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A multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer

OBJECTIVE: The objective of this study was to assess the comparative efficacy in third-line setting for metastatic CRC (mCRC) patients using matched population of FRESCO trial with fruquintinib and real-world data with other TKIs. MATERIALS AND METHODS: The arm of fruquintinib from the FRESCO phase...

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Autores principales: Jin, Ying, Li, Jin, Shen, Lin, Xu, Jianming, Zhang, Yanqiao, Zhang, Jingdong, Pan, Hongming, Qu, Xiujuan, Chen, Yamin, Zhang, Qiang, Li, Jinnan, Sun, Miaomiao, Qin, Shukui
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9730021/
https://www.ncbi.nlm.nih.gov/pubmed/36505849
http://dx.doi.org/10.3389/fonc.2022.1044328
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author Jin, Ying
Li, Jin
Shen, Lin
Xu, Jianming
Zhang, Yanqiao
Zhang, Jingdong
Pan, Hongming
Qu, Xiujuan
Chen, Yamin
Zhang, Qiang
Li, Jinnan
Sun, Miaomiao
Qin, Shukui
author_facet Jin, Ying
Li, Jin
Shen, Lin
Xu, Jianming
Zhang, Yanqiao
Zhang, Jingdong
Pan, Hongming
Qu, Xiujuan
Chen, Yamin
Zhang, Qiang
Li, Jinnan
Sun, Miaomiao
Qin, Shukui
author_sort Jin, Ying
collection PubMed
description OBJECTIVE: The objective of this study was to assess the comparative efficacy in third-line setting for metastatic CRC (mCRC) patients using matched population of FRESCO trial with fruquintinib and real-world data with other TKIs. MATERIALS AND METHODS: The arm of fruquintinib from the FRESCO phase III trial (NCT02314819) included the data of patients with metastatic CRC that progressed after at least two lines of chemotherapy and received fruquintinib treatment. An external control arm was constructed using real-world data (RWD) of patients who received other TKIs based on key eligibility criteria of FRESCO. The baseline characteristics of two arms was balanced by propensity score matching (PSM). The Kaplan–Meier method and Cox proportional hazard model was used to evaluate progression free survival (PFS) and to estimate hazard ratios (HRs) and 95% confidence intervals (CIs), respectively. RESULTS: Overall, 128 patients were successfully matched by PSM in each, fruquintinib and other TKIs group. The patients in fruquintinib group showed significant increase in median PFS than other TKIs (3.71 vs. 2.49 months, HR = 0.67, 95%CI, 0.48-0.94, p = 0.019). In the subgroup analysis, fruquintinib showed a significant benefit in PFS compared with other TKIs among patients undergoing two or three previous chemotherapy regimens (HR 0.58, 95%CI 0.40-0.84; p=0.004), with rectum as primary disease site (HR 0.52, 95%CI 0.31-0.87; p=0.013), with left sided primary tumor location (HR 0.62, 95%CI 0.42-0.90; p=0.011), with multiple metastasis sites (HR 0.68, 95%CI 0.48-0.97; p=0.034) and with lung metastasis (HR 0.65, 95%CI 0.43-0.98; p=0.042). CONCLUSION: With the approach of establishing the external control arm from RWD, this study has demonstrated that treatment with fruquintinib significantly prolonged PFS as compared to other TKIs in patients as third-line mCRC treatment.
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spelling pubmed-97300212022-12-09 A multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer Jin, Ying Li, Jin Shen, Lin Xu, Jianming Zhang, Yanqiao Zhang, Jingdong Pan, Hongming Qu, Xiujuan Chen, Yamin Zhang, Qiang Li, Jinnan Sun, Miaomiao Qin, Shukui Front Oncol Oncology OBJECTIVE: The objective of this study was to assess the comparative efficacy in third-line setting for metastatic CRC (mCRC) patients using matched population of FRESCO trial with fruquintinib and real-world data with other TKIs. MATERIALS AND METHODS: The arm of fruquintinib from the FRESCO phase III trial (NCT02314819) included the data of patients with metastatic CRC that progressed after at least two lines of chemotherapy and received fruquintinib treatment. An external control arm was constructed using real-world data (RWD) of patients who received other TKIs based on key eligibility criteria of FRESCO. The baseline characteristics of two arms was balanced by propensity score matching (PSM). The Kaplan–Meier method and Cox proportional hazard model was used to evaluate progression free survival (PFS) and to estimate hazard ratios (HRs) and 95% confidence intervals (CIs), respectively. RESULTS: Overall, 128 patients were successfully matched by PSM in each, fruquintinib and other TKIs group. The patients in fruquintinib group showed significant increase in median PFS than other TKIs (3.71 vs. 2.49 months, HR = 0.67, 95%CI, 0.48-0.94, p = 0.019). In the subgroup analysis, fruquintinib showed a significant benefit in PFS compared with other TKIs among patients undergoing two or three previous chemotherapy regimens (HR 0.58, 95%CI 0.40-0.84; p=0.004), with rectum as primary disease site (HR 0.52, 95%CI 0.31-0.87; p=0.013), with left sided primary tumor location (HR 0.62, 95%CI 0.42-0.90; p=0.011), with multiple metastasis sites (HR 0.68, 95%CI 0.48-0.97; p=0.034) and with lung metastasis (HR 0.65, 95%CI 0.43-0.98; p=0.042). CONCLUSION: With the approach of establishing the external control arm from RWD, this study has demonstrated that treatment with fruquintinib significantly prolonged PFS as compared to other TKIs in patients as third-line mCRC treatment. Frontiers Media S.A. 2022-11-24 /pmc/articles/PMC9730021/ /pubmed/36505849 http://dx.doi.org/10.3389/fonc.2022.1044328 Text en Copyright © 2022 Jin, Li, Shen, Xu, Zhang, Zhang, Pan, Qu, Chen, Zhang, Li, Sun and Qin https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Jin, Ying
Li, Jin
Shen, Lin
Xu, Jianming
Zhang, Yanqiao
Zhang, Jingdong
Pan, Hongming
Qu, Xiujuan
Chen, Yamin
Zhang, Qiang
Li, Jinnan
Sun, Miaomiao
Qin, Shukui
A multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer
title A multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer
title_full A multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer
title_fullStr A multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer
title_full_unstemmed A multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer
title_short A multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer
title_sort multi-center effectiveness comparison study of fruquintinib with constructed external control cohort of other targeted kinase inhibitors using real-world data in third-line treatment of metastatic colorectal cancer
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9730021/
https://www.ncbi.nlm.nih.gov/pubmed/36505849
http://dx.doi.org/10.3389/fonc.2022.1044328
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