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A pilot trial of gemcitabine and vinorelbine plus capecitabine in locally advanced or metastatic nonsmall cell lung cancer.

Lee DH, Han JY, Yoon SM, Lee JJ, Lee HG, Kim HY, Yoon SJ, Hong EK, Lee JS

Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, Korea.

OBJECTIVES: We conducted a pilot study of gemcitabine, vinorelbine and capecitabine combination to evaluate its toxicity and efficacy in chemo-naive patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) after a short phase IB trial. METHODS: Eligible chemo-naive patients with stage IIIB or IV NSCLC received outpatient administration of gemcitabine 900 mg/m2 and vinorelbine 25 mg/m2 intravenously on days 1 and 8, every 3 weeks, concurrently with capecitabine 1000 mg/m2 given orally twice a day on days 1 to 5 and 8 to 12 (dose level I), or days 1 to 6 and 8 to 13 (dose level II). RESULTS: Between November 2002 and December 2003, 19 patients participated in the study at either dose level I (7 patients) or dose level II (12 patients). The maximum tolerated dose, defined as the dose at which no more than 1 of 6 patients in a cohort experienced a dose-limiting toxicity (DLT) in the first cycle, was not established. However, 1 of 7 patients at dose level I, and 2 of 12 at dose level II experienced DLTs (ie, grade 3 hepatotoxicity in 2 patients, and grade 3 febrile neutropenia in 1 patient). In addition, 2 patients experienced treatment-related pneumonitis requiring mechanical ventilator support after the second course of therapy. Objective tumor response was observed in 5 (26.3%) of 19 patients. Further patient accrual was stopped according to the study design. CONCLUSIONS: This 3-drug combination showed disappointing antitumor activity against NSCLC with unexpected life-threatening pulmonary toxicity. No further investigation of this regimen is recommended for patients with NSCLC.

Published 7 April 2006 in Am J Clin Oncol, 29(2): 143-7.
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