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Previous Volume 331:502-507 August 25, 1994 Number 8 Next

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ABSTRACT

Background The combination of radiation therapy and chemotherapy with fluorouracil plus semustine after surgery has been established as an effective approach to decreasing the risk of tumor relapse and improving survival in patients with rectal cancer who are at high risk for relapse or death. We sought to determine whether the efficacy of chemotherapy could be improved by administering fluorouracil by protracted infusion throughout the duration of radiation therapy and whether the omission of semustine would reduce the toxicity and delayed complications of chemotherapy without decreasing its antitumor efficacy.

Methods Six hundred sixty patients with TNM stage II or III rectal cancer received intermittent bolus injections or protracted venous infusions of fluorouracil during postoperative radiation to the pelvis. They also received systemic chemotherapy with semustine plus fluorouracil or with fluorouracil alone in a higher dose, both before and after the pelvic irradiation.

Results With a median follow-up of 46 months among surviving patients, patients who received a protracted infusion of fluorouracil had a significantly increased time to relapse (P = 0.01) and improved survival (P = 0.005). There was no evidence of a beneficial effect in the patients who received semustine plus fluorouracil.

Conclusions A protracted infusion of fluorouracil during pelvic irradiation improved the effect of combined-treatment postoperative adjuvant therapy in patients with high-risk rectal cancer. Semustine plus fluorouracil was not more effective than a higher dose of systemic fluorouracil given alone.

Source Information

From the Mayo Clinic, Rochester, Minn. (M.J.O., J.A.M., H.S.W., L.L.G.); the Duluth Clinic, Duluth, Minn. (J.E.K.); Temple University School of Medicine (J.S.M.) and the University of Pennsylvania Cancer Center (D.G.H.), Philadelphia; the Dana-Farber Cancer Institute, Boston (R.J.M.); and the M.D. Anderson Cancer Center, Houston (T.A.R.).Coordinated by the North Central Cancer Treatment Group, Rochester, Minn. Other participants include the Southwest Oncology Group, the Eastern Cooperative Oncology Group, Cancer and Acute Leukemia Group B, the Radiation Therapy Oncology Group, and the M.D. Anderson Cancer Center.

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