Olaparib plus bevacizumab as first-line maintenance in ovarian cancer: New England Journal of Medicine

I. Ray-Coquard, P. Pautier, S. Pignata, D. Pérol, A. González-Martín, R. Berger, K. Fujiwara, I. Vergote, N. Colombo, J. Mäenpää, F. Selle, J. Sehouli, D. Lorusso, E.M. Guerra Alía, A. Reinthaller, S. Nagao, C. Lefeuvre-Plesse, U. Canzler, G. Scambia, A. LortholaryF. Marmé, P. Combe, N. De Gregorio, M. Rodrigues, P. Buderath, C. Dubot, A. Burges, B. You, E. Pujade-Lauraine, P. Harter

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown. METHODS: We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or BRCA mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death. RESULTS: Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P
Original languageEnglish
Pages (from-to)2416-2428
Number of pages13
JournalNew Engl. J. Med.
Volume381
Issue number25
DOIs
Publication statusPublished - 2019

Keywords

  • bevacizumab
  • olaparib
  • placebo
  • antineoplastic agent
  • nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor
  • phthalazine derivative
  • piperazine derivative
  • acute myeloid leukemia
  • adult
  • advanced cancer
  • aged
  • anemia
  • aplastic anemia
  • Article
  • cancer grading
  • cancer survival
  • controlled study
  • disease exacerbation
  • double blind procedure
  • drug efficacy
  • drug safety
  • drug tolerability
  • drug withdrawal
  • fatigue
  • female
  • follow up
  • gene mutation
  • human
  • hypertension
  • major clinical study
  • myelodysplastic syndrome
  • nausea
  • outcome assessment
  • ovary cancer
  • phase 3 clinical trial
  • priority journal
  • progression free survival
  • quality of life
  • randomized controlled trial
  • tumor suppressor gene
  • clinical trial
  • maintenance chemotherapy
  • middle aged
  • mortality
  • multicenter study
  • multimodality cancer therapy
  • ovary tumor
  • very elderly
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols
  • Bevacizumab
  • Combined Modality Therapy
  • Double-Blind Method
  • Female
  • Humans
  • Maintenance Chemotherapy
  • Middle Aged
  • Ovarian Neoplasms
  • Phthalazines
  • Piperazines
  • Poly(ADP-ribose) Polymerase Inhibitors
  • Progression-Free Survival
  • Quality of Life

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  • Cite this

    Ray-Coquard, I., Pautier, P., Pignata, S., Pérol, D., González-Martín, A., Berger, R., Fujiwara, K., Vergote, I., Colombo, N., Mäenpää, J., Selle, F., Sehouli, J., Lorusso, D., Guerra Alía, E. M., Reinthaller, A., Nagao, S., Lefeuvre-Plesse, C., Canzler, U., Scambia, G., ... Harter, P. (2019). Olaparib plus bevacizumab as first-line maintenance in ovarian cancer: New England Journal of Medicine. New Engl. J. Med., 381(25), 2416-2428. https://doi.org/10.1056/NEJMoa1911361