Chemoradiation therapy with docetaxel in elderly patients with stage II/III esophageal cancer: A phase 2 trial

Abstract

PurposeThe most effective treatments in elderly patients with esophageal cancer remain a subject of debate. This multicenter phase 2 study was designed to evaluate the efficacy and toxicity of chemoradiation therapy (CRT) with docetaxel (DTX) in elderly patients with stage II/III (non-T4) esophageal cancer. Methods and materialsPatients ≥70 years of age with clinical stage II/III esophageal cancer received DTX at a weekly dose of 10 mg/m2 during 6 consecutive weeks and concurrent radiation therapy (60 Gy in 30 fractions). The primary endpoint was the 2-year survival rate, and the required number of enrolled patients was 37. ResultsBetween July 2008 and January 2011, 16 patients were enrolled. The study was prematurely closed because of slow accrual. Characteristics of the patients were as follows: median age, 77 years (range, 73-81); performance status 0/1, 4/12; and clinical stage IIA/IIB/III, 3/4/9. Of the 16 patients, 14 (87.5%) completed the CRT. The 2-year survival rate was 62.5% (90% confidence interval [CI], 42.5-82.5). The median survival time was 27.7 months (95% CI, 23.3-32.2 months) and the median progression-free survival was 15.2 months (95% CI, 5.4-25.0 months). Seven patients achieved complete response, resulting in a complete response rate of 43.8% (95% CI, 19.8-70.1). Grade 3 or higher acute toxicities included esophagitis (31.3%), anorexia (12.5%), leukopenia (6.3%), neutropenia (6.3%), thrombocytopenia (6.3%), mucositis (6.3%), and infection (6.3%). Grade 3 or higher late toxicities included esophagitis (12.5%), pleural effusion (12.5%), pneumonitis (6.3%), and pericardial effusion (6.3%). ConclusionsCRT with DTX might be a treatment option for elderly patients with stage II/III esophageal cancer, particularly for patients who are medically unfit for surgery or cisplatin-containing therapy. However, further improvements of this therapy are required to decrease the incidence of esophagitis.