Department of Pharmacy, Hospital Universitario Central de Asturias, Oviedo, Spain.
Department of Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain.
Clin Transl Oncol. 2019 Dec;21(12):1781-1785. doi: 10.1007/s12094-019-02154-3. Epub 2019 Jun 17.
Our aim was to assess efficacy and safety and prognostic factors associated with TAS-102 in clinical practice.
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.
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.
Results suggest reconsidering TAS-102 in patients with ECOG > 0, something that should be investigated in prospective randomized clinical trials.
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。
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。
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。
