Efficacy and safety of regorafenib plus biweekly trifluridine/tipiracil for refractory metastatic colorectal cancer: a multicenter single-arm phase II trial.

IF 4.8 2区医学 Q1 ONCOLOGY

Oncologist Pub Date : 2025-06-04 DOI:10.1093/oncolo/oyaf129

Xiangling Wang, Zhen Li, Dan Sha, Haipeng Ren, Cuihua Yi, Shuguang Li, Peng Wang, Yunxia Chu, Changlun Li, Guanglian Shan, Jian Wang, Xiaorong Yang, Jing Hao

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引用次数: 0

Abstract

Background: Both regorafenib and trifluridine/tipiracil (TAS-102) monotherapies have shown significant but limited survival benefits in metastatic colorectal cancer (mCRC) cases who progress after standard treatments. This study aimed to evaluate the efficacy and safety of regorafenib plus biweekly TAS-102 in refractory mCRC.

Methods: In this single-arm multicenter phase II trial (ChiCTR2300071752), eligible patients received regorafenib at 120 mg/day for 21 days in a 4-week cycle or were treated with a dose-escalation strategy (80 mg/day, followed by weekly increase of 40 mg to 120 mg/day). TAS-102 was administered biweekly (30 mg/m2 bid on days 1-5). The primary endpoint was progression-free survival (PFS). The secondary endpoints included safety, response rate (ORR), disease control rate (DCR), and overall survival (OS).

Results: Between March 1, 2022 and December 1, 2023, 28 patients were enrolled. Totally 24 patients had at least one response evaluation. Median PFS and OS were 4.9 months (95% CI, 4.2-5.6) and 15.4 months (95% CI, 11.1-19.7). The ORR was 8.3% and the DCR was 83.3%. Grade 3 or 4 treatment-related adverse events occurred in 21.4% of patients, including hypertension (7.1%), neutropenia (7.1%), thrombocytopenia (3.6%), and hoarseness (3.6%).

Conclusions: Regorafenib plus biweekly TAS-102 showed promising benefits in refractory mCRC cases, and adverse events were generally tolerable and manageable.

Discussion: (ClinicalTrials.gov Identifier: ChiCTR2300071752. IRB Approved: KYLL-202203-026-1.).

查看原文本刊更多论文

瑞非尼联合双周曲氟定/替吡拉西治疗难治性转移性结直肠癌的疗效和安全性：一项多中心单组II期试验

背景：瑞非尼和trifluridine/tipiracil （TAS-102）单药治疗在标准治疗后进展的转移性结直肠癌（mCRC）患者中显示出显著但有限的生存益处。本研究旨在评估瑞非尼联合双周TAS-102治疗难治性mCRC的疗效和安全性。方法：在这项单臂多中心II期试验（ChiCTR2300071752）中，符合条件的患者在4周周期中接受regorafenib治疗，剂量为120 mg/天，持续21天，或采用剂量递增策略（80 mg/天，随后每周增加40 mg至120 mg/天）。TAS-102每两周给药（30mg /m2 bid，第1-5天）。主要终点为无进展生存期（PFS）。次要终点包括安全性、缓解率（ORR）、疾病控制率（DCR）和总生存期（OS）。结果：在2022年3月1日至2023年12月1日期间，28名患者入组。共有24例患者至少有一次反应评估。中位PFS和OS分别为4.9个月（95% CI, 4.2-5.6）和15.4个月（95% CI, 11.1-19.7）。ORR为8.3%，DCR为83.3%。21.4%的患者发生3级或4级治疗相关不良事件，包括高血压（7.1%）、中性粒细胞减少症（7.1%）、血小板减少症（3.6%）和声音嘶哑（3.6%）。结论：瑞非尼加每两周一次的TAS-102治疗难治性mCRC有很好的疗效，不良事件通常是可容忍和可控的。ClinicalTrials.gov标识符：ChiCTR2300071752。IRB批准：KYLL-202203-026-1。

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来源期刊

Oncologist 医学-肿瘤学

CiteScore

10.40

自引率

3.40%

发文量

309

审稿时长

3-8 weeks

期刊介绍： The Oncologist® is dedicated to translating the latest research developments into the best multidimensional care for cancer patients. Thus, The Oncologist is committed to helping physicians excel in this ever-expanding environment through the publication of timely reviews, original studies, and commentaries on important developments. We believe that the practice of oncology requires both an understanding of a range of disciplines encompassing basic science related to cancer, translational research, and clinical practice, but also the socioeconomic and psychosocial factors that determine access to care and quality of life and function following cancer treatment.