Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer

K. Moore, N. Colombo, G. Scambia, B.-G. Kim, A. Oaknin, M. Friedlander, A. Lisyanskaya, A. Floquet, A. Leary, G.S. Sonke, C. Gourley, S. Banerjee, A. Oza, A. González-Martín, C. Aghajanian, W. Bradley, C. Mathews, J. Liu, E.S. Lowe, R. BloomfieldP. DiSilvestro

Research output: Contribution to journalArticlepeer-review


3 years after standard treatment with surgery and platinum-based chemotherapy. The benefit of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor olaparib in relapsed disease has been well established, but the benefit of olaparib as maintenance therapy in newly diagnosed disease is uncertain. METHODS We conducted an international, randomized, double-blind, phase 3 trial to evaluate the efficacy of olaparib as maintenance therapy in patients with newly diagnosed advanced (International Federation of Gynecology and Obstetrics stage III or IV) high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian-Tube cancer (or a combination thereof) with a mutation in BRCA1, BRCA2, or both (BRCA1/2) who had a complete or partial clinical response after platinumbased chemotherapy. The patients were randomly assigned, in a 2:1 ratio, to receive olaparib tablets (300 mg twice daily) or placebo. The primary end point was progression-free survival. RESULTS Of the 391 patients who underwent randomization, 260 were assigned to receive olaparib and 131 to receive placebo. A total of 388 patients had a centrally confirmed germline BRCA1/2 mutation, and 2 patients had a centrally confirmed somatic BRCA1/2 mutation. After a median follow-up of 41 months, the risk of disease progression or death was 70% lower with olaparib than with placebo (Kaplan-Meier estimate of the rate of freedom from disease progression and from death at 3 years, 60% vs. 27%; hazard ratio for disease progression or death, 0.30; 95% confidence interval, 0.23 to 0.41; P
Original languageEnglish
Pages (from-to)2495-2505
Number of pages11
JournalNew England Journal of Medicine
Issue number26
Publication statusPublished - 2018


  • antineoplastic agent
  • nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor
  • olaparib
  • phthalazine derivative
  • piperazine derivative
  • adult
  • clinical trial
  • controlled study
  • double blind procedure
  • endometrioid carcinoma
  • female
  • genetics
  • germline mutation
  • human
  • Kaplan Meier method
  • maintenance chemotherapy
  • middle aged
  • multicenter study
  • multimodality cancer therapy
  • ovary tumor
  • peritoneum tumor
  • phase 2 clinical trial
  • randomized controlled trial
  • tumor suppressor gene
  • uterine tube tumor
  • Adult
  • Antineoplastic Agents
  • Carcinoma, Endometrioid
  • Combined Modality Therapy
  • Double-Blind Method
  • Fallopian Tube Neoplasms
  • Female
  • Genes, BRCA1
  • Genes, BRCA2
  • Germ-Line Mutation
  • Humans
  • Kaplan-Meier Estimate
  • Maintenance Chemotherapy
  • Middle Aged
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Phthalazines
  • Piperazines
  • Poly(ADP-ribose) Polymerase Inhibitors
  • Progression-Free Survival


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