Phase II study to evaluate the efficacy of Trastuzumab in combination with Capecitabine and Oxaliplatin in first-line treatment of HER2-positive advanced gastric cancer: HERXO trial
Phase II study to evaluate the efficacy of Trastuzumab in combination with Capecitabine and Oxaliplatin in first-line treatment of HER2-positive advanced gastric cancer: HERXO trial
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DOI：
10.1007/s00280-019-03820-7
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发表时间：
2019-06-01
影响因子：
3
通讯作者：
Lopez, C.
中科院分区：
文献类型：
--
作者：
Rivera, Fernando;Romero, C.;Lopez, C.
目的III期ToGA试验确定顺铂、氟嘧啶和曲妥珠单抗为HER 2阳性晚期胃癌（AGC）的标准治疗方案。然而，如在HER 2阴性AGC中所证明的，基于奥沙利铂的方案可以改善耐受性，保持有效。本试验的目的是探讨卡培他滨，奥沙利铂（XALIX）和曲妥珠单抗在HER-2阳性晚期胃癌患者的潜在活性和安全性。MethodsWe进行了多中心，前瞻性，非随机，非对照，开放标签和国家（西班牙）II期研究。HER 2阳性晚期胃癌或胃食管连接部（EGJ）癌患者接受XALIX和曲妥珠单抗作为一线治疗。主要终点为客观肿瘤缓解率（ORR）。结果从2011年9月至2013年12月，纳入了来自西班牙10家医院的45例患者。中位年龄为65岁，82.2%为男性，69%患有胃癌，31%患有EGJ肿瘤。中位随访13.7个月（7.1-20.9）时，估计的中位无进展生存期和总生存期分别为7.1个月（95%CI 5.5-8.7）和13.8个月（95%CI 10.1-17.4），8.9%、37.8%和31.1%的患者达到完全缓解、部分缓解和疾病稳定。关于安全性，44.4%的患者发生3级或以上不良事件，最常见的是腹泻（26.6%）、疲乏（15.5%）、恶心（20%）和呕吐（13.3%）。只有两名患者（4.4%）无症状的2级左心室射血分数reduction. ConclusionsXadminX-曲妥珠单抗是一个有前途的和有效的治疗作为一线治疗HER 2阳性AGC患者，与其他铂类药物为基础的方案获得的结果。该方案可行，耐受性好，心脏毒性发生率低。
PurposeThe phase III ToGA trial established cisplatin, fluoropyrimidine and trastuzumab as the standard treatment in HER2-positive advanced gastric cancer (AGC). However, as demonstrated in HER2-negative AGC, oxaliplatin-based regimens could improve tolerance remaining effective. The aim of this trial was to explore the potential activity and safety of capecitabine, oxaliplatin (XELOX) and trastuzumab in patients with HER-2 positive advanced gastric cancer.MethodsWe conducted a multicentre, prospective, non-randomised, non-controlled, open-label and national (Spanish) phase II study. Patients with HER2-positive advanced gastric or gastro-oesophageal junction (EGJ) cancer received XELOX and trastuzumab as first-line treatment. Primary endpoint was objective tumour response rate (ORR).Results45 patients from ten hospitals in Spain were included from September 2011 to December 2013. Median age was 65 years, 82.2% were male, 69% had gastric cancer and 31% had EGJ tumours. At a median follow-up of 13.7months (7.1-20.9), the estimated median progression-free survival and overall survival were 7.1 (95% CI 5.5-8.7) and 13.8months (95% CI 10.1-17.4), respectively, with 8.9%, 37.8% and 31.1% of patients achieving complete response, partial response and stable disease. Regarding safety, 44.4% of the patients had grade 3 or greater adverse events, being the most frequent diarrhoea (26.6%), fatigue (15.5%), nausea (20%) and vomiting (13.3%). Only two patients (4.4%) developed asymptomatic grade 2 left ventricle ejection fraction reduction.ConclusionsXELOX-trastuzumab is a promising and effective therapy as first-line treatment for patients with HER2-positive AGC, with comparable results to the ones obtained with other platinum-based regimens. This scheme is feasible and tolerable with a low incidence of cardiac toxicity.