Time to second progression (PFS2) and second subsequent therapy (TSST) for patients (pts) with newly diagnosed, advanced ovarian cancer (OC) and a BRCA mutation (BRCAm) treated …

A Oaknin,K Moore,N Colombo,G Scambia,B-G Kim,M Friedlander, A Lisyanskaya,A Floquet,A Leary,GS Sonke,C Gourley,S Banerjee,AM Oza, A González-Martín,C Aghajanian,W Bradley, ES Lowe, R Bloomfield, P DiSilvestro

Annals of Oncology(2019)

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摘要
BackgroundSOLO1 (NCT01844986; GOG-3004) pts with newly diagnosed, advanced OC and a BRCAm treated with mt ola had a substantial progression-free survival benefit vs placebo (pbo) (HR 0.30 [95% CI 0.23–0.41], P < 0.001; Moore et al. NEJM 2018). The impact of first line use of PARP inhibitors (PARPi) on subsequent therapy is of clinical interest. Secondary objectives included PFS2 and TSST, which indicate the effect of treatment beyond first progression.MethodsPts were randomized 2:1 to ola 300 mg bid or pbo for up to 2 years or until disease progression. After first progression, PFS2 was assessed every 12 weeks (radiological, CA125 or clinical progression).ResultsThere were 121 PFS2 events (HR 0.50, 95% CI 0.35–0.72, median PFS2 was not reached (NR) [ola] vs 41.9 months [m; pbo]). Median TSST was NR (ola) vs 40.7 m (pbo; HR 0.45, 95% CI 0.32–0.63). Based on Kaplan-Meier estimates, at …
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