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Clinical Research
New Findings Offer Improved Therapy for Early-Stage, BRCA Mutation-Associated Breast Cancer
New findings from a multi-national investigation of a new treatment demonstrate it has the potential to improve the outcomes for patients with hereditary BRCA mutations and high-risk, early-stage breast cancer. These results represent the first time a Poly(ADP-ribose)-polymerase (PARP) inhibitor has been shown to significantly reduce the risk of breast cancer returning in high-risk patients following completion of standard chemotherapy, surgery and radiation therapy.
The paper, “Adjuvant Olaparib for Patients with BRCA1 or BRCA2 Mutated Breast Cancer,” appears in the June 3 issue of the New England Journal of Medicine and was presented on June 6 as the first abstract during the plenary session at the 2021 American Association of Clinical Oncology (ASCO) Annual Meeting.
Led by top experts in BRCA-associated breast cancer from around the world, the OlympiA trial’s co-chairs were Charles E. Geyer, Jr., M.D., a breast medical oncologist and deputy director of the Houston Methodist Cancer Center, Judy E. Garber, M.D., M.P.H., of the Dana-Farber Cancer Institute, and Bella Kaufman, M.D., of the Sheba Medical Center in Israel. Geyer was the principal investigator on the NCI-sponsored portion of the study conducted in the U.S. and has provided scientific leadership on the trial since 2013.
OlympiA represents a successful global collaboration among leading international academic breast cancer research groups, cancer genetics experts, the National Cancer Institute and pharmaceutical industry partners to evaluate the efficacy and safety of olaparib to address the unmet need for improved therapy for individuals with high-risk, BRCA mutation-associated early breast cancer.
Charles E. Geyer, Jr., M.D.
Lois E. and Carl A. Davis Centennial Chair in Cancer Research,
Cancer Center Professor of Medicine in Oncology Deputy Director, Cancer Center
Houston Methodist
Weill Cornell Medical College
The OlympiA trial recruited 1,836 patients from 420 centers across 23 countries. A randomized double-blind phase 3 trial, OlympiA was designed to test the efficacy of the PARP inhibitor drug olaparib and showed that it significantly improved invasive and distant disease-free survival when given for 52 weeks following the completion of such standard therapies as chemotherapy, surgery and radiation.
Patients were recruited from June 2014 through May 2019 and patients who consented to participate were randomly assigned to receive olaparib or a placebo. After three years following initiation of treatment with olaparib, 85.9 percent of patients were alive and free of recurrent, invasive breast cancer and new second cancers, compared with 77.1 percent of patients who received a placebo. During this same timeframe, 87.5 percent of patients receiving olaparib were alive and free of distant metastatic disease, compared to 80.4 percent on the placebo.

While olaparib was also associated with 27 fewer deaths than those on placebo, researchers say longer blinded follow up is required to assess the impact of this therapy on overall survival. What is certain, say researchers, is that germline BRCA1 and BRCA2 sequencing is becoming an important biomarker for the selection of systemic therapy in early breast cancer.
The study was supported by funding from the U.S. National Cancer Institute (grants U10CA180868, UG1CA189867, U10CA180822) and AstraZeneca as part of an alliance between AstraZeneca and Merck Sharp & Dohme Corp (ClinicalTrials.gov NCT02032823). The study was coordinated by the Breast International Group in academic partnership with Frontier Science & Technology Research Foundation and NRG Oncology (BIG 6-13, NSABP B-55).
For more information: Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. The New England Journal of Medicine. Andrew N.J. Tutt, M.B., Ch.B., Ph.D., Judy E. Garber, M.D., M.P.H., Bella Kaufman, M.D., Giuseppe Viale, M.D., Debora Fumagalli, M.D., Ph.D., Priya Rastogi, M.D., Richard D. Gelber, Ph.D., Evandro de Azambuja, M.D., Ph.D., Anitra Fielding, M.B., Ch.B., Judith Balmaña, M.D., Ph.D., Susan M. Domchek, M.D., Karen A. Gelmon, M.D., Simon J. Hollingsworth, Ph.D., Larissa A. Korde, M.D., M.P.H., Barbro Linderholm, M.D., Ph.D., Hanna Bandos, Ph.D., Elżbieta Senkus, M.D., Ph.D., Jennifer M. Suga, M.D., Zhimin Shao, M.D., Andrew W. Pippas, M.D., Zbigniew Nowecki, M.D., Ph.D., Tomasz Huzarski, M.D., Ph.D., Patricia A. Ganz, M.D., Peter C. Lucas, M.D., Ph.D., Nigel Baker, M.Sc., Sibylle Loibl, M.D., Ph.D., Robin McConnell, M.Sc., Martine Piccart, M.D., Ph.D., Rita Schmutzler, M.D., Dr.Med.Habil., Guenther G. Steger, M.D., Joseph P. Costantino, Dr.P.H., Amal Arahmani, Ph.D., Norman Wolmark, M.D., Eleanor McFadden, M.A., Vassiliki Karantza, M.D., Ph.D., Sunil R. Lakhani, M.D., Greg Yothers, Ph.D., Christine Campbell, M.Sc., and Charles E. Geyer, Jr., M.D. for the OlympiA Clinical Trial Steering Committee and Investigators* DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa2105215
Lisa Merkl, June 2021
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