A trifluridine/tipiracil combination tablet has been approved by the US Food and Drug Administration for adults with nonresectable metastatic gastric adenocarcinoma who have received at least two previous chemotherapy regimens and experienced radiologic disease progression.
The approval is based on the results of the double-blind, placebo-controlled TAGS trial, which reported: [33]
Significantly improved median overall survival among patients with non-resectable metastatic gastric adenocarcinoma who were randomised to trifluridine/tipiracil (5.7 vs. 3.6 months in the placebo group; hazard ratio: 0.69, 95% CI 0.56 to 0.85). Trifluridine/tipiracil was also associated with improved progression-free survival.
Of the 507 patients enrolled in the trial, more than 60% had received at least three previous chemotherapy regimens (211 out of 337 patients in the trifluridine/tipiracil group and 106 out of 170 in the placebo group). The most frequently reported grade 3 (severe but not life-threatening) or worse adverse events in the trifluridine/tipiracil group were neutropenia (114 [34%]), anaemia (64 [19%]), and leukopenia (31 [9%]).
The combination tablet of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, is already approved for the treatment of advanced refractory colorectal cancer.
Pre-registration for this new advanced gastric cancer indication was filed in the EU in October 2018 and is awaiting approval.
See Management: approach See Management: treatment algorithmAssociate Professor
Department of GI Medical Oncology
University of Texas
MD Anderson Cancer Center
Houston
TX
MBM declares that she has no competing interests.
Dr Mariela Blum Murphy would like to gratefully acknowledge Dr Valerie Reed and Dr Prajnan Das, previous contributors to this topic.
Director
Gastrointestinal Radiation Oncology
Massachusetts General Hospital Cancer Center
Boston
MA
TH declares that he has no competing interests.
Head of Department
Department of Gastroenterology
Sana Klinikum
Remscheid
Germany
AL declares that he has no competing interests.
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