title: A phase II study of vinorelbine, a new derivative of vinca alkaloid, for previously untreated advanced non-small cell lung cancer. Japan Vinorelbine Lung Cancer Study Group.
abstract: To evaluate the effectiveness of vinorelbine (NVB) in patients with non-small cell lung cancer (NSCLC), a late Phase II study was conducted. A total of 80 patients with Stage III or IV NSCLC who had no previous therapy were entered into the study. Seventy-nine patients were eligible for response and toxicity. NVB was administered weekly by intravenous injection at a dose of 25 mg/m2 in 20 ml of saline and was generally administered in four cycles or more, unless patients had disease progression. Of the 79 eligible patients, 23 (29.1%) showed a partial response (95% confidence interval, 19.1-40.4%). The median duration of partial responses was 14.7+ weeks. The median survival time for all patients was 40.1+ weeks. The major toxicity was leukopenia. Grade 3 and 4 leukopenia occurred in 48 patients (60.8%). Other toxicities of grade 3 or more included anemia (6.3%), local cutaneous reaction (3.8%), pneumonitis (1.3%), nausea and vomiting (1.3%), mucositis (1.3%) and constipation (1.3%). The absolute dose-intensity of NVB was 22.33 mg/m2/week. A weekly schedule of intravenous administration of 25 mg/m2/week of NVB was reasonable for maintenance of activity, and acceptable for toxicity in the chemotherapy of advanced NSCLC.
authors.affiliation: National Kinki Central Hospital for Chest Diseases, Osaka, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Furuse
authors.forename: K
authors.initials: K
authors.lastname: Kubota
authors.forename: M
authors.initials: M
authors.lastname: Kawahara
authors.forename: M
authors.initials: M
authors.lastname: Ogawara
authors.forename: E
authors.initials: E
authors.lastname: Kinuwaki
authors.forename: M
authors.initials: M
authors.lastname: Motomiya
authors.forename: Y
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: H
authors.initials: H
authors.lastname: Niitani
authors.forename: A
authors.initials: A
authors.lastname: Sakuma
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D014747:Vinblastine; D000077235:Vinorelbine