Japanese Journal of Clinical Oncology 33:288-296 (2003)
© 2003 Foundation for Promotion of Cancer Research
Results of a Randomized Trial with or without 5-FU-based Preoperative Chemotherapy followed by Postoperative Chemotherapy in Resected Colon and Rectal Carcinoma
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/m2/day) by continuous intravenous infusion for 5 days beginning on day 6 before surgery and postoperatively with MMC (6 mg/m2) 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.
+ For participating physicians and institutions, see Appendix.
For reprints and all correspondence: Shingo Kameoka, Department of Surgery II, Tokyo Women’s Medical University, 8–1 Kawada-chou, Sinjyuku-ku, Tokyo 162-0054, Japan.
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