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

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Giuseppe Cicero MD PhD, Raffaele Addeo MD, Rossella De Luca PhD, Giuseppe Lo Re MD PhD, Leonardo Gulotta MD, Pierenrico Marchesa MD, Gaspare Gulotta MD PhD

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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.

Keywords: chemotherapy, elderly patients, Lonsurf, metastatic colorectal cancer, quality of life, TAS-102, trifluridine/ tipiracil.

Citation: Cicero G, Addeo R, De Luca R, Lo Re G, Gulotta L, Marchesa P, Gaspare G. TAS-102 in elderly patients with mCRC: a real-world study. Drugs in Context 2020; 9: 2020-6-3. DOI: 10.7573/dic.2020-6-3

Contributions: Data Collection: GC, RD. Data interpretation: GC, RA. Statistical analysis: GC. Manuscript writing: GC, RA. Manuscript editing: all authors. All authors reviewed and approved the final version of this manuscript. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest relevant to this manuscript. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2020/09/dic.2020-6-3-COI.pdf

Acknowledgements: None.

Funding declaration: There was no funding associated with the preparation of this article.

Copyright: Copyright © 2020 Cicero G, Addeo R, De Luca R, Lo Re G, Gulotta L, Marchesa P, Gaspare G. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2020 Cicero G, Addeo R, De Luca R, Lo Re G, Gulotta L, Marchesa P, Gaspare G. https://doi.org/10.7573/dic.2020-6-3. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/tas-102-in-metastatic-colorectal-cancer-mcrc-efficacy-tolerability-and-quality-of-life-in-heavily-pretreated-elderly-patients-a-real-life-study

Correspondence: Giuseppe Cicero, Department of Surgical, Oncological and Oral Sciences, University of Palermo, Via del Vespro, 129, 90127 Palermo, Italy. giuseppe.cicero@unipa.it

Provenance: Submitted; externally peer reviewed.

Submitted: 9 June 2020; Peer review comments to author: 14 July 2020; Revised manuscript received: 25 August 2020; Accepted: 26 August 2020; Publication date: 18 September 2020.

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