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

TLDR

The study evaluated the efficacy and toxicity of 5‑fluorouracil plus cisplatin chemoradiotherapy in patients with Stage I esophageal squamous cell carcinoma. Seventy‑two Stage I (T1N0M0) patients aged 20‑75 received cisplatin 70 mg/m² on day 1, 5‑FU 700 mg/m²/day for days 1‑4, and 30 Gy of radiotherapy (2 Gy/day, 5 days/week, days 1‑21), repeated twice with a one‑week break, with salvage surgery for residual tumor or recurrence. The regimen achieved an 87.5 % complete‑response rate (95 % CI 77.6‑94.1), no Grade 4 toxicity, and 4‑year overall survival of 80.5 % (95 % CI 71.3‑89.7) and relapse‑free survival of 68 % (95 % CI 57.3‑78.8), supporting its consideration as a new standard treatment.

Abstract

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.