Preliminary result of a multicenter phase II study of chemoradiotherapy with docetaxel for elderly patients with stage II/III esophageal carcinoma.

Abstract

122 Background: Definitive chemoradiotherapy (CRT) with 5-fluorouracil plus cisplatin (CDDP) is one of the most common treatment modalities for esophageal carcinoma (EC). However, there are limited data on CRT in elderly patients, and it is difficult for elderly patients to receive chemotherapy with CDDP due to poor organ function. The aim of this prospective study was to clarify the efficacy and safety of definitive CRT with docetaxel in elderly patients. Methods: Eligibility criteria included clinical stage II/III (UICC 6th, non-T4) EC, PS 0-1, age over 70 years, and no desire for surgical treatment. A total of 40 patients were planned for enrollment. Chemotherapy consisted of 6 cycles of a 1-h infusion of docetaxel (10 mg/m2) repeated weekly. Radiation was concurrently administered to a dose of 60 Gy in 30 fractions. At this time, we evaluate the preliminary data of efficacy and safety of definitive CRT with docetaxel in elderly patients. Results: A total of 16 patients were enrolled between July 2008 and January 2011, at which point, the trial was closed due to poor accrual. The median age was 77 years (range, 73-81); male/female: 14/2; PS 0/1: 4/12; cStage IIA/IIB/III/IV: 3/4/8/1. Fourteen patients (88%) completed the treatment protocol, 1 patient (6%) could not complete the treatment because of severe toxicities, and 1 (6%) refused to continue the treatment. The complete response (CR) rate was 19% (3/16). In this preliminary analysis, the median follow-up time was 17 months. The 1-year survival rate was 87.5%. The most common grade 3 or 4 toxicities were 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: This regimen is considered as feasible on hematological toxicities, however slightly toxic on non-hematological toxicities with modest activity. Lower rate of CR seemed to be due to severe esophagitis. Further follow-up is needed to estimate the efficacy of this treatment.