Specific Toxicity of Maintenance Olaparib <i>Versus</i> Placebo in Advanced Malignancies: A Systematic Review and Meta-analysis
Angela Dalia Ricci, Alessandro Rizzo, Marco Novelli, Simona Tavolari, Andrea Palloni, Nastassja Tober, Francesca Abbati, Veronica Mollica, Stefania De Lorenzo, Daniela Turchetti, Mariacristina Di Marco, Giovanni Brandi
Abstract
BACKGROUND/AIM: We performed a systematic review and meta-analysis to investigate the safety of maintenance with olaparib after platinum-based chemotherapy in cancer patients. MATERIALS AND METHODS: Eligible studies included randomized controlled trials (RCTs) regarding the clinical role of olaparib maintenance therapy versus placebo in BRCA-mutated, advanced cancers. Safety profile from each selected study was investigated for all-grade and G3-G4 haematological and non-haematological adverse drug events (ADEs). RESULTS: Four RTCs that involved 1099 patients were included in the analysis. Overall incidences of all-grade and G3-4 ADEs in olaparib group were 97.6% and 41%, respectively. Patients treated with maintenance olaparib showed higher risk of all-grade and G3-G4 anaemia, all-grade neutropenia and thrombocytopenia. Moreover, all-grade and G3-G4 fatigue, all-grade vomiting, diarrhoea, nausea and decreased appetite were more common in the olaparib group compared to placebo. CONCLUSION: Despite an increased risk and incidence of several haematological and non-haematological toxicities, olaparib is a relatively safe agent for the treatment of advanced solid tumors. Prompt identification of ADEs is mandatory to avoid therapy discontinuation and optimize treatment.