Efficacy and safety of trifluridine/tipiracil in third-line and beyond for the treatment of patients with metastatic colorectal cancer in routine clinical practice: patterns of use and prognostic nomogram

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.…”

“…More than half of patients maintained or even improved their performance status, nearly one-third achieved disease control, and median PFS and OS reached 3 months and almost 8 months, respectively. These results are in line with the benefits observed with trifluridine/tipiracil in the RECOURSE trial [9][10][11], along with other compassionate use programmes and observational studies that confirm the use of trifluridine/tipiracil as a feasible treatment alternative for refractory mCRC in a real-life setting [14,15,[18][19][20].…”

“…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.…”

Сonfirmatory study of the efficacy and tolerability of trifluridine/tipiracil (TAS-102) therapy in the Russian population with chemorefractory metastatic colorectal cancer

“…Начало курса терапии было отложено в регистрационном исследовании у 53%, в исследовании в РФ -52%; редукция дозы FTD/TPI -у 14% и 26,9% соответственно [3]. Такое, практически в 2 раза, увеличение числа случаев редукции препарата, возможно, явилось одним из факторов, ассоциированным с более высокими показатели выживаемости пациентов в РФ [10].…”