Adjuvant olaparib for patients with BRCA1- Or BRCA2-mutated breast cancer: New England Journal of Medicine

A.N.J. Tutt, J.E. Garber, B. Kaufman, G. Viale, D. Fumagalli, P. Rastogi, R.D. Gelber, E. de Azambuja, A. Fielding, J. Balmaña, S.M. Domchek, K.A. Gelmon, S.J. Hollingsworth, L.A. Korde, B. Linderholm, H. Bandos, E. Senkus, J.M. Suga, Z. Shao, A.W. PippasZ. Nowecki, T. Huzarski, P.A. Ganz, P.C. Lucas, N. Baker, S. Loibl, R. McConnell, M. Piccart, R. Schmutzler, G.G. Steger, J.P. Costantino, A. Arahmani, N. Wolmark, E. McFadden, V. Karantza, S.R. Lakhani, G. Yothers, C. Campbell, Jr. Geyer C.E.

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND Poly(adenosine diphosphate–ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation–associated early breast cancer. METHODS We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)–negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease–free survival. RESULTS A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease–free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P
Original languageEnglish
Pages (from-to)2394-2405
Number of pages12
JournalNew Engl. J. Med.
Volume384
Issue number25
DOIs
Publication statusPublished - 2021

Keywords

  • antineoplastic agent
  • epidermal growth factor receptor 2
  • ERBB2 protein, human
  • nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor
  • olaparib
  • phthalazine derivative
  • piperazine derivative
  • adjuvant chemotherapy
  • adult
  • breast tumor
  • clinical trial
  • controlled study
  • disease free survival
  • double blind procedure
  • female
  • genetics
  • germline mutation
  • human
  • mastectomy
  • middle aged
  • mortality
  • multicenter study
  • phase 3 clinical trial
  • randomized controlled trial
  • tumor suppressor gene
  • Adult
  • Antineoplastic Agents
  • Breast Neoplasms
  • Chemotherapy, Adjuvant
  • Disease-Free Survival
  • Double-Blind Method
  • Female
  • Genes, BRCA1
  • Genes, BRCA2
  • Germ-Line Mutation
  • Humans
  • Mastectomy
  • Middle Aged
  • Phthalazines
  • Piperazines
  • Poly(ADP-ribose) Polymerase Inhibitors
  • Receptor, ErbB-2

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