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Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer

BACKGROUND: A previous phase I/II C-TASK FORCE study of trifluridine/tipiracil plus bevacizumab for patients with heavily pretreated metastatic colorectal cancer (mCRC) showed promising activity with an acceptable toxicity profile. This retrospective study aimed to investigate the safety and efficac...

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Autores principales: Kotani, Daisuke, Kuboki, Yasutoshi, Horasawa, Satoshi, Kaneko, Asumi, Nakamura, Yoshiaki, Kawazoe, Akihito, Bando, Hideaki, Taniguchi, Hiroya, Shitara, Kohei, Kojima, Takashi, Tsuji, Akihito, Yoshino, Takayuki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6935149/
https://www.ncbi.nlm.nih.gov/pubmed/31881856
http://dx.doi.org/10.1186/s12885-019-6475-6
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author Kotani, Daisuke
Kuboki, Yasutoshi
Horasawa, Satoshi
Kaneko, Asumi
Nakamura, Yoshiaki
Kawazoe, Akihito
Bando, Hideaki
Taniguchi, Hiroya
Shitara, Kohei
Kojima, Takashi
Tsuji, Akihito
Yoshino, Takayuki
author_facet Kotani, Daisuke
Kuboki, Yasutoshi
Horasawa, Satoshi
Kaneko, Asumi
Nakamura, Yoshiaki
Kawazoe, Akihito
Bando, Hideaki
Taniguchi, Hiroya
Shitara, Kohei
Kojima, Takashi
Tsuji, Akihito
Yoshino, Takayuki
author_sort Kotani, Daisuke
collection PubMed
description BACKGROUND: A previous phase I/II C-TASK FORCE study of trifluridine/tipiracil plus bevacizumab for patients with heavily pretreated metastatic colorectal cancer (mCRC) showed promising activity with an acceptable toxicity profile. This retrospective study aimed to investigate the safety and efficacy of trifluridine/tipiracil plus bevacizumab compared with trifluridine/tipiracil monotherapy in patients with heavily pretreated mCRC in clinical settings. METHODS: Records of patients with mCRC refractory to standard therapies who initiated trifluridine/tipiracil plus bevacizumab from January 2016 to March 2018 or trifluridine/tipiracil monotherapy from June 2014 to December 2015 were retrospectively reviewed at our institution. RESULTS: Totally, 60 patients received trifluridine/tipiracil plus bevacizumab and 66 received trifluridine/tipiracil monotherapy. All patients had previously received standard chemotherapy. Median progression-free survival (PFS) was 3.7 months [95% confidence interval (CI), 2.3–5.1] in the trifluridine/tipiracil plus bevacizumab group and 2.2 months (95% CI, 1.8–2.6) in the trifluridine/tipiracil monotherapy group [hazards ratio (HR) 0.69; 95% CI 0.48–0.99]. PFS rate at 16 weeks was 46.6% for the trifluridine/tipiracil plus bevacizumab group and 33.9% for the trifluridine/tipiracil monotherapy group. Although a relatively higher incidence of grade ≥ 3 neutropenia was observed in the trifluridine/tipiracil plus bevacizumab group than that in the other group (50.0% vs. 40.9%, p = 0.371), the incidence of febrile neutropenia was not high (3.3% vs. 7.8%, p = 0.444). CONCLUSIONS: In real-world settings, trifluridine/tipiracil plus bevacizumab prolonged PFS and helped achieve higher 16-week PFS rate compared with trifluridine/tipiracil monotherapy in patients with heavily pretreated mCRC with manageable toxicities. TRIAL REGISTRATION: Retrospectively registered.
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spelling pubmed-69351492019-12-30 Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer Kotani, Daisuke Kuboki, Yasutoshi Horasawa, Satoshi Kaneko, Asumi Nakamura, Yoshiaki Kawazoe, Akihito Bando, Hideaki Taniguchi, Hiroya Shitara, Kohei Kojima, Takashi Tsuji, Akihito Yoshino, Takayuki BMC Cancer Research Article BACKGROUND: A previous phase I/II C-TASK FORCE study of trifluridine/tipiracil plus bevacizumab for patients with heavily pretreated metastatic colorectal cancer (mCRC) showed promising activity with an acceptable toxicity profile. This retrospective study aimed to investigate the safety and efficacy of trifluridine/tipiracil plus bevacizumab compared with trifluridine/tipiracil monotherapy in patients with heavily pretreated mCRC in clinical settings. METHODS: Records of patients with mCRC refractory to standard therapies who initiated trifluridine/tipiracil plus bevacizumab from January 2016 to March 2018 or trifluridine/tipiracil monotherapy from June 2014 to December 2015 were retrospectively reviewed at our institution. RESULTS: Totally, 60 patients received trifluridine/tipiracil plus bevacizumab and 66 received trifluridine/tipiracil monotherapy. All patients had previously received standard chemotherapy. Median progression-free survival (PFS) was 3.7 months [95% confidence interval (CI), 2.3–5.1] in the trifluridine/tipiracil plus bevacizumab group and 2.2 months (95% CI, 1.8–2.6) in the trifluridine/tipiracil monotherapy group [hazards ratio (HR) 0.69; 95% CI 0.48–0.99]. PFS rate at 16 weeks was 46.6% for the trifluridine/tipiracil plus bevacizumab group and 33.9% for the trifluridine/tipiracil monotherapy group. Although a relatively higher incidence of grade ≥ 3 neutropenia was observed in the trifluridine/tipiracil plus bevacizumab group than that in the other group (50.0% vs. 40.9%, p = 0.371), the incidence of febrile neutropenia was not high (3.3% vs. 7.8%, p = 0.444). CONCLUSIONS: In real-world settings, trifluridine/tipiracil plus bevacizumab prolonged PFS and helped achieve higher 16-week PFS rate compared with trifluridine/tipiracil monotherapy in patients with heavily pretreated mCRC with manageable toxicities. TRIAL REGISTRATION: Retrospectively registered. BioMed Central 2019-12-27 /pmc/articles/PMC6935149/ /pubmed/31881856 http://dx.doi.org/10.1186/s12885-019-6475-6 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Kotani, Daisuke
Kuboki, Yasutoshi
Horasawa, Satoshi
Kaneko, Asumi
Nakamura, Yoshiaki
Kawazoe, Akihito
Bando, Hideaki
Taniguchi, Hiroya
Shitara, Kohei
Kojima, Takashi
Tsuji, Akihito
Yoshino, Takayuki
Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer
title Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer
title_full Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer
title_fullStr Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer
title_full_unstemmed Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer
title_short Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer
title_sort retrospective cohort study of trifluridine/tipiracil (tas-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6935149/
https://www.ncbi.nlm.nih.gov/pubmed/31881856
http://dx.doi.org/10.1186/s12885-019-6475-6
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