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/m(2) 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.

RCT Entities:   Population Interventions Outcomes