title: Phase II trial of vinorelbine and oxaliplatin as first-line therapy in malignant pleural mesothelioma.
abstract: 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.
  
  
  CONCLUSIONS
  VO has activity in MPM with most patients responding or having stable disease, although this doublet is associated with significant toxicity.
authors.affiliation: Lung and Mesothelioma Unit, Department of Medical Oncology, St Bartholomew's Hospital, West Smithfield, London EC1A 7BE, United Kingdom. d.a.fennell@qmul.ac.uk
authors.forename: Dean A
authors.initials: DA
authors.lastname: Fennell
authors.forename: Jeremy P
authors.initials: JP
authors.lastname: C Steele
authors.forename: Jonathan
authors.initials: J
authors.lastname: Shamash
authors.forename: Michael T
authors.initials: MT
authors.lastname: Sheaff
authors.forename: Marie T
authors.initials: MT
authors.lastname: Evans
authors.forename: Tyronne I
authors.initials: TI
authors.lastname: Goonewardene
authors.forename: Maria L
authors.initials: ML
authors.lastname: Nystrom
authors.forename: N H
authors.initials: NH
authors.lastname: Gower
authors.forename: Robin M
authors.initials: RM
authors.lastname: Rudd
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008654:Mesothelioma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010997:Pleural Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D014747:Vinblastine; D000077235:Vinorelbine