Real-world evidence of trifluridine/tipiracil plus bevacizumab in metastatic colorectal cancer using an administrative claims database in Japan.
FTD/TPI
TAS-102
real-world data
regorafenib
trifluridine/tipiracil + bevacizumab
Journal
ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
received:
24
05
2023
revised:
04
07
2023
accepted:
06
07
2023
medline:
29
8
2023
pubmed:
11
8
2023
entrez:
10
8
2023
Statut:
ppublish
Résumé
Trifluridine/tipiracil (FTD/TPI) and regorafenib (REG) are standard therapies for refractory metastatic colorectal cancer (mCRC). No results of large real-world data directly comparing FTD/TPI + bevacizumab (BEV) with FTD/TPI or REG monotherapy have been reported. We evaluated the efficacy and safety of FTD/TPI + BEV in a real-world setting. This retrospective study used a Japanese claims database provided by Medical Data Vision Co., Ltd. (Tokyo, Japan). Eligible patients were aged 20 years and over with a diagnosis of mCRC, and received their first dose of FTD/TPI or REG from 2014 to 2021. The primary endpoint was overall survival (OS) in a propensity score matching (PSM) population in which PSM was carried out by matching using a 1 : 1 ratio for the FTD/TPI + BEV group and the control group (FTD/TPI or REG) by propensity score. To enhance robustness, sensitivity analyses of OS were carried out using the inverse probability treatment weighted (IPTW) approach and the analysis in the all eligible population. Secondary endpoints included time to treatment discontinuation (TTD), incidence of adverse events, and post-treatment. Eligible population was 2369 for the FTD/TPI + BEV group and 9318 for the control group. The PSM population was 1787 for each group. Median OS (mOS) was longer in the FTD/TPI + BEV group compared to the control group [17.0 versus 11.6 months, hazard ratio (HR) = 0.70, P < 0.001] in the PSM population. Similarly, mOS was longer for the FTD/TPI + BEV group compared to that for the control group in IPTW analyses and in the all eligible population (both HRs = 0.68). Median TTD was 3.3 months for the FTD/TPI + BEV group and 1.8 months for the control group in the PSM population (P < 0.001). Real-world data showed that FTD/TPI + BEV was significantly associated with OS and TTD compared to FTD/TPI or REG. In clinical practice, FTD/TPI + BEV can be a favorable regimen for refractory mCRC.
Sections du résumé
BACKGROUND
Trifluridine/tipiracil (FTD/TPI) and regorafenib (REG) are standard therapies for refractory metastatic colorectal cancer (mCRC). No results of large real-world data directly comparing FTD/TPI + bevacizumab (BEV) with FTD/TPI or REG monotherapy have been reported. We evaluated the efficacy and safety of FTD/TPI + BEV in a real-world setting.
MATERIALS AND METHODS
This retrospective study used a Japanese claims database provided by Medical Data Vision Co., Ltd. (Tokyo, Japan). Eligible patients were aged 20 years and over with a diagnosis of mCRC, and received their first dose of FTD/TPI or REG from 2014 to 2021. The primary endpoint was overall survival (OS) in a propensity score matching (PSM) population in which PSM was carried out by matching using a 1 : 1 ratio for the FTD/TPI + BEV group and the control group (FTD/TPI or REG) by propensity score. To enhance robustness, sensitivity analyses of OS were carried out using the inverse probability treatment weighted (IPTW) approach and the analysis in the all eligible population. Secondary endpoints included time to treatment discontinuation (TTD), incidence of adverse events, and post-treatment.
RESULTS
Eligible population was 2369 for the FTD/TPI + BEV group and 9318 for the control group. The PSM population was 1787 for each group. Median OS (mOS) was longer in the FTD/TPI + BEV group compared to the control group [17.0 versus 11.6 months, hazard ratio (HR) = 0.70, P < 0.001] in the PSM population. Similarly, mOS was longer for the FTD/TPI + BEV group compared to that for the control group in IPTW analyses and in the all eligible population (both HRs = 0.68). Median TTD was 3.3 months for the FTD/TPI + BEV group and 1.8 months for the control group in the PSM population (P < 0.001).
CONCLUSIONS
Real-world data showed that FTD/TPI + BEV was significantly associated with OS and TTD compared to FTD/TPI or REG. In clinical practice, FTD/TPI + BEV can be a favorable regimen for refractory mCRC.
Identifiants
pubmed: 37562196
pii: S2059-7029(23)00849-9
doi: 10.1016/j.esmoop.2023.101614
pmc: PMC10515287
pii:
doi:
Substances chimiques
tipiracil
NGO10K751P
Uracil
56HH86ZVCT
Bevacizumab
2S9ZZM9Q9V
Trifluridine
RMW9V5RW38
regorafenib
24T2A1DOYB
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
101614Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
Références
ESMO Open. 2023 Jun;8(3):101558
pubmed: 37236086
Lancet Oncol. 2020 Mar;21(3):412-420
pubmed: 31999946
Lancet. 2019 Oct 19;394(10207):1467-1480
pubmed: 31631858
Lancet. 2013 Jan 26;381(9863):303-12
pubmed: 23177514
N Engl J Med. 2023 May 4;388(18):1657-1667
pubmed: 37133585
ESMO Open. 2021 Apr;6(2):100093
pubmed: 33744811
Int J Clin Oncol. 2021 Jan;26(1):111-117
pubmed: 33083913
Lancet Oncol. 2017 Sep;18(9):1172-1181
pubmed: 28760399
Oncologist. 2020 Dec;25(12):e1855-e1863
pubmed: 32666647
BMJ Support Palliat Care. 2017 Sep;7(3):300-307
pubmed: 28130325
Int J Clin Oncol. 2022 Dec;27(12):1859-1866
pubmed: 36201089
N Engl J Med. 2015 May 14;372(20):1909-19
pubmed: 25970050
Lancet Oncol. 2013 Jan;14(1):29-37
pubmed: 23168366
CA Cancer J Clin. 2018 Nov;68(6):394-424
pubmed: 30207593