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  • 1From the Institute of Cancer Research and Royal Marsden Hospital, London (J. de Bono), and AstraZeneca, Translational Medicine, Cambridge (C.A.A.) - all in the United Kingdom; Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Malaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Sud, Villejuif (K.F.), and the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - all in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah Comprehensive Cancer Center, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Radboud University Medical Center, Nijmegen, the Netherlands (N.M.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (C.G., J.K., W.W.); Merck, Kenilworth, NJ (J. Burgents); AstraZeneca, Precision Medicine, Oncology Research and Development, Gaithersburg, MD (A.K.); and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.).

The New England Journal of Medicine
|April 29, 2020
PubMed
Summary
This summary is machine-generated.

Olaparib significantly improved progression-free survival in men with metastatic castration-resistant prostate cancer and DNA repair gene alterations. This PARP inhibitor offers a new treatment option for advanced prostate cancer patients.

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Area of Science:

  • Oncology
  • Genetics
  • Pharmacology

Background:

  • Loss-of-function alterations in DNA repair genes, including homologous recombination repair (HRR), are linked to cancer treatment response.
  • Poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors have shown promise in various cancers with specific genetic profiles.

Purpose of the Study:

  • To evaluate the efficacy of the PARP inhibitor olaparib compared to standard hormonal agents in men with metastatic castration-resistant prostate cancer (mCRPC).
  • To assess olaparib's effectiveness in patients with documented alterations in HRR-related genes.

Main Methods:

  • A randomized, open-label, phase 3 trial (PROfound) involving men with mCRPC who progressed on enzalutamide or abiraterone.
  • Patients were selected based on qualifying alterations in prespecified HRR genes (BRCA1, BRCA2, ATM, or others).
  • Participants were randomized 2:1 to receive olaparib or physician's choice of enzalutamide/abiraterone, with imaging-based progression-free survival as the primary endpoint.

Main Results:

  • In cohort A (BRCA1/2, ATM alterations), olaparib significantly extended median progression-free survival (7.4 vs. 3.6 months) and improved objective response rates.
  • Overall survival showed a trend favoring olaparib, with high crossover rates from the control arm.
  • Significant benefits for olaparib were observed in the overall study population (cohorts A and B) for progression-free survival.

Conclusions:

  • Olaparib demonstrated superior efficacy over enzalutamide or abiraterone in men with mCRPC and HRR gene alterations.
  • The study supports olaparib as a targeted therapy option for prostate cancer patients with specific DNA repair defects.
  • Key toxicities associated with olaparib included anemia and nausea.