Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02115, USA.
Yale Cancer Center, New Haven, CT, USA.
Cancer Chemother Pharmacol. 2018 Dec;82(6):961-969. doi: 10.1007/s00280-018-3686-5. Epub 2018 Oct 22.
Trifluridine/tipiracil (FTD/TPI; TAS-102, Lonsurf®), a novel form of chemotherapy for metastatic colorectal cancer (mCRC), has shown clinical benefit in the global, phase III RECOURSE trial, regardless of patient age. Here, we report the safety and tolerability profile of FTD/TPI from an expanded-access program (EAP) in the US patients with mCRC whose disease has progressed on the standard therapies.
A total of 549 patients (≥ 18 years) with histologically confirmed mCRC following two or more regimens of standard therapy and an Eastern Cooperative Oncology Group performance status of 0 or 1 participated in this open-label EAP. During the 28-day treatment cycle, patients took FTD/TPI 35 mg/m twice daily for 5 days followed by 2 days of rest for 2 weeks, with a 14-day rest period. Data were collected for therapy duration, treatment discontinuation, and adverse events. Age-based post hoc analysis was performed to determine the safety of FTD/TPI in elderly (≥ 65 years) versus younger (< 65 years) patients.
FTD/TPI-treated patients in this EAP had a similar therapy duration and time to treatment discontinuation to those in the RECOURSE trial. The safety profile in elderly patients was consistent with that in younger patients, with no unexpected safety concerns.
This USA-based, open-label EAP has confirmed a similar safety and tolerability profile for FTD/TPI to that observed in the RECOURSE trial. Furthermore, FTD/TPI is well tolerated and can be considered as a treatment option in elderly patients with mCRC.
NCT02286492.
替氟尿苷/盐酸拓扑替康（FTD/TPI；TAS-102，Lonsurf®）是一种新型化疗药物，用于转移性结直肠癌（mCRC），在全球 III 期 RECOURSE 试验中显示出临床获益，无论患者年龄如何。在此，我们报告了美国 mCRC 患者在标准治疗进展后的 FTD/TPI 扩展访问计划（EAP）的安全性和耐受性概况。
共有 549 名（≥18 岁）接受过两种或两种以上标准治疗方案且东部肿瘤协作组体能状态为 0 或 1 的组织学证实的 mCRC 患者参与了这项开放性 EAP。在 28 天的治疗周期中，患者每天接受 FTD/TPI 35mg/m2，每日两次，连续 5 天，然后休息 2 天，2 周为一个周期，14 天的休息期。收集治疗持续时间、治疗中断和不良事件的数据。基于年龄的事后分析用于确定 FTD/TPI 在老年（≥65 岁）与年轻（<65 岁）患者中的安全性。
该 EAP 中接受 FTD/TPI 治疗的患者与 RECOURSE 试验中的患者具有相似的治疗持续时间和停药时间。老年患者的安全性特征与年轻患者一致，没有出现意外的安全性问题。
这项基于美国的开放性 EAP 证实了 FTD/TPI 的安全性和耐受性与 RECOURSE 试验中观察到的相似。此外，FTD/TPI 耐受性良好，可考虑作为老年 mCRC 患者的治疗选择。
NCT02286492。
