Bevacizumab with peri-operative epirubicin, cisplatin and capecitabine (ECX) in localised gastro-oesophageal adenocarcinoma: a safety report
Bevacizumab with peri-operative epirubicin, cisplatin and capecitabine (ECX) in localised gastro-oesophageal adenocarcinoma: a safety report
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DOI：
10.1093/annonc/mds533
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发表时间：
2013-03-01
影响因子：
50.5
通讯作者：
Cunningham, D.
中科院分区：
文献类型：
--
作者：
Okines, A. F. C.;Langley, R. E.;Cunningham, D.
背景：围手术期化疗和手术是局限性食管胃腺癌的标准治疗方法，然而，结果仍然很差。患者和方法：ST03是一项多中心、随机、II/III期研究，比较围手术期使用或不使用贝伐单抗(ECX-B)的ECX。II期试验(n=200)的主要结果是安全性，特别是胃肠道穿孔率和心脏毒性。结果：在2007年10月至2010年4月期间随机选择了200名患者。91/101(90%)ECX和86/99(87%)ECX-B患者完成了术前化疗，7例ECX和9例ECX-B患者因毒副反应停止化疗。胃肠道穿孔(3例ECX，1例ECX-B)、心脏事件(1例ECX，4例ECX-B)和静脉血栓栓塞症(VES，8例ECX，7例ECX-B)较少见。动脉血栓栓塞症事件(ATE、心肌梗死(MI)或脑血管意外)在ECX-B组(5例)比ECX组(1例)更常见。伤口延迟愈合、吻合口漏和消化道出血发生率相似。无症状左心室射血分数(LVEF)下降(<15%和/或<10%<正常值下限)分别为15.3%和8.9%，无心衰发生(中位随访22个月)。结论：围术期ECX化疗加用贝伐单抗是可行的，毒性可接受，对手术疗效无不良影响。
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 = 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.