TAS-102 in metastatic colorectal cancer (mCRC): efficacy, tolerability, and quality of life in heavily pretreated elderly patients: a real-life study

Abstract

Background TAS-102 is an oral monotherapy, combining trifluridine and tipiracil hydrochloride, indicated for the treatment of pretreated metastatic colorectal cancer (mCRC). The aim of this real-life study is to evaluate the efficacy and safety of TAS-102 in heavily pretreated elderly patients with mCRC whose disease has progressed with standard therapies. Methods In this retrospective observational study, we enrolled 50 elderly patients >70 years of age (median age 78 years) with a diagnosis of mCRC who were previously treated or were not considered candidates for treatment with other available therapies. Patients aged >70 years with advanced colorectal cancer and with an ECOG performance status of grade 0 ( n =18) or grade 1 ( n =32) were included. Overall survival and progression-free survival were the primary endpoints, whereas objective response rate, tolerability, and quality of life were the secondary endpoints. Results Treatment with TAS-102 appeared to be well tolerated and side effects were generally mild, achieving disease control and a benefit on quality of life. The median overall survival was 6.7 (95% CI 5.7–11.3) and the median progression-free survival was 2.1 months (95% CI 1.2–3.2), estimated using the Kaplan–Meier method. Conclusion TAS-102 represents a manageable and effective therapeutic opportunity and appeared to be well tolerated with generally mild side effects in elderly patients with mCRC who were heavily pretreated with standard therapies.

Severe pancytopenia caused by trifluridine/tipiracil in patients with metastatic colorectal cancer and an impaired renal function: A case report

“… 3 , 4 Furthermore, the tolerability has been confirmed, even in elderly patients. 4 , 5 However, the incidence of grade ≥3 hematological adverse events in patients with renal impairment was higher than that in patients with a normal renal function. 3 , 6 Therefore, great care should be taken when administering FTD/TPI to patients with an impaired renal function.…”

“…Trifluridine/tipiracil (FTD/TPI) is one of the anticancer drugs that is used in later‐line therapy for metastatic colorectal cancer. Although the incidence of hematological toxicity due to FTD/TPI treatment is high, it has been reported that the incidence of severe adverse events and discontinuation of treatment is relatively low and that most toxic effects can be managed by dose modification and/or delayed administration 3,4 . Furthermore, the tolerability has been confirmed, even in elderly patients 4,5 .…”

“…Although the incidence of hematological toxicity due to FTD/TPI treatment is high, it has been reported that the incidence of severe adverse events and discontinuation of treatment is relatively low and that most toxic effects can be managed by dose modification and/or delayed administration 3,4 . Furthermore, the tolerability has been confirmed, even in elderly patients 4,5 . However, the incidence of grade ≥3 hematological adverse events in patients with renal impairment was higher than that in patients with a normal renal function 3,6 .…”

Clinical characteristics and survival outcomes in patients aged 75 years or older with advanced colorectal cancer treated using traditional Chinese medicine: an observational retrospective study

“…This may be the main reason why PFS was shorter in our patients who were treated with TCM alone than in those treated with TCM in combination with conventional chemotherapy. Median PFS was 2.1 months in rigorously screened patients who received TAS-102 ( Cicero et al, 2020 ). This value is similar to the median PFS of 3 months in our patients who received TCM alone, which had the additional advantages of low cost and fewer side effects.…”

Severe pancytopenia caused by trifluridine/tipiracil in patients with metastatic colorectal cancer and an impaired renal function: A case report

“…Trifluridine/tipiracil (FTD/TPI) is one of the anticancer drugs that is used in later-line therapy for metastatic colorectal cancer. Although the incidence of hematological toxicity due to FTD/TPI treatment is high, it has been reported that the incidence of severe adverse events and discontinuation of treatment is relatively low and that most toxic effects can be managed by dose modification and/or delayed administration 3,4 . Furthermore, the tolerability has been confirmed, even in elderly patients 4,5 .…”