The following article features coverage from the ESMO World Congress on Gastrointestinal Cancer 2018 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Third-line trifluridine/tipiracil prolonged progression-free survival (PFS) and overall survival (OS) in patients with metastatic gastric cancer (mGC), according to phase 3 data presented at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2018.1

The trifluridine/tipiracil combination is approved for the treatment of patients with refractory metastatic colorectal cancer, and showed antitumor activity against gastric cancer in a phase 2 trial. The purpose of this study was to determine the efficacy and safety of trifluridine and tipiracil in patients with relapsed/refractory mGC.

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The international phase 3 TAGS trial ( Identifier: NCT02500043) randomly assigned 507 patients with nonresectable mGC treated with at least 2 prior chemotherapy regimens 2:1 to receive trifluridine plus tipiracil and supportive care or placebo plus supportive care. Baseline characteristics were similar between groups.

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The median PFS was 2.0 months with trifluridine plus tipiracil compared with 1.8 months with placebo (hazard ratio [HR], 0.57; 95% CI, 0.70; P < .0001). The 6-month PFS was similar between groups, at 7.7% and 6.4% with trifluridine/tipiracil or placebo, respectively.

OS was significantly prolonged with trifluridine and tipiracil with a median of 5.7 months compared with 3.6 months with placebo (HR, 0.69; 95% CI, 0.56-0.85; P = .0003). The 12-month OS with the combination was improved compared with placebo (21.2% and 13.0%, respectively).

Adverse events (AEs) occurred more frequently with trifluridine and tipiracil, with 79.4% of patients experiencing a grade 3 or higher AE compared with 57.7% in the placebo group. Grade 3/4 hematologic AEs of interest included neutropenia, leucopenia, anemia, and lymphocytopenia.

The authors concluded that these results suggest that trifluridine plus tipiracil “is an effective treatment option for patients with heavily pretreated mGC.”

Read more of Cancer Therapy Advisor‘s coverage of the ESMO World Congress on Gastrointestinal Cancer 2018 meeting by visiting the conference page.


  1. Tabernero J, Shitara K, Dvorkin M, et al. Overall survival results from a phase III trial of trifluridine/tipiracil versus placebo in patients with metastatic gastric cancer refractory to standard therapies (TAGS). Ann Oncol. 2018;29 (suppl 5;abstr LBA-002):v122-3. doi:10.1093/annonc/mdy208.001