title: Randomized phase II trial of cisplatin with mitomycin or doxorubicin for malignant mesothelioma by the Cancer and Leukemia Group B.
abstract: OBJECTIVE
  The Cancer and Leukemia Group B (CALGB) conducted a randomized phase II multicenter trial to evaluate the activity of two cisplatin-containing regimens (cisplatin and mitomycin [CM], or cisplatin and doxorubicin [CD]) in patients with malignant pleural or peritoneal mesothelioma (protocol CALGB 8435).
  
  
  METHODS
  Seventy-nine patients were entered between June 1984 and October 1986. Eligibility included a performance status of 0 to 2 by CALGB criteria, and no prior chemotherapy. Central pathology review was performed. Randomization was stratified according to the cell type (epithelial v mixed or sarcomatous) and the presence of measurable versus assessable disease. Of the 79 patients entered, 70 were included in this analysis (35 on CM and 35 on CD), including 48 with epithelial cell type and 22 with mixed or sarcomatous cell types. Sixty-six patients had pleural mesothelioma and four had peritoneal mesothelioma. There were 34 cases with measurable disease and 36 with assessable disease.
  
  
  RESULTS
  The overall response rate was 26% for CM (two complete responses [CRs], three partial responses [PRs], and four regressions) and 14% for CD (four PRs and one regression). Median time to treatment failure was 3.6 months for CM and 4.8 months for CD, and median survival duration from study entry was 7.7 and 8.8 months, respectively, with no significant differences between treatments. Good performance status (0 or 1) was associated with significantly longer survival duration (P = .013). Both regimens were well tolerated and there were no treatment-related deaths due to toxicity.
  
  
  CONCLUSIONS
  Moderate antitumor activity has been observed with both regimens. In this randomized phase II trial, the overall response rates, time to treatment failure, and overall survival appear to be similar for the two regimens tested.
authors.affiliation: Department of Neoplastic Diseases, Mount Sinai School of Medicine, New York.
authors.forename: A P
authors.initials: AP
authors.lastname: Chahinian
authors.forename: K
authors.initials: K
authors.lastname: Antman
authors.forename: M
authors.initials: M
authors.lastname: Goutsou
authors.forename: J M
authors.initials: JM
authors.lastname: Corson
authors.forename: Y
authors.initials: Y
authors.lastname: Suzuki
authors.forename: C
authors.initials: C
authors.lastname: Modeas
authors.forename: J E
authors.initials: JE
authors.lastname: Herndon
authors.forename: J
authors.initials: J
authors.lastname: Aisner
authors.forename: R R
authors.initials: RR
authors.lastname: Ellison
authors.forename: L
authors.initials: L
authors.lastname: Leone
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008654:Mesothelioma / Q000188:drug therapy*; D008875:Middle Aged; D008937:Mitomycins / Q000008:administration & dosage; D010534:Peritoneal Neoplasms / Q000188:drug therapy; D010997:Pleural Neoplasms / Q000188:drug therapy; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D008937:Mitomycins; D004317:Doxorubicin; D002945:Cisplatin