Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials.
T Yoshino, JM Cleary, E Van Cutsem, RJ Mayer, A Ohtsu, E Shinozaki, A Falcone, K Yamazaki, T Nishina, R Garcia-Carbonero, Y Komatsu, H Baba, G Argilés, A Tsuji, A Sobrero, K Yamaguchi, M Peeters, K Muro, A Zaniboni, N Sugimoto Show all
Annals of Oncology | Published : 2020
BACKGROUND: The phase II J003 (N = 169) and phase III RECOURSE (N = 800) trials demonstrated a significant improvement in survival with trifluridine (FTD)/tipiracil (TPI) versus placebo in patients with refractory metastatic colorectal cancer. This post hoc analysis investigated pharmacokinetic data of FTD/TPI exposure and pharmacodynamic markers, such as chemotherapy-induced neutropenia (CIN) and clinical outcomes. PATIENTS AND METHODS: A total of 210 patients from RECOURSE were enrolled in this substudy. A limited sampling approach was used, with three pharmacokinetic samples drawn on day 12 of cycle 1. Patients were categorized as being above or below the median area under the plasma conc..View full abstract