Trifluridine/tipiracil (FTD/TPI) in patients (pts) with metastatic gastroesophageal junction cancer (mGEJC): Subgroup analysis from TAGS.
(2019) 2019 ASCO Annual Meeting I - GASTROINTESTINAL (NONCOLORECTAL) CANCER
Files
4038.pdf
Open Access - Adobe PDF
- 390.53 KB
Details
- Authors
- Abstract
- ackground: The incidence of GEJC is increasing in North America and Europe, especially among white men. Many pts present with metastatic disease or relapse locally or systemically after resection of early-stage disease. The global phase 3 study TAGS (NCT02500043) demonstrated the efficacy and safety of FTD/TPI in previously treated pts with metastatic gastric cancer (mGC)/mGEJC. Here we report results in the mGEJC subgroup from TAGS. Methods: Pts with mGC/mGEJC treated with ≥2 prior chemotherapy regimens 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. A preplanned efficacy and safety analysis was performed in pts with mGEJC. Results: Of 507 randomized pts, 145 (29%) had GEJC as the sole primary disease site (FTD/TPI, 98/337; placebo, 47/170). Of pts with mGEJC, 85% were male and 83% were white (overall population, 73% and 70%). Baseline characteristics were generally balanced for pts with mGEJC across treatment groups, except for fewer pts having prior gastrectomy (40% vs 55%) and more pts having received ≥3 prior regimens (74% vs 66%) in the FTD/TPI group than in the placebo group. FTD/TPI had an efficacy benefit in pts with mGEJC, and the FTD/TPI safety profile was similar in this subgroup and the overall population (table). Conclusions: FTD/TPI showed a manageable safety profile and efficacy benefit in pts with mGEJC in the TAGS trial, despite heavier pretreatment of the FTD/TPI than the placebo group.
- Affiliations
Citations
Mansoor, W., Arkenau, H.-T., ALSINA, M., Shitara, K., Tejani, M. A., Thuss-Patience, P. C., Cuffe, S., Dvorkin, M., Park, D., Ando, T., Van den Eynde, M., Beretta, G. D., Zaniboni, A., Doi, T., Tabernero, J., Ilson, D. H., Makris, L., McGuigan, S., & Van Cutsem, E. (2019). Trifluridine/tipiracil (FTD/TPI) in patients (pts) with metastatic gastroesophageal junction cancer (mGEJC): Subgroup analysis from TAGS. Journal of Clinical Oncology, 37(15_suppl), 4038. https://doi.org/10.1200/jco.2019.37.15_suppl.4038 (Original work published 2019)