The combination of trifluridine/tipiracil conferred superior overall survival compared with placebo in the third- and fourth-line metastatic gastric cancer treatment settings. This finding, derived from an exploratory subgroup analysis of the TAGS study, was presented at the 2021 Gastrointestinal Cancers Symposium.
A total of 337 patients in the TAGS study’s (ClinicalTrials.gov identifier: NCT02500043) intention-to-treat group had received trifluridine/tipiracil as third- (n=126) or fourth-line (n=211) treatment and were compared with 64 and 106 placebo controls, respectively. Baseline characteristics were well balanced between treatment arms.
The median overall survival (OS) was significantly longer in the active treatment groups compared with the placebo groups. Median OS was 6.8 months for trifluridine/tipiracil vs 3.2 months for placebo (HR, =0.67; 95% CI, 0.47-0.97; P <.05) in the third-line group. It was 5.2 months vs 3.7 months (HR, 0.72; 95% CI, 0.55-0.95; P <.03) in the fourth-line group. The median progression-free survival also was significantly longer in the active treatment groups vs placebo groups (P= .0004 and P <.0001, respectively, for the third- and fourth-line).
Quality-of-life (QOL) results among patients in the subgroup analysis were consistent with those of the overall TAGS study population. No clinically significant deterioration in QoL, as measured by the QLQ-C30 and other subscales, was observed. The frequency of adverse events was similar between the 2 groups as well.
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