PERIOPERATIVE CHEMOTHERAPY IN PATIENTS WITH ORAL-CANCER

In the final report of a prospective, randomized controlled clinical t rial, we report the results of using adjuvant perioperative chemothera py in patients with oral cancer. Our study is based on the hypothesis of Goldie and Coldman. A total of 135 patients with alveolobuccal carc inoma, classified as clinically stage III and IV, were entered on the protocol. After a curative resection, they were randomized. The patien ts in the test arm of the study received methotrexate 50 mg/m(2) on th e 3rd, 10th, and 17th postoperative days. The patients in the control arm underwent observation. This analysis at 24 months showed a disease -free survival rate of 61% in the test arm versus 37% in the control a rm, which is statistically highly significant (P < 0.01). Analysis of the recurrence pattern showed that recurrence at the primary site was dramatically reduced during the first 6 postoperative months (P = 0.00 2). Our study provided further clinical evidence in support of the con cepts of Goldie and Coldman that the tinting of chemotherapeutic drugs is critical for a successful end result.