title: Ifosfamide and vinorelbine as first-line chemotherapy for advanced non-small cell lung carcinoma.
abstract: We evaluated the efficacy and toxicity of the novel combination of ifosfamide (IFX) and vinorelbine (VNB) as first-line chemotherapy in patients with stage IIIB and IV non-small cell lung cancer (NSCLC). Between March 1993 and November 1994, 44 patients (17 stage IIIB; 27 stage IV) received a regimen consisting of IFX, 2 g/m2 in a 1-h infusion, days 1-3; mesna, 400 mg/m2 in an i.v. bolus at hours 0 and 4 and 800 mg orally at hour 8, days 1-3; and VNB, 35 mg/ m2 in a 20-min infusion, days 1 and 15. During the first course only, a half dose of VNB (17.5 mg/m2) was administered on days 8 and 22. Courses were repeated every 28 days. Forty patients were fully evaluable for response, and 44 were assessable for toxicity. Objective regression was recorded in 13 of 40 patients (33%). No patient achieved a complete response. Thirteen patients presented a partial response (33%); 17 (42%) had no change; and progressive disease was observed in 10 (25%). The median duration of response was 10 months, and the median time to treatment failure for the whole group was 4 months. Median survival was 11 months. The dose-limiting toxic effect was myelosuppression. Leukopenia occurred in 25 patients (57%) and was grade 3 or 4 in 8 patients (18%). Twelve patients (27%) developed peripheral neurotoxicity, while five had mild IFX-induced CNS toxicity. Phlebitis was observed in 15 of 30 patients (50%) who did not have central implantable venous systems. The IFX-VNB combination exhibited an activity against NSCLC that was among the highest reported for non-cisplatin-containing regimens, with a toxicity profile that was easily managed.
authors.affiliation: Grupo Oncológico Cooperativo del Sur, Neuquén, República Argentina.
authors.forename: C
authors.initials: C
authors.lastname: Vallejo
authors.forename: A
authors.initials: A
authors.lastname: Romero
authors.forename: J
authors.initials: J
authors.lastname: Perez
authors.forename: M
authors.initials: M
authors.lastname: Cuevas
authors.forename: J
authors.initials: J
authors.lastname: Lacava
authors.forename: C
authors.initials: C
authors.lastname: Sabatini
authors.forename: M
authors.initials: M
authors.lastname: Dominguez
authors.forename: R
authors.initials: R
authors.lastname: Rodriguez
authors.forename: M
authors.initials: M
authors.lastname: Barbieri
authors.forename: L
authors.initials: L
authors.lastname: Romero Acuña
authors.forename: J
authors.initials: J
authors.lastname: Romero Acuña
authors.forename: M
authors.initials: M
authors.lastname: Langhi
authors.forename: S
authors.initials: S
authors.lastname: Amato
authors.forename: M
authors.initials: M
authors.lastname: Salvadori
authors.forename: E
authors.initials: E
authors.lastname: Ortiz
authors.forename: M
authors.initials: M
authors.lastname: Machiavelli
authors.forename: B
authors.initials: B
authors.lastname: Leone
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001853:Bone Marrow / Q000187:drug effects; D001921:Brain / Q000187:drug effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005100:Expectorants / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage* / Q000009:adverse effects; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D015080:Mesna / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D010525:Peripheral Nerves / Q000187:drug effects; D010689:Phlebitis / Q000139:chemically induced; D012074:Remission Induction; D015996:Survival Rate; D017211:Treatment Failure; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D018906:Antineoplastic Agents, Alkylating; D000972:Antineoplastic Agents, Phytogenic; D005100:Expectorants; D014747:Vinblastine; D015080:Mesna; D000077235:Vinorelbine; D007069:Ifosfamide