Clinical and quality of life outcomes with trifluridine/tipiracil: PRECONNECT and TALLISUR studies

IF 2.7 Q3 ONCOLOGY Colorectal Cancer Pub Date : 2023-08-17 DOI:10.2217/crc-2022-0013

L. Wyrwicz, J. Taieb, T. Price, J. Bachet, M. Karthaus, L. Vidot, Bénédicte Chevallier, T. Reisländer, L. Weiss, V. Heinemann

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Abstract

Background: QLQ-C30 Global Health Status (GHS) and Eastern Cooperative Oncology Group performance status (ECOG PS) data from PRECONNECT and TALLISUR studies were pooled. Materials & methods: Association between changes in ECOG PS and QLQ-C30 GHS in patients with metastatic colorectal cancer (mCRC) receiving trifluridine/tipiracil (FTD/TPI) was evaluated using Cox regression analysis. Results: 1100 patients were included. There was no clinically relevant change from baseline in QLQ-C30 GHS score through cycle 7. 63.0% of patients maintained/improved ECOG PS. The presence of liver metastasis increased the risk of QLQ-C30 GHS score/ECOG PS deterioration. The association between time to ECOG PS deterioration and change in QLQ-C30 GHS score over time was significant (HR 1.71 [95% CI: 1.4, 2.2]). Conclusion: ECOG PS and QLQ-C30 GHS scores were maintained during FTD/TPI treatment, and these measures were associated. Factors that increased the risk of deterioration included the presence of liver/lung metastasis, younger age and shorter time since first metastasis. Clinical Trial Registration: PRECONNECT (EudraCT Number: 2016-002311-18 ) and TALLISUR (EudraCT-Number: 2017-000292-83 ).

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三氟吡啶/替吡拉西的临床和生活质量结果：PRECONNECT和TALLISUR研究

背景:我们汇总了来自PRECONNECT和TALLISUR研究的QLQ-C30全球健康状况(GHS)和东部合作肿瘤组绩效状况(ECOG PS)数据。材料与方法:采用Cox回归分析评估接受三氟吡啶/替吡拉西(FTD/TPI)治疗的转移性结直肠癌(mCRC)患者ECOG PS和QLQ-C30 GHS变化的相关性。结果:纳入1100例患者。从基线到第7周期，QLQ-C30 GHS评分没有临床相关的变化。63.0%的患者维持/改善了ECOG PS，肝转移的存在增加了QLQ-C30 GHS评分/ECOG PS恶化的风险。ECOG PS恶化的时间与QLQ-C30 GHS评分随时间的变化之间存在显著相关性(HR 1.71 [95% CI: 1.4, 2.2])。结论:在FTD/TPI治疗期间，ECOG PS和QLQ-C30 GHS评分保持不变，且这些指标具有相关性。增加恶化风险的因素包括存在肝/肺转移、年龄较小和首次转移后时间较短。临床试验注册:PRECONNECT (EudraCT号:2016-002311-18)和TALLISUR (EudraCT号:2017-000292-83)。

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来源期刊

Colorectal Cancer ONCOLOGY-

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期刊介绍： Colorectal cancer is a major cause of morbidity and mortality, particularly in the developed world. Risk factors for colorectal cancer are on the rise in many countries; populations are aging, and obesity and diabetes are increasing. National screening programs are helping to detect cancer while it is still curable; however, colorectal cancer remains the third leading cause of cancer deaths in the USA and options are still limited for those with more advanced disease. Consequently, colorectal cancer is a major research priority for government, pharmaceutical companies and non-profit organizations. Research into diagnosis and optimum treatment of the disease is progressing rapidly, with new advances reported every day. Colorectal Cancer presents reviews, analysis and commentary. on all aspects of colorectal cancer.