Gemcitabine plus carboplatin versus mitomycin, ifosfamide, and cisplatin in patients with stage IIIB or IV non-small-cell lung cancer: a phase III randomized study of the London Lung Cancer Group

R. M. Rudd, N. H. Gower, S. G. Spiro, T. G. Eisen, P. G. Harper, J. A. H. Littler, M. Hatton, P. W. M. Johnson, W. M. C. Martin, E. M. Rankin, L. E. James, W. M. Gregory, W. Qian, S. M. Lee

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    Abstract

    NOTE: THE SYMBOLS/SPECIAL CHARACTERS IN THIS ABSTRACT CANNOT BE DISPLAYED CORRECTLY ON THIS PAGE. PLEASE REFER TO THE ABSTRACT ON THE PUBLISHER’S WEBSITE FOR AN ACCURATE DISPLAY.
    PURPOSE: This phase III randomized trial compared two chemotherapy regimens, gemcitabine plus carboplatin and mitomycin, ifosfamide, and cisplatin, in chemotherapy-naive patients with advanced non-small-cell lung cancer (NSCLC). The regimens were compared with regard to effects on survival, response rates, toxicity, and quality of life. PATIENTS AND METHODS: Eligible patients had previously untreated stage IIIB or IV NSCLC suitable for cisplatin-based chemotherapy. Randomly assigned patients were to receive four cycles, each at 3-week intervals, of carboplatin area under the curve of 5 on day 1 plus gemcitabine 1,200 mg/m2 on days 1 and 8 (GCa) or mitomycin 6 mg/m2, ifosfamide 3g/m2, and cisplatin 50 mg/m2 on day 1 (MIC). RESULTS: Between February 1999 and August 2001, 422 patients (GCa, n = 212; MIC, n = 210) were randomly assigned in the United Kingdom. The majority of patients received the intended four cycles (GCa, 64%; MIC, 61%). There was a significant survival advantage for GCa compared with MIC (hazard ratio, 0.76; 95% CI, 0.61 to 0. 93; P = .008). Median survival was 10 months with GCa and 7.6 months with MIC (difference, 2.4 months; 95% CI, 1.0 to 4.0), and 1-year survival was 40% with GCa and 30% with MIC (difference, 10%; 95% CI, 3% to 18%). Overall response rates were similar (42% for GCa v 41% for MIC; P = .84). More thrombocytopenia occurred with GCa (P = .03), but this was not associated with increased hospital admission or fatality. GCa caused less nausea, vomiting, constipation, and alopecia and was associated with fewer admissions for administration and better quality of life. CONCLUSION: In patients with advanced NSCLC, GCa chemotherapy was shown to be a better-tolerated treatment that conferred a survival advantage over MIC.
    Original languageEnglish
    Pages (from-to)142-153
    Number of pages12
    JournalJournal of Clinical Oncology
    Volume23
    Issue number1
    DOIs
    Publication statusPublished - 2005

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    Rudd, R. M., Gower, N. H., Spiro, S. G., Eisen, T. G., Harper, P. G., Littler, J. A. H., Hatton, M., Johnson, P. W. M., Martin, W. M. C., Rankin, E. M., James, L. E., Gregory, W. M., Qian, W., & Lee, S. M. (2005). Gemcitabine plus carboplatin versus mitomycin, ifosfamide, and cisplatin in patients with stage IIIB or IV non-small-cell lung cancer: a phase III randomized study of the London Lung Cancer Group. Journal of Clinical Oncology, 23(1), 142-153. https://doi.org/10.1200/JCO.2005.03.037