title: Vinorelbine and gemcitabine as second- or third-line therapy for malignant pleural mesothelioma.
abstract: OBJECTIVE
  Pemetrexed-cisplatin is the only FDA-approved regimen for malignant pleural mesothelioma (MPM), and the impact on survival is modest. No drugs have been shown to improve survival as second-line therapy, yet vinorelbine and gemcitabine are prescribed based on the results of small phase II trials. To augment the existing limited data, we examined our institutional experience with vinorelbine and gemcitabine in patients with previously treated MPM.
  
  
  METHODS
  We reviewed charts of patients with MPM treated with vinorelbine and/or gemcitabine as second- or third-line therapy between 2003 and 2010. Toxicity was graded according to the Common Terminology Criteria for Adverse Events Version 4.0. CT scans were reviewed with a reference radiologist according to modified RECIST criteria.
  
  
  RESULTS
  Sixty patients were identified: 33 treated with vinorelbine, 15 gemcitabine, and 12 both agents. Eighty-three percent initially received pemetrexed-platinum. Toxicity was substantial: 46% experienced at least one episode of grade 3-4 toxicity. Of 56 patients evaluable radiologically, there was 1 partial response (gemcitabine) giving a response rate of 2% (95% CI: 0-10%). Forty-six percent had stable disease. Median progression free survival was 1.7 months for vinorelbine and 1.6 months for gemcitabine. Median overall survival was 5.4 and 4.9 months, respectively.
  
  
  CONCLUSIONS
  Response to second- or third-line vinorelbine or gemcitabine is rare. The high rate of stable disease warrants the continued use of these agents in this setting, though the impact on survival is questionable. These data justify the choice of placebo control arms in randomized trials of novel agents in previously treated patients.
authors.affiliation: Department of Medicine, Division of Solid Tumor Oncology, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, United States. Electronic address: zauderem@mskcc.org.
authors.forename: Marjorie G
authors.initials: MG
authors.lastname: Zauderer
authors.affiliation: Georgetown University School of Medicine, United States.
authors.forename: Samantha L
authors.initials: SL
authors.lastname: Kass
authors.affiliation: Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, United States.
authors.forename: Kaitlin
authors.initials: K
authors.lastname: Woo
authors.affiliation: Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, United States.
authors.forename: Camelia S
authors.initials: CS
authors.lastname: Sima
authors.affiliation: Department of Radiology, Memorial Sloan Kettering Cancer Center, United States.
authors.forename: Michelle S
authors.initials: MS
authors.lastname: Ginsberg
authors.affiliation: Department of Medicine, Division of Solid Tumor Oncology, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, United States.
authors.forename: Lee M
authors.initials: LM
authors.lastname: Krug
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008654:Mesothelioma / Q000188:drug therapy* / Q000401:mortality; D000086002:Mesothelioma, Malignant; D008875:Middle Aged; D010997:Pleural Neoplasms / Q000188:drug therapy* / Q000401:mortality; D012189:Retrospective Studies; D016879:Salvage Therapy / Q000379:methods; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine
keywords: Chemotherapy; Gemcitabine; Mesothelioma; Vinorelbine