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35, No. 7-8, 2012
Issue release date: August 2012
Onkologie 2012;35:427–431

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

Idelevich E. · Kashtan H. · Klein Y. · Buevich V. · Baruch N.B. · Dinerman M. · Tokar M. · Kundel Y. · Brenner B.
aInstitute of Oncology, bDepartment of Surgery, Kaplan Medical Center, Rehovot and the Faculty of Medicine, The Hebrew University of Jerusalem, cInstitute of Oncology, Davidoff Center, Rabin Medical Center, Petach Tiqva and the Sackler Faculty of Medicine, Tel-Aviv University, Ramat-Aviv, Tel-Aviv, dDepartment of Oncology, Soroka Medical Center, Beer Sheva, Israel

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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/m2 infusion on day 1 followed by 5-FU 1,000 mg/m2 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.

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