Limitations
A strength of this analysis was the relatively large patient population of the TAGS trial. One key limitation was the exploratory post hoc nature of this analysis, which was not powered to investigate differences in efficacy and safety between the BWL subgroups. Imbalances in weight loss between the treatment arms precluded comparisons between treatment arms in this analysis. Imbalances in other baseline characteristics, including ECOG PS between the BWL subgroups may have had an impact on tolerability. Finally, longitudinal weight data over subsequent cycles could not be measured, because many patients, particularly those in the placebo group, discontinued after the end of the first cycle of treatment. The mechanisms underlying poor survival outcomes in patients with ≥ 3% BWL remain unclear, and in this regard, an examination of the link between BWL and inflammatory indices such as C-reactive protein or with baseline neutrophil to lymphocyte ratio will be helpful for future analyses [