Feasibility study on protracted infusional 5-fluorouracil and consecutive low-dose cisplatin for advanced gastric cancer.
In this phase II trial 31 patients with advanced gastric cancer (21 with metastatic cancer and 10 with locally advanced cancer) were treated with a continuous 24-hour infusion of 5-fluorouracil (5-FU) 330 mg/m2/day plus low-dose cisplatin (CDDP) 6 mg/m2/day by bolus infusion on days 1-5. The regimen with a combination of 5-FU and low-dose CDDP (FLDP) was repeated weekly for two to four courses according to response and tolerance. In 24 (77%) of the 31 patients, four courses of this regimen were administered. The overall response rate was in 14/31 (45%) patients with measurable disease, including one complete response and 13 partial responses. An especially high response rate of 60% was seen in 10 patients with liver metastasis. Median survival time was 11 months (range 6-27+) in the 10 cases of locally advanced cancer and 11 months (range 6-24+) in the 21 cases of metastatic cancer. Toxicity was primarily hematologic. Leukopenia and thrombocytopenia of World Health Organization (WHO) grade 3 or 4 occurred in 4/31 (13%) and 4/31 (13%) of patients, respectively. Renal dysfunction, which is a major toxicity associated with CDDP, was not observed without hydration. The patients were able to eat during therapy and preserved a good quality of life. A randomized trial including the FLDP regimen is needed to compare it with other active regimens, particularly the use of high-dose CDDP.
Kondo
K
K
Department of Surgery II, Nagoya University School of Medicine, Japan.
Murase
M
M
Kodera
Y
Y
Akiyama
S
S
Ito
K
K
Yokoyama
Y
Y
Takagi
H
H
Shirasaka
T
T
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D013274:Stomach Neoplasms / Q000188:drug therapy*
D002945:Cisplatin; D005472:Fluorouracil