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Bevacizumab with peri-operative epirubicin, cisplatin and capecitabine (ECX) in localised gastro-oesophageal adenocarcinoma: a safety report

Lookup NU author(s): Dr Fareeda Coxon, Dr Chris Plummer

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Abstract

Background: Pen-operative chemotherapy and surgery is a standard treatment of localised oesophagogastric adenocarcinoma; however, the outcomes remain poor.Patients and methods: ST03 is a multicentre, randomised, phase II/III study comparing pen-operative ECX with or without bevacizumab (ECX-B). The primary outcome measure of phase II (n = 200) was safety, specifically gastrointestinal (GI) perforation rates and cardiotoxicity.Results: Two hundred patients were randomised between October 2007 and April 2010. Ninety-one/101 (90%) ECX and 86/99 (87%) ECX-B patients completed pre-operative chemotherapy; 7 ECX and 9 ECX-B patients stopped due to toxicity. Gastrointestinal perforations (3 ECX, 1 ECX-B), cardiac events (1 ECX, 4 ECX-B) and venous thromboembolic events (VEs, 8 ECX, 7 ECX-B) were uncommon. Arterial thromboembolic events (ATEs, myocardial infarction (MI) or cerebrovascular accident) were more frequent with ECX-B (5 versus 1 with ECx). Delayed wound healing, anastomotic leaks and GI bleeding rates were similar.More asymptomatic left ventricular ejection fraction (LVEF) falls (>= 15% and/or to <50%) occurred with ECX-B (21.2% versus 11.1% with ECX). Clinically significant falls (>= 10% to below lower limit of normal, LLN) occurred in (15.3%) and (8.9%) respectively, with no associated cardiac failure (median 22 months follow-up).Conclusions: Addition of bevacizumab to pen-operative ECX chemotherapy is feasible with acceptable toxicity and no negative impact on surgical outcomes.


Publication metadata

Author(s): Okines AFC, Langley RE, Thompson LC, Stenning SP, Stevenson L, Falk S, Seymour M, Coxon F, Middleton GW, Smith D, Evans L, Slater S, Waters J, Ford D, Hall M, Iveson TJ, Petty RD, Plummer C, Allum WH, Blazeby JM, Griffin M, Cunningham D

Publication type: Article

Publication status: Published

Journal: Annals of Oncology

Year: 2013

Volume: 24

Issue: 3

Pages: 702-709

Print publication date: 01/03/2013

ISSN (print): 0923-7534

ISSN (electronic): 1569-8041

Publisher: Oxford University Press

URL: http://dx.doi.org/10.1093/annonc/mds533

DOI: 10.1093/annonc/mds533


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