Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial

E Pujade-Lauraine; JA Ledermann; F Selle; V Gebski; RT Penson; AM Oza; J Korach; T Huzarski; A Poveda; S Pignata; M Friedlander; N Colombo; P Harter; K Fujiwara; IL Ray-Coquard; S Banerjee; J Liu; ES Lowe; R Bloomfield; P Pautier; T Byrski; N Colombo; G Scambia; M Nicoletto; F Nussey; A Clamp; A Poveda Velasco; M Rodrigues; JP Lotz; D Provencher; A Prat Aparicio; L Vidal Boixader; C Scott; K Tamura; M Yunokawa; A Lisyanskaya; J Medioni; N Pécuchet; C Dubot; T de la Motte Rouge; MC Kaminsky; B Weber; A Lortholary; C Parkinson; J Ledermann; S Williams; J Cosin; J Hoffman; M Plante; A Covens; G Sonke; F Joly; A Floquet; H Hirte; A Amit; TW Park-Simon; K Matsumoto; S Tjulandin; JH Kim; L Gladieff; R Sabbatini; D O'Malley; P Timmins; D Kredentser; N Laínez Milagro; MP Barretina Ginesta; A Tibau Martorell; A Gómez de Liaño Lista; B Ojeda González; L Mileshkin; M Mandai; I Boere; P Ottevanger; JH Nam; E Filho; S Hamizi; F Cognetti; D Warshal; E Dickson-Michelson; S Kamelle; N McKenzie; G Rodriguez; D Armstrong; E Chalas; P Celano; K Behbakht; S Davidson; S Welch; L Helpman; A Fishman; I Bruchim

Journal article

Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial

E Pujade-Lauraine, JA Ledermann, F Selle, V Gebski, RT Penson, AM Oza, J Korach, T Huzarski, A Poveda, S Pignata, M Friedlander, N Colombo, P Harter, K Fujiwara, IL Ray-Coquard, S Banerjee, J Liu, ES Lowe, R Bloomfield, P Pautier Show all

Lancet Oncology | ELSEVIER SCIENCE INC | Published : 2017

DOI: 10.1016/S1470-2045(17)30469-2

Abstract

Background Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib. Methods This international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial evaluated olaparib tablet maintenance treatment in platinum-sensitive, relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy. Eligible patients were aged 18 years or..

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