Clinical Division of Oncology, Department of Medicine I, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Department of Oncology, University Hospital Zurich, Zurich, Switzerland.
Clin Colorectal Cancer. 2018 Dec;17(4):274-279. doi: 10.1016/j.clcc.2018.05.012. Epub 2018 Jun 8.
Treatment sequencing for patients with refractory metastatic colorectal cancer (mCRC) has been highly debated. The thymidine-based nucleoside trifluridine/tipiracil (TAS-102) and the multikinase inhibitor regorafenib have demonstrated clinical benefits in randomized phase III trials compared with placebo. However, limited data are available on the most optimal therapy sequence involving TAS-102 and regorafenib.
In the present retrospective, observational, real-life study, clinical data on mCRC patients treated with TAS-102 or an alternative salvage treatment at the Medical University of Vienna and University Hospital Zurich were collected from January 2013 to December 2016.
A total of 85 patients whose disease had progressed during fluoropyrimidine-based therapy (FBT) with or without an antibody were included. The disease control rate in patients treated with TAS-102 after FBT-based treatment was 24% compared with 35% in patients treated with regorafenib after FBT-based treatment (adjusted odds ratio, 1.75; 95% confidence interval, 0.41-7.47; P = .449). The progression-free survival (PFS) and overall survival (OS) for patients treated with TAS-102 was 2.8 months (quartile, 2.0-4.8 months) and 15.9 months, respectively. When the data were analyzed according to the subgroups of patients with or without an FBT-free period, the TAS-102-treated patients with a previous FBT-free interval had a PFS of 3.1 months and OS of 17.7 months compared with a PFS of 2.2 months and OS of 8.1 months for patients who received TAS-102 immediately after FBT.
Our results have confirmed the efficacy of TAS-102 and regorafenib in the real-life setting. The treatment sequence analysis showed a tendency for longer PFS and OS for TAS-102-treated patients after an FBT-free interval. Prospective randomized data are needed to gain more information about the most beneficial therapy sequence in the salvage treatment of mCRC.
对于难治性转移性结直肠癌（mCRC）患者的治疗顺序一直存在高度争议。基于胸苷的核苷三氟胸苷/替匹嘧啶（TAS-102）和多激酶抑制剂瑞戈非尼在随机 III 期试验中与安慰剂相比显示出临床获益。然而，关于涉及 TAS-102 和瑞戈非尼的最佳治疗顺序的有限数据。
在这项回顾性、观察性、真实世界的研究中，从 2013 年 1 月至 2016 年 12 月，收集了在维也纳医科大学和苏黎世大学医院接受 TAS-102 或替代挽救治疗的 mCRC 患者的临床数据。
共纳入 85 例在氟嘧啶类药物治疗（FBT）基础上进展的患者，其中 41 例接受了抗体治疗，44 例未接受抗体治疗。在 FBT 治疗基础上接受 TAS-102 治疗的患者疾病控制率为 24%，而在 FBT 治疗基础上接受瑞戈非尼治疗的患者疾病控制率为 35%（调整后的优势比，1.75；95%置信区间，0.41-7.47；P=0.449）。接受 TAS-102 治疗的患者的无进展生存期（PFS）和总生存期（OS）分别为 2.8 个月（四分位距，2.0-4.8 个月）和 15.9 个月。当根据有或无 FBT 无进展期的患者亚组进行数据分析时，与 FBT 后立即接受 TAS-102 治疗的患者相比，先前有 FBT 无进展期的 TAS-102 治疗患者的 PFS 为 3.1 个月，OS 为 17.7 个月，而接受 TAS-102 治疗的患者的 PFS 为 2.2 个月，OS 为 8.1 个月。
我们的结果证实了 TAS-102 和瑞戈非尼在真实环境中的疗效。治疗顺序分析显示，在 FBT 无进展期后接受 TAS-102 治疗的患者的 PFS 和 OS 有延长的趋势。需要前瞻性随机数据来获得有关 mCRC 挽救治疗中最有益治疗顺序的更多信息。
