Front-Line Treatment of Advanced Non–Small-Cell Lung Cancer With Docetaxel and Gemcitabine: A Multicenter Phase II Trial

• Published in: Journal of clinical oncology Vol. 17; no. 3; pp. 914 - 920
• Main Authors: GEORGOULIAS, V, KOUROUSSIS, C, HATZAKIS, K, KALBAKIS, K, KOTSAKIS, A, VARDAKIS, N, VLACHONICOLIS, J, ANDROULAKIS, N, KAKOLYRIS, S, DIMOPOULOS, M.-A, PAPADAKIS, E, BOUROS, D, APOSTOLOPOULOU, F, PAPODIMITRIOU, C, AGELIDOU, A
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 01.03.1999; Lippincott Williams & Wilkins
• Subjects: Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Chemotherapy; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Female; Hematologic Diseases - chemically induced; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Nausea - chemically induced; Paclitaxel - administration & dosage; Paclitaxel - analogs & derivatives; Pharmacology. Drug treatments; Survival Analysis; Taxoids; Human; Lung disease; Drug combination; Prognosis; Gemcitabine; Respiratory disease; Multicenter study; Docetaxel; Malignant tumor; Bronchopulmonary; Chemotherapy; Treatment; Antimetabolic; Taxane derivatives; Phase II trial; Bronchus disease; Advanced stage; Fluorine Organic compounds; Antimitotic; Pyrimidine nucleoside; Non small cell carcinoma
• DOI: 10.1200/jco.1999.17.3.914
• ISSN: 0732-183X

To evaluate the tolerance and efficacy of the combination of docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC). Fifty-one chemotherapy-naive patients with NSCLC were treated with gemcitabine 900 mg/m2 intravenously on days 1 and 8 and docetaxel 100 mg/m2 intravenously on day 8 with granulocyte colony-stimulating factor (150 microg/m2, subcutaneously) support from day 9 to day 15. Treatment was repeated every 3 weeks. The patients' median age was 64 years. The World Health Organization performance status was 0 to 1 in 39 patients and 2 in 12 patients. Fifteen patients (29%) had stage IIIB disease, and 36 (71%) had stage IV; histology was mainly squamous cell carcinoma (59%). A partial response was achieved in 19 patients (37.5%; 95% confidence interval, 24% to 50%); stable disease and progressive disease were each observed in 16 patients (31.4%). The median duration of response and the time to tumor progression were 5 and 6 months, respectively. The median survival was 13 months, and the actuarial 1-year survival was 50.7%. Grade 4 anemia and thrombocytopenia were rare (2%). Four patients (8%) developed grade 3 or 4 neutropenia, and all were complicated with fever; there was no treatment-related death. Grade 3 or 4 diarrhea occurred in three patients (6%), grade 2 or 3 neurotoxicity in four patients (8%), grade 2 or 3 asthenia in 10 patients (20%), and grade 2 or 3 edema in 10 patients (20%). The combination of docetaxel/gemcitabine is well tolerated, can be used for outpatients, and is active for the treatment of advanced NSCLC. This treatment merits further comparison with other cisplatin- or carboplatin-based combinations.