title: Results of a randomized trial with or without 5-FU-based preoperative chemotherapy followed by postoperative chemotherapy in resected colon and rectal carcinoma.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D011184:Postoperative Period; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D015996:Survival Rate
chemical_list: D016685:Mitomycin; D005472:Fluorouracil