Trifluridine/Tipiracil联合Bevacizumab治疗对难治性转移性结直肠癌患者健康相关生活质量和表现状态的影响：一项III期sunshine试验分析

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical colorectal cancer Pub Date : 2024-12-11 DOI:10.1016/j.clcc.2024.12.002

Julien Taieb , Marwan Fakih , Josep Tabernero , Fortunato Ciardiello , Eric Van Cutsem , Gemma Soler , Elizabeth Calleja , Valentine Barboux , Lucas Roby , Nadia Amellal , Gerald W. Prager

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引用次数: 0

摘要

背景：与FTD/TPI相比，trifluridine/tipiracil (FTD/TPI) +贝伐单抗治疗难治性转移性结直肠癌（mCRC）的疗效在SUNLIGHT试验中得到证实。这项分析调查了FTD/TPI +贝伐单抗治疗对患者生活质量（QoL）和东部肿瘤合作组（ECOG PS）的影响。方法：在基线和每个治疗周期第1天进行问卷调查（EORTC QLQ-C30和EQ-5D-5L）和ECOG PS评估。评估两组间生活质量最终恶化时间（TTDD）和ECOG PS恶化时间。使用重复测量混合效应模型比较生活质量和ECOG PS从基线的变化。采用Kaplan-Meier和Cox回归方法评估ECOG PS维持在0-1的患者的生活质量TTDD、ECOG PS恶化至≥2的时间、总生存期（OS）和无进展生存期（PFS）。结果：从基线到第6周期，两个治疗组的生活质量评分相似，随着时间的推移没有临床相关的变化。接受FTD/TPI +贝伐单抗治疗的患者比接受FTD/TPI的患者生活质量的TTDD更长，ECOG PS恶化的时间更长。在维持ECOG PS的患者中，与FTD/TPI组相比，FTD/TPI +贝伐单抗组的中位OS和PFS延长。结论：本SUNLIGHT分析显示，与FTD/TPI治疗的患者相比，FTD/TPI +贝伐单抗治疗的患者生活质量无临床相关变化，TTDD和ECOG PS恶化时间延长。

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Impact of Treatment With Trifluridine/Tipiracil in Combination With Bevacizumab on Health-Related Quality of Life and Performance Status in Refractory Metastatic Colorectal Cancer: An Analysis of the Phase III SUNLIGHT Trial

Background

The efficacy of trifluridine/tipiracil (FTD/TPI) + bevacizumab compared to FTD/TPI for treatment of refractory metastatic colorectal cancer (mCRC) was demonstrated in the SUNLIGHT trial. This analysis of SUNLIGHT investigated the impact of treatment with FTD/TPI + bevacizumab on patient quality of life (QoL) and Eastern Cooperative Oncology Group performance status (ECOG PS).

Methods

Questionnaires (EORTC QLQ-C30 and EQ-5D-5L) and ECOG PS assessments were conducted at baseline and on Day 1 of each treatment cycle. Time to definitive deterioration (TTDD) of QoL and time to ECOG PS worsening between treatment arms was assessed. A repeated-measures mixed-effects model was used to compare changes in QoL and ECOG PS from baseline. Kaplan–Meier and Cox regression methods were used to assess TTDD of QoL, time to ECOG PS worsening to ≥ 2, and overall survival (OS) and progression-free survival (PFS) in patients maintaining an ECOG PS of 0-1.

Results

Both treatment arms showed similar QoL scores from baseline to cycle 6, with no clinically relevant change over time. Patients receiving FTD/TPI + bevacizumab had a longer TTDD of QoL than patients receiving FTD/TPI, as well as longer time to ECOG PS worsening. In patients with maintained ECOG PS, median OS and PFS was prolonged in the FTD/TPI + bevacizumab arm compared to the FTD/TPI arm.

Conclusion

This analysis of SUNLIGHT showed that patients treated with FTD/TPI + bevacizumab had no clinically relevant changes in QoL, and prolonged TTDD and time to ECOG PS worsening, compared to patients treated with FTD/TPI.

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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.