Abstract
4039 Background: FTD/TPI was approved in 2015 for pretreated pts with mCRC based on the phase 3 RECOURSE trial. FTD/TPI recently demonstrating significantly improved overall survival vs placebo in pretreated pts with mGC/mGEJC in the phase 3 TAGS trial. Methods: We evaluated the pooled safety of FTD/TPI in TAGS and RECOURSE in all pts who received ≥1 dose of FTD/TPI (safety population). Pts were required to have ECOG PS 0/1 and to have received ≥2 previous chemotherapy lines. Results: FTD/TPI and placebo were administered to 335 and 168 pts, respectively, in TAGS, and 533 and 265 pts in RECOURSE. Baseline characteristics were balanced across treatment groups and reflected the disease populations. In the pooled population, 66% of pts were men and 75% had received ≥3 prior systemic treatments. The safety profile of FTD/TPI was comparable between studies (table). In TAGS and RECOURSE, the most common any-cause grade (gr) ≥3 AEs in FTD/TPI-treated pts were neutropenia (34%; 35%), anemia (19%; 17%), and leukopenia (9%; 13%). Gr ≥3 febrile neutropenia occurred in 2% and 4% of pts and gr ≥3 GI AEs in 21% and 12%. Gr ≥3 cardiac AEs were reported in 1% of FTD/TPI-treated pts (both studies), in contrast to results obtained with other third-line agents. Similar proportions of FTD/TPI-treated pts in both studies had AEs leading to dosing delay, dose reduction, or treatment discontinuation. Dosing delay was used more often than dose reduction to manage AEs. TRAEs leading to death occurred in one FTD/TPI-treated pt ( < 1%) in each trial. Conclusions: In a pooled analysis, FTD/TPI was well tolerated with a consistent safety profile in pts with mGC/mGEJC or mCRC. The most frequent AEs were hematologic and GI, which were managed with dosing delays/dose reductions. Clinical trial information: NCT02500043; NCT01607957. [Table: see text]
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