(ChemotherapyAdvisor) – Adding bevacizumab to chemotherapy regimens that include gemcitabine/cisplatin does not significantly improve progression-free survival (PFS) or overall survival (OS) in patients with advanced metastatic mesothelioma (MM), according to a team of US-based researchers. This conclusion is based on a study entitled “Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase II Trial of Gemcitabine/Cisplatin Plus Bevacizumab or Placebo in Patients With Malignant Mesothelioma,” which was published in the July 10 issue of the Journal of Clinical Oncology.
In this study, the investigators randomized patients (N=115) to receive a combination regimen including gemcitabine (1,250mg/m2, days 1, 8), cisplatin (75mg/m2), and bevacizumab (15mg/kg) or placebo every 21 days for 6 cycles, followed by treatment with bevacizumab or placebo every 21 days until progression. Of the 115 enrollees, 108 patients were evaluable when the primary end point (progression-free survival). Median PFS time was 6.9 months for the bevacizumab arm and 6.0 months for the placebo arm (P=.88). Median overall survival (OS) times were 15.6 and 14.7 months in the bevacizumab and placebo arms, respectively (P=.91). Partial response rates were similar (24.5% for bevacizumab vs 21.8% for placebo; P=.74). A higher pretreatment plasma VEGF concentration (n=56) was associated with shorter PFS (P=.02) and OS (P=.0066), independent of treatment arm. There were no statistically significant differences in toxicity of grade 3 or greater.
The investigators concluded: “The addition of bevacizumab to gemcitabine/cisplatin in this trial did not significantly improve PFS or OS in patients with advanced MM.”