Phase II trial of vinorelbine and oxaliplatin as first-line therapy in malignant pleural mesothelioma

Lung Cancer. 2005 Feb;47(2):277-81. doi: 10.1016/j.lungcan.2004.08.005.


The incidence of malignant pleural mesothelioma (MPM) is increasing. Treatment options are limited, although recently published data have offered cause for optimism. We reported a response rate of 24% with low toxicity for single agent vinorelbine. Here we report a phase II trial of vinorelbine with oxaliplatin (VO) in patients with untreated MPM. Chemotherapy consisted of vinorelbine 30 mg/m(2), days 1 and 8 of a 21-day-cycle, and oxaliplatin 130 mg/m(2), day 1. Treatment continued up to six cycles. The primary endpoint was objective response. Secondary endpoints were toxicity, progression-free and overall survival. Responses were assessed by modified RECIST criteria. Twenty-six patients were enrolled. There were six partial remissions, 17 patients with stable disease, and three patients with PD. Response rate was 23% (95% confidence interval 9-44%). Median number of cycles delivered was four. Progression-free survival from first treatment was 4.7 months, and overall survival was 8.8 months. One-year-survival was 27%. Toxicity (% of patients with at least one episode of grade 3 or 4 toxicity): neutropenia 18%, phlebitis 12%, malaise 12%, anorexia 12%, nausea and vomiting 12%, constipation 6%. Quality of life assessed by Rotterdam symptom checklist was associated with stabilization or improvement of psychological well-being and lung symptoms in the majority of patients, but deterioration in physical symptoms.

Conclusion: VO has activity in MPM with most patients responding or having stable disease, although this doublet is associated with significant toxicity.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Disease Progression
  • Female
  • Humans
  • Male
  • Mesothelioma / drug therapy*
  • Mesothelioma / pathology
  • Middle Aged
  • Organoplatinum Compounds / administration & dosage
  • Oxaliplatin
  • Pleural Neoplasms / drug therapy*
  • Pleural Neoplasms / pathology
  • Survival Analysis
  • Treatment Outcome
  • Vinblastine / administration & dosage
  • Vinblastine / analogs & derivatives*
  • Vinorelbine


  • Organoplatinum Compounds
  • Oxaliplatin
  • Vinblastine
  • Vinorelbine