Gemcitabine versus gemcitabine/carboplatin in advanced non-small cell lung cancer : Preliminary findings in a phase III trial of the Swedish Lung Cancer Study Group

• Gemcitabine is an active agent in non-small cell lung cancer, with single-agent treatment producing response rates of approximately 20% and median survivals of approximately 7 to 9 months. In a pilot trial in advanced non-small cell lung cancer, the gemcitabine/ carboplatin combination produced a response rate of 43% and median survival of 12 months with good tolerability. Preliminary results of a phase III trial comparing gemcitabine alone with gemcitabine/carboplatin in 332 patients with stage IIIB or IV non-small cell lung cancer are now available. Patients were randomized to receive gemcitabine 1,250 mg/m2 on days 1 and 8 every 21 days or the same gemcitabine regimen plus carboplatin at an area under the concentration-time curve of 5 mg/mL/min on day 1 for a maximum of six cycles. Hematologic toxicity was more common in the combination arm, grade 4 thrombocytopenia occurred in 23.5% v 5.3% of patients, but infrequently resulted in clinical complications. Nonhematologic toxicity was moderate and similar in frequency in the combination and gemcitabine arms (25% and 28%, respectively). Among 275 patients, overall response rates were 30% (2% complete response and 28% partial response) in the combination arm and 12% (all partial responses) in the gemcitabine arm. Median time to disease progression was 6 months in the combination arm and 4 months in the gemcitabine arm. Median survival in the study population was 9 months, a promising finding given the high proportion of elderly patients in the study (37% = 70 years of age). Full mature results of the trial, including comparative survival results and data on quality of life, are awaited. Copyright 2002, Elsevier Science (USA). All rights reserved.

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