title: Gemcitabine and cisplatin in unresectable malignant mesothelioma of the pleura: a phase II study of the Southwest Oncology Group (SWOG 9810).
abstract: OBJECTIVE
  The purpose of this open-label phase II SWOG study was to evaluate the activity of gemcitabine (Gemzar; Eli Lilly, Indiana, USA) and cisplatin combination therapy, in patients with unresectable malignant mesothelioma of the pleura.
  
  
  METHODS
  Fifty eligible chemotherapy naïve patients with histologically proven malignant mesothelioma of the pleura, and a SWOG performance status 0-2 were enrolled between February 1999 and August 2000. Treatment consisted of gemcitabine 1000mg/m(2) and cisplatin 30mg/m(2) on days 1, 8 and 15 of a 28-day cycle, until progression of disease or two cycles beyond complete response.
  
  
  RESULTS
  Using SWOG response criteria, one patient had a confirmed complete response and five patients had a confirmed partial response, for a total response rate of 12% (95% CI 5-24%). All the responses were seen in patients with epithelioid or unspecified histology. Stable disease was seen in 25 patients (50%). The median overall survival was 10 months (95% CI 7-15 months), with a median progression-free survival of 6 months. Sixteen patients experienced Grade 4 toxicity. Twelve of these Grade 4 toxicities were hematologic. There were no treatment-related deaths.
  
  
  CONCLUSIONS
  Cisplatin-gemcitabine combination chemotherapy has modest activity with an acceptable toxicity profile, as first line treatment for patients with malignant mesothelioma.
authors.affiliation: Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, OH 44195, USA. kalmads@ccf.org
authors.forename: Sujith R
authors.initials: SR
authors.lastname: Kalmadi
authors.forename: Cathryn
authors.initials: C
authors.lastname: Rankin
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Kraut
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Jacobs
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Petrylak
authors.forename: David J
authors.initials: DJ
authors.lastname: Adelstein
authors.forename: Mary Louise
authors.initials: ML
authors.lastname: Keohan
authors.forename: Robert N
authors.initials: RN
authors.lastname: Taub
authors.forename: Ernest C
authors.initials: EC
authors.lastname: Borden
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008654:Mesothelioma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008875:Middle Aged; D010997:Pleural Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine