METHODS. CT+RT included cisplatin administered 100 mg/m(2), d.l plus 5-fluorouracil 1000 mg/m(2) D.1 to 5, ci (120 hrs), q every 3rd week for 3 cycles, followed by RT. RT included external beam irradiation 64.8 Gy in 1.8 Gy fractions, five days a week, by 4-field box technique. The median follow-up was 46 months. Ninety-four patients were evaluable for survival, 47 in the CT+RT group and 47 in the RT group. Ninety-two patients were evaluable for response. Known prognostic factors were equally distributed between the two groups.

RESULTS. Of the 43 patients evaluable before RT, 31 (72%) achieved a partial or complete response after CT alone. After RT, 52 patients attained a complete response, 25 in the CT+RT group and 27 in the RT-group. Sixty-three patients developed distant metastases or local relapse, 30 in the CT+RT group and 33 in the RT group. In the CT+RT group 6 of the 9 patients with metastases also had local progression at relapse, in the RT group, 7 of 17 patients. The survival rates for the two groups are not statistically different. Thirty-seven patients are alive, 29 have no evidence of disease. Fifty-seven have died, 29 in the CT+RT group and 28 in the RT group. Fifty-four deaths were related to cancer, and 3 to therapy.

CONCLUSIONS. Sequential CT and RT did not improve the survival, local control, or metastasis rate compared with RT alone. (C) 1996 American Cancer Society.