title: Phase II study of ifosfamide plus vinorelbine in metastatic breast cancer patients previously treated with combination chemotherapy.
abstract: Forty-six patients were included in a phase II study to evaluate the response rate and toxicity of a combination of ifosfamide and vinorelbine in metastatic breast cancer patients previously treated with one or more regimens of chemotherapy. Treatment consisted of ifosfamide 1.6 g/m(2) IV days 1-3 (with mesna) and vinorelbine 25 mg/m(2) IV days 1 and 8, every 3 weeks up to 6 cycles. The median age was 55 years (range 40-76), the World Health Organization (WHO) performance status was 0-1 in 93% of the patients and 2 in the remaining 7%. In all, 43% had received two or more previous lines of chemotherapy, and 91% had been treated with anthracyclines. Forty-four patients were evaluable for response, and all patients for toxicity. The overall response rate was 36.4% [95% confidence interval (CI) 22.4-52.2]. Stabilization was observed in 20.4% and progression in 43.2%. The median time to progression was 25 weeks (95% CI 14-36). Median relative dose intensity (=actual received dose intensity/planned dose intensity) was 0.99 for ifosfamide and 0. 80 for vinorelbine. The main toxicity was hematological, with 63% of the patients experiencing grade 3-4 neutropenia. With a moderate toxicity, this is an active regimen that may be taken into consideration in pretreated metastatic breast cancer patients when further chemotherapy is indicated.
authors.affiliation: Fundación Jiménez Díaz, Madrid, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Lobo
authors.forename: A
authors.initials: A
authors.lastname: Frau
authors.forename: A
authors.initials: A
authors.lastname: Barnadas
authors.forename: M
authors.initials: M
authors.lastname: Méndez
authors.forename: J
authors.initials: J
authors.lastname: Lizón
authors.forename: M
authors.initials: M
authors.lastname: Provencio
authors.forename: J J
authors.initials: JJ
authors.lastname: Albistur
authors.forename: P
authors.initials: P
authors.lastname: Martínez
authors.forename: M J
authors.initials: MJ
authors.lastname: Sánchez
authors.forename: M
authors.initials: M
authors.lastname: Constenla
authors.forename: L G
authors.initials: LG
authors.lastname: Estévez
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007262:Infusions, Intravenous; D015080:Mesna / Q000008:administration & dosage; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000903:Antibiotics, Antineoplastic; D014747:Vinblastine; D015080:Mesna; D000077235:Vinorelbine; D007069:Ifosfamide