Phase II study of ifosfamide plus vinorelbine in metastatic breast cancer patients previously treated with combination chemotherapy

• Published in: Cancer chemotherapy and pharmacology Vol. 44; no. 7; pp. S5 - S8
• Main Authors: LOBO, F, FRAU, A, ESTEVEZ, L. G, BARNADAS, A, MENDEZ, M, LIZON, J, PROVENCIO, M, ALBISTUR, J. J, MARTINEZ, P, SANCHEZ, M. J, CONSTENLA, M
• Format: Conference Proceeding Journal Article
• Language: English
• Published: Berlin Springer 1999
• Subjects: Adult; Aged; Antibiotics, Antineoplastic - therapeutic use; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast Neoplasms - drug therapy; Chemotherapy; Disease Progression; Drug Resistance, Neoplasm; Female; Humans; Ifosfamide - administration & dosage; Infusions, Intravenous; Medical sciences; Mesna - administration & dosage; Middle Aged; Neoplasm Metastasis - drug therapy; Pharmacology. Drug treatments; Treatment Outcome; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives; Vinorelbine; World; Antineoplastic agent; Human; Drug combination; Mesna; Ifosfamide; Toxicity; Malignant tumor; Alkaloid; Chemotherapy; Oxazaphosphinane derivatives; Treatment; Nitrogen mustard; Phase II trial; Female; Advanced stage; Mammary gland; Vinorelbine
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s002800051108

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.