A Phase II Trial of Chemoradiotherapy for Stage I Esophageal Squamous Cell Carcinoma: Japan Clinical Oncology Group Study (JCOG9708)

医学 养生 临床终点 放化疗 内科学 食管切除术 胃肠病学 阶段(地层学) 外科 氟尿嘧啶 置信区间 顺铂 放射治疗 毒性 临床研究阶段 食管癌 化疗 临床试验 癌症 古生物学 生物
作者
Hoichi Kato,Aki-Hiro Sato,Hisami Fukuda,Yoshikazu Kagami,Harushi Udagawa,A Togo,Nobuhiro Ando,Otsuo Tanaka,Masayuki Shinoda,Hideaki Yamana,Satoshi Ishikura
出处
期刊:Japanese Journal of Clinical Oncology [Oxford University Press]
卷期号:39 (10): 638-643 被引量:278
标识
DOI:10.1093/jjco/hyp069
摘要

The study objective was to evaluate the efficacy and toxicity of chemoradiotherapy with 5-fluorouracil (5-FU) plus cisplatin in patients with Stage I esophageal squamous cell carcinoma (ESCC). The primary endpoint was proportion of complete response (%CR).Patients with Stage I (T1N0M0) ESCC, aged 20-75 years, without indication of endoscopic mucosal resection were eligible. Treatment consisted of cisplatin 70 mg/m(2) (day 1) and 5-FU 700 mg/m(2)/day (days 1-4) combined with 30 Gy radiotherapy (2 Gy/day, 5 days/week, days 1-21). The cycle was repeated twice with 1-week split. Salvage surgery was recommended for residual tumor or local recurrence.From December 1997 to June 2000, 72 patients were enrolled. No ineligible patient or major protocol violation was observed. There were 63 CRs for %CR of 87.5% [95% confidence interval (CI): 77.6-94.1]. Six patients with residual tumor successfully underwent esophagectomy. There was no Grade 4 toxicity. Four-year survival proportion was 80.5% (95% CI: 71.3-89.7), and 4-year major relapse-free survival proportion was 68% (95% CI: 57.3-78.8) (mucosal recurrence removed by endoscopy was not counted as an event).High CR proportion and survival proportion with mild toxicity suggest that this regimen could be considered as a candidate of new standard treatment to be compared with surgery in patients with Stage I ESCC.
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