Long-term toxicity and survival of definitive chemoradiotherapy (CRT) in patients (pts) with T4/M1LYM esophageal carcinoma

Abstract

4209 Background: Although definitive CRT is considered to be standard of care in non-surgical treatment for loco-regional esophageal carcinoma, there have been few reports indicating the treatment results for locally advanced disease. We have previously reported a multicenter phase II trial of the definitive CRT in pts with T4/M1LYM (UICC1987) esophageal carcinoma, which resulted in median survival time of 9months and 3-year survival rate of 23% despite substantial toxicities (Ohtsu et al.JCO'99). The aim of this analysis was to clarify long-term toxicity and survival in pts registered into the study. Methods: Eligibility criteria of this study required T4 and/or M1LYM squamous cell carcinoma of the thoracic esophagus, age ≤ 75, PS 0–2, no prior therapy, and written informed consent. The treatment consisted of 5-FU combined with CDDP and concurrent radiotherapy of 60Gy. For responders, 2 additional courses of chemotherapy were administered. Toxicity and survival data were updated on February 2003, 5.75 years after the last accrual. Late toxicity was evaluated in CR pts using RTOG/EORTC late radiation morbidity scoring schema. Results: From August 1992 to May 1997, 54 pts were enrolled into this trial. There were 36 pts with T4 and 18 with non-T4 (M1LYM only) disease. 18 of 54 pts achieved CR (33%).The updated analysis revealed the actual 5-year survival rate of 17% (9/54): 14% (5/36) in T4 and 22% (4/18) in non-T4 disease. Of the 18 CR pts, grade 3 or worse cardiopulmonary toxicity occurred in 5 (26%) pts: cardiotoxicity in 3 (17%), pleural effusion in 4 (22%), and esophageal stricture in 2 (11%) pts. Eleven of the 18 pts have already died: 7 due to recurrent disease, 3 other malignancies (lung, pancreas, and acute leukemia), and 1 cardiac failure. Seven pts are still alive with no evidence of disease 5.8–8.2 years after initiation of the CRT including 1 pt on-therapy for late toxicity. Conclusions: Definitive CRT provided 17% 5-year survival rate even for unresectable T4/M1LYM esophageal carcinoma, although late toxicity was non-negligible issues that should be addressed. No significant financial relationships to disclose.