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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

From St Bartholomew’s Hospital; Cancer Research UK and UCL Cancer Trials Centre; University College Hospitals Trust; Royal Marsden Hospital; Guy’s and St Thomas’ NHS Trust; and Medical Research Council Clinical Trials Unit, London; Clatterbridge Centre for Oncology, Wirral; Weston Park Hospital, Sheffield; Cancer Research UK Oncology Unit, Southampton General Hospital, Southampton; Norfolk and Norwich University Hospital, Norfolk; and Ninewells Hospital, University of Dundee, Dundee, United Kingdom

Address reprint requests to Nicole Gower, London Lung Cancer Group, Cancer Research United Kingdom and University College London Cancer Trials Centre, 158-160 N Gower St, London NW1 2ND, United Kingdom; e-mail: ng{at}ctc.ucl.ac.uk

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.

Supported in part by the London Lung Cancer Group London, UK (registered charity No. 1074994), which received funding from Lilly Oncology to support this trial.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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