title: Docetaxel (Taxotere) and gemcitabine in the treatment of non-small cell lung cancer: preliminary results.
abstract: A phase II study was performed to investigate the tolerance and efficacy of the combination of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) and gemcitabine in chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC). To date, 24 patients (five with stage IIIB and 19 with stage IV NSCLC) have been treated according to the protocol: gemcitabine 900 mg/m2 was administered on days 1 and 8 as a 30-minute infusion and docetaxel 100 mg/m2 was administered on day 8 as a 1-hour infusion after appropriate premedication. Granulocyte colony-stimulating factor 150 microg/m2 subcutaneously was given on days 9 to 15. Treatment was repeated every 3 weeks. Grade 3/4 granulocytopenia occurred in seven (29%) patients, and one (4%) of these patients developed febrile neutropenia. Grade 3/4 thrombocytopenia and anemia were observed in three (13%) and one (4%) patient, respectively. Grade 2 neurotoxicity and fatigue occurred in one (4%) patient each. Other toxicities were mild. There were no treatment-related deaths. Eight patients experienced a partial response (53.3%; 95% confidence interval, 28.1% to 78.6%), and stable and progressive disease were documented in two (13%) and five (33%) patients, respectively. The median delivered dose was 600 mg/m2/wk and 33 mg/m2/wk for gemcitabine and docetaxel, respectively. These preliminary data suggest that the docetaxel/gemcitabine combination has significant antitumor activity and is well tolerated in chemotherapy-naive patients with NSCLC. The study is ongoing.
authors.affiliation: Department of Medical Oncology, School of Medicine, University of Crete, Greece.
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
authors.forename: C
authors.initials: C
authors.lastname: Kourousis
authors.forename: N
authors.initials: N
authors.lastname: Androulakis
authors.forename: S
authors.initials: S
authors.lastname: Kakolyris
authors.forename: M A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: D
authors.initials: D
authors.lastname: Bouros
authors.forename: C
authors.initials: C
authors.lastname: Papadimitriou
authors.forename: K
authors.initials: K
authors.lastname: Hatzakis
authors.forename: P
authors.initials: P
authors.lastname: Heras
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: T
authors.initials: T
authors.lastname: Kotsakis
authors.forename: N
authors.initials: N
authors.lastname: Vardakis
authors.forename: N
authors.initials: N
authors.lastname: Meramveliotakis
authors.forename: D
authors.initials: D
authors.lastname: Hatzidaki
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000031:analogs & derivatives* / Q000627:therapeutic use; D043823:Taxoids; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D017239:Paclitaxel; D000093542:Gemcitabine