Olaparib Maintenance Prolongs PFS Compared With Placebo in Newly Diagnosed Advanced Ovarian Cancer
Olaparib maintenance therapy after platinum chemotherapy substantially prolonged PFS compared with placebo in newly diagnosed advanced ovarian cancer.
|The following article features coverage from the European Society for Medical Oncology (ESMO) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Maintenance therapy with olaparib decreased the risk of progression or death by 70% compared with placebo among women with newly diagnosed advanced ovarian cancer harboring a BRCA1/2 mutation, according to results from the phase 3 SOLO1 trial presented at the ESMO 2018 Congress in Munich, Germany, and simultaneously published in the New England Journal of Medicine.1,2
Relapse of advanced ovarian cancer commonly occurs within 3 years after standard treatment. The PARP inhibitor olaparib is effective in relapsed disease, but it is unknown whether maintenance therapy in newly diagnosed advanced ovarian cancer can improve outcomes. The purpose of this trial was to evaluate the outcomes of maintenance olaparib in this population.
In the international, double-blind, phase 3 SOLO1 trial, 391 patients were randomly assigned in a 2:1 ratio to receive 300 mg of olaparib twice daily or placebo. All patients had newly diagnosed stage III or stage IV high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer harboring a BRCA1/2 mutation, who had all achieved a complete or partial response to platinum-based chemotherapy. The primary end point was progression-free survival (PFS).
Olaparib maintenance therapy significantly prolonged PFS during a median follow-up of 41 months, with a 3-year rate of 60% compared with 27% with placebo (hazard ratio, 0.30; 95% CI, 0.23-0.41; P< .001).
There were no new safety signals with olaparib; results were consistent with previously known toxicities.
The authors concluded that “the use of maintenance therapy with olaparib provided a substantial benefit with regard to PFS among women with newly diagnosed advanced ovarian cancer and a BRCA1/2 mutation.”
Disclosure: This study was funded by pharmaceutical companies. For a full list of disclosures, please refer to the study.
Read more of Cancer Therapy Advisor's coverage of the ESMO 2018 meeting by visiting the conference page.
- Moore KN, et al. Maintenance olaparib following platinum-based chemotherapy in newly diagnosed patients (pts) with advanced ovarian cancer (OC) and a BRCA1/2 mutation (BRCAm): phase III SOLO1 trial. Presented at: the ESMO 2018 Congress; Munich, Germany: October 19-23, 2018. Abstract LBA7_PR.
- Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer[published online October 21, 2018]. N Engl J Med. doi: 10.1056/NEJMoa1810858