Summary
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.
Conclusions
Evidence from real-world data and clinical trials supports the use of FTD-TPI + bev in mCRC patients with PS 2.
