title: Mitomycin-ifosfamide-cisplatinum (MIP) vs MIP-interferon vs cisplatinum-carboplatin in metastatic non-small-cell lung cancer: a FONICAP randomised phase II study. Italian Lung Cancer Task Force.
abstract: The FONICAP group is screening, with randomised phase II studies, the activity of new chemotherapy programmes for advanced non-small-cell lung cancer (NSCLC) looking for regimens with > 30% activity. In the present study, three regimens were tested: MIP (mitomycin 6 mg m-2, ifosfamide 3 g m-2, cisplatinum 80 mg m-2 on day 1 every 28 days); MIP-IFN (MIP and interferon alpha-2b 3 MU s.c. three times a week); and PC (cisplatinum 60 mg m-2 and carboplatin 400 mg m-2 on day 1 every 28 days). Overall 93 chemotherapy-naive patients were enrolled: 23 received MIP, 27 received MIP-IFN and 43 received PC. Eighty per cent of the patients had stage IV and 20% stage IIIb disease (positive pleural effusion or supraclavicular nodes). Response rates were as follows: MIP = 9% (95% CI 1-28%), MIP-IFN = 7% (95% CI 1-24%) and PC = 14% (95% CI 5-28%). The overall median survival was 183 days. Grade III-IV leucopenia was observed in 36% of patients treated with MIP-IFN vs 10% in the other two arms, and thrombocytopenia grade III-IV was reported in nearly 10% of patients overall. In conclusion, (1) all three regimens investigated have poor activity (< 30%); (2) when tested in multicentre randomised phase II trials, MIP displays lower activity than in phase II trials; (3) PC has similar activity to other platinum-containing regimens; (4) randomised phase II studies are a reliable and quick method of determining the anti-tumour activity of novel chemotherapeutic regimens in NSCLC.
authors.affiliation: Department of Medical Oncology I, Istituto Nazionale per la Ricerca sul Cancro, V. le Benedetto XY, Genoa, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Ardizzoni
authors.forename: G F
authors.initials: GF
authors.lastname: Addamo
authors.forename: E
authors.initials: E
authors.lastname: Baldini
authors.forename: U
authors.initials: U
authors.lastname: Borghini
authors.forename: L
authors.initials: L
authors.lastname: Portalone
authors.forename: F
authors.initials: F
authors.lastname: De Marinis
authors.forename: R
authors.initials: R
authors.lastname: Lionetto
authors.forename: P F
authors.initials: PF
authors.lastname: Conte
authors.forename: P
authors.initials: P
authors.lastname: Bruzzi
authors.forename: M C
authors.initials: MC
authors.lastname: Pennucci
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007372:Interferons / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016685:Mitomycin; D008937:Mitomycins / Q000008:administration & dosage
chemical_list: D008937:Mitomycins; D016685:Mitomycin; D007372:Interferons; D016190:Carboplatin; D002945:Cisplatin; D007069:Ifosfamide