ALEXANDRIA, Va. — A new American Society of Clinical Oncology (ASCO) guideline update recommends offering 1 year of adjuvant olaparib to patients with high-risk early-stage human epidermal growth factor receptor 2 (HER2)-negative breast cancer and germline BRCA mutations after completion of (neo)adjuvant chemotherapy and local treatment, including radiation. The recommendations update the 2020 guideline from ASCO, the American Society for Radiation Oncology (ASTRO), and the Society of Surgical Oncology (SSO) published on the management of hereditary breast cancer.¹

The updated recommendation is the result of a new ASCO initiative aimed at providing clinicians with timely and practical guidance that reflects the latest practice-changing research. This recommendation update incorporates evidence from the OlympiA randomized controlled trial following presentation at the 2021 ASCO Annual Meeting and publication in the New England Journal of Medicine on June 3, 2021.²

“Guideline updates have traditionally required months to review new data, assemble an expert panel, develop, approve, and publish recommendations — making it difficult to provide timely support to clinicians seeking to keep abreast of rapidly advancing research. ASCO’s new rapid guideline updating strategy is meant to address this need by providing rapid evidence review and dissemination of practice-changing trial results,” said ASCO Chief Executive Officer Clifford A. Hudis, MD, FACP, FASCO.

OlympiA trial authors reported a significant improvement in invasive and distant disease-free survival with adjuvant use of the poly (adenosine diphosphate–ribose) polymerase (PARP) inhibitor olaparib compared with placebo in patients with early-stage, HER2–negative breast cancer with high risk of recurrence and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants.² These clear and positive data prompted ASCO to issue a provisional update of the guideline recommendation focused specifically on the role of olaparib in this setting.

“The findings from the OlympiA trial — presented just last week — mark a significant improvement in the care of these patients. ASCO’s Expert Guideline Panel and Evidence-based Medicine Committee noted this and then quickly produced and provisionally approved this guideline update to enable patients to begin to benefit from this research advance as quickly as possible," said Julie Gralow, MD, FACP, FASCO, ASCO Executive Vice President and Chief Medical Officer.

With provisional ASCO approval, a formal assessment and submission for publication in the Journal of Clinical Oncology will follow; the guideline update is now available at https://www.asco.org/research-guidelines/quality-guidelines/guidelines/breast-cancer#143725.

2021 Updated Recommendation:

For patients with early-stage, human epidermal growth factor receptor 2 (HER2)–negative breast cancer with high risk of recurrence and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants, one year of adjuvant olaparib should be offered after completion of (neo)adjuvant chemotherapy and local treatment, including radiation. For those who had surgery first, adjuvant olaparib is recommended for patients with TNBC and tumor size > 2 cm or any involved axillary nodes.

For patients with hormone receptor-positive disease, adjuvant olaparib is recommended for those with at least four involved axillary lymph nodes. For patients who had neoadjuvant chemotherapy, adjuvant olaparib is recommended for patients with TNBC and any residual cancer. Adjuvant olaparib is recommended for patients with residual disease and an estrogen receptor status and tumor grade (CSP+EG) score ≥3. 

Information about breast cancer is available for patients at Cancer.Net.

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References 

1. Tung NM, Boughey JC, Pierce LJ, et al: Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline. J Clin Oncol 38:2080-2106, 2020 
2. Tutt ANJ, Garber JE, Kaufman B, et al: Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med, 2021