Adjuvant @entity1499 escalated to @entity137 for resectable stage III and IV XXXX --a prospective, randomized study.

@entity1 @entity137 @entity260 @entity1500 @entity1499 @entity204 @entity213
To determine if adjuvant @entity1499 ( @entity1500 ), escalated weekly to @entity137 , could improve disease-free survival (DFS) and overall survival by preventing recurrent disease, 60 @entity1 with potentially resectable stage III or IV @entity213 were stratified by primary site, stage, and nutritional status, then randomized by pairs to receive or not receive adjuvant @entity1500 . All received standard surgery and postoperative radiation therapy. Five @entity1 were taken off study because of unresectability at the time of surgery, leaving 55 evaluable @entity1 . There were no statistically significant imbalances in known prognostic factors between the two treatment arms. @entity1500 was begun at 40 mg/m2 and escalated 10 mg/m2 weekly (four doses preoperatively; four doses postoperatively, preradiation therapy; eight doses postradiation therapy) to mucosal or hematologic @entity137 . The median peak @entity1500 dose achieved was 80 mg/m2. Although three @entity1 were hospitalized with @entity1500 @entity137 , none died of @entity1500 @entity137 . No @entity1 receiving @entity1500 had disease progression during treatment, and there was no @entity260 . Thirty-two @entity1 died (median survival, 19 months); 23 @entity1 are alive with median follow-up of 43 months. There was no statistically significant difference in actuarial DFS (P = 1.0) or overall survival (P = .61). Although @entity1 on the @entity1500 arm appeared to have less local and regional recurrences at first recurrence (thus more distant metastases), this did not reach statistical significance (P = .06). There was no significant difference between the sites of recurrence at @entity204 or last follow-up (P = .38).
