Trifluridine/Tipiracil (TAS-102) for refractory metastatic colorectal cancer in clinical practice: a feasible alternative for patients with good performance status

Early Clinical Experience with Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: The ROS Study

“…In addition to the tumour burden and liver metastasis, our study supports the role of alkaline phosphatase levels, dose reductions, and neutrophil/lymphocyte ratios as survival markers. These findings agree with recently published observational studies that also revealed longer OS in patients with a single metastatic site [15], liver metastases [26], alkaline phosphatase levels < 200 or ≤500 IU/L [15,18], trifluridine/tipiracil dose reductions [15,16], and neutrophil/lymphocyte ratios < 5 [15,20]. However, they also found the potential influence of other factors such as ECOG performance status [15,16,[18][19][20]26], platelet count ≤ 350 × 10 9 /L [15], KRAS status [18], time to synchronous or metachronous metastasis [19], leukocyte count < 8 × 10 9 /L [18], or neutropaenia as an adverse event [15,17,19,21], which did not independently affect survival in our study.…”

“…These findings agree with recently published observational studies that also revealed longer OS in patients with a single metastatic site [15], liver metastases [26], alkaline phosphatase levels < 200 or ≤500 IU/L [15,18], trifluridine/tipiracil dose reductions [15,16], and neutrophil/lymphocyte ratios < 5 [15,20]. However, they also found the potential influence of other factors such as ECOG performance status [15,16,[18][19][20]26], platelet count ≤ 350 × 10 9 /L [15], KRAS status [18], time to synchronous or metachronous metastasis [19], leukocyte count < 8 × 10 9 /L [18], or neutropaenia as an adverse event [15,17,19,21], which did not independently affect survival in our study. Based on these findings, some attempts have been made to achieve nomograms to screen for the patients who can benefit the most from trifluridine/tipiracil.…”

“…The safety profile of trifluridine/tipiracil was consistent with that previously reported in clinical trials [ 30 ], compassionate use programmes [ 17 , 18 , 19 ], and other observational studies [ 15 , 16 , 20 , 21 ]. No new safety concern arose and the main ≥3 grade treatment-related adverse events included afebrile neutropaenia, anaemia, and thrombocytopaenia.…”

“…Compassionate use programmes and cohort studies endorsed the use of trifluridine/tipiracil in non-trial conditions [ 14 , 15 , 16 , 17 , 18 , 19 ]. Many of them also addressed the unmet need of identifying prognostic or predictive factors, which included pre-treatment performance status [ 15 , 16 , 18 , 19 , 20 ], KRAS status [ 18 ], time to metastasis [ 19 ], number of metastases [ 15 ], time from metastasis diagnosis [ 19 ] or first-line therapy [ 17 ], alkaline phosphatase levels [ 15 , 18 ], platelet and leucocyte counts [ 15 , 18 ], and neutrophil/leucocyte ratio [ 15 , 20 ], as well as on-treatment neutropaenia [ 15 , 17 , 19 , 21 ], and dose reductions [ 15 , 16 ]. However, there is no consensus on the specific factors that should be considered to select patients who benefit the most from trifluridine/tipiracil.…”

Early clinical experience with trifluridine/tipiracil for refractory metastatic colorectal cancer: The ROS study.

“…The safety profile of trifluridine/tipiracil was consistent with that previously reported in clinical trials [30], compassionate use programmes [17][18][19], and other observational studies [15,16,20,21]. No new safety concern arose and the main ≥3 grade treatmentrelated adverse events included afebrile neutropaenia, anaemia, and thrombocytopaenia.…”