BACKGROUND/AIMS: This study was designed to clarify the effects of treatment and toxicity between 5-fluorouracil (5-FU) plus bolus infusion of Cisplatin (CDDP) and 5-FU plus continuous infusion of low-dose CDDP in advanced gastric cancer. METHODOLOGY:Seventy-three patients with advanced gastric cancer were enrolled in this study to compare the antitumor effect and toxicity between the bolus infusion of CDDP and the continuous infusion of low-dose CDDP in combination with the continuous infusion of 5-FU. Sixty-five eligible patients were divided into two groups: group A: curative resection cases; and, group B: non-curative, recurrent or inoperable cases. Patients were classified into two arms in each group. One arm of treatment regimen is 5-FU and bolus infusion of CDDP (A-1, B-1) and the other arm is 5-FU and continuous infusion of low-dose CDDP (A-2, B-2). RESULTS:Response rates were 9.1% and 38.5% in arm B-1 and arm B-2, respectively, although the difference between the two was not at a significant level. Frequently observed toxicities during the treatment were gastrointestinal symptoms such as nausea, vomiting, and anorexia. The incidence of side effects in arm A-2 and arm B-2 was almost the same as that in arm A-1 and arm B-1. CONCLUSIONS: These results revealed that there was no advantage of low-dose continuous infusion of CDDP with 5-FU in terms of response rate and clinical toxicity in our present study.
RCT Entities:
BACKGROUND/AIMS: This study was designed to clarify the effects of treatment and toxicity between 5-fluorouracil (5-FU) plus bolus infusion of Cisplatin (CDDP) and 5-FU plus continuous infusion of low-dose CDDP in advanced gastric cancer. METHODOLOGY: Seventy-three patients with advanced gastric cancer were enrolled in this study to compare the antitumor effect and toxicity between the bolus infusion of CDDP and the continuous infusion of low-dose CDDP in combination with the continuous infusion of 5-FU. Sixty-five eligible patients were divided into two groups: group A: curative resection cases; and, group B: non-curative, recurrent or inoperable cases. Patients were classified into two arms in each group. One arm of treatment regimen is 5-FU and bolus infusion of CDDP (A-1, B-1) and the other arm is 5-FU and continuous infusion of low-dose CDDP (A-2, B-2). RESULTS: Response rates were 9.1% and 38.5% in arm B-1 and arm B-2, respectively, although the difference between the two was not at a significant level. Frequently observed toxicities during the treatment were gastrointestinal symptoms such as nausea, vomiting, and anorexia. The incidence of side effects in arm A-2 and arm B-2 was almost the same as that in arm A-1 and arm B-1. CONCLUSIONS: These results revealed that there was no advantage of low-dose continuous infusion of CDDP with 5-FU in terms of response rate and clinical toxicity in our present study.