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.
RCT Entities:
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.
Authors: Mustafa Altinbas; Ozlem Er; Metin Ozkan; Yusuf Solak; H Senol Coskun; Can Kucuk; Sebnem Gursoy Journal: Med Oncol Date: 2005 Impact factor: 3.064
Authors: Der Sheng Sun; Eun Kyoung Jeon; Hye Sung Won; Ji Chan Park; Byoung Young Shim; Suk Young Park; Young Seon Hong; Hoon Kyo Kim; Yoon Ho Ko Journal: Gastric Cancer Date: 2014-08-07 Impact factor: 7.370