PRELIMINARY RESULT OF A MULTICENTER PHASE II STUDY OF CHEMORADIOTHERAPY WITH DOCETAXEL FOR ELDERLY PATIENTS WITH STAGE II/III ESOPHAGEAL CARCINOMA

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Abstract

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 various comorbidities and poor organ function, including poor renal function. The aim of this multicenter phase II study was to clarify the efficacy and safety of definitive CRT with docetaxel (DTX) 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 DTX (10 mg/m2) repeated weekly. Radiation was concurrently applied at a dose of 60 Gy in 30 fractions. The primary end point was the 2-year survival rate. At this time, we evaluate the preliminary data of efficacy and safety of definitive CRT with DTX 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); PS 0/1: 4/12; cStage IIA/IIB/III: 3/4/9. Fourteen patients (88%) completed CRT, one patient (6%) could not complete CRT because of severe toxic effects, and one (6%) refused to continue the treatment. The complete response rate was 37.5% (6 of 16). In this preliminary analysis, the median follow-up time was 19 months. The 1-year survival rate was 85.7%. The grade 3 or 4 toxic effects were esophagitis (31%), anorexia (13%), leukopenia (6%), neutropenia (6%), thrombocytopenia (6%), mucositis (6%), and infection (6%). No treatment-related deaths were observed.

Conclusions

These results suggest that CRT with DTX at this dose is not suitable for elderly patients with locally advanced EC due to severe toxicity.

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