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PurposeThis pilot study was designed to evaluate the efficacy and toxicity of the gemcitabine/vinorelbine combination in non-small-cell lung cancer (NSCLC) patients who had failed cisplatin-based first-line chemotherapy.Patients and methodsEligible patients had refractory or resistant NSCLC, WHO performance status 0-2, adequate hematologic parameters and normal hepatic, renal and cardiac function. Gemcitabine (1200 mg/m2) was administered on days 1, 8 and 15; vinorelbine (25 mg/m2) was administered on days 1 and 8, every 4 weeks until patients experienced disease progression.ResultsFrom September 1997 to March 1998, 16 patients were enrolled (six: stage IIIB: ten: stage IV). All 16 patients were assessable for toxicity and evaluated for response. One complete (6.25%) response and no partial responses were observed. Median survival was 25 weeks (95% CI 19-30). A median of 3.31 courses per patient was administered, and the median interval between courses was 28 days. The median delivered dose was 664.85 mg/m2 per week of gemcitabine and 10.71 mg/m2 per week of vinorelbine, corresponding to a relative dose intensity of 0.73 and 0.85, respectively. Grade 2/3 thrombocytopenia occurred in 13 (24.52%) of 53 courses administered. Neutropenia Grade 2/3 occurred in 14 courses (26.41%). There were seven (13.20%) episodes of fever related to the drug administration. Mild asthenia was observed in six (37.5%) patients. Other toxicities were mild to moderate.ConclusionThese results suggest that this gemcitabine/vinorelbine combination is not an active salvage regimen in patients with refractory NSCLC. The combination merits further evaluation with modified regimens.

Original publication




Journal article


Lung cancer (Amsterdam, Netherlands)

Publication Date





47 - 53


Hospital General Universitario de Valencia, Spain.


Humans, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Recurrence, Local, Thrombocytopenia, Neutropenia, Vinblastine, Deoxycytidine, Antineoplastic Combined Chemotherapy Protocols, Treatment Outcome, Pilot Projects, Adult, Aged, Middle Aged, Female, Male, Vinorelbine