Fruquintinib in refractory metastatic colorectal cancer: a multicenter real-world study

IF 7.1 2区 医学 Q1 ONCOLOGY
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Abstract

Background

Fruquintinib has been approved by the Food and Drug Administration for refractory metastatic colorectal cancer (mCRC). In clinical practice, fruquintinib is sometimes used in combination with other drugs, but its efficacy and safety are still unknown. In this study, we present a comprehensive analysis of the real-world treatment modalities involving fruquintinib in late-line settings for mCRC across six centers in China.

Patients and methods

Patients with refractory mCRC who received fruquintinib treatment in six centers in China between 1 January 2021 and 31 June 2022 were included in this study. Patients were categorized into two cohorts: the monotherapy group (treated solely with fruquintinib) and the combined group (received fruquintinib combined with chemotherapy and/or anti-programmed cell death protein 1 antibodies). Demographic, clinical, survival, and safety data were retrospectively analyzed. The study was registered at clinicaltrials.gov as NCT06202417.

Results

A total of 520 patients were included in this study. The median follow-up time was 9.7 months. The disease control rate was 64.8%. The median progression-free survival was 5.0 months and the median overall survival was 11.4 months. Of them, 387 (74.4%) were treated with fruquintinib alone, while 133 (25.6%) were administered fruquintinib plus chemotherapy and/or anti-programmed cell death protein 1 antibodies, respectively. Adverse events were reported by 91.3% (457/520) of patients. The rate of grade 3 or 4 toxicity was 42.4% (237/520). No treatment-related death occurred.

Conclusion

Fruquintinib, either as a standalone treatment or in combination with other medications, demonstrates substantial efficacy and favorable tolerability in refractory mCRC patients.
弗鲁喹替尼治疗难治性转移性结直肠癌:一项多中心真实世界研究
背景美国食品和药物管理局已批准将伐醌替尼用于治疗难治性转移性结直肠癌(mCRC)。在临床实践中,fruquintinib有时会与其他药物联合使用,但其疗效和安全性仍然未知。在本研究中,我们全面分析了中国6个中心在mCRC晚线治疗中使用fruquintinib的实际治疗模式。患者和方法本研究纳入了2021年1月1日至2022年6月31日期间在中国6个中心接受fruquintinib治疗的难治性mCRC患者。患者分为两组:单药治疗组(仅接受福仑替尼治疗)和联合治疗组(接受福仑替尼联合化疗和/或抗程序性细胞死亡蛋白1抗体治疗)。对人口统计学、临床、生存和安全性数据进行了回顾性分析。该研究在 clinicaltrials.gov 上注册为 NCT06202417。中位随访时间为 9.7 个月。疾病控制率为 64.8%。无进展生存期中位数为 5.0 个月,总生存期中位数为 11.4 个月。其中,387人(74.4%)单独接受了fruquintinib治疗,133人(25.6%)分别接受了fruquintinib加化疗和/或抗程序性细胞死亡蛋白1抗体治疗。91.3%的患者(457/520)报告了不良事件。3级或4级毒性发生率为42.4%(237/520)。结论无论是单独治疗还是与其他药物联合治疗,弗仑替尼对难治性mCRC患者都具有显著的疗效和良好的耐受性。
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来源期刊
ESMO Open
ESMO Open Medicine-Oncology
CiteScore
11.70
自引率
2.70%
发文量
255
审稿时长
10 weeks
期刊介绍: ESMO Open is the online-only, open access journal of the European Society for Medical Oncology (ESMO). It is a peer-reviewed publication dedicated to sharing high-quality medical research and educational materials from various fields of oncology. The journal specifically focuses on showcasing innovative clinical and translational cancer research. ESMO Open aims to publish a wide range of research articles covering all aspects of oncology, including experimental studies, translational research, diagnostic advancements, and therapeutic approaches. The content of the journal includes original research articles, insightful reviews, thought-provoking editorials, and correspondence. Moreover, the journal warmly welcomes the submission of phase I trials and meta-analyses. It also showcases reviews from significant ESMO conferences and meetings, as well as publishes important position statements on behalf of ESMO. Overall, ESMO Open offers a platform for scientists, clinicians, and researchers in the field of oncology to share their valuable insights and contribute to advancing the understanding and treatment of cancer. The journal serves as a source of up-to-date information and fosters collaboration within the oncology community.
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