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Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer
Yasutoshi Kuboki
Corresponding Author
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This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC 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 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
Keywords
trifluridine/tipiracil plus bevacizumab; TAS-102; mCRC; Lonsurf
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CURRENT STATUS: Published
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Posted 18 Dec, 2019
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On 27 Dec, 2019
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On 17 Dec, 2019
Editorial decision: Accept
On 17 Dec, 2019
Editor assigned
On 16 Dec, 2019
Editor invited
On 15 Dec, 2019
No comments provided
Editorial decision: Minor revision
On 03 Dec, 2019
Editor assigned
On 02 Dec, 2019
Submission checks complete
On 01 Dec, 2019
Editor invited
On 01 Dec, 2019
No comments provided
Editorial decision: Minor revision
On 22 Nov, 2019
Editor assigned
On 20 Nov, 2019
Submission checks complete
On 19 Nov, 2019
Editor invited
On 19 Nov, 2019
No comments provided
Editorial decision: Major revision
On 17 Oct, 2019
Review #2 received
Received 15 Oct, 2019
Reviewer #2 agreed
On 01 Oct, 2019
Review #1 received
Received 26 Sep, 2019
Reviewer #1 agreed
On 19 Sep, 2019
Reviewers invited
Invitations sent on 19 Sep, 2019
Submission checks complete
On 01 Sep, 2019
Editor assigned
On 27 Aug, 2019
Editor invited
On 26 Aug, 2019
First submitted
On 24 Aug, 2019
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Subject Areas
Oncology
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This preprint is under consideration at BMC Cancer. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer
Yasutoshi Kuboki
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 4
Posted 18 Dec, 2019
Published
On 27 Dec, 2019
No community comments so far
Submission checks complete
On 17 Dec, 2019
Editorial decision: Accept
On 17 Dec, 2019
Editor assigned
On 16 Dec, 2019
Editor invited
On 15 Dec, 2019
No comments provided
Editorial decision: Minor revision
On 03 Dec, 2019
Editor assigned
On 02 Dec, 2019
Submission checks complete
On 01 Dec, 2019
Editor invited
On 01 Dec, 2019
No comments provided
Editorial decision: Minor revision
On 22 Nov, 2019
Editor assigned
On 20 Nov, 2019
Submission checks complete
On 19 Nov, 2019
Editor invited
On 19 Nov, 2019
No comments provided
Editorial decision: Major revision
On 17 Oct, 2019
Review #2 received
Received 15 Oct, 2019
Reviewer #2 agreed
On 01 Oct, 2019
Review #1 received
Received 26 Sep, 2019
Reviewer #1 agreed
On 19 Sep, 2019
Reviewers invited
Invitations sent on 19 Sep, 2019
Submission checks complete
On 01 Sep, 2019
Editor assigned
On 27 Aug, 2019
Editor invited
On 26 Aug, 2019
First submitted
On 24 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Oncology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC 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 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
Figure 1