Olaparib wins early BRCA mutation-positive breast cancer

The addition of olaparib (Lynparza) to standard treatment significantly improved disease-free survival (DFS) in early-risk, high-risk, HER2-negative breast cancer and germline patients. BRCA Mutations, according to the results of Phase III trials.

Interim results from the OlympiA trial showed that patients receiving PARP inhibitors had a 42% reduced risk of invasive DFS compared to patients receiving placebo (HR 0.58, 95% CI 0.41-0.82). It showed a 43% reduction in the risk of distant metastases. DFS (HR 0.57, 95% CI 0.39-0.83) reported Andrew Tat (MB, ChB, PhD) at the Cancer Institute and King’s College in London.

“The OlympiA study is the first to report that the PARP inhibitor olaparib is beneficial as an adjunct therapy to early germline. BRCA-“Related cancers,” Tut said at a pre-conference press conference. American Society of Clinical Oncology (ASCO) Virtual conference. “These results show that one year of standard treatment after olaparib has brought significant benefits to the germline. BRCA-Mutant carriers at high risk of recurrence and HER2-negative breast cancer. “

The decrease in DFS was “statistically very significant because it had to meet the rigorous criteria of the interim analysis,” Tutt said.

The survey results were announced at the same time. New England Journal of Medicine..

Although the outcomes of most patients with early-stage breast cancer and germline are generally good, BRCA1Some people are at increased risk of recurrence with the standard-treated / 2 mutation. “Therefore, additional or adjuvant new targeted therapies are needed,” Tutt said.

“These results are very important because 5% of all breast cancers are associated with breast cancer. BRCA1 / 2 In addition to showing the reduction of invasive recurrence and distant disease with olaparib, the study “further emphasizes the importance of genetic testing,” said ASCO President Dr. Lori J. Pierce. Administer to the appropriate patient to find out which patients will benefit from this treatment. “

“I think it may even open the door to additional trials of adjuvant PARP inhibitors for other patients. BRCA1 / 2-Related cancers, “Pierce added.

Olaparib is already Approved in metastatic setting In germline BRCA Mutant carrier, OlympiA, contains germline BRCA Mutant carrier of HER2-negative early-stage breast cancer. This randomized, double-blind study enrolled 1,836 patients who had already received standard postoperative adjuvant chemotherapy or preoperative chemotherapy, surgery, and radiation therapy.

Patients were randomly assigned to receive either olaparib or placebo for one year, and the primary endpoint was invasive DFS (local recurrence of breast cancer, metastatic recurrence of breast cancer, other new cancers, and any cause). It was a combination of deaths due to). Secondary endpoints included overall survival and distant DFS (a combination of metastatic breast cancer, new cancers, and death from any cause).

At a median 2.5-year follow-up, an estimated 3-year invasive DFS in patients receiving standard treatment and olaparib was 85.9% compared to 77.1% of patients who received standard treatment plus placebo. Remote DFS also improved with olaparib (87.5% vs. 80.4% placebo).

The estimated 3-year overall survival was also higher in olaparib than in placebo (92.0% vs. 88.3%), but there was no statistically significant difference, which is inevitable given early follow-up, Tutt said. explained.

Tutt reported that the adverse events (AEs) of olaparib were consistent with those already indicated in previous studies and approved labels. The more common and serious AEs (grade 3 and above) in olaparib included anemia, low white blood cell levels, and fatigue. Olaparib did not increase serious AEs such as hospitalization and the development of leukemia and other cancers, Tutt said.