A phase II trial of weekly paclitaxel and high-dose 5-fluorouracil plus leucovorin in patients with chemotherapy-pretreated metastatic breast cancer.
BACKGROUND
Weekly paclitaxel and infusional high-dose 5-fluorouracil/leucovorin (HDFL) are both effective regimens for metastatic breast cancer (MBC) patients.


METHODS
A study was designed using weekly paclitaxel 90 mg/m(2) 1-hour infusion followed by 2,000 mg/m(2) 5-fluorouracil plus 300 mg/m(2) leucovorin 24-hour infusion on days 1, 8 and 15, repeated every 28 days, in patients who had previously received a > or =1 regimen for MBC. The dose of paclitaxel was adjusted in each cycle according to toxicity.


RESULTS
A total of 182 cycles were given to 28 patients. The doses of paclitaxel needed to be reduced only in 22 (12%) cycles. Forty-five cycles were skipped or delayed more than 7 days, mostly due to neutropenia, infection, or neurotoxicity. Twenty-five patients were evaluable for response. Four had complete response, 13 partial response, seven stable disease, and two progressive disease. The response rate was 60.7% (95% CI: 42.6-78.8). Median survival was 18.1 months (95% CI: 11.4-24.9), and progression-free survival seven months.


CONCLUSIONS
Weekly paclitaxel plus infusional HDFL is an active and well tolerated regimen for pretreated MBC patients.
Lin
Chia-Chi
CC
Departments of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Cheng
Ann-Lii
AL
Hsu
Chih-Hung
CH
Lu
Yen-Shen
YS
Hsu
Chiun
C
Yeh
Kun-Huei
KH
Wu
Chen-Yao
CY
Huang
Chiun-Sheng
CS
Yang
Chih-Hsin
CH
D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome
D017239:Paclitaxel; D002955:Leucovorin; D005472:Fluorouracil