Trifluridine/tipiracil (FTD/TPI) in patients (pts) aged ≥65 years with metastatic gastric/gastroesophageal junction cancer (mGC/mGEJC): Subgroup analysis from TAGS.
2019 American Society of Clinical Oncology (ASCO) Annual Meeting; Chicago, Ilinois, United States
Placebos, Gastric cancer, Drug safety, Treatment efficacy, Chemotherapy, Cancer incidence
Background: 60% of newly diagnosed GC pts are > 65 y of age, a proportion that is increasing. The global phase 3 study TAGS (NCT02500043) demonstrated the efficacy and safety of FTD/TPI in previously treated pts with mGC/mGEJC. Here we report results in the pt subgroup aged ≥65 in 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/safety analysis was performed in pts aged ≥65 y.
Results: Of 507 randomized pts, 228 (45%) were aged ≥65 y (range 65–89). The pt subset aged ≥65 y was similar to the overall population, except for a higher incidence of moderate renal impairment in the elderly subgroup (31% vs 17%). For pts aged ≥65 y, baseline characteristics were generally balanced across the treatment groups, although more pts treated with FTD/TPI than with placebo had ECOG PS 1 (69% vs 59%). FTD/TPI had an efficacy benefit in pts aged ≥65 y, and the FTD/TPI safety profile was similar in this subgroup vs the overall population (table). Treatment-related deaths (one in each treatment group) did not occur in pts aged ≥65 y. No drug-related deaths associated with cardiotoxicity were reported in pts aged ≥65 y. Although dose modifications were used more often in this subgroup, there was no increase in discontinuations vs the overall population.
Conclusions: FTD/TPI was safe and effective in pts aged ≥65 y, who had a higher incidence of moderate renal impairment vs the overall population. Clinical trial information: NCT02500043
Shitara, Kohei; Doi, Toshihiko; Hosaka, Hisashi; Thuss-Patience, Peter C.; Santoro, Armando; Jiménez-Fonseca, Paula; Longo, Federico; Ozyilkan, Ozgur; Cicin, Irfan; Park, David; Tejani, Mohamedtaki Abdulaziz; Zaanan, Aziz; Bilancia, Domenico; Pericay, Carles; Ozguroglu, Mustafa; Alsina, Maria; Makris, Lukas; McGuigan, Sandra; and Ilson, David H., "Trifluridine/tipiracil (FTD/TPI) in patients (pts) aged ≥65 years with metastatic gastric/gastroesophageal junction cancer (mGC/mGEJC): Subgroup analysis from TAGS." (2019). Articles, Abstracts, and Reports. 1383.