Background
Colorectal cancer, tumour, CRC, tumour-related
ADVERSE EVENTS, COLORECTAL CANCER, METASTASES, TUMOUR
Colorectal cancer (CRC) is the third most common cause of cancer-related mortality worldwide, with approximately 20–25% of patients presenting with metastases at initial diagnosis [Treatment goals for patients with mCRC are curative and focus on prolonging survival, improving tumour-related symptoms, inhibiting tumour progression, and/or maintaining the quality of life (QoL), especially during second-line treatment [Trifluridine/tipiracil (FTD/TPI) significantly improved overall survival (OS) in patients with mCRC with a history of heavily treated refractory CRC compared with placebo [Compared with irinotecan-based regimens, FTD/TPI plus bevacizumab is expected to reduce the incidence of adverse events (AEs) with subjective symptoms and maintain the QoL. If FTD/TPI plus bevacizumab proves to be a feasible alternative to irinotecan-based regimens, then many patients with mCRC might have the option to avoid irinotecan and the associated AEs during second-line treatment. Therefore, the phase II/III TRiflUridine/tipiracil in Second-line sTudY (TRUSTY) aimed to demonstrate the noninferiority (in terms of OS) of FTD/TPI plus bevacizumab vs. FOLFIRI plus bevacizumab or S-1 and irinotecan plus bevacizumab as second-line treatment in Japanese patients with mCRC.