Real-world clinical outcomes of patients with metastatic colorectal cancer (mCRC) treated with trifluridine-tipiracil + bevacizumab by performance status.

e15606 Background: The functional status of patients with mCRC is associated with treatment tolerance and survival. The phase 3 SUNLIGHT trial, which showed overall survival (OS) improvement in patients with chemotherapy-refractory mCRC, no more than 2 prior lines of therapy, and treated with trifluridine-tipiracil + bevacizumab (FTD-TPI+bev) as compared to FTD-TPI alone, only enrolled patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1. In this study, we investigated the real-world characteristics and clinical outcomes of patients with mCRC treated with FTD-TPI+bev having ECOG PS 2 as compared to PS 0-1. Methods: We analyzed retrospective deidentified data from United States based electronic medical records and linked claims in the ConcertAI RWD360 dataset. Adult patients with a diagnosis of mCRC and exposure to FTD-TPI+bev in any line of therapy were included in the study. Patients were categorized as having ECOG PS 0-1 (or Karnofsky 70-100) or PS 2 (or Karnofsky 50-60) at the time of first exposure to FTD-TPI+bev (index date). Patient demographic and clinical characteristics were examined. Kaplan-Meier analyses were used to estimate the real-world OS (rwOS), time to treatment discontinuation (rwTTD), and time to next treatment or death (rwTTNTD) from the index date; groups were compared using log-rank test. Results: This study included 660 patients; 574 (87%) with PS 0-1 (347 PS 1), and 86 (13%) with PS 2. Overall, 54% of patients were male, 66% were White, and 71% received FTD-TPI+bev as ≥ 4th line therapy. Median age at index date was 60 years in patients with PS 0-1 and 61.5 years in PS 2. Median time from mCRC diagnosis to index date was 24 months in patients with PS 0-1 and 22 months in patients with PS 2. Median rwTTD and rwTTNTD were comparable among patients with ECOG PS 0-1 vs. 2. Median rwTTD was 3.6 (95% CI 4.3-5.3) months in patients with PS 0-1 and 3.3 (95% CI 3.5-6.1) months in patients with PS 2 (p = 0.10). Similarly, median rwTTNTD was 4.8 (95% CI 3.3-3.9) months in patients with PS 0-1 and 4.4 (95% CI 2.8-4.0) months in patients with PS 2 (p = 0.57). After excluding patients who had not yet discontinued FTD-TPI+bev at data cut-off (n = 105 PS 0-1, n = 14 PS 2), 62% (n = 293) of the patients with PS 0-1 and 43% (n = 31) of the patients with PS 2 received a subsequent line of therapy after FTD-TPI+bev (p = 0.002). Accordingly, median rwOS was significantly longer in patients with PS 0-1 vs. PS 2 [9.8 (95% CI 8.8-10.1) vs. 6.8 (95% CI 5.6-8.1) months, respectively; p = 0.001]. Conclusions: Real-world evidence shows no difference by performance status in rwTTD and rwTTNTD with FTD-TPI+bev in patients with mCRC. While rwOS was shorter in patients with PS 2 and fewer patients with PS 2 received a subsequent line of therapy, the similar rwTTD and rwTTNTD suggest comparable tolerability and disease control with FTD-TPI+bev in patients with ECOG PS 0-1 and PS 2.