Clinical Outcomes of Patients With Metastatic Colorectal Cancer Treated With Trifluridine-Tipiracil + Bevacizumab by Performance Status

PURPOSE Eastern Cooperative Oncology Group (ECOG) performance status (PS) is associated with treatment tolerance and survival in metastatic colorectal cancer (mCRC). The SUNLIGHT trial showed improved overall survival with trifluridine-tipiracil + bevacizumab (FTD-TPI + bev) versus FTD-TPI alone, but only enrolled patients with ECOG PS 0-1. We assessed adverse events (AEs) and outcomes with FTD-TPI + bev in mCRC patients with PS 2 and 0-1 in a real-world setting and in the TASCO1 and SOLSTICE trials, which evaluated patients ineligible for first-line intensive therapy. METHODS Patients with mCRC exposed to FTD-TPI + bev, categorized as PS 0-1 or 2, from ConcertAI RWD360 were included. The frequency of grade 3+ AEs was examined. Real-world time to treatment discontinuation (rwTTD) and real-world time to next treatment or death (rwTTNTD) were estimated using Kaplan-Meier analysis. Analysis of combined data from TASCO1 and SOLSTICE included duration of therapy and AEs. RESULTS The real-world data set included 574 (87%) PS 0-1 patients and 86 (13%) PS 2 patients; 71% received FTD-TPI + bev as ≥fourth-line therapy. The clinical trial data set included 409 (81%) patients with PS 0-1 and 94 (19%) patients with PS 2. The median rwTTD was 3.3 and 3.6 months ( P = .10); the median rwTTNTD was 4.4 and 4.8 months ( P = .57) in patients with PS 2 and 0-1, respectively. The most common grade 3+ AE was neutropenia in real-world and trial data sets, seen in 42.9% and 46.8%, respectively, in the PS 2 group and 39.2% and 52.2%, respectively, in the PS 0-1 group. CONCLUSION Evidence from real-world data and clinical trials supports the use of FTD-TPI + bev in mCRC patients with PS 2.