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Body weight loss as a prognostic and predictive factor in previously treated patients with metastatic gastric cancer: post hoc analyses of the randomized phase III TAGS trial
Ghidini, M. Hochster, H. Doi, T. Van Cutsem, E. Makris, L. Takahashi, O. Benhadji, K. A. Mansoor, Was
Ghidini, M.
Hochster, H.
Doi, T.
Van Cutsem, E.
Makris, L.
Takahashi, O.
Benhadji, K. A.
Mansoor, Was
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Abstract
Background: Body weight loss (BWL) is a negative prognostic factor in metastatic gastric or gastroesophageal junction cancer (mGC/GEJC). In the phase III TAGS study, trifluridine/tipiracil improved survival versus placebo in third- or later-line mGC/GEJC. These retrospective analyses examined the association of early BWL with survival outcomes in TAGS.
Methods: Efficacy and safety were assessed in patients who experienced < 3% or ≥ 3% BWL from treatment start until day 1 of cycle 2 (early BWL). The effect of early BWL on overall survival (OS) was assessed by univariate and multivariate analyses.
Results: Body weight data were available for 451 of 507 (89%) patients in TAGS. In the trifluridine/tipiracil and placebo arms, respectively, 74% (224/304) and 65% (95/147) experienced < 3% BWL, whereas 26% (80/304) and 35% (52/147) experienced ≥ 3% BWL at cycle 1 end. Median OS was longer in < 3% BWL versus ≥ 3% BWL subgroups (6.5 vs 4.9 months for trifluridine/tipiracil; 6.0 vs 2.5 months for placebo). In univariate analyses, an unadjusted HR of 0.58 (95% CI, 0.46-0.73) for the < 3% vs ≥ 3% BWL subgroup indicated a strong prognostic effect of early BWL. Multivariate analyses confirmed early BWL as both prognostic (P < 0.0001) and predictive (interaction P = 0.0003) for OS. Similar results were obtained for progression-free survival. Any-cause grade ≥ 3 adverse events were reported in 77% and 82% of trifluridine/tipiracil-treated and 45% and 67% of placebo-treated patients with < 3% and ≥ 3% BWL, respectively.
Conclusions: In TAGS, early BWL was a strong negative prognostic factor for OS in patients with mGC/GEJC receiving third- or later-line treatment.
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Date
2023
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Ghidini M, Hochster H, Doi T, Van Cutsem E, Makris L, Takahashi O, et al. Body weight loss as a prognostic and predictive factor in previously treated patients with metastatic gastric cancer: post hoc analyses of the randomized phase III TAGS trial. Gastric Cancer. 2023 Apr 28. PubMed PMID: 37106214. Epub 2023/04/28. eng.