title: Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small-cell lung cancer: A randomized phase III study of the Italian Lung Cancer Project.
abstract: OBJECTIVE
  To compare gemcitabine and cisplatin (GC) with mitomycin, ifosfamide, and cisplatin (MIC) chemotherapy in patients with stage IIIB (limited to T4 for pleural effusion and N3 for supraclavicular lymph nodes) or stage IV non-small-cell lung cancer (NSCLC). The end points were the evaluation of quality of life (QoL), response rates, survival, and toxicity.
  
  
  METHODS
  Three hundred seven patients were randomized to receive either gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 plus cisplatin 100 mg/m(2) on day 2, every 28 days, or mitomycin 6 mg/m(2), ifosfamide 3,000 mg/m(2), and mesna on day 1 plus cisplatin 100 mg/m(2) on day 2, every 28 days. The whole-blood cell count was repeated on day 1 in both arms and weekly in the GC arm before each gemcitabine administration.
  
  
  RESULTS
  No major differences in changes in QoL were observed between the two treatment arms. The objective response rate was 38% in the GC arm compared with 26% in the MIC arm (P =.029). The median survival time was 8.6 months in the GC arm and 9.6 months in the MIC arm (P =.877, log-rank test). Grade 3 and 4 thrombocytopenia was significantly worse in the GC arm (64% v 28%, P <.001), whereas grade 3 and 4 alopecia was reported more commonly in the MIC arm (39% v 12%, P <. 001).
  
  
  CONCLUSIONS
  We report an increased response rate without changes in QoL and a similar overall survival, time to progression, and time to treatment failure for the GC when compared with the MIC regimen in the treatment of advanced NSCLC.
authors.affiliation: Department of Medical Oncology, Policlinico Hospital, Perugia, Italy. scagliotti@ihnet.it
authors.forename: L
authors.initials: L
authors.lastname: Crinò
authors.forename: G V
authors.initials: GV
authors.lastname: Scagliotti
authors.forename: S
authors.initials: S
authors.lastname: Ricci
authors.forename: F
authors.initials: F
authors.lastname: De Marinis
authors.forename: M
authors.initials: M
authors.lastname: Rinaldi
authors.forename: C
authors.initials: C
authors.lastname: Gridelli
authors.forename: A
authors.initials: A
authors.lastname: Ceribelli
authors.forename: R
authors.initials: R
authors.lastname: Bianco
authors.forename: M
authors.initials: M
authors.lastname: Marangolo
authors.forename: F
authors.initials: F
authors.lastname: Di Costanzo
authors.forename: M
authors.initials: M
authors.lastname: Sassi
authors.forename: S
authors.initials: S
authors.lastname: Barni
authors.forename: A
authors.initials: A
authors.lastname: Ravaioli
authors.forename: V
authors.initials: V
authors.lastname: Adamo
authors.forename: L
authors.initials: L
authors.lastname: Portalone
authors.forename: G
authors.initials: G
authors.lastname: Cruciani
authors.forename: A
authors.initials: A
authors.lastname: Masotti
authors.forename: G
authors.initials: G
authors.lastname: Ferrara
authors.forename: F
authors.initials: F
authors.lastname: Gozzelino
authors.forename: M
authors.initials: M
authors.lastname: Tonato
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D007558:Italy; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D018401:Sample Size; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D016685:Mitomycin; D002945:Cisplatin; D007069:Ifosfamide; D000093542:Gemcitabine