Olaparib Tablets as Maintenance in BRCA1/2-Mutant Relapsed Ovarian Cancer

Get Permission

Eric Pujade-Lauraine, MD

Eric Pujade-Lauraine, MD

A phase III trial (SOLO2/ENGOT-Ov21) has shown improved progression-free survival with an olaparib tablet formulation vs placebo as maintenance therapy in patients with BRCA1/2-mutant platinum-sensitive relapsed ovarian cancer. These study results were reported by Eric Pujade-Lauraine, MD, of the Université Paris Descartes, and colleagues in The Lancet Oncology. A capsule formulation is currently approved in the United States; the new tablet formulation could reduce the total daily pill burden from 16 capsules to 4 tablets. 

In the double-blind trial, 295 patients with relapsed high-grade serous ovarian cancer or high-grade endometrioid cancer who had received at least 2 lines of previous chemotherapy regimens were randomized 2:1 between September 2013 and November 2014 to receive olaparib at 300 mg/d (two 150-mg tablets twice daily; n = 196) or matching placebo tablets (n = 99). Randomization was stratified by response to previous platinum chemotherapy and length of platinum-free interval. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. The trial is ongoing. 

Survival and Adverse Events 

Median follow-up was 22 months. Median progression-free survival was 19.1 months in the olaparib group vs 5.5 months in the placebo group (hazard ratio [HR] = 0.30, P < .0001). Overall survival data are not yet mature (24% of planned events for analysis); median overall survival has not been reached in either group, with death occurring in 23% vs 27% (HR = 0.80, P = .43). 

The most common grade ≥ 3 adverse events in the olaparib group were anemia (19% vs 2% of the placebo group), fatigue/asthenia (4% vs 2%), and neutropenia (5% vs 4%). Serious adverse events occurred in 18% vs 8%, with the most common in the olaparib group being anemia (4%), abdominal pain (2% patients), and intestinal obstruction (2%). One patient in the olaparib group died of an adverse event considered related to treatment (acute myeloid leukemia). 

The investigators concluded: “Olaparib tablet maintenance treatment provided a significant progression-free survival improvement with no detrimental effect on quality of life in patients with platinum-sensitive, relapsed ovarian cancer, and a BRCA1/2 mutation. Apart from anaemia, toxicities with olaparib were low grade and manageable.” 

The study was funded by AstraZeneca. 

Pujade-Lauraine E, et al: Lancet Oncol 18:1274-1284, 2017. 




By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.