The American Society of Clinical Oncology (ASCO) now recommends offering 1 year of adjuvant olaparib therapy to patients with early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.
The change in management of hereditary breast cancer is outlined in an update to 2020 guidelines, and it comes as a “rapid recommendation” on the heels of the phase 3 OlympiA trial results, which indicated a 42% improvement in invasive and distant disease-free survival with the PARP inhibitor olaparib (Lynparza) in comparison with placebo.
The OlympiA trial results, as reported by Medscape Medical News, were presented during the plenary session of the American Society of Clinical Oncology (ASCO) 2021 annual meeting and were published June 3 in The New England Journal of Medicine.
“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,” states an ASCO press release.
The previous 2020 guidelines stated: “There are insufficient data…to recommend a PARP inhibitor for patients with nonmetastatic breast cancer.” The OlympiA trial changed that. ASCO now recommends that patients with early-stage, HER2-negative, BRCA-mutated breast cancer at high risk for recurrence be offered olaparib after completion of chemotherapy and local treatment, including radiotherapy.
The update states: “For those who had surgery first, adjuvant olaparib is recommended for patients with TNBC [triple-negative breast cancer] 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.”
“The findings from the OlympiA trial — presented just last week — mark a significant improvement in the care of these patients,” Julie Garlow, MD, ASCO’s executive vice president and chief medical officer, states in the ASCO press release.
“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,” she said.
A formal assessment and submission for publication in the Journal of Clinical Oncology will follow, the release notes.
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