Role of definitive chemoradiotherapy using docetaxel and 5-fluorouracil in patients with unresectable locally advanced esophageal squamous cell carcinoma: a phase II study

Abstract

Definitive chemoradiotherapy (CRT) with docetaxel (DOC) and 5-fluorouracil (5-FU) is a unique regimen for esophageal cancer. In this prospective phase II study, antitumor effect and safety of CRT using DOC and 5-FU for inoperable locally advanced esophageal cancer were evaluated. DOC 7.5 mg/m was infused on days 1, 8, 22, and 29. 5-FU 250 mg/m /day was infused continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Radiotherapy was given to 66 Gy in 33 fractions. Eleven patients with thoracic and five with cervical esophageal cancer were eligible. All patients had esophageal squamous cell carcinoma (ESCC). The response rate was 94%, with complete response in five patients (31%) and partial response in 10 (63%). Hematologic toxicity was mild; only one patient (6%) had Grade 1 leukopenia. Nonhematologic Grade 3 or higher adverse events were esophagitis (31%), anorexia (6%), and esophago-bronchial fistula (6%). No treatment-related deaths occurred. The median time to progression was 20 months and overall 3-year and 5-year survival were 44% and 31%, respectively. Definitive CRT using DOC and 5-FU could be performed safely, and it demonstrated a favorable antitumor effect for ESCC. This regimen might be indicated in patients in whom it is desirable to avoid myelosuppression and progression of renal impairment.

Survival and prognostic factors of patients with esophageal fistula in advanced esophageal squamous cell carcinoma

“…The tumor would cause esophageal fistula if it subsides too quickly or the infection affects the ability of normal tissue regeneration [12,13]. In patients with advanced ESCC, the incidence of the esophageal fistula was 10-15% [14,15]. There have been a few reports of esophageal fistula, but all of them have limitations [16,17].…”

Development and validation of a risk prediction model for radiotherapy-related esophageal fistula in esophageal cancer

“…Esophageal fistula is one of the serious complications related with the radiotherapy, and 4.3–24% patients were reported to develop esophageal fistula after the chemoradiotherapy [4, 7–13]. Due to the related infection, massive hemorrhage or unhealed abscess [14–17], the prognosis of patients with esophageal fistula was extremely poor; with the median survival of only two or 3 months [17–19].…”

Risk factors for esophageal fistula in patients with locally advanced esophageal carcinoma receiving chemoradiotherapy

“…The incidence of esophageal fistula in EC patients receiving chemoradiotherapy has been reported to be 6%–22%. 2 , 8 – 12 The prognosis of esophageal fistula is very poor. According to the data in previous studies, the mean survival time was only 2–2.5 months.…”