Abstract
Background. The outcome of patients with refractory metastatic colorectal cancer (mCRC) treated with trifluridine/tipiracil (FTD/TPI) beyond the second-line has not been studied in Saudi Arabia. Therefore, this multicenter retrospective analysis was conducted to evaluate the efficacy of FTD/TPI. Methods. This multicenter retrospective analysis included five centers in Saudi Arabia. FTD/TPI was administered to all the patients beyond the oxaliplatin- and irinotecan-based chemotherapy regimens. The electronic medical records were reviewed, and progression-free survival (PFS) and overall survival (OS) were determined. Results. The study included 100 patients with a mean age of 55.4±11.8 years. The overall response to FTD/TPI was 4%. The median PFS was 4 months (95% confidence interval (CI) 3.487–4.513), and the median OS was 11 months (95% CI, 9.226–12.771). In a Cox regression analysis of the independent predictors for PFS, advanced stage of the disease (P=0.037; HR, 2.614; and CI, 1.102–7.524), presence of lymph node metastasis (P=0.018; HR, 3.664; and 95% CI, 1.187–8.650), and >2 metastatic sites (P=0.020; HR, 1.723; and 95% CI, 1.089–2.727) were independent factors predicting disease progression. The Cox regression analysis confirmed that age≥55 years (P=0.046; HR, 1.667; and 95%, 1.097–3.100), advanced disease stage (P=0.044; HR, 1.283; and 95% CI, 1.035–2.940), prior use of adjuvant chemotherapy (P=0.037; HR, 0.892; and 95% CI, 0.481–0.994), liver metastasis (P=0.025; HR, 2.015; and 95% CI, 1.091–3.720), >2 metastatic sites (P=0.038; HR, 1.248; and 95% CI, 1.036–1.846), development of neutropenia after receiving first cycle of FTD/TPI (P=0.042; HR, 1.505; and 95% CI, 1.064–2.167), and increased number of FTD/TPI cycles (P=0.002; HR, 0.769; and 95% CI, 0.664–0.891) were independent variables for OS. Conclusion. Treatment with FTD/TPI is feasible and effective in daily clinical practice in Saudi Arabian patients. The risk of progression increased with advanced disease stage, lymph node metastasis, bone metastasis, and metastasis to >2 sites. Age≥55 years, advanced disease stage, liver metastasis, metastasis to >2 sites, neutropenia after the first cycle of FTD/TPI, and increased number of FTD/TPI cycles were independent factors predicting mortality.