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Phase III Trial of Gemcitabine Plus Carboplatin Versus Single-Agent Gemcitabine in the Treatment of Locally Advanced or Metastatic Non–Small-Cell Lung Cancer: The Swedish Lung Cancer Study Group

From the Department of Pulmonary Medicine and Oncologic Center, University Hospital, Linköping; Department of Pulmonary Medicine, Karolinska University Hospital, Stockholm; Department of Pulmonary Medicine, Akademiska Hospital University of Uppsala, Uppsala; Ronny Westberg Clinical Research, Sundbyberg, Sweden; and Eli Lilly and Company, Indianapolis, IN.

Address reprint requests to Christer Sederholm, MD, Department of Pulmonary Medicine, University Hospital, S-581 85 Linköping, Sweden; e-mail: christer.sederholm{at}lio.se

PURPOSE: This phase III study compared overall survival in patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) when treated with single-agent gemcitabine versus gemcitabine/carboplatin. Secondary objectives were to compare response, time to progression, toxicity, and quality of life.

PATIENTS AND METHODS: Chemotherapy-naive patients received either gemcitabine alone (1,250 mg/m² on days 1 and 8; gemcitabine arm) or with carboplatin (area under the curve 5 on day 1; GC arm) every 21 days.

RESULTS: Demographics and disease characteristics of 334 randomly assigned patients were comparable on both arms. An intent-to-treat analysis showed significantly better overall survival (log-rank P = .0205) and 2-year survival (15% v 5%; P = .009) favoring the GC arm. Per Cox multivariate analysis, only two covariates, treatment arm (GC v G) and baseline performance status (0 or 1 v 2), independently influenced survival. Per-protocol analyses showed significantly longer median time to progression (5.7 v 3.9 months; P = .0001) and significantly higher objective response rate (29.6 v 11.3%; P < .0001) in the GC arm. Grade 3 to 4 leucopenia and thrombocytopenia were significantly more pronounced in the GC arm (P for both variables < .001) but importantly without associated increases in fever, infection, bleeding, or hospitalizations. There was no discernible difference in global quality-of-life patterns between treatment arms.

CONCLUSION: In advanced NSCLC, gemcitabine/carboplatin therapy resulted in significant survival benefit compared with single-agent gemcitabine without undue increase in toxicity.

Supported by grant from Eli Lilly and Company, Indianapolis, IN.

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

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