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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

DOI

10.1016/s0169-5002(99)00092-6

Type

Journal article

Journal

Lung cancer (Amsterdam, Netherlands)

Publication Date

01/2000

Volume

27

Pages

47 - 53

Addresses

Hospital General Universitario de Valencia, Spain.

Keywords

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