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Clinical Trial
. 2004 Nov;23(11 Suppl):1473-6.

[Chemoradiotherapy followed by surgery in treatment of locally advanced esophageal carcinoma: a phase II trial]

[Article in Chinese]
Affiliations
  • PMID: 15566661
Clinical Trial

[Chemoradiotherapy followed by surgery in treatment of locally advanced esophageal carcinoma: a phase II trial]

[Article in Chinese]
Jian-Hua Fu et al. Ai Zheng. 2004 Nov.

Abstract

Background & objective: Recently, neoadjuvant therapy has become the focus of interest in an effort to prolong survival and reduce recurrence rates in patients with oesophageal cancer. This study was designed to evaluate the tolerance and the short-term outcome of chemoradiotherapy followed by surgery for patients with locally advanced esophageal squamous carcinoma, to observe effects of chemoradiotherapy on tumor resection rate, incidence of complications after surgery, and perioperative mortality.

Methods: From January 2000 to September 2003, Thirty-four consecutive patients with locally advanced esophageal squamous carcinoma were entered into this phase II study. The clinical pre-treatment staging of the tumors were determined by chest CT scan, abdomial CT Scan, EUS, and bronchoscopy examination. Chemotherapy and radiotherapy were performed concurrently. The chemotherapy consisted of Vinorelbine (or 5-Fluorouracil) and Cisplatin. 5-Fluorouracil at 2.4 g/m(2) was administered in continuous infusion for days 1-3 and days 22-25. Vinorelbine at 25 mg/m(2) per day was administered in bolus infusion on d1, d8, d22 and d29. Cisplatin at 75 mg/m(2) was administered by intravenously infusion on d1 and d22. A total radiotherapy dose of 40 Gy was delivered in 20 daily fractions of 2.0 Gy each (given 5 d/wk for 4 weeks). After completion of chemoradiotherapy, clinical restaging was performed. Esophagectomy and lymphadenectomies were performed 3-5 weeks after chemoradiotherapy.

Results: Thirty-three patients completed the planned chemoradiotherapy, and 32 patients underwent surgery. The toxicities of chemoradiotherapy such as myelotoxicity, pulmonary toxicity, esophagitis were grade I or II. No death was resulted from chemoradiotherapy. The clinical response rate of chemoradiotherapy was 85.3%, the pathological complete response rate was 25%, the resectability rate was 100%. Postoperative pulmonary infection occurred in 8 patients (22.9%), anastomotic leak in 3 patients (9.4%). Two patients (6.3%) died perioperatively because of ARDS and anastomotic leak complicated with heart failure.

Conclusions: The short-term results of this study suggest that the strategy of chemoradiotherapy followed by surgery is safe,although it caused considerable toxicity and increased operation-related complications rate and perioperative mortality rate compared with surgery alone at the same period. Preoperative chemoradiotherapy is able to significantly reduce the tumor stage, and achieve substantially high clinical response rate and pathological complete response rate.

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