Efficacy and safety of trifluridine/tipiracil (FTD/TPI) in patients (pts) with metastatic gastric cancer (mGC) with or without prior gastrectomy: results from a phase III study (TAGS)
Thuss-Patience, P. Lorenzen, S. Ettrich, T. Karthaus, M. Ilson, D. H. Prokharau, A. Arkenau, H. T. Ghidini, M. Fujitani, K. Van Cutsem, E.
Thuss-Patience, P.
Lorenzen, S.
Ettrich, T.
Karthaus, M.
Ilson, D. H.
Prokharau, A.
Arkenau, H. T.
Ghidini, M.
Fujitani, K.
Van Cutsem, E.
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Abstract
Background: The phase 3 study TAGS demonstrated that the novel oral
therapy FTD/TPI (TAS-102) represents an effective treatment option with
a manageable safety profile for pts with heavily pretreated mGC. In an earlier
single-arm Japanese phase 2 trial in mGC, no differences were found
in the pharmacokinetics of either FTD or TPI in pts with or without prior
gastrectomy. We evaluated the efficacy and safety of FTD/TPI in pts with
or without prior gastrectomy within the TAGS study.
Methods: In this global phase 3 study of adult pts with mGC who had
received ?2 prior regimens of chemotherapy, pts were randomized 2:1 to
receive FTD/TPI (35 mg/m2 BID on days 1-5 and 8-12 of each 28-day
cycle) or placebo, plus best supportive care. We performed a preplanned
analysis of efficacy and safety endpoints in pt subgroups with or without
prior gastrectomy.
Results: Of 507 randomized pts, 221 (44%) had a prior gastrectomy (FTD/
TPI, 147/337; placebo, 74/170). Baseline pt characteristics were balanced
across pt subgroups. FTD/TPI prolonged survival versus placebo regardless
of gastrectomy (table). The frequency of neutropenia/leukopenia appeared
to be higher among FTD/TPI-treated pts with vs without gastrectomy,
but this did not result in more treatment discontinuations (table).
Conclusions: In the TAGS study, subgroup analysis demonstrated that
FTD/TPI is an effective treatment option with a manageable safety profile
for pts with heavily pretreated mGC, regardless of prior gastrectomy.
Clinical trial information: NCT02500043. Reused with permission from
the American Society of Clinical Oncology (ASCO). This abstract was accepted
and previously presented at the ASCO GI 2019. All rights reserved.
Description
Date
2019
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Thuss-Patience P, Lorenzen S, Ettrich T, Karthaus M, Ilson DH, Prokharau A, et al. Efficacy and safety of trifluridine/tipiracil (FTD/TPI) in patients (pts) with metastatic gastric cancer (mGC) with or without prior gastrectomy: results from a phase III study (TAGS). Oncology Research and Treatment. 2019;42:307-8