New Option Emerging for Refractory mCRC

Alok A. Khorana, MD


August 21, 2015

Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer

Mayer RJ, Van Cutsem E, Falcone A, et al
N Engl J Med. 2015;372:1909-1919

Study Summary

TAS-102, an oral agent that combines trifluridine and tipiracil hydrochloride, has been shown in Asian studies[1,2] to be of benefit for patients with metastatic colorectal cancer. In this phase 3 trial, patients who had progressed on at least two previous systemic regimens were randomly assigned, in a 2:1 ratio, to receive either TAS-102 or placebo. The median overall survival improved from 5.3 months with placebo to 7.1 months with TAS-102 (HR, 0.68). Major toxicity was neutropenia or febrile neutropenia. Overall, the drug was well tolerated.


The results of this study confirm meaningful benefit to patients with metastatic colorectal cancer who have been heavily pretreated. The findings suggest that even in 5-fluorouracil-refractory patients, this agent is beneficial and extends survival without compromising quality of life. FDA approval is awaited, as are results of combination trials. However, once approved, the drug will immediately add a new, well-tolerated oral option for patients who have progressed on standard prior regimens and targeted therapy.



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