Specific Toxicity of Maintenance Olaparib Versus Placebo in Advanced Malignancies: A Systematic Review and Meta-analysis

Anticancer Res. 2020 Feb;40(2):597-608. doi: 10.21873/anticanres.13989.

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.

Keywords: Olaparib; PARP; anemia; fatigue; meta-analysis; randomized clinical trial; review.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Antineoplastic Agents / toxicity*
  • Humans
  • Neoplasms / drug therapy*
  • Phthalazines / toxicity*
  • Piperazines / toxicity*
  • Placebos / toxicity*
  • Poly(ADP-ribose) Polymerase Inhibitors / toxicity*

Substances

  • Antineoplastic Agents
  • Phthalazines
  • Piperazines
  • Placebos
  • Poly(ADP-ribose) Polymerase Inhibitors
  • olaparib