Higher rates of invasive disease-free survival seen in adjuvant setting for HER2-negative early-stage disease with germline BRCA1<\/em> or BRCA2<\/em> mutations<\/p>\n<\/h3>\n <\/b><\/p>\n <\/b><\/p>\n FRIDAY, June 4, 2021 (HealthDay News) — The addition of therapy with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib in an adjuvant setting improves invasive disease-free survival in early-stage human epidermal growth factor receptor 2 (HER2)-negative breast cancer with germline BRCA1 <\/em>or BRCA2 <\/em>mutations, according to a study scheduled for presentation June 6 at the American Society of Clinical Oncology annual meeting and simultaneously published June 3 in the New England Journal of Medicine<\/em>.<\/p>\n Andrew Tutt, M.B., Ch.B., Ph.D., from King’s College London in the United Kingdom, and colleagues conducted a randomized phase 3 trial involving 1,836 patients with high-risk early breast cancer that was negative for HER2 and had germline BRCA1<\/em> or BRCA2<\/em><\/em> mutations. All patients had received standard adjuvant or neoadjuvant chemotherapy, surgery, and radiation therapy if needed. Participants were randomly assigned to receive one year of continuous oral olaparib or placebo.<\/p>\n The researchers found that the independent data monitoring committee recommended data unblinding as the interim analysis at a median follow-up of 2.5 years indicated a significant benefit for olaparib versus placebo for invasive disease-free survival (hazard ratio, 0.58). Three-year invasive disease-free survival was 85.9 versus 77.1 percent. There was significant improvement in distant disease-free survival (DDFS) with olaparib versus placebo (hazard ratio, 0.57); three-year DDFS was 87.5 versus 80.4 percent. Overall survival was longer for olaparib, but the difference was not statistically significant at an interim analysis.<\/p>\n “The OlympiA study results, the first reporting the effects of a PARP inhibitor as an ‘adjuvant therapy’ on survival endpoints, suggest a possible addition to the standard of care,” Tutt said in a statement.<\/p>\n Several authors disclosed ties to the biopharmaceutical and medical device industries, including AstraZeneca, which funded the study; one author submitted a European patent request.<\/p>\n Abstract<\/a><\/p>\n More Information<\/a><\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n