Population-adjusted indirect treatment comparison of the SOLO1 and PAOLA-1/ENGOT-ov25 trials evaluating maintenance olaparib or bevacizumab or the combination of both in newly diagnosed, advanced BRCA-mutated ovarian cancer

Ignace Vergote, Isabelle Ray-Coquard, Daniel M. Anderson, Guilherme Cantuaria, Nicoletta Colombo, Claire Garnier-Tixidre, Lucy Gilbert, Philipp Harter, Robert Hettle, Domenica Lorusso, Johanna Mäenpää, Christian Marth, Koji Matsumoto, Mario Ouwens, Andrés Poveda, Francesco Raspagliesi, Kirsty Rhodes, María J. Rubio Pérez, Ronnie Shapira-Frommer, Ayumi ShikamaMagdalena Sikorska, Kathleen Moore, Paul DiSilvestro

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Abstract

Background: 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). Methods: An 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. Results: Data 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). 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.

Original languageEnglish
Pages (from-to)415-423
Number of pages9
JournalEuropean Journal of Cancer
Volume157
DOIs
Publication statusPublished - 2021
Publication typeA1 Journal article-refereed

Keywords

  • Bevacizumab
  • BRCA mutation
  • Newly diagnosed
  • Olaparib
  • Ovarian cancer

Publication forum classification

  • Publication forum level 2

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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