A Phase II study of paclitaxel by 24-hour infusion and ifosfamide in anthracycline-resistant metastatic breast carcinoma.

Abstract

BACKGROUND:

A Phase II study was performed to investigate the efficacy and tolerability of paclitaxel and ifosfamide chemotherapy for the treatment of anthracycline-resistant metastatic breast carcinoma (MBC).

METHODS:

Recurrent or progressed MBC within 12 months after anthracycline-based chemotherapy was defined as anthracycline-resistant. A 24-hour infusion of paclitaxel (175 mg/m(2)) on Day 1 and subsequent infusions of ifosfamide (1.8 g/m(2)/day) with mesna (360 mg/m(2)/day) on Days 2- 4, were performed every 3 weeks. Twenty-one patients were eligible for toxicity analysis. Response rate and survival duration were evaluated in 21 patients. Frontline chemotherapy was the FAC (5-fluorouracil, doxorubicin, cyclophosphamide) regimen in all patients.

RESULTS:

Objective response was found in 9 patients (42.9%), including complete response in 3 (13.4%). Median response duration and median survival duration were 10 months (range, 2-24+) and 19+ months (range, 2-32+), respectively. Sixteen (76%) experienced Grade 3/4 leukopenia controllable with granulocyte macrophage colony-stimulating factor. Other significant toxicities were peripheral neuropathy (n = 3), mucositis (n = 2), and liver dysfunction (n = 1). However, there was no chemotherapy-related death.

CONCLUSIONS:

Paclitaxel by 24-hour infusion combined with ifosfamide is efficacious in the treatment of anthracycline-resistant MBC with tolerable toxicity. Further trials verifying the result of the authors' study are warranted.

• Authors: Jae H Seo, Young M Whang, Byung S Kim, Chul W Choi, Sang W Shin, Yeul H Kim, Jun S Kim, Bum H Goo
• Journal: Cancer (Cancer) Vol. 94 Issue 7 Pg. 1925-30 (Apr 01 2002) ISSN: 0008-543X [Print] United States
• PMID: 11932893 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)
• Copyright: Copyright 2002 American Cancer Society.

Chemical References

• Anthracyclines
• Paclitaxel
• Ifosfamide

Topics

• Adult
• Anthracyclines (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (drug therapy, mortality, pathology)
• Disease Progression
• Drug Administration Schedule
• Drug Resistance, Neoplasm
• Female
• Humans
• Ifosfamide (administration & dosage)
• Infusions, Intravenous
• Leukopenia (chemically induced)
• Male
• Middle Aged
• Neoplasm Metastasis
• Paclitaxel (administration & dosage)
• Survival Rate