Phase II study of chemoradiotherapy with docetaxel for elderly patients with stage II/III esophageal carcinoma: An updated report.

Abstract

208 Background: Definitive chemoradiotherapy (CRT) is one of the curative options for resectable esophageal carcinoma (EC). However, there are limited data on CRT in elderly patients, and it is difficult for elderly patients to receive chemotherapy containing cisplatin. The aim of this prospective study was to clarify the efficacy and safety of definitive CRT with docetaxel (DTX) in elderly patients. Methods: The eligibility criteria for this study were as follows: clinical stage II-III (UICC 6th, non-T4) EC; performance status (PS) 0-1; age > 70; and no desire for surgical treatment. Chemotherapy consisted of 6 cycles of a 1-h infusion of DTX (10 mg/m2) repeated weekly. Radiation was concurrently applied at a dose of 60 Gy in 30 fractions. We calculated that with a sample size of 37 patients, assuming that the expected and threshold 2-year survival was 50% and 30% with one-sided alpha of 5% with 80% power. Results: Between July 2008 and January 2011, 16 patients were enrolled. The study was closed prematurely due to poor accrual. The median age was 77 years (range, 73-81); male/female: 14/2; PS 0/1: 4/12; clinical Stage IIA/IIB/III: 3/4/9. Of the 16 patients, 14 (88%) completed the CRT, 1 patient (6%) could not complete the treatment because of grade 3 esophagitis, and 1 (6%) refused to continue the treatment. The median follow-up time was 57.9 months. Six patients achieved complete response (CR), resulting in a 37.5% CR rate (95% confidence interval (CI): 15.2-64.6). The 2-year overall survival rate was 62.5% (95% CI: 39.0-86.0). The median survival time was 27.8months (95% CI: 23.7-31.9). Acute toxicities included grade 3/4 esophagitis (31%), anorexia (13%), leukopenia (6%), neutropenia (6%), thrombocytopenia (6%), mucositis (6%), and infection (6%). No treatment-related deaths were observed. Grade 3 or 4 esophagitis, pleural effusion, pericardial effusion, and pneumonitis developed as late adverse events in 13%, 13%, 6%, and 6% of patients, respectively. Conclusions: Although it is difficult to conclude about efficacy of CRT with DTX for elderly stage II-III EC patients, considering that this study was terminated prematurely, CRT with DTX seemed to have substantial clinical activity. Clinical trial information: 000001846.