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- W2980011635 abstract "Abstract Background Trifluridine/tipiracil (FTD/TPI, also known as TAS-102) is an oral cytotoxic agent consisting of a thymidine-based nucleoside analogue and a thymidine phosphorylase inhibitor. TAGS (NCT02500043), a phase III study showed FTD/TPI significantly improved overall survival (OS) compared to placebo (P) in heavily pretreated metastatic gastric cancer (mGC) patients (pts) (Shitara K. et al, Lancet Oncol. 2018). Here we show the results in Japanese subpopulation. Methods This study enrolled pts aged 18 years or older (20 years or older in Japan) with histologically confirmed, non-resectable mGC, Eastern Cooperative Oncology Group Performance Status 0/1, and two or more prior chemotherapy regimens. Pts were randomised 2:1 to receive FTD/TPI (35 mg/m2 BID on days 1-5 and 8-12 of each 28-day cycle) or P. Primary endpoint was OS. Key secondary endpoints were progression-free survival (PFS) and safety. Results Between Feb 2016 and Jan 2018, 507 pts were randomised to receive FTD/TPI (n = 337) or P (n = 170). 73 pts were enrolled from 9 sites in Japan, of which 46 pts were randamized in FTD/TPI. Median OS was 6.3 months (m) for FTD/TPI and 5.9 m for P (Hazard Ratio (HR) 0.77, 95% Confidence Interval (CI) 0.46-1.30). Median PFS was 2.0 m for FTD/TPI and 1.7 m for P (HR 0.33, 95% CI 0.19-0.59). Overall response rate and disease control rate for FTD/TPI were 2.6% and 38.5%, respectively. Grade 3 or worse adverse events (AEs) of any cause were reported in 37/46 (80.4%) FTD/TPI-treated pts and 9/27 (33.3%) placebo-treated pts. Grade 3/4 haematological AEs in FTD/TPI-treated pts included neutropenia (52.2%), anaemia (41.3%) and leucopenia (6.5%). Three FTD/TPI-treated pts experienced febrile neutropenia. No new safety signals were observed. Also, we are going to show the details of safety. Conclusions FTD/TPI was effective and well tolerated in Japanese pts with heavily pretreated mGC. The results in Japanese subpopulation were consistent with the overall population." @default.
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- W2980011635 date "2019-10-01" @default.
- W2980011635 modified "2023-09-23" @default.
- W2980011635 title "The results of Japanese subgroup analyses from TAGS: a phase 3 study of FTD/TPI (TAS-102) in heavily pretreated mGC" @default.
- W2980011635 doi "https://doi.org/10.1093/annonc/mdz339.027" @default.
- W2980011635 hasPublicationYear "2019" @default.
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