Department of Medicine I, Clin. Div. of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria
Neoplasma. 2018;65(4):599-603. doi: 10.4149/neo_2018_170727N506.
The oral multikinase inhibitor regorafenib had beneficial effects in randomized clinical phase III trials compared to the placebo in patients with metastatic colorectal cancer (mCRC) who progressed on standard therapies. The factors which influence regorafenib response and therapy sequence during treatment history are still highly discussed, and herein we analyzed the therapy algorithm, outcome and clinical markers following regorafenib application in a single center register study. Clinical data for 48 metastatic colorectal cancer patients were collected from 01.01.2013 to 31.12.2016. Treatment effects according to various patient and tumor characteristics were evaluated using univariate and multivariate Cox proportional hazard regression models. The 48 patients comprised 14 (29%) females and 34 (71%) males, with mean age 64.2±9 and ECOG 0-1. Progression free survival under regorafenib therapy was 2.9 months (quartiles 2.2; 4.4) and the overall response rate was 2 (4%) and disease control rate was 19 (40%). Overall survival (OS) and progression free survival (PFS) were investigated under regorafenib in the chemotherapy regimen given immediately before and afterthis treatment. Variables including tumor localization, Ras status, CEA and CA 19-9 plasma levels were analyzed for their impact on PFS, and the regorafenib-related adverse events were also observed. Our study confirms the efficacy of regorafenib in a real-life setting. We established that response rate and PFS in regorafenib treatment are independent of tumor localization, Ras status or biomarkers such as CEA and CA 19-9. Trifluridin/tripacil application or re-induction of chemotherapy +/- target therapy was effective following regorafenib therapy.
口服多激酶抑制剂瑞戈非尼与安慰剂相比，在接受标准治疗后进展的转移性结直肠癌（mCRC）患者的随机临床 III 期试验中具有有益的效果。影响瑞戈非尼反应和治疗史中治疗顺序的因素仍在激烈讨论中，在此我们分析了单一中心登记研究中瑞戈非尼应用后的治疗算法、结果和临床标志物。从 2013 年 1 月 1 日至 2016 年 12 月 31 日，我们从 48 名转移性结直肠癌患者中收集了临床数据。使用单变量和多变量 Cox 比例风险回归模型评估了各种患者和肿瘤特征的治疗效果。48 例患者包括 14 例（29%）女性和 34 例（71%）男性，平均年龄为 64.2±9 岁，ECOG 0-1。瑞戈非尼治疗下的无进展生存期为 2.9 个月（四分位数 2.2；4.4），总缓解率为 2（4%），疾病控制率为 19（40%）。在接受这种治疗之前和之后立即给予的化疗方案下，我们研究了瑞戈非尼下的总生存期（OS）和无进展生存期（PFS）。分析了肿瘤定位、Ras 状态、CEA 和 CA 19-9 血浆水平等变量对 PFS 的影响，并观察了与瑞戈非尼相关的不良事件。我们的研究在真实环境中证实了瑞戈非尼的疗效。我们发现，瑞戈非尼治疗的缓解率和 PFS 与肿瘤定位、Ras 状态或 CEA 和 CA 19-9 等生物标志物无关。瑞戈非尼治疗后，三氟尿苷/替匹嘧啶应用或重新诱导化疗 +/- 靶向治疗是有效的。
