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PurposeGiven the cisplatin-related myelotoxicity and nonhematologic toxicities, we were prompted to undertake a study of the noncisplatin combination of paclitaxel plus gemcitabine to evaluate the efficacy, tolerance, and survival of this combination in patients with locally advanced and metastatic non-small-cell lung cancer (NSCLC).Patients and methodsPatients received gemcitabine 2,000 mg/m(2) and paclitaxel 150 mg/m(2) on days 1 and 15 of a 28-day cycle, for a maximum of eight cycles.ResultsBetween December 1997 and June 1998, 89 untreated NSCLC patients were enrolled; 30 (34%) had stage IIIB disease (23 with malignant pleural effusion and seven without), and 59 (66%) had stage IV disease. Eighty-six percent of patients had a performance status of 0 or 1. The median number of cycles administered was four (range, one to eight cycles). The mean dose-intensity for both paclitaxel and gemcitabine was nearly 100%. Hematologic and nonhematologic toxicities were mild. Thirty-eight patients received second-line chemotherapy after completion of the study. The overall intent-to-treat response rate was 32.2%, with a higher response rate for stage IIIB patients (43.3%) than for stage IV patients (26.3%). Overall median survival was 9.9 months, and 1-year survival was 38.8% (14.2 months for stage IIIB and 7.7 months for stage IV; P =.007). Median survival was 10.2 months for patients with a performance status of 0 or 1 and 4.8 months for patients with a performance status of 2 (P =.007).ConclusionA biweekly paclitaxel/gemcitabine regimen was well tolerated, with an acceptable response rate and a reasonable median survival time, especially in patients with good performance status. It merits further exploration in future studies.

Original publication

DOI

10.1200/jco.2001.19.4.1071

Type

Journal article

Journal

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Publication Date

02/2001

Volume

19

Pages

1071 - 1077

Addresses

Hospital Clínico Lozano Blesa and Hospital Miguel Servet, Zaragoza.

Keywords

Spanish Lung Cancer Group, Humans, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Metastasis, Paclitaxel, Deoxycytidine, Antineoplastic Combined Chemotherapy Protocols, Drug Administration Schedule, Karnofsky Performance Status, Adult, Aged, Middle Aged, Female, Male