替氟尿苷/盐酸拓扑替康（TAS-102）治疗难治性转移性结直肠癌的临床实践：一种适合身体状况良好的患者的可行选择。
Trifluridine/Tipiracil (TAS-102) for refractory metastatic colorectal cancer in clinical practice: a feasible alternative for patients with good performance status.
机构信息
Department of Pharmacy, Hospital Universitario Central de Asturias, Oviedo, Spain.
Department of Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain.
出版信息
Clin Transl Oncol. 2019 Dec;21(12):1781-1785. doi: 10.1007/s12094-019-02154-3. Epub 2019 Jun 17.
INTRODUCTION
Our aim was to assess efficacy and safety and prognostic factors associated with TAS-102 in clinical practice.
METHOD
Retrospective, multicenter, and observational study including patients with advanced refractory colorectal cancer who started TAS-102 between March 2016 and August 2018. The primary end point was overall survival (OS). Secondary end points included progression-free survival, toxicity and analyze prognostic factors present at the beginning of TAS-102.
RESULT
84 patients were evaluable. The median OS was 8.30 (95% CI 6.23-9.87) months and PFS was 2.62 (95% CI 2.36-3.05) months. In multivariate analysis, ECOG 0 and reduced dose combined with more cycles were associated with better prognosis. Patients with an ECOG > 0 had worse prognosis (HR 3.34, 95% CI 1.09-10.27, p = 0.035). 95.2% experienced some type of adverse effect and 45.2% had grade ≥ 3 toxicities.
CONCLUSION
Results suggest reconsidering TAS-102 in patients with ECOG > 0, something that should be investigated in prospective randomized clinical trials.
介绍
我们的目的是评估 TAS-102 在临床实践中的疗效和安全性以及与预后相关的因素。
方法
这是一项回顾性、多中心、观察性研究，纳入了 2016 年 3 月至 2018 年 8 月期间开始使用 TAS-102 的晚期难治性结直肠癌患者。主要终点是总生存期（OS）。次要终点包括无进展生存期、毒性和分析 TAS-102 开始时存在的预后因素。
结果
84 例患者可评估。中位 OS 为 8.30 个月（95%CI 6.23-9.87），PFS 为 2.62 个月（95%CI 2.36-3.05）。多变量分析显示，ECOG 0 和减少剂量联合更多周期与更好的预后相关。ECOG>0 的患者预后较差（HR 3.34，95%CI 1.09-10.27，p=0.035）。95.2%的患者出现某种类型的不良反应，45.2%的患者出现 3 级及以上毒性。
结论
结果表明，对于 ECOG>0 的患者，应重新考虑使用 TAS-102，这应该在前瞻性随机临床试验中进行研究。
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