Real-world data (RWD) of the use of trifluridine/tipiracil hydrochloride (TFT) in patients with metastatic colorectal cancer: The Greater Manchester experience

Abstract

Background Trifluridine/tipiracil hydrochloride has shown to improve progression-free survival (PFS) and overall survival (OS) in patients with metastatic colorectal cancer (mCRC). Exploratory analysis suggested that patients with good prognostic characteristics GPC (18 months since first diagnosis) carry better prognosis vs. poor prognostic characteristics (PPC). We report the Greater Manchester experience of the use of TFT. Methods All consecutive patients who received TFT between August 2016 and August 2019 were included. Data were collected from electronic records. Univariate survival analysis was performed with Kaplan-Meier curve and log-rank test. Cox regression was used for multivariable analysis. Results All consecutive pts (n=188) were included; median follow up was 7.1 months. Median age was 66 IQR (59-72); 60% were male; 22% had right; 43% had left; 35% had rectal cancers. RAS mutation was identified in 29.8%. Twenty-nine (16%) received bevacizumab and 23.4% received anti-EGFR treatment. Seventy-eight (41%) had ≤ 3 sites of metastases; 134 (74%), 120 (66%) and 70 (40%) had liver, lung and peritoneal metastasis respectively; 123 (65.4%) had ≤18months since diagnosis of first metastasis, 64 patients (34%) had GPC while 122 (64.9%) had PPC. Median time from stage IV diagnosis to starting treatment was 23.9 months IQR (14.9-38.5). Thirty-six (19%) had HB < 0.001. Patients with GPC had better OS of 12.9 months (95% CI 10.11-15.77) compared to 7.45 months in patients with PPC (95% CI 10.1 to 15.7), p< 0.001. Patients with liver metastasis had a shorter median PFS 2.7 months and OS 7.5 months (95% CI 6.3-8.8) when compared with patients with no liver metastasis with PFS 4.3 months (95% CI: 2.5 to 2.9), p=0.002 and OS of 12 months (95% CI: 9.3-14.7), p=0.001. Patients who were in the GPC group and had no liver metastasis had an improved median OS of 13.9 months when compared with the rest of patients in whom median OS was 7.8 (95% CI 7.2 to 20.7), p=0.002. Multivariable analysis showed that GPC was an independent prognostic factors for OS (HR 0.582; 95% CI 0.3-0.8; p=0.005). Grade 3 neutropenia was an independent prognostic factor for PFS (HR 0.55; 95% CI 0.39-0.79; p=0.001) and OS (HR0.4; 95% CI 0.2-0.6; P< 0.001). Conclusion Our RWD on TFT was associated with a better OS than expected. This RWD study was able to validate GPC, GPC with no liver metastases and grade ≥ 3 neutropenia as subgroups benefiting the most from TFT.