Abstract
Background
Trifluridine/tipiracil (TAS-102) has achieved modest efficacy in the late-line treatment
of metastatic colorectal cancer. The present study aimed to explore the clinical efficacy
and drug toxicities of TAS-102 for patients with metastatic colorectal cancer in real-world
clinical setting.
Methods
From October 2020 to February 2022, patients with metastatic colorectal cancer who
failed from 2 or more lines of prior therapy and treated with TAS-102 monotherapy,
in combination with bevacizumab or immune checkpoint inhibitors (ICIs) were analyzed.
The evaluation indicators were progression free survival (PFS), objective response
rate , disease control rate (DCR), overall survival (OS) and drug toxicities.
Results
A total of 70 patients were enrolled. The objective response rate and DCR were 1.4%
and 68.6%. The median PFS and OS were 6.0 (95% CI: 4.1-7.9) and 10.0 (95% CI: 8.3-11.7)
months. Compared with TAS-102 monotherapy and TAS-102 plus ICIs, TAS-102 plus bevacizumab
obtained superior DCR (75.9% vs. 50% vs. 40%, P = .047), PFS (6.3m vs. 3.0 m vs. 3.0 m, P = .041) and OS (12.0 m vs. 6.5 m vs. 6.0m, P = .013). Patients without prior regorafenib or fruquintinib therapy obtained better
median PFS (6.3 vs. 4.3 m, P = .031) and OS (NR vs. 9.0 m, P = .036). Other indicators, including age, tumor site, KRAS status and use of fluoropyrimidine
as last regimen before TAS-102, did not affect the clinical efficacy of TAS-102. The
most frequent adverse events were leukopenia, neutropenia, anemia, fatigue, nausea,
and vomiting.
Conclusion
In real-world clinical setting, TAS-102 showed consistent clinical efficacy and manageable
safety with previous prospective clinical studies. Compared with monotherapy and TAS-102
plus ICIs, TAS-102 plus bevacizumab demonstrated better clinical efficacy for metastatic
colorectal cancer.
Keywords
Abbreviations:
TAS-102 (Trifluridine/tipiracil), ICIs (immune checkpoint inhibitors), PFS (progression free survival), ORR (objective response rate), DCR (disease control rate), OS (overall survival), AE (adverse events), CR (complete response), PR (partial response), SD (stable disease), PD (progressive disease), MSS (microsatellite stable), pMMR (mismatch repair proficient)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: November 30, 2022
Accepted:
November 28,
2022
Received in revised form:
November 11,
2022
Received:
August 21,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2022 Elsevier Inc. All rights reserved.
