Maintenance Olaparib in Newly Diagnosed Advanced Ovarian Cancer
Posted: Tuesday, January 22, 2019
Findings from a phase III SOLO-1 clinical trial, published in The New England Journal of Medicine, indicate that olaparib as maintenance treatment provides a significant survival benefit for patients with newly diagnosed advanced high-grade ovarian cancer. In fact, Kathleen Moore, MD, of the Stephenson Cancer Center at the University of Oklahoma, and colleagues noted that some patients were able to stop receiving treatment at 2 years and to live without disease progression for months without treatment.
“The use of maintenance therapy with olaparib provided a substantial benefit with regard to progression-free survival among women with newly diagnosed advanced ovarian cancer and a BRCA1/2 mutation, with a 70% lower risk of disease progression or death with olaparib than with placebo,” concluded the investigators.
The double-blind study included 391 patients with newly diagnosed advanced serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with a BRCA1, BRCA2, or BRCA1/2 mutation. All patients had achieved a partial or complete response after platinum-based chemotherapy. Participants were randomly assigned to receive either 300 mg of olaparib twice daily (n = 260) or placebo (n = 131). Most of the patients (388) had a centrally confirmed germline BRCA1/2 mutation.
At a median follow-up of 41 months, participants receiving olaparib had a 70% lower risk of disease progression than those taking placebo (hazard ratio for disease progression or death = 0.30%; P < .001). The Kaplan-Meier estimate of the rate of progression-free survival at 3 years was 60% for the olaparib group versus 27% for the placebo group. Toxicities were as expected for the use of olaparib, with the most common adverse events of any grade being nausea (77% olaparib vs. 38% placebo) and fatigue (63% olaparib vs. 42% placebo).
Disclosure: The study authors’ disclosure information may be found at nejm.org.