Phase II Study of Chemoradiotherapy With 5-Fluorouracil and Cisplatin for Stage II¨CIII Esophageal Squamous Cell Carcinoma: JCOG Trial (JCOG 9906)
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Purpose

In this Phase II study, we evaluated the efficacy and toxicity of chemoradiotherapy (CRT) with cisplatin (CDDP) and 5-fluorouracil (5-FU) for Stage II¨CIII esophageal squamous cell carcinoma (ESCC).

Patients and Methods

Patients with clinical Stage II¨CIII (T1N1M0 or T2?N0?M0) thoracic ESCC were enrolled between April 2000 and March 2002. Chemotherapy comprised two courses of protracted infusion of 5-FU (400 mg/mmlns="""">2/day) on Days 1? and 8?2, and 2-h infusion of CDDP (40 mg/mmlns="""">2) on Days 1 and 8; this regimen was repeated every 5 weeks. Concurrent radiotherapy involved 60-Gy irradiation (30 fractions) for 8 weeks with a 2-week break. Responders received two courses of 5-FU (800 mg/mmlns="""">2/day) on Days 1? and CDDP (80 mg/mmlns="""">2) on Day 1. Final analysis was conducted in March 2007. Survival and late toxicities were monitored for 5 years.

Results

The characteristics of the 76 patients enrolled were as follows: median age, 61 years; male/female, 68/8; performance status 0/1, 59/17 patients; Stage IIA/IIB/III, 26/12/38 patients. Of the 74 eligible patients, 46 (62.2 % ) achieved complete response. Median survival time was 29 months, with 3- and 5-year survival rates of 44.7 % and 36.8 % , respectively. Acute toxicities included Grade 3/4 esophagitis (17 % ), nausea (17 % ), hyponatremia (16 % ), and infection without neutropenia (12 % ). Late toxicities comprised Grade 3/4 esophagitis (13 % ), pericardial (16 % ) and pleural (9 % ) effusion, and radiation pneumonitis (4 % ), causing 4 deaths.

Conclusions

CRT is effective for Stage II¨CIII ESCC with manageable acute toxicities and can provide a nonsurgical treatment option. However, further improvement is required for reduction in late toxicity.

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