title: [Phase II study of gemcitabine (GEM) and docetaxel (TXT) combination chemotherapy for unresectable non small cell lung cancer].
abstract: A phase I study of gemcitabine (GEM) and docetaxel (TXT) combination chemotherapy had been performed for unresectable non-small-cell lung cancer, and the dose level of GEM (1,000 mg/m2) on days 1 and 8, and TXT (70 mg/m2) on day 8 every 21 days had been recommended. The combination chemotherapy was repeated> or =2 courses in this phase II study, and the efficacy and safety were evaluated. 31 patients were entered, and the mean number of courses was 3.1. Leukopenia, neutropenia, anemia and fatigue were observed as major adverse reactions. The severe adverse reactions (> or =Grade 3) were leukopenia 48.4% and neutropenia 70.9%. With G-CSF support, all except 2 patients were administered as per schedule, and the TXT dosage in 2 patients was reduced. Other toxicities were mild. The overall response rate was 71.0%, and MST was 515 days. All except the 2 fatal cases on initial hospital admission made the shift to outpatient therapy. These results indicate the efficacy and safety of GEM and TXT combination chemotherapy.
authors.affiliation: Dept. of Respiratory Medicine, Higashi Yamato Hospital.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Terao
authors.forename: Kenmei
authors.initials: K
authors.lastname: Kuramoto
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine