Prospective Phase II Study of Neoadjuvant Therapy with Cisplatin, 5-Fluorouracil, and Bevacizumab for Locally Advanced Resectable Esophageal Cancer

作者：Efraim Idelevich, Hanoch Kashtan, Yoram Klein, Victor Buevich, Noa Ben Baruch, Michael Dinerman, Margarita Tokar, Yulia Kundel, Baruch Brenner · 发表于：Onkologie · 年份：2012 · DOI：10.1159/000340072 · 被引用次数：29 · 研究领域：Esophageal Cancer Research and Treatment、Gastric Cancer Management and Outcomes、Esophageal and GI Pathology

BACKGROUND: We investigated the efficacy and tolerability of cisplatin and 5-fluorouracil (5-FU) plus bevacizumab as neoadjuvant therapy for patients with locally advanced resectable esophageal cancer. PATIENTS AND METHODS: In this prospective phase II study, 22 patients with adenocarcinoma and 6 with squamous cell carcinoma received 2 4-day cycles of bevacizumab 7.5 mg/kg followed by cisplatin 80 mg/m(2) infusion on day 1 followed by 5-FU 1,000 mg/m(2) as a 96-h continuous infusion on days 1-4, separated by a 3-week interval. RESULTS: The response rate was 39%, the R0 resection rate was 43%, and the median overall survival (OS) was 17 months. The regimen was well tolerated, with the most common severe toxicities being venous thromboembolism (10%), nausea, and gastrointestinal bleeding (7% each). In 37 patients previously treated with cisplatin and 5-FU alone at our institution and thus serving as historical controls, the response rate was 30%, the R0 resection rate was 44%, and the median OS was 23 months. There was no statistically significant difference between the 2 groups of patients. CONCLUSION: Adding bevacizumab to cisplatin and 5-FU neoadjuvant chemotherapy was active and well tolerated but did not seem to improve the resection rate or OS compared with prior regimens, including the historical controls at our institution.