We assessed the efficacy and toxicity of etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin (ESHAOx) combination chemotherapy in patients with refractory or relapsed Hodgkin's lymphoma (HL). This was an open-label, non-randomized, multi-center phase II study. The ESHAOx regimen consisted of intravenous (i.v.) etoposide 40 mg/m2 on days 1 to 4, i.v. methylprednisolone 500 mg on days 1 to 5, i.v. cytarabine 2 g/m2 on day 5, and i.v. oxaliplatin 130 mg/m2 on day 1. Cycles (up to six) were repeated every 3 weeks. In an effort to identify prognostic markers, the serum levels of cytokines including tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and vascular endothelial growth factor (VEGF) were measured at the time of study entry. A total of 37 patients were enrolled, and 36 were available for evaluation of tumor response. The overall response rate was 72.2% (26/36) (complete response, 33.3% [12/36]; partial response, 38.9% [14/36]). The median time to progression was 34.9 months (95% confidence interval, 23.1-46.7 months). The most common grade 3 or 4 hematological adverse events were neutropenia (16/37, 43.2%), followed by thrombocytopenia (10/37, 27.0%). Grade 3 or 4 non-hematological adverse events were nausea (3/37, 8.1%), anorexia (2/37, 5.4%), mucositis (1/37, 2.7%), and skin rash (1/37, 2.7%). There were no treatment-related deaths. High levels of TNF-α and CRP were significantly associated with poorer overall survival (p = 0.00005 for TNF-α, p = 0.0004 for CRP, respectively). The ESHAOx regimen exhibited antitumor activity and an acceptable safety profile in patients with refractory or relapsed HL. Trial Registration: ClinicalTrials.gov. Registered February 21, 2011, https://clinicaltrials.gov/ct2/show/NCT01300156.

中文翻译：

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依托泊苷，甲基强的松龙，大剂量阿糖胞苷和奥沙利铂（ESHAOx）的II期研究用于难治性或复发性霍奇金淋巴瘤患者。

我们评估了依托泊苷，甲基强的松龙，大剂量阿糖胞苷和奥沙利铂（ESHAOx）联合化疗对难治性或复发性霍奇金淋巴瘤（HL）患者的疗效和毒性。这是一项开放标签，非随机，多中心的II期研究。ESHAOx方案包括在第1至4天静脉注射（iv）依托泊苷40 mg / m2，在第1至5天静脉注射甲基泼尼松龙500 mg，在第5天静脉注射阿糖胞苷2 g / m2和在第1天静脉注射奥沙利铂130 mg / m2每3周重复一次周期（最多六个）。为了确定预后指标，在进入研究时测量了包括肿瘤坏死因子-α（TNF-α），C反应蛋白（CRP）和血管内皮生长因子（VEGF）在内的细胞因子的血清水平。总共招募了37位患者，和36个可用于评估肿瘤反应。总体缓解率为72.2％（26/36）（完全缓解率为33.3％[12/36]；部分缓解率为38.9％[14/36]）。中位进展时间为34.9个月（95％置信区间为23.1-46.7个月）。最常见的3或4级血液学不良事件是中性粒细胞减少（16 / 37，43.2％），其次是血小板减少症（10 / 37，27.0％）。3或4级非血液学不良事件为恶心（3/37，8.1％），厌食（2/37，5.4％），粘膜炎（1/37，2.7％）和皮疹（1/37，2.7％） ）。没有与治疗有关的死亡。高水平的TNF-α和CRP与较差的总体存活率显着相关（TNF-α的p = 0.00005，CRP的p = 0.0004）。ESHAOx方案在顽固性或复发性HL患者中表现出抗肿瘤活性和可接受的安全性。试用注册：ClinicalTrials.gov。注册于2011年2月21日，https：//clinicaltrials.gov/ct2/show/NCT01300156。