title: Activity of high-dose epirubicin combined with gemcitabine in advanced non-small-cell lung cancer: a multicenter phase I and II study.
abstract: The aim of the study was to evaluate efficacy and tolerance of epirubicin and gemcitabine as first-line chemotherapy in patients with advanced non-small-cell lung cancer. A phase I study was performed with the combination of escalating doses of epirubicin intravenously on day 1 and a fixed dose of gemcitabine on days 1 and 8 of a 21 -day cycle. Eighteen patients were included in the phase I part of the study before the maximum tolerated dose was found. Dose-limiting toxicity was febrile neutropenia. The phase II part of the study was continued with epirubicin 100 mg m(-2) on day 1 and gemcitabine 1125 mg m(-2) on days 1 and 8 of a 21-day cycle. Forty-three chemotherapy-naive patients were included. The median age of the patients was 60 years (range 26-75). Most patients (74%) were in stage IV. Granulocytopenia CTC grade 4 occurred in 32.5% and thrombocytopenia grade 4 in 11.6% of cycles. Febrile neutropenia occurred in six patients. Non-haematological toxicity was mainly mucositis CTC grade 2 and 3 in 35% of patients. The tumour response rate was 49% (95% confidence interval (CI) 35-63%). The median survival time for the patients was 42 weeks (95% CI 13-69).
authors.affiliation: Department of Pulmonary Diseases, University Hospital, Groningen, The Netherlands.
authors.forename: J W
authors.initials: JW
authors.lastname: van Putten
authors.forename: P
authors.initials: P
authors.lastname: Eppinga
authors.forename: Z
authors.initials: Z
authors.lastname: Erjavec
authors.forename: G
authors.initials: G
authors.lastname: de Leede
authors.forename: J
authors.initials: J
authors.lastname: Nabers
authors.forename: J B
authors.initials: JB
authors.lastname: Smeets
authors.forename: D
authors.initials: D
authors.lastname: Th Sleijfer
authors.forename: H J
authors.initials: HJ
authors.lastname: Groen
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D015251:Epirubicin / Q000008:administration & dosage; D006801:Humans; D011788:Quality of Life; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D000093542:Gemcitabine