A Phase II study of paclitaxel by 24-hour infusion and ifosfamide in anthracycline-resistant metastatic breast carcinoma.
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.
Seo
Jae H
JH
Department of Internal Medicine, Division of Hematology/Oncology, College of Medicine, Korea University, Seoul, Korea.
Whang
Young M
YM
Kim
Byung S
BS
Choi
Chul W
CW
Shin
Sang W
SW
Kim
Yeul H
YH
Kim
Jun S
JS
Goo
Bum H
BH
D000328:Adult; D018943:Anthracyclines / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018450:Disease Progression; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage; D015996:Survival Rate
D018943:Anthracyclines; D017239:Paclitaxel; D007069:Ifosfamide