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

A. F. C. Okines, R. E. Langley, L. C. Thompson, S. P. Stenning, L. Stevenson, S. Falk, M. Seymour, F. Coxon, G. W. Middleton, D. Smith, L. Evans, S. Slater, J. Waters, D. Ford, M. Hall, T. J. Iveson, R. D. Petty, C. Plummer, W. H. Allum, J. M. BlazebyM. Griffin, D. Cunningham

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    Abstract

    BACKGROUND: Peri-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 peri-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 (VTEs, 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 peri-operative ECX chemotherapy is feasible with acceptable toxicity and no negative impact on surgical outcomes.

    Original languageEnglish
    Article numbermds533
    Pages (from-to)702-709
    Number of pages8
    JournalAnnals of Oncology
    Volume24
    Issue number3
    DOIs
    Publication statusPublished - Mar 2013

    Keywords

    • Adenocarcinoma
    • Aged
    • Antibodies, Monoclonal, Humanized
    • Antineoplastic Combined Chemotherapy Protocols
    • Cisplatin
    • Deoxycytidine
    • Epirubicin
    • Esophageal Neoplasms
    • Female
    • Fluorouracil
    • Humans
    • Male
    • Middle Aged
    • Myocardial Infarction
    • Stomach Neoplasms
    • Stroke Volume
    • Thromboembolism
    • Treatment Outcome

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