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

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical colorectal cancer Pub Date : 2023-03-01 DOI:10.1016/j.clcc.2022.11.005

Caiyun Nie , Weifeng Xu , Beibei Chen , Huifang Lv , Jianzheng Wang , Yingjun Liu , Yunduan He , Saiqi Wang , Jing Zhao , Xiaobing Chen

{"title":"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","authors":"Caiyun Nie , Weifeng Xu , Beibei Chen , Huifang Lv , Jianzheng Wang , Yingjun Liu , Yunduan He , Saiqi Wang , Jing Zhao , Xiaobing Chen","doi":"10.1016/j.clcc.2022.11.005","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p><span><span>Trifluridine/tipiracil (TAS-102) has achieved modest efficacy in the late-line treatment of </span>metastatic colorectal cancer. The present study aimed to explore the clinical efficacy and </span>drug toxicities of TAS-102 for patients with metastatic colorectal cancer in real-world clinical setting.</p></div><div><h3>Methods</h3><p><span><span>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 </span>bevacizumab<span> or immune checkpoint inhibitors (ICIs) were analyzed. The evaluation indicators were </span></span>progression free survival (PFS), objective response rate , disease control rate (DCR), overall survival (OS) and drug toxicities.</p></div><div><h3>Results</h3><p>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%, <em>P</em> = .047), PFS (6.3m vs. 3.0 m vs. 3.0 m, <em>P</em> = .041) and OS (12.0 m vs. 6.5 m vs. 6.0m, <em>P</em><span><span> = .013). Patients without prior regorafenib or </span>fruquintinib therapy obtained better median PFS (6.3 vs. 4.3 m, </span><em>P</em> = .031) and OS (NR vs. 9.0 m, <em>P</em><span><span> = .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 </span>leukopenia, neutropenia, anemia, fatigue, nausea, and vomiting.</span></p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"22 1","pages":"Pages 76-84"},"PeriodicalIF":3.3000,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical colorectal cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1533002822001311","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 1

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.

查看原文本刊更多论文

三氟吡啶/替吡拉西单药联合贝伐单抗或免疫检查点抑制剂治疗转移性结直肠癌癌症的临床研究

背景三氟吡啶/替吡拉西（TAS-102）在转移性癌症的晚期治疗中取得了适度的疗效。本研究旨在探讨TAS-102在现实临床环境中对转移性结直肠癌癌症患者的临床疗效和药物毒性。方法从2020年10月至2022年2月，对2个或2个以上既往治疗失败的转移性癌症患者进行分析，这些患者接受TAS-102单药治疗，联合贝伐单抗或免疫检查点抑制剂（ICIs）。评估指标为无进展生存期（PFS）、客观缓解率、疾病控制率（DCR）、总生存期（OS）和药物毒性。结果共有70例患者入选。客观缓解率和DCR分别为1.4%和68.6%。中位PFS和OS分别为6.0（95%CI:4.1-7.9）和10.0（95%CI:8.3-11.7）个月。与TAS-102单药治疗和TAS-102联合ICIs相比，TAS-102加贝伐单抗获得了更好的DCR（75.9%vs.50%vs.40%，P=.047）、PFS（6.3m/3.0m/3.0m，P=.041）和OS（12.0m/6.5m/6.0m，P=.013），包括年龄、肿瘤部位、KRAS状态以及在TAS-102之前使用氟嘧啶作为最后方案，均不影响TAS-102的临床疗效。最常见的不良事件是白细胞减少、中性粒细胞减少、贫血、疲劳、恶心和呕吐。结论在真实的临床环境中，TAS-102与以往的前瞻性临床研究显示出一致的临床疗效和可控的安全性。与单药治疗和TAS-102加ICIs相比，TAS-102加贝伐单抗对转移性癌症表现出更好的临床疗效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Clinical colorectal cancer 医学-肿瘤学

CiteScore

5.50

自引率

2.90%

发文量

审稿时长

27 days

期刊介绍： Clinical Colorectal Cancer is a peer-reviewed, quarterly journal that publishes original articles describing various aspects of clinical and translational research of gastrointestinal cancers. Clinical Colorectal Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of colorectal, pancreatic, liver, and other gastrointestinal cancers. The main emphasis is on recent scientific developments in all areas related to gastrointestinal cancers. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.