Post-hoc analyses of overall survival (OS) and progression-free survival (PFS) in the TRIO-013/LOGiC trial of lapatinib (L) in combination with capecitabine plus oxaliplatin (CapeOx).

Abstract

133 Background: Results of the primary and secondary endpoints (OS and PFS, respectively) in the primary efficacy population for the randomized, phase III trial (TRIO-013/LOGiC; NCT00680901), conducted in patients with advanced, HER2-positive upper gastrointestinal adenocarcinoma were previously presented (Hecht JR et al, ASCO 2013). Differences in OS were non-significant between the lapatinib (CapeOx + L) and placebo (CapeOx + P) arms. In prespecified analyses, a treatment effect of L was observed in Asian (majority Chinese or South Korean) patients and patients <60 years (y) when comparing OS in the two arms. Methods: Here, we present the results of post-hoc analyses in TRiO-013/LOGiC which assessed OS, PFS and safety by age and by region. Results: In the Asian subgroups, median OS was longer with L compared with P (see Table). In the rest of the world (ROW) subgroups, median OS was longer in patients <60 y but shorter in patients ≥60 y with L compared with P (see Table). Similar findings were observed for PFS in the 4 subgroups (see Table).More adverse events (AEs) were observed in the Asian subgroups; overall, the incidence of AEs (by region) was similar between age subgroups. Conclusions: OS and PFS were improved in Asian patients (both age subgroups) and younger patients in ROW given CapeOx + L, compared with CapeOx + P. The lower OS and PFS observed in older patients in the ROW subgroups may have affected the overall data. Further trials with CapeOx + L in Asian populations are being considered. Clinical trial information: NCT00680901. [Table: see text]