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Olaparib (Lynparza) BRCA Testing
July 14, 2021
DELRAY BEACH, FL – Earlier this month, Phase III OlympiA trial results were published in the New England Journal of Medicine for the adjuvant treatment of PARP inhibitor olaparib (Merck/AstraZeneca’s Lynparza). These results demonstrated significant delay in cancer progression in germline BRCA1/2-mutated, early-stage, HER2-negative breast cancer patients. The study results show 85.9 percent of patients who received olaparib as an adjuvant were invasive disease-free and 87.5 percent were free of distant disease recurrence versus 77.1 and 80.4 percent for the placebo group, respectively.1 More importantly, and potentially more meaningful, only 59 patients have passed away in the adjuvant group compared to 86 patients in the placebo group1, out of a total of 1836 patients. This data, even though trending positively, will continue to be compiled and monitored.
This has reawakened the conversation about the need to universally offer germline genetic testing to all breast cancer patients. “If the FDA approves olaparib in the adjuvant setting for early-stage BRCA1/2-mutated breast cancer patients, it will most likely trigger a reevaluation of current guidelines on when to test patients for these mutations,” even though several organizations like the National Comprehensive Cancer Network (NCCN) and the American Society of Breast Surgeons already recommend genetic testing for all breast cancer patients.2 Despite the evidence supporting early assessment of gene mutations in breast cancer patients, “studies have shown that less than 10 percent of adults with BRCA1/2 mutation in the US have been identified, and less than 20 percent of breast and ovarian cancer patients who should receive testing according to current guidelines are actually receiving it,” which could have deadly consequences.2 Using this data, not offering a patient the genetic test necessary and individualizing their treatment plan could drastically alter their disease trajectory and outcome. Nadine Tung, the director of Beth Israel Deaconess Medical Center’s cancer risk and prevention program, sadly states, “unfortunately, less than half of patients with breast cancer who qualify for germline genetic testing [by NCCN criteria] are offered testing.”2
Tutt ANJ, Garber JE, Kaufman B, et al. Adjuvant Olaparib for Patients with BRCA1– or BRCA2-Mutated Breast Cancer [published online ahead of print, 2021 Jun 3]. N Engl J Med. 2021;10.1056/NEJMoa2105215. doi:10.1056/NEJMoa2105215
Hopkins C. Lynparza Benefit in Early BRCA-Mutated Breast Cancer Reignites Universal Genetic Testing Discussion. Precision Oncology News. https://www.precisiononcologynews.com/cancer/lynparza-benefit-early-brca-mutated-breast-cancer-reignites-universal-genetic-testing#.YMNzsflKjIV. Published June 7, 2021. Accessed June 11, 2021.