Real-world experience of trifluridine/tipiracil in patients with metastatic colorectal cancer: A multicenter United Kingdom study

Chara Stavraka (Lead / Corresponding author), Athanasios Pouptsis (Contributing member), Paul Kabuubi (Contributing member), Vasileios Angelis (Contributing member), Mark Baxter (Contributing member), Ainsley Barrie (Contributing member), Amparo Costa (Contributing member), Alia Nizam (Contributing member), Julien De Naurois (Contributing member), Christos Mikropoulos (Contributing member), Mark Hill (Contributing member), Janet Graham (Contributing member), Victoria Harris (Contributing member), John Bridgewater (Contributing member), Paul Ross (Contributing member)

Research output: Contribution to journalMeeting abstract

9 Citations (Scopus)

Abstract

Background: TAS-102 is an orally administered combination of the thymidine-based nucleic acid analogue, trifluridine and the thymidine phosphorylase inhibitor, tipiracil hydrochloride. Following the phase III RECOURSE study, it received approval as third line treatment for metastatic colorectal cancer showing significant improvement in overall and progression free survival and an acceptable toxicity profile. Methods: We performed a multicenter retrospective observational study of patients with metastatic colorectal cancer receiving TAS-102 as third line treatment between 2016 and 2018 in Cancer centers across the UK. Results: A total of 143 patients were included (94 men, 49 women). Median age was 68 years (35-82). All patients had received at least 2 lines of fluoropyrimidine-based chemotherapy doublet with oxaliplatin or irinotecan. About 90% of patients had ECOG ≥ 1. Median duration of treatment was 2.9 months (0.5-22.9), with a response rate of 1.6% and stable disease achieved in 24%. Median OS was 7 months (95% CI 5.84-8.15) and median PFS 2.6 months (95% CI 2.2-3.36). A dose reduction was required in 28% of patients, while 8% discontinued treatment due to toxicity. AEs reported included fatigue 81.3% (G3 16.8%), nausea 34.5% (G3 4.5%) and diarrhoea 25.5% (G3 1.8%). Neutropenia was common 50.4%, (≥ G3: 25.4%) with 4.2% cases of neutropenic fever while thrombocytopenia was less frequent 8.7% (≥ G3 1.8%). Conclusions: The OS, PFS and ORR observed in our real-world experience were consistent with the RECOURSE trial, though we noted a lower disease control rate. Overall, TAS-102 was well tolerated and the most prevalent adverse events seen in our patients were in keeping with those reported in the trial. Although severe toxicities were less frequent than the trial, we experienced higher rates of toxicity induced dose reductions and treatment cessations, which could reflect the differences between trial and real world populations. Further validation is warranted.
Original languageEnglish
Pages (from-to)668-668
Number of pages1
JournalJournal of Clinical Oncology
Volume37
Issue number4
Early online date29 Jan 2019
DOIs
Publication statusPublished - 1 Feb 2019

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Trifluridine
Colorectal Neoplasms
irinotecan
oxaliplatin
Thymidine Phosphorylase
Withholding Treatment
Therapeutics
Neutropenia
Thrombocytopenia
Thymidine
Nucleic Acids
Nausea
Disease-Free Survival
Observational Studies
Fatigue
United Kingdom
Diarrhea
Fever
Retrospective Studies
Drug Therapy

Cite this

Stavraka, Chara ; Pouptsis, Athanasios ; Kabuubi, Paul ; Angelis, Vasileios ; Baxter, Mark ; Barrie, Ainsley ; Costa, Amparo ; Nizam, Alia ; De Naurois, Julien ; Mikropoulos, Christos ; Hill, Mark ; Graham, Janet ; Harris, Victoria ; Bridgewater, John ; Ross, Paul. / Real-world experience of trifluridine/tipiracil in patients with metastatic colorectal cancer : A multicenter United Kingdom study. In: Journal of Clinical Oncology. 2019 ; Vol. 37, No. 4. pp. 668-668.
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title = "Real-world experience of trifluridine/tipiracil in patients with metastatic colorectal cancer: A multicenter United Kingdom study",
abstract = "Background: TAS-102 is an orally administered combination of the thymidine-based nucleic acid analogue, trifluridine and the thymidine phosphorylase inhibitor, tipiracil hydrochloride. Following the phase III RECOURSE study, it received approval as third line treatment for metastatic colorectal cancer showing significant improvement in overall and progression free survival and an acceptable toxicity profile. Methods: We performed a multicenter retrospective observational study of patients with metastatic colorectal cancer receiving TAS-102 as third line treatment between 2016 and 2018 in Cancer centers across the UK. Results: A total of 143 patients were included (94 men, 49 women). Median age was 68 years (35-82). All patients had received at least 2 lines of fluoropyrimidine-based chemotherapy doublet with oxaliplatin or irinotecan. About 90{\%} of patients had ECOG ≥ 1. Median duration of treatment was 2.9 months (0.5-22.9), with a response rate of 1.6{\%} and stable disease achieved in 24{\%}. Median OS was 7 months (95{\%} CI 5.84-8.15) and median PFS 2.6 months (95{\%} CI 2.2-3.36). A dose reduction was required in 28{\%} of patients, while 8{\%} discontinued treatment due to toxicity. AEs reported included fatigue 81.3{\%} (G3 16.8{\%}), nausea 34.5{\%} (G3 4.5{\%}) and diarrhoea 25.5{\%} (G3 1.8{\%}). Neutropenia was common 50.4{\%}, (≥ G3: 25.4{\%}) with 4.2{\%} cases of neutropenic fever while thrombocytopenia was less frequent 8.7{\%} (≥ G3 1.8{\%}). Conclusions: The OS, PFS and ORR observed in our real-world experience were consistent with the RECOURSE trial, though we noted a lower disease control rate. Overall, TAS-102 was well tolerated and the most prevalent adverse events seen in our patients were in keeping with those reported in the trial. Although severe toxicities were less frequent than the trial, we experienced higher rates of toxicity induced dose reductions and treatment cessations, which could reflect the differences between trial and real world populations. Further validation is warranted.",
author = "Chara Stavraka and Athanasios Pouptsis and Paul Kabuubi and Vasileios Angelis and Mark Baxter and Ainsley Barrie and Amparo Costa and Alia Nizam and {De Naurois}, Julien and Christos Mikropoulos and Mark Hill and Janet Graham and Victoria Harris and John Bridgewater and Paul Ross",
year = "2019",
month = "2",
day = "1",
doi = "10.1200/JCO.2019.37.4_suppl.668",
language = "English",
volume = "37",
pages = "668--668",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "4",

}

Stavraka, C, Pouptsis, A, Kabuubi, P, Angelis, V, Baxter, M, Barrie, A, Costa, A, Nizam, A, De Naurois, J, Mikropoulos, C, Hill, M, Graham, J, Harris, V, Bridgewater, J & Ross, P 2019, 'Real-world experience of trifluridine/tipiracil in patients with metastatic colorectal cancer: A multicenter United Kingdom study', Journal of Clinical Oncology, vol. 37, no. 4, pp. 668-668. https://doi.org/10.1200/JCO.2019.37.4_suppl.668

Real-world experience of trifluridine/tipiracil in patients with metastatic colorectal cancer : A multicenter United Kingdom study. / Stavraka, Chara (Lead / Corresponding author); Pouptsis, Athanasios (Contributing member); Kabuubi, Paul (Contributing member); Angelis, Vasileios (Contributing member); Baxter, Mark (Contributing member); Barrie, Ainsley (Contributing member); Costa, Amparo (Contributing member); Nizam, Alia (Contributing member); De Naurois, Julien (Contributing member); Mikropoulos, Christos (Contributing member); Hill, Mark (Contributing member); Graham, Janet (Contributing member); Harris, Victoria (Contributing member); Bridgewater, John (Contributing member); Ross, Paul (Contributing member).

In: Journal of Clinical Oncology, Vol. 37, No. 4, 01.02.2019, p. 668-668.

Research output: Contribution to journalMeeting abstract

TY - JOUR

T1 - Real-world experience of trifluridine/tipiracil in patients with metastatic colorectal cancer

T2 - A multicenter United Kingdom study

AU - Stavraka, Chara

A2 - Pouptsis, Athanasios

A2 - Kabuubi, Paul

A2 - Angelis, Vasileios

A2 - Baxter, Mark

A2 - Barrie, Ainsley

A2 - Costa, Amparo

A2 - Nizam, Alia

A2 - De Naurois, Julien

A2 - Mikropoulos, Christos

A2 - Hill, Mark

A2 - Graham, Janet

A2 - Harris, Victoria

A2 - Bridgewater, John

A2 - Ross, Paul

PY - 2019/2/1

Y1 - 2019/2/1

N2 - Background: TAS-102 is an orally administered combination of the thymidine-based nucleic acid analogue, trifluridine and the thymidine phosphorylase inhibitor, tipiracil hydrochloride. Following the phase III RECOURSE study, it received approval as third line treatment for metastatic colorectal cancer showing significant improvement in overall and progression free survival and an acceptable toxicity profile. Methods: We performed a multicenter retrospective observational study of patients with metastatic colorectal cancer receiving TAS-102 as third line treatment between 2016 and 2018 in Cancer centers across the UK. Results: A total of 143 patients were included (94 men, 49 women). Median age was 68 years (35-82). All patients had received at least 2 lines of fluoropyrimidine-based chemotherapy doublet with oxaliplatin or irinotecan. About 90% of patients had ECOG ≥ 1. Median duration of treatment was 2.9 months (0.5-22.9), with a response rate of 1.6% and stable disease achieved in 24%. Median OS was 7 months (95% CI 5.84-8.15) and median PFS 2.6 months (95% CI 2.2-3.36). A dose reduction was required in 28% of patients, while 8% discontinued treatment due to toxicity. AEs reported included fatigue 81.3% (G3 16.8%), nausea 34.5% (G3 4.5%) and diarrhoea 25.5% (G3 1.8%). Neutropenia was common 50.4%, (≥ G3: 25.4%) with 4.2% cases of neutropenic fever while thrombocytopenia was less frequent 8.7% (≥ G3 1.8%). Conclusions: The OS, PFS and ORR observed in our real-world experience were consistent with the RECOURSE trial, though we noted a lower disease control rate. Overall, TAS-102 was well tolerated and the most prevalent adverse events seen in our patients were in keeping with those reported in the trial. Although severe toxicities were less frequent than the trial, we experienced higher rates of toxicity induced dose reductions and treatment cessations, which could reflect the differences between trial and real world populations. Further validation is warranted.

AB - Background: TAS-102 is an orally administered combination of the thymidine-based nucleic acid analogue, trifluridine and the thymidine phosphorylase inhibitor, tipiracil hydrochloride. Following the phase III RECOURSE study, it received approval as third line treatment for metastatic colorectal cancer showing significant improvement in overall and progression free survival and an acceptable toxicity profile. Methods: We performed a multicenter retrospective observational study of patients with metastatic colorectal cancer receiving TAS-102 as third line treatment between 2016 and 2018 in Cancer centers across the UK. Results: A total of 143 patients were included (94 men, 49 women). Median age was 68 years (35-82). All patients had received at least 2 lines of fluoropyrimidine-based chemotherapy doublet with oxaliplatin or irinotecan. About 90% of patients had ECOG ≥ 1. Median duration of treatment was 2.9 months (0.5-22.9), with a response rate of 1.6% and stable disease achieved in 24%. Median OS was 7 months (95% CI 5.84-8.15) and median PFS 2.6 months (95% CI 2.2-3.36). A dose reduction was required in 28% of patients, while 8% discontinued treatment due to toxicity. AEs reported included fatigue 81.3% (G3 16.8%), nausea 34.5% (G3 4.5%) and diarrhoea 25.5% (G3 1.8%). Neutropenia was common 50.4%, (≥ G3: 25.4%) with 4.2% cases of neutropenic fever while thrombocytopenia was less frequent 8.7% (≥ G3 1.8%). Conclusions: The OS, PFS and ORR observed in our real-world experience were consistent with the RECOURSE trial, though we noted a lower disease control rate. Overall, TAS-102 was well tolerated and the most prevalent adverse events seen in our patients were in keeping with those reported in the trial. Although severe toxicities were less frequent than the trial, we experienced higher rates of toxicity induced dose reductions and treatment cessations, which could reflect the differences between trial and real world populations. Further validation is warranted.

U2 - 10.1200/JCO.2019.37.4_suppl.668

DO - 10.1200/JCO.2019.37.4_suppl.668

M3 - Meeting abstract

VL - 37

SP - 668

EP - 668

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 4

ER -