Mitomycin-ifosfamide-cisplatinum (MIP) vs MIP-interferon vs cisplatinum-carboplatin in metastatic non-small-cell lung cancer: A FONICAP randomised phase II study

A. Ardizzoni, G. F. Addamo, E. Baldini, U. Borghini, L. Portalone, F. De Marinis, R. Lionetto, P. F. Conte, P. Bruzzi, M. C. Pennucci, M. Venturini, M. Rinaldi, R. Rosso, F. Salvati

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)115-119
Number of pages5
JournalBritish Journal of Cancer
Volume71
Issue number1
Publication statusPublished - 1995

Keywords

  • Chemotherapy
  • Cisplatinum
  • Non-small-cell lung cancer
  • Randomised study

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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    Ardizzoni, A., Addamo, G. F., Baldini, E., Borghini, U., Portalone, L., De Marinis, F., Lionetto, R., Conte, P. F., Bruzzi, P., Pennucci, M. C., Venturini, M., Rinaldi, M., Rosso, R., & Salvati, F. (1995). Mitomycin-ifosfamide-cisplatinum (MIP) vs MIP-interferon vs cisplatinum-carboplatin in metastatic non-small-cell lung cancer: A FONICAP randomised phase II study. British Journal of Cancer, 71(1), 115-119.