The overall survival benefit associated with trifluridine/tipiracil (TAS-102) was maintained and increased to a full 2 months in heavily pretreated patients with metastatic colorectal cancer (mCRC), according to an update survival analysis presented at the 2016 Gastrointestinal Cancers Symposium in San Francisco, CA.1

For the phase 3 RECOURSE trial, researchers randomly assigned 800 patients in a 2:1 fashion to receive trifluridine/tipiracil or placebo plus best supportive care.

At the time of the original analysis, median overall survival was 7.1 months (95% CI, 6.5 – 7.8) with the experimental agent vs 5.3 months (95% CI, 4.6 – 6.0) with placebo (HR, 0.68; 95% CI, 0.58 – 0.81; P < .0001). The 1-year survival rate was 26.6% (95% CI, 22.2 – 31.1) and 17.6% (95% CI, 12.7 – 23.1), respectively.

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In this updated analysis, median overall survival was 7.2 months (95% CI, 6.6 – 7.8) for the trifluridine/tipiracil group compared with 5.2 months (95% CI, 4.6 – 5.9) for the placebo group (HR, 0.69; 95% CI, 0.59 – 0.81; P < .0001). The 1-year survival rate was 27.1% (95% CI, 23.3 – 30.9) with trifluridine/tipiracil and 16.6% (95% CI, 12.4 – 21.4) with placebo.

Of note, researchers found that the overall survival benefit appeared to be maintained for all patients regardless of baseline prognostic status.

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Trifluridine is an antineoplastic thmyidine-based nucleoside analog and tipiracil is a thymidine phosphorylase inhibitor. The oral combination agent was approved by the U.S. Food and Drug Administration in September 2015 for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor biological therapy, and if RAS wild-type, an anti-epidermal growth factor receptor therapy.


  1. Mayer RJ, Ohtsu A, Yoshino T, et al. TAS-102 versus placebo plus best supportive care in patients with metastatic colorectal cancer refractory to standard therapies: Final survival results of the phase III RECOURSE trial [abstract]. J Clin Oncol. 2016;34(suppl 4S; abstr 634).