Abstract
Background
The combination drug TAS-102 is a novel oral nucleoside antitumor agent containing
trifluridine and tipiracil hydrochloride, which prevents the degradation of trifluridine.
The global phase III RECOURSE trial (Study of TAS-102 in Patients With Metastatic
Colorectal Cancer Refractory to Standard Chemotherapies) demonstrated that TAS-102
prolonged the survival of patients with metastatic colorectal cancer (mCRC) whose
disease progressed after standard therapies. TAS-102 was first approved in Japan in
March 2014, and little is known about its safety and efficacy in clinical practice,
especially for mCRC patients with previous regorafenib treatment.
Patients and Methods
We investigated the safety and efficacy of TAS-102 monotherapy in clinical practice
for patients with mCRC refractory to standard therapies who were treated from May
2014 to January 2015.
Results
A total of 55 patients received TAS-102. The Eastern Cooperative Oncology Group performance
status was 0, 1, and 2 in 41.8%, 47.3%, and 10.9% of patients. Of the 55 patients,
32 (58.2%) had been treated with regorafenib before receiving TAS-102. The median
progression-free survival and overall survival was 2.0 months and 5.3 months, respectively.
Emergency hospitalization was required for 23.6% of the patients during TAS-102 treatment,
although most of the events (76.9%) were disease-related. The most common grade 3
or 4 adverse events were neutropenia (41.8%), leukopenia (27.2%), anemia (23.6%),
febrile neutropenia (5.5%), and fatigue (3.6%). The frequency of grade ≥ 3 events
was not significantly increased among the patients who had compared with those who
had not received regorafenib. The progression-free survival (median 2.1 vs. 2.0 months)
and overall survival (median 6.2 vs. 4.7 months) were similar for the 2 subgroups.
Conclusion
The safety and efficacy of TAS-102 monotherapy in clinical practice were maintained,
irrespective of previous regorafenib treatment.
Keywords
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Article info
Publication history
Published online: November 27, 2015
Accepted:
November 23,
2015
Received in revised form:
October 23,
2015
Received:
August 27,
2015
Identification
Copyright
© 2015 Elsevier Inc. All rights reserved.
