BACKGROUND: Our previous study confirmed the efficacy of postoperative treatment with mitomycin C (MMC) and oral 5-fluorouracil (5-FU) for colorectal cancer. The 2nd trial was designed to evaluate the effectiveness of additional preoperative chemotherapy to postoperative treatment with MMC and oral 5-FU for curatively resected colorectal cancer patients. PATIENTS AND METHODS: 1355 patients (colon 755; rectum 600) were enrolled in this study. The pre- and postoperative chemotherapy (PPC) group was treated preoperatively with 5-FU (320 mg/m(2)/day) by continuous intravenous infusion for 5 days beginning on day 6 before surgery and postoperatively with MMC (6 mg/m(2)) on days 7 and 14 and in months 2, 4 and 6, by bolus injection and oral 5-FU (200 mg/day) for 6 months. The postoperative chemotherapy (PC) group received postoperative chemotherapy only. RESULTS: In an intent-to-treat analysis, the 5-year survival rate in the PPC group and the PC group was 77.3% and 75.7% for colon cancer and 67.2% and 69.2% for rectal cancer, respectively. In a per-protocol analysis, the 5-year DFS rate in the PPC group and the PC group was 76.0% and 80.7% for colon cancer and 60.5% and 63.0% for rectal cancer, respectively, indicating no significant differences between the two groups. Adverse reactions were generally mild, confirming the safety of this preoperative chemotherapeutic regimen. CONCLUSION: In the PC group, the 5-year survival rate was nearly identical with that seen in our earlier research using the same regimen, reaffirming the clinical effectiveness of postoperative MMC by protracted intravenous infusion and oral 5-FU. However, our findings did not support additional preoperative chemotherapy for curative resection in patients with colorectal cancer.
RCT Entities:
BACKGROUND: Our previous study confirmed the efficacy of postoperative treatment with mitomycin C (MMC) and oral 5-fluorouracil (5-FU) for colorectal cancer. The 2nd trial was designed to evaluate the effectiveness of additional preoperative chemotherapy to postoperative treatment with MMC and oral 5-FU for curatively resected colorectal cancerpatients. PATIENTS AND METHODS: 1355 patients (colon 755; rectum 600) were enrolled in this study. The pre- and postoperative chemotherapy (PPC) group was treated preoperatively with 5-FU (320 mg/m(2)/day) by continuous intravenous infusion for 5 days beginning on day 6 before surgery and postoperatively with MMC (6 mg/m(2)) on days 7 and 14 and in months 2, 4 and 6, by bolus injection and oral 5-FU (200 mg/day) for 6 months. The postoperative chemotherapy (PC) group received postoperative chemotherapy only. RESULTS: In an intent-to-treat analysis, the 5-year survival rate in the PPC group and the PC group was 77.3% and 75.7% for colon cancer and 67.2% and 69.2% for rectal cancer, respectively. In a per-protocol analysis, the 5-year DFS rate in the PPC group and the PC group was 76.0% and 80.7% for colon cancer and 60.5% and 63.0% for rectal cancer, respectively, indicating no significant differences between the two groups. Adverse reactions were generally mild, confirming the safety of this preoperative chemotherapeutic regimen. CONCLUSION: In the PC group, the 5-year survival rate was nearly identical with that seen in our earlier research using the same regimen, reaffirming the clinical effectiveness of postoperative MMC by protracted intravenous infusion and oral 5-FU. However, our findings did not support additional preoperative chemotherapy for curative resection in patients with colorectal cancer.