A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer.
BACKGROUND
With the introduction of cisplatin-containing regimens in the treatment of advanced gastric cancer, promising clinical results have been reported. A 61.5% response rate was observed with a combination of 5-fluorouracil (5-FU) infusion and bolus cisplatin; however, the superiority of cisplatin-containing regimens to other regimens has not been clearly verified in any randomized controlled studies. A prospective, randomized study of 5-FU and cisplatin (FP) versus 5-FU, doxorubicin, and mitomycin C (FAM) versus 5-FU alone (FU) in previously untreated patients with advanced gastric cancer is reported.


METHODS
A total of 324 patients were entered into the trial and 295 patients (103 for FP, 98 for FAM, 94 for FU) were evaluable. The patients were randomized to receive FP, FAM, or FU after stratifying by the following factors: performance status, presence of measurable disease, and resection of the primary tumor.


RESULTS
The overall response rate for patients with measurable disease in the FP arm was significantly higher than in the FAM and FU arms (51% for FP; 25% for FAM; 26% for FU). The durations of response for each arm, however, were not significantly different. Even though the median time to progression for the FP arm (21.8 weeks) was longer than that for the FAM arm (12 weeks; P < 0.05) and for the FU arm (9.1 weeks; P < 0.005), there was no statistical difference in overall survival among the three arms. Toxicity for all three regimens was moderate and consisted primarily of myelosuppression, nausea, vomiting, and alopecia.


CONCLUSIONS
Although the FP regimen showed a significantly higher response rate and a longer time to progression than the FAM or FU regimens, a survival benefit was not observed.
Department of Internal Medicine, Seoul National University Hospital, Korea.
N K
NK
Kim
Y S
YS
Park
D S
DS
Heo
C
C
Suh
S Y
SY
Kim
K C
KC
Park
Y K
YK
Kang
D B
DB
Shin
H T
HT
Kim
H J
HJ
Kim
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008937:Mitomycins / Q000008:administration & dosage* / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D012074:Remission Induction; D013274:Stomach Neoplasms / Q000188:drug therapy*; D015996:Survival Rate
D008937:Mitomycins; D004317:Doxorubicin; D002945:Cisplatin; D005472:Fluorouracil