Impact of Olaparib Maintenance Therapy on Outcomes in Ovarian Cancer
Posted: Tuesday, September 11, 2018
Olaparib maintenance therapy did not worsen health-related quality of life in patients who had recurrent platinum-sensitive ovarian cancer with a BRCA1 or BRCA2 mutation; in fact, it seemed to prolong progression-free survival compared with placebo in those who had received at least two prior lines of chemotherapy. These findings, based on the SOLO2/ENGOT Ov-21 randomized clinical trial, were published in The Lancet Oncology, by Michael Friedlander, MBChB, PhD, of The University of New South Wales Clinical School, Randwick, Australia, and colleagues from various centers around the world.
In this phase III study, 196 patients received olaparib (300-mg tablets twice daily), and 99 patients received placebo. After 12 months, health-related quality of life did not differ significantly between the two groups, as measured by adjusted mean change from baseline of trial outcome index scores (–2.90 vs. –2.87, respectively). Moreover, the duration of good quality of life (defined as the time without significant symptoms of toxicity) improved in the olaparib maintenance therapy group compared with placebo (15.03 months vs. 7.70 months, P < .0001). Similarly, the duration of quality-adjusted progression-free survival also improved in the olaparib group compared with placebo (13.96 months vs. 7.28 months).
The most commonly reported adverse events in patients receiving olaparib were nausea, fatigue, vomiting, diarrhea, dysgeusia, headache, abdominal pain, decreased appetite, and constipation. The authors recommended olaparib maintenance in this patient population despite the associated toxicity profile: “All these predefined endpoints support the benefit to patients of a prolongation of progression-free survival, which is the primary endpoint in maintenance trials in ovarian cancer and should be routinely included in future trials.”