A multicenter phase II trial of vinorelbine plus gemcitabine in previously untreated inoperable (Stage IIIB/IV) non-small cell lung cancer.

STUDY
OBJECTIVE: Vinorelbine and gemcitabine are two active single agents used in the treatment of non-small cell lung cancer (NSCLC). A clinical trial was conducted to evaluate the efficacy and toxicity of vinorelbine plus gemcitabine in patients with inoperable (stage IIIB or IV) NSCLC.
DESIGN: A multicenter phase II study. Vinorelbine, 20 mg/m(2), was given as a 10-min IV infusion, followed by a 30-min IV infusion of gemcitabine, 800 mg/m(2), on days 1, 8, and 15 of each 28-day cycle. PATIENTS AND MEASUREMENTS: From March 1998 to August 1998, 40 patients were enrolled in the study. The efficacy and toxicity of the treatment were recorded.
RESULTS: All patients are evaluable for treatment response and toxicity profile. Two patients achieved a complete response, and 27 patients achieved a partial response, with an overall response rate of 72.5% (95% confidence interval, 58.7 to 86.3%). Median survival time was 11 months. The significant (World Health Organization grade, 3/4) toxicities were myelosuppression, including leukopenia (47.5% of patients), anemia (17.5% of patients), and thrombocytopenia (12.5% of patients). However, febrile neutropenia occurred in three patients and accounted for one treatment-related death. Fatigue, or flu-like syndrome, occurred in 17 patients, and the symptoms were reversed spontaneously 1 to 2 days after injection in 10 patients. Another seven patients needed dose reduction to ameliorate symptoms. Interstitial pneumonitis occurred in six patients who recovered after steroid treatment. No patient suffered from grade 3 or 4 nausea/vomiting.
CONCLUSION: The combination of vinorelbine and gemcitabine in patients with advanced NSCLC is a highly active non-cisplatin-containing regimen with an acceptable toxicity profile.