecedented long-term benefit with maintenance olaparib for a subset of platinum-sensitive, recurrent ovarian cancer patients.
Publisher: Springer Nature
Research Division(s): Stem Cells And Cancer
PubMed ID: 30353045
Publisher's Version: https://doi.org/10.1038/s41416-018-0271-y
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2019-02-05 08:28:48

Last Modified: 2019-02-05 08:40:35