A phase II study of irinotecan and docetaxel with concurrent radiotherapy as preoperative treatment in resectable esophageal cancer

Abstract

4245 Background: Esophageal cancer, while less frequent among cancers in the U.S., it is highly lethal. In the last decade, adenocarcinoma of the esophagus has had the most rapid increase in rate among solid tumors. Patients presenting with local regional disease often succumb to systemic spread. Preoperative chemoradiotherapy followed by surgery appears to offer a survival advantage over surgery alone; however, efficacy with 5-FU/Platinum based therapy is limited partly by failure to eradicate occult disease. Docetaxel and irinotecan are newer agents that have demonstrated activity in GI malignancies. The objective of this study is to determine the response rate and safety of preoperative docetaxel and irinotecan in patients with carcinoma of the esophagus. Methods: 14 patients, 10 adeno. 4 scc, 13M/1F, 4AA, 10C with resectable esophageal cancer have been enrolled to date. Docetaxel 35 mg/m2and irinotecan 50 mg/m2 were given weekly for 3 consecutive weeks. Following a one week break, docetaxel 30mg/m2 was given weekly followed sequentially by irinotecan 45 mg/m2 for 3 weeks. Each agent was given concurrently with radiation. Results: The principal toxicities were neutropenia, wt. loss, asthenia, and nausea. Neutropenia requiring dose modification occurred in 4 of 14 patients during combination chemo alone. 2 patients required feeding tubes; one for early esophagitis. Pretreatment dysphagia resolved during induction chemo in 13 of 14 patients. 2 pCR and 3PR observed among patients who had esophagectomy. 1 pt refused surgery after cCR, 3 pt unfit post chemo/RT and 1 death unrelated to treatment, and 4 pt completing Chemo/RT. Conclusion: The treatment regimen is well tolerated. Preoperative therapy has not altered surgical complication rate or recovery. The pCR rate observed thus far is encouraging for this regimen and accrual continues to determine the true response rate and overall survival. Prophylactic filgrastim has been added to improve adherence to dose schedule. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho-Biotech Novartis