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An Exploration of Trifluridine/Tipiracil Monotherapy and in Combination With Bevacizumab or Immune Checkpoint Inhibitors for Patients With Metastatic Colorectal Cancer: A Real-World Study

  • Caiyun Nie
    Affiliations
    Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China

    State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, Henan Province, China

    Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China

    Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China
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  • Weifeng Xu
    Affiliations
    Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China

    State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, Henan Province, China

    Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China

    Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China
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  • Beibei Chen
    Affiliations
    Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China

    State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, Henan Province, China

    Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China

    Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China
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  • Huifang Lv
    Affiliations
    Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China

    State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, Henan Province, China

    Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China

    Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China
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  • Jianzheng Wang
    Affiliations
    Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China

    State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, Henan Province, China

    Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China

    Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China
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  • Yingjun Liu
    Affiliations
    Department of General Surgery, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China
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  • Yunduan He
    Affiliations
    Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China

    State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, Henan Province, China

    Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China

    Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China
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  • Saiqi Wang
    Affiliations
    Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China

    State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, Henan Province, China

    Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China

    Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China
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  • Jing Zhao
    Affiliations
    Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China

    State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, Henan Province, China

    Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China

    Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China
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  • Xiaobing Chen
    Correspondence
    Address for correspondence: Xiaobing Chen, Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, Zhengzhou City, Henan Province, 450008, China.
    Affiliations
    Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan Province, China

    State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou University, Zhengzhou, Henan Province, China

    Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China

    Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, Zhengzhou, Henan Province, China
    Search for articles by this author
Published:November 30, 2022DOI:https://doi.org/10.1016/j.clcc.2022.11.005

      Abstract

      Background

      Trifluridine/tipiracil (TAS-102) has achieved modest efficacy in the late-line treatment of metastatic colorectal cancer. The present study aimed to explore the clinical efficacy and drug toxicities of TAS-102 for patients with metastatic colorectal cancer in real-world clinical setting.

      Methods

      From October 2020 to February 2022, patients with metastatic colorectal cancer who failed from 2 or more lines of prior therapy and treated with TAS-102 monotherapy, in combination with bevacizumab or immune checkpoint inhibitors (ICIs) were analyzed. The evaluation indicators were progression free survival (PFS), objective response rate , disease control rate (DCR), overall survival (OS) and drug toxicities.

      Results

      A total of 70 patients were enrolled. The objective response rate and DCR were 1.4% and 68.6%. The median PFS and OS were 6.0 (95% CI: 4.1-7.9) and 10.0 (95% CI: 8.3-11.7) months. Compared with TAS-102 monotherapy and TAS-102 plus ICIs, TAS-102 plus bevacizumab obtained superior DCR (75.9% vs. 50% vs. 40%, P = .047), PFS (6.3m vs. 3.0 m vs. 3.0 m, P = .041) and OS (12.0 m vs. 6.5 m vs. 6.0m, P = .013). Patients without prior regorafenib or fruquintinib therapy obtained better median PFS (6.3 vs. 4.3 m, P = .031) and OS (NR vs. 9.0 m, P = .036). Other indicators, including age, tumor site, KRAS status and use of fluoropyrimidine as last regimen before TAS-102, did not affect the clinical efficacy of TAS-102. The most frequent adverse events were leukopenia, neutropenia, anemia, fatigue, nausea, and vomiting.

      Conclusion

      In real-world clinical setting, TAS-102 showed consistent clinical efficacy and manageable safety with previous prospective clinical studies. Compared with monotherapy and TAS-102 plus ICIs, TAS-102 plus bevacizumab demonstrated better clinical efficacy for metastatic colorectal cancer.

      Keywords

      Abbreviations:

      TAS-102 (Trifluridine/tipiracil), ICIs (immune checkpoint inhibitors), PFS (progression free survival), ORR (objective response rate), DCR (disease control rate), OS (overall survival), AE (adverse events), CR (complete response), PR (partial response), SD (stable disease), PD (progressive disease), MSS (microsatellite stable), pMMR (mismatch repair proficient)
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