Abstract

Ev. Bethesda Krankenhaus, Bocholderstr. IJ-IJ, 45355 Essen, Germany A randomized trial has been conducted from 1987 to 1994 to prove the benefit of concomitant chemotherapy to radiotherapy in advanced anal carcinoma. One hundred and three of 110 patients with T<sub>3</sub> and T<sub>4</sub> tumors or lymphnode metastases were evaluable. Radiotherapy consisted of 45 Gy in 5 weeks. After a rest period of 6 weeks patients with complete or partial remission received a boost of 15 resp. 20 Gy. Chemotherapy consisted of Mitomycin 15mg/m<sup>2</sup> day I and 750mg/m<sup>2</sup> 5FU continuously day 1–5 and 29–33. There was no significant increase of early and late toxicity. Complete remission rate of 81% vs. 55% was significantly better in the combinded arm, raising to 98% vs. 81% if results obtained with surgery were included (<i>P</i>=0.0008). Local control after primary treatment remained different during follow up estimated to be 58% vs. 31% at 5 years. Colostomy free survival increased significantly, estimated at 5 years to be 41% vs. 22%. There was no difference in overall survival for both groups. New concepts to optimize the effect of concomitant use of radiotherapy and chemotherapy will be presented.

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