Real-world Efficacy and Safety of Modified Trifluridine/tipiracil (TAS-102) Administration in Patients with Refractory Metastatic Colorectal Cancer Progression after Regorafenib Treatment

針對Regorafenib治療無效的轉移性大腸直腸癌，調整後的TAS-102服藥方式可有效降低藥物副作用

李冠陵(Kuan-Ling Li) ； 蔡祥麟(Hsiang-Lin Tsai) ； 蘇偉智(Wei-Chih Su) ； 黃敬文(Ching-Wen Huang) ； 王照元(Jaw-Yuan Wang)

《中華民國大腸直腸外科醫學會雜誌》 32卷4期 (2021/12) Pp. 191-199

https://doi.org/10.6312/SCRSTW.202112_32(4).11022

摘要

Purpose. The RECOURSE and TERRA studies revealed high percentages of severe neutropenia (grade ≥ 3) when the standard administration of trifluridine/tipiracil (TAS-102) was employed. We therefore aimed to explore the efficacy and safety of a modified administration of TAS-102 in patients with refractory metastatic colorectal cancer (mCRC) progression after regorafenib treatment. Methods. We observationally analyzed the medical records of the 33 qualified patients with mCRC who started TAS-102 between December 2018 and November 2020. The demographic, clinical, tumor, and treatment variables were recorded. We analyzed the efficacy and safety of a modified method of administering TAS-102 and compared these data with those of the RECOURSE and TERRA studies. Results. Severe neutropenia (grade ≥ 3) was the most common severe adverse event in the RECOURSE, TERRA, and our studies. Our study demonstrated a relatively low incidence of grade 3 or 4 neutropenia (9.1% versus 38.0% [RECOURSE] versus 33.2% [TERRA]) but similar median progression-free survival (PFS) and overall survival (OS) (median PFS: 2.0 months; median OS: 7.0 months). Conclusions. In the observational study, we showed that this modified administration of TAS-102 has lower incidence of severe neutropenia for mCRC patients with progression after regorafenib treatment.

關鍵字

Trifluridine/tipiracil (TAS-102) ； Modified administration ； Refractory metastatic colorectal cancer (mCRC) ； Efficacy ； Safety

並列摘要

目的：接受過Regorafenib治療反應不佳的轉移性大腸直腸癌患者，藉由調整後的TAS102服藥方式來降低藥物本身帶來的毒性跟副作用。方法：藉回溯性觀察，於2018年12月到2020年11月間蒐集罹患轉移性大腸直腸癌並且以Regorafenib做為第三線但治療無效的患者，將TAS-102做為第四線以後的治療選擇，並記錄這些病患之疾病無惡化存活期、整體存活、最佳客觀反應率、疾病控制率、藥物毒性資料。結果：共計33位患者被納入此觀察性研究，其中有19位（57.6%）患者有兩處以上的遠端轉移。有18位（54.5%）患者有突變型KRAS基因，所有患者的BRAF基因皆為野生型。此研究未觀察到3級以上的嚴重副作用，最常見的為1和2級的血紅素低下以及倦怠感。腫瘤治療成效方面，這群患者之平均疾病無惡化存活期為2個月，平均整體存活為7個月，與先前其他的大型觀察性研究無太大差異。結論：嗜中性球低下是患者服用TAS-102最常見之三級以上嚴重副作用，使用調整過後的給藥方式可以有效降低此副作用，且不會降低藥物治療惡性腫瘤的效果。

並列關鍵字

TAS-102 ； 調整後服藥方式 ； 副作用

參考文獻

Jianming Xu, Tae Won Kim, Lin Shen et al. Results of a randomized, double-blind, placebo-controlled, phase III trial of trifluridine/tipiracil (TAS-102) monotherapy in Asian patients with previously treated metastatic colorectal cancer: The TERRA study. J Clin Oncol 2018; 36: 350-8.

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