Safety and Efficacy of Trifluridine-Tipiracil Hydrochloride Oral Combination (TAS-102) in Patients with Unresectable Colorectal Cancer

Abstract

Aim: To retrospectively examine efficacy and safety of oral combination of trifluridine and tipiracil hydrochloride as the second-line therapeutic agent for unresectable colorectal cancer. Patient and Methods: Treatment outcomes of 17 patients who had received TAS-102 at our Institution from January 2015 to January 2017 were analyzed. The indications for second-line TAS-102 treatment were intolerance to other multi-drug combination (four patients) or patient refusal of the standard second-line therapy (13 patients). Results: Among 17 patients who received TAS-102 as second-line therapy, partial response was observed in two (12%) and stable disease in two (12%). Outcomes of TAS-102 given as second-line therapy were: median overall survival of 5 months, response rate of 12% and disease control of 24%. Overall, no adverse events other than neutropenia were noted. Conclusion: Our findings suggest a beneficial role of TAS-102 in second-line therapy for unresectable colorectal carcinoma. Patients and MethodsWith approval of the Institutional Review Board (protocol 27-283[8168]), 17 patients who received TAS-102 as second-line therapy between January 2015 and January 2017 at The Jikei University School of Medicine Daisan Hospital were enrolled. According to RECIST 1.1 criteria (4), response rate, disease control rate and adverse effects were retrospectively examined. All patients had been diagnosed with unresectable metastatic colorectal cancer, and comparative parameters consisted of: sex, age, performance status (PS), primary tumor site, resected/not resected primary tumor, treatment stage, number of TAS-102 doses, organs of metastasis and number of metastases. TAS-102 was given orally at 35 mg/m2 twice a day for 28 days (one course): 2-Week cycles of 5 days of treatment and 2 days of rest, followed by 14 days of rest. All data analyses were performed using Microsoft Excel software. ResultsSeventeen patients received TAS-102 during the study period. The median age of patients was 65 years (range=37-83 years) and all had PS of 1 or 2; the majority of patients were men. The colon was the most frequent primary site and in more than half of the patients, the primary lesion had been resected. Previous chemotherapies included: One regimen in 1643

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

“…The effects of population aging and the increased diagnosis of cancer in the elderly will require greater coordination between oncologists and geriatricians to identify which older adults might be able to undergo the various systemic treatments available; for this aim, a complete geriatric assessment is helpful. Furthermore, an analysis of the subgroup of the appeal study 9 , 11 did not indicate age as a potential factor of increased toxicity or decreased efficacy of TAS-102. Thus, TAS-102 was shown to have a definite clinical activity in a population of patients widely pretreated for mCRC, including those whose disease was refractory to fluorouracil and in all patient subgroups.…”

“…Therefore, age alone should not preclude the use of TAS-102 in patients aged >70 years. 10 , 11 However, despite the high incidence of this disease in elderly patients, the available clinical practice information regarding this population is limited and incomplete. Based on the results of the RECOURSE subgroups as well as on studies by Van Cutsem et al 8 and others, 9 , 12 , 13 we conducted a study to evaluate the safety and efficacy of TAS-102 in heavily pretreated elderly patients with mCRC.…”