title: Phase I study of epirubicin plus vinorelbine with or without G-CSF in advanced non-small cell lung cancer.
abstract: The present phase I study was designed to determine the maximum tolerated dose (MTD) of epirubicin, administered every 3 weeks to patients with advanced non-small cell lung cancer (NSCLC), and combined with a conventional dose of vinorelbine [25 mg/m2 intravenously (i.v.) days 1 and 8] with or without the support of granulocyte-colony stimulating factor (G-CSF). 18 patients entered the study. The patients received the following four dose levels of epirubicin (i.v., day 1): 50 mg/m2 (3 patients) and 60 mg/m2 (6 patients) without G-CSF, 75 mg/m2 (3 patients) and 90 mg/m2 (6 patients) with G-CSF (5 micrograms/kg days 4-6 and 9-15). In the patients treated without G-CSF the MTD of epirubicin was 60 mg/m2 and leukopenia was the dose-limiting toxicity. In the patients treated with G-CSF the MTD was 90 mg/m2, myelotoxicity being the dose-limiting toxicity. We observed 1/3 partial response (PR) with epirubicin at the dose of 75 mg/m2 and 2/6 PR at 90 mg/m2. These results would indicate the usefulness of a phase II study with epirubicin at the dose of 90 mg/m2 in association with conventional dose of vinorelbine with the support of G-CSF in advanced NSCLC.
authors.affiliation: Cattedra di Oncologia Medica, Facoltà di Medicina e Chirurgia, Università degli Studi di Napoli, Federico II, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Gridelli
authors.forename: S
authors.initials: S
authors.lastname: De Placido
authors.forename: R
authors.initials: R
authors.lastname: Pepe
authors.forename: P
authors.initials: P
authors.lastname: Incoronato
authors.forename: G
authors.initials: G
authors.lastname: Airoma
authors.forename: A
authors.initials: A
authors.lastname: Rossi
authors.forename: G
authors.initials: G
authors.lastname: Palazzolo
authors.forename: A R
authors.initials: AR
authors.lastname: Bianco
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D014747:Vinblastine; D000077235:Vinorelbine