A Phase II trial of gemcitabine and docetaxel in patients with chemotherapy-naive, advanced nonsmall cell lung carcinoma

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Abstract
BACKGROUND The goals of the current study were to determine the safety and efficacy of a nonplatinum‐containing doublet, gemcitabine and docetaxel, in the treatment of patients with chemotherapy‐naive nonsmall cell lung carcinoma (NSCLC). METHODS Thirty‐two patients with advanced, chemotherapy‐naive NSCLC were treated with gemcitabine (1000 mg/m2) and docetaxel (40 mg/m2) administered on Days 1 and 8 every 21 days. All patients were evaluable for toxicity and survival and 27 patients were evaluable for response. RESULTS This combination was extremely well tolerated with Grade 3 or 4 neutropenia occurring in 6 of 32 patients (19%) (grading was based on the National Cancer Institute Common Toxicity Criteria). There were two episodes of Grade 3 thrombocytopenia and no episodes of Grade 3 or 4 anemia. Grade 3 or 4 nonhematologic toxicities included nausea (occurring in 1 of 32 patients), diarrhea (occurring in 1 of 32 patients), fatigue (occurring in 10 of 32 patients), fluid retention (occurring in 2 of 32 patients), anorexia (occurring in 4 of 32 patients), and transaminitis (occurring in 2 of 32 patients). Six patients experienced Grade 3 pneumonitis that was at least possibly related to the combination of gemcitabine and docetaxel. There was 1 complete response and 7 partial responses for an overall response rate of 30%. The 1‐year and median survivals were 35% and 7.9 months, respectively. CONCLUSIONS In the current study, the regimen of gemcitabine (1000 mg/m2) and docetaxel (40 mg/m2) administered on Days 1 and 8 every 21 days was well tolerated with manageable hematologic and nonhematologic toxicities. The responses were comparable to those achieved with platinum‐based combination chemotherapy and the 2‐year survival was an encouraging 19%. These data would support the further study of this nonplatinum doublet in patients with advanced NSCLC. Cancer 2002;95:1714–19. © 2002 American Cancer Society. DOI 10.1002/cncr.10843

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