Treatment of patients with advanced nonsmall cell lung carcinoma using docetaxel and gemcitabine plus granulocyte-colony stimulating factor

BACKGROUND. A combination regimen comprised of docetaxel, gemcitabine, and granulocyte-colony stimulating factor (G-CSF) was studied in patients with advanced nonsmall cell lung carcinoma (NSCLC) to determine its antitumor ef ficacy and tolerance. METHODS. Thirty-four patients with advanced measurable NSCLC (3 patients wi th Stage IIIB and 31 patients with Stage IV disease) were treated with an i ntravenous combination chemotherapy regimen comprised of docetaxel, 80 mg/m (2), on Day 1 and gemcitabine, 1000 mg/m(2), on Days 1 and 10; G-CSF, 5 mu g/kg, was administered subcutaneously between Days 2 and 8. Treatment cycle s were repeated every 3 weeks. All patients were evaluable for toxicity and response assessment. A total of 163 courses was administered. RESULTS. Objective tumor response was noted in 17 patients (50%; 95% confid ence interval, 32.5-67.5%), including 2 complete responses (6%) and 15 part ial responses (44%). There was no change in 10 patients (29%) and 7 patient s developed progressive disease. The median duration of response was 6.5 mo nths (range, 3-15 months) and the median time to disease progression for al l patients was 6.8 months (range, 1.8-18 months). The median overall surviv al time was 13.0 months (range, 2.5-23+ months) with a 1-year survival rate of 55.8%. Myelosuppression was the most Frequently encountered adverse rea ction, although World Health Organization Grade 3 or 4 leukocytopenia and/o r granulocytopenia occurred in only 18% and 24% of patients, respectively. Other toxicities generally were mild to moderate, and always fully reversib le. CONCLUSIONS. With a response rate of 50% and a median survival time of 13 m onths, the drug combination described in the current study appears to have significant activity against advanced metastatic NSCLC. Due to its fairly g ood tolerance and ease of administration, further investigation of this reg imen appears warranted. (C) 2000 American Cancer Society.