Discussion
hematologic and gastrointestinal toxicities
DISEASE
These analyses of the TAGS study showed that FTD/TPI administered as third- or later-line treatment in patients with mGC/GEJC improved survival outcomes compared with placebo and was tolerable regardless of the type of previous therapy patients had received, although OS and PFS differences were most pronounced between those who had previously received IRI versus those who had not. The patterns of prior therapy received were balanced between the treatment arms. Disease and prior treatment characteristics were as anticipated across prior treatment subgroups.Owing to variability in standard of care across regions, prior treatment patterns differed between patients in Europe and those in Japan (Di Bartolomeo et al. Irrespective of prior therapy, FTD/TPI treatment was associated with OS, PFS, and daily functioning benefit versus placebo, which was consistent with results in the overall population (Shitara et al. With respect to daily functioning, as measured by ECOG ≥ 2 (patient no longer able to carry out any work activities; Oken et al. Across subgroups, there were no appreciable differences in the FTD/TPI safety profile by prior therapy type. FTD/TPI was mainly associated with hematologic and gastrointestinal toxicities, which were demonstrated to be both predictable and manageable, as seen by the low rate of treatment-related discontinuations in the overall population and across the subgroups (Shitara et al. These data are consistent with related analyses of TAGS, in which median OS and PFS with FTD/TPI trended higher in patients who had received 2 prior therapies than in those who had received 3 or more lines of prior therapy (Tabernero et al. In addition, the trends of increased FTD/TPI efficacy in patients who did not previously receive IRI, PAC, or RAM are aligned with recent observations. Early data suggested feasibility of FTD/TPI plus IRI in an IRI-naive population (Mizukami et al. Data from these analyses add to existing evidence (Kato et al. 