Abstract
BackgroundIn the absence of randomised head-to-head trials, we conducted a population-adjusted indirect treatment comparison (PA-ITC) of phase III trial data to evaluate the relative efficacy and safety of maintenance olaparib and bevacizumab alone and in combination in patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation (BRCAm). MethodsAn unanchored PA-ITC was performed on investigator-assessed progression-free survival (PFS) data. Individual patient data from SOLO1 (olaparib versus placebo) and from BRCA-mutated patients in PAOLA-1/ENGOT-ov25 (olaparib plus bevacizumab versus placebo plus bevacizumab) were pooled. Each arm of PAOLA-1 was weighted so that key baseline patient characteristics were similar to the SOLO1 cohort. Analyses were performed in patients with complete baseline data. Weighted Cox regression analysis was used to estimate the comparative efficacy of different maintenance therapy strategies, supplemented by weighted Kaplan–Meier analyses. ResultsData from SOLO1 patients (olaparib, n = 254; placebo, n = 126) were compared with data from BRCA-mutated PAOLA-1 patients (olaparib plus bevacizumab, n = 151; placebo plus bevacizumab, n = 71). Adding bevacizumab to olaparib was associated with a numerical improvement in PFS compared with olaparib alone (hazard ratio [HR] 0.71; 95% confidence interval [CI] 0.45–1.09). Statistically significant improvements in PFS were seen with olaparib alone versus placebo plus bevacizumab (HR 0.48; 95% CI 0.30–0.75), olaparib plus bevacizumab versus placebo (0.23; 0.14–0.34), and placebo plus bevacizumab versus placebo (0.65; 0.43–0.95). ConclusionsResults of this hypothesis-generating PA-ITC analysis support the use of maintenance olaparib alone or with bevacizumab in patients with newly diagnosed, advanced ovarian cancer and a BRCAm.
Highlights
The majority of women with newly diagnosed, advanced ovarian cancer relapse within 3 years despite undergoing cytoreductive surgery and first-line platinum-based chemotherapy [1]
Results of this hypothesis-generating population-adjusted indirect treatment comparison (PA-ITC) analysis support the use of maintenance olaparib alone or with bevacizumab in patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation (BRCAm). a 2021 The Authors
Maintenance olaparib is approved in various countries for women with advanced ovarian cancer and a BRCAm who are in response after first-line platinumbased chemotherapy [5e8]
Summary
The majority of women with newly diagnosed, advanced ovarian cancer relapse within 3 years despite undergoing cytoreductive surgery and first-line platinum-based chemotherapy [1]. In the primary analysis of the SOLO1 trial (NCT01844986; GOG 3004), maintenance olaparib provided a significant progression-free survival (PFS) benefit versus placebo in newly diagnosed, BRCAmutated advanced ovarian cancer (hazard ratio [HR] 0.30; 95% confidence interval [CI] 0.23e0.41) [3]. In the absence of randomised head-to-head trials, we conducted a population-adjusted indirect treatment comparison (PA-ITC) of phase III trial data to evaluate the relative efficacy and safety of maintenance olaparib and bevacizumab alone and in combination in patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation (BRCAm). Conclusions: Results of this hypothesis-generating PA-ITC analysis support the use of maintenance olaparib alone or with bevacizumab in patients with newly diagnosed, advanced ovarian cancer and a BRCAm. a 2021 The Authors.
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