Final report of Intergroup Trial 0122 (ECOG PE-289, RTOG 90-12): Phase II trial of neoadjuvant chemotherapy plus concurrent chemotherapy and high-dose radiation for squamous cell carcinoma of the esophagus

Purpose: To determine the outcome of neoadjuvant chemotherapy followed by c oncurrent chemotherapy plus high-dose radiation therapy in patients with lo cal/regional squamous cell carcinoma of the esophagus. Methods and Materials: Forty-five patients with clinical Stage T1-4N0-1M0 s quamous cell carcinoma were entered on a prospective single-arm study, of w hich 38 were eligible. Patients received 3 monthly cycles of 5-FU (1000 mg/ m(2)/24 h x 5 days) and cisplatin (100 mg/m(2) day 1; neoadjuvant segment) followed by 2 additional monthly cycles of 5-FU (1000 mg/m(2)/24 h x 5 days ) and cisplatin (75 mg/m(2) day 1) plus concurrent 6480 cGy (combined modal ity segment). The median follow-up in surviving patients,vas 59 months. Results: For the 38 eligible patients, the primary tumor response rate was 47% complete, 8% partial, and 3% stable disease. The first site of clinical failure was 39% local/regional and 24% distant. For the total patient grou p, there were 6 deaths during treatment, of which 9% (4/45) were treatment related. The median survival was 20 months. Actuarial survival at 3 years w as 30%, and at 5 years, 20%. Conclusion: This intensive neoadjuvant approach does not appear to offer a benefit compared with conventional doses and techniques of combined modalit y therapy. However, high dose radiation (6480 cGy) appears to be tolerable, and is being tested further in Intergroup Trial INT 0123. (C) 1999 Elsevie r Science Inc.