Japanese Journal of Clinical Oncology Advance Access originally published online on May 4, 2006
Japanese Journal of Clinical Oncology 2006 36(4):237-244; doi:10.1093/jjco/hyl014
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© 2006 Foundation for Promotion of Cancer Research
Adjuvant Chemotherapy with Uracil–Tegafur for Pathological Stage III Rectal Cancer after Mesorectal Excision with Selective Lateral Pelvic Lymphadenectomy: A Multicenter Randomized Controlled Trial*
1 Colorectal Surgery Division, 2 Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, 3 Department of Biostatistics/Epidemiology and Preventive Health Sciences, University of Tokyo, Tokyo, 4 National Cancer Center Hospital East, Kashiwa, Chiba and 5 Department of Surgery, Teikyo University, Tokyo, Japan
For reprints and all correspondence: Takayuki Akasu, Colorectal Surgery Division, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: takasu{at}ncc.go.jp
Received December 28, 2005; accepted February 22, 2006
Background: Although adjuvant radiotherapy was proved to be effective for local control of rectal cancer even after standardized mesorectal excision, the role of adjuvant chemotherapy after such standardized surgery remains to be clarified. We aimed to assess the efficacy of a combination of uracil and tegafur for pathological stage III rectal cancer treated by standardized mesorectal excision with selective lateral pelvic lymphadenectomy.
Methods: We randomly assigned patients with completely resected stage III rectal cancer, who underwent standardized mesorectal excision with selective lateral pelvic lymphadenectomy, to receive either oral uracil–tegafur (400 mg/m2 tegafur per day) for one year or no treatment. Standardization and quality control of the surgery and pathological techniques were ensured by use of the guidelines of the Japanese Society for Cancer of the Colon and Rectum. The primary endpoint was relapse-free survival. The secondary endpoint was overall survival.
Results: We enrolled and randomized 276 patients. Excluding two ineligible patients, 274 were included in the analysis. Planned interim analysis 2 years after accrual termination revealed significant prolongation of relapse-free survival (P = 0.001) and overall survival (P = 0.005) in the uracil–tegafur group. The 3-year relapse-free survival and overall survival rates were 78 and 91% in the chemotherapy group and 60 and 81% in the surgery-alone group, respectively. Local recurrence rates were low in both groups. Grade 3 events occurred in 17% of the chemotherapy patients, but no grade 4 or more events occurred.
Conclusion: Adjuvant chemotherapy with uracil–tegafur improves survival of patients with stage III rectal cancer after standardized mesorectal excision with selective lateral pelvic lymphadenectomy.
Key Words: adjuvant chemotherapy • uracil–tegafur • rectal cancer • surgery
* This work was presented at the 40th American Society of Clinical Oncology annual meeting, New Orleans, USA, June 5–8, 2004.
The investigators and institutions participating in the National Surgical Adjuvant Study of Colorectal Cancer are listed at end of report.
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