Quality-of-Life and Patient-Centered Outcomes With Olaparib Maintenance in Relapsed Ovarian Cancer
In the phase III SOLO2 trial reported in The Lancet Oncology, Friedlander et al found that olaparib maintenance therapy did not worsen health-related quality of life vs placebo in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1 or BRCA2 mutation. In the study, maintenance therapy with olaparib tablets significantly prolonged progression-free survival vs placebo in patients who had received at least two prior lines of chemotherapy.
SOLO2 Details
In the trial, 196 patients were randomized to receive olaparib tablets at 300 mg twice daily and 99 to placebo. The most common adverse events of any grade in the olaparib group were nausea, vomiting, and fatigue. The prespecified primary health-related quality of life analysis was change from baseline in the Trial Outcome Index (TOI) score during the first 12 months.
Other planned quality-of-life analyses included the patient-centered outcomes of duration of good quality of life—defined as time without significant symptoms of toxicity (TWiST)—and quality-adjusted progression-free survival (QAPFS). TWiST was defined as time without significant symptoms of toxicity (grade ≥ 2 nausea, vomiting, or fatigue) after randomization and before disease progression. QAPFS is the product of the adjusted mean estimate of the EuroQol five-dimensions five-level (EQ-5D-5L) single-index utility score from randomization to disease progression and the area under the Kaplan-Meier curve for time to progression.
Quality-of-Life Outcomes
Mean TOI scores at baseline were 75.26 in the olaparib group and 77.12 in the placebo group. The adjusted average mean change from baseline over the first 12 months in TOI was –2.90 vs –2.87 (estimated difference= –0.03, P = .98). Mean duration of QAPFS was 13.96 months vs 7.28 months (difference = 6.68 months, P < .0001). Mean duration of TWiST was 15.03 months vs7.70 months (difference = 7.33 months, P <.0001).
The investigators concluded, “Olaparib maintenance therapy did not have a significant detrimental effect on [health-related quality of life] compared with placebo. There were clinically meaningful patient-centred benefits in both TWiST and QAPFS despite the adverse effects associated with olaparib. These patient-centred endpoints support the improvement in progression-free survival, the primary endpoint in SOLO2, and should be included in future trials of maintenance therapies.”
Michael Friedlander, MBChB, of the University of New South Wales Clinical School, is the corresponding author for The Lancet Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
