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


Journal

BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800

Informations de publication

Date de publication:
27 Dec 2019
Historique:
received: 24 08 2019
accepted: 17 12 2019
entrez: 29 12 2019
pubmed: 29 12 2019
medline: 8 5 2020
Statut: epublish

Résumé

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. 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. 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). 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. Retrospectively registered.

Sections du résumé

BACKGROUND 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 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 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 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 BACKGROUND
Retrospectively registered.

Identifiants

pubmed: 31881856
doi: 10.1186/s12885-019-6475-6
pii: 10.1186/s12885-019-6475-6
pmc: PMC6935149
doi:

Substances chimiques

Drug Combinations 0
Pyrrolidines 0
trifluridine tipiracil drug combination 0
Bevacizumab 2S9ZZM9Q9V
Uracil 56HH86ZVCT
Thymine QR26YLT7LT
Trifluridine RMW9V5RW38

Types de publication

Clinical Trial Comparative Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1253

Références

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pubmed: 22951287
J Clin Oncol. 2018 Feb 1;36(4):350-358
pubmed: 29215955
Lancet Oncol. 2014 Sep;15(10):1065-75
pubmed: 25088940
Lancet. 2013 Jan 26;381(9863):303-12
pubmed: 23177514
Lancet Oncol. 2015 May;16(5):499-508
pubmed: 25877855
J Clin Oncol. 2012 Oct 1;30(28):3499-506
pubmed: 22949147
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pubmed: 28760399
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pubmed: 26723516
Oncol Rep. 2015 May;33(5):2135-42
pubmed: 25812794
N Engl J Med. 2015 May 14;372(20):1909-19
pubmed: 25970050

Auteurs

Daisuke Kotani (D)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Yasutoshi Kuboki (Y)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. ykuboki@east.ncc.go.jp.
Department of Experimental Therapeutics, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. ykuboki@east.ncc.go.jp.

Satoshi Horasawa (S)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Translational Research Support Section, Translational Research Management Division, Clinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.

Asumi Kaneko (A)

Department of Pharmacy, National Cancer Center Hospital East, Kashiwa, Japan.

Yoshiaki Nakamura (Y)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Translational Research Support Section, Translational Research Management Division, Clinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.

Akihito Kawazoe (A)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Hideaki Bando (H)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.

Hiroya Taniguchi (H)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Translational Research Support Section, Translational Research Management Division, Clinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.

Kohei Shitara (K)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Takashi Kojima (T)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Akihito Tsuji (A)

Department of Medical Oncology, Graduated School of Medicine, Kagawa University, Takamatsu, Japan.

Takayuki Yoshino (T)

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

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Classifications MeSH