RT Journal Article
T1 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.
A1 Vergote, Ignace
A1 Ray-Coquard, Isabelle
A1 Anderson, Daniel M
A1 Cantuaria, Guilherme
A1 Colombo, Nicoletta
A1 Garnier-Tixidre, Claire
A1 Gilbert, Lucy
A1 Harter, Philipp
A1 Hettle, Robert
A1 Lorusso, Domenica
A1 Mäenpää, Johanna
A1 Marth, Christian
A1 Matsumoto, Koji
A1 Ouwens, Mario
A1 Poveda, Andrés
A1 Raspagliesi, Francesco
A1 Rhodes, Kirsty
A1 Rubio Pérez, María J
A1 Shapira-Frommer, Ronnie
A1 Shikama, Ayumi
A1 Sikorska, Magdalena
A1 Moore, Kathleen
A1 DiSilvestro, Paul
K1 BRCA mutation
K1 Bevacizumab
K1 Newly diagnosed
K1 Olaparib
K1 Ovarian cancer
AB 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). 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. 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). 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.
YR 2021
FD 2021-09-28
LK http://hdl.handle.net/10668/18587
UL http://hdl.handle.net/10668/18587
LA en
DS RISalud
RD Apr 7, 2025