Conference Proceedings

Adverse events (AEs) with maintenance olaparib tablets in patients (pts) with BRCA-mutated (BRCAm) platinum-sensitive relapsed serous ovarian cancer (PSR SOC): Phase III SOLO2 trial.

Jonathan A Ledermann, Alain Lortholary, Richard T Penson, Emma Gibbs, Diane M Provencher, Ilan Bruchim, Tomas Huzarski, Maria Pilar Barretina-Ginesta, Roberto Sabbatini, Linda R Mileshkin, Nicoletta Colombo, Tjoung-Won Park-Simon, Koji Matsumoto, Gabe S Sonke, Olga N Mikheeva, Jae-Weon Kim, Gustavo Colagiovanni Girotto, Hannelore Denys, Elizabeth S Lowe, Eric Pujade-Lauraine

Journal of Clinical Oncology | American Society of Clinical Oncology (ASCO) | Published : 2017

Abstract

5518 Background: In the SOLO2 trial (ENGOT Ov-21; NCT01874353), maintenance therapy with the PARP inhibitor olaparib significantly improved PFS vs placebo (PBO) in BRCAm PSR SOC pts (HR 0.30, 95% CI 0.22–0.41, Pone pt. Conclusions: Most AEs experienced by pts receiving olaparib tablets in SOLO2 were low grade and manageable. Initial nausea, vomiting and fatigue generally improved with ongoing treatment. The majority of AEs first occurred within the first three months of treatment. AEs causing treatment discontinuation were rare and mainly hematological. Clinical trial information: NCT01874353. [Table: see text]

University of Melbourne Researchers