A multicenter prospective observational study for health assessment questionnaires EQ-5D-5L and G8 in unresectable advanced pancreatic cancer treated with first-line gemcitabine plus nab-paclitaxel therapy.
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引用次数: 0
Abstract
Background: In chemotherapy for unresectable advanced pancreatic cancer (UPC), the clinical utility of pre-treatment health assessment questionnaires, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) and G8, is unknown. This study aimed to fill this gap.
Methods: This multicenter, prospective, observational study investigated the association of EQ-5D-5L and G8 with the clinical outcomes of first-line gemcitabine plus nab-paclitaxel (GnP) for UPC. Differences in survival were analyzed using the log-rank test, and multivariate analyses were performed using the Cox proportional hazards model.
Results: Between April 2022 and September 2023, 60 patients were enrolled, and their data were analyzed. When patients were classified into two groups using the median EQ-5D-5L utility value (0.824), progression-free survival (PFS) and overall survival (OS) were significantly longer in patients with high EQ-5D-5L utility values than in those with low utility values (median PFS 7.0 vs. 4.7 months, P < 0.01; median OS 12 vs. 8.0 months, P = 0.023). Such differences were not observed in the EQ-5D-5L Visual Analog Scale or G8 scores. There was no association between the occurrence of severe adverse events and EQ-5D-5L or G8 scores. Multivariate analyses showed that high EQ-5D-5L utility value (≥ 0.824), high albumin (≥ 3.8 g/dl), and low carcinoembryonic antigen (CEA) (< 5.4 ng/mL) were preferable independent efficacy predictors for PFS and also independent prognostic factors for OS.
Conclusion: Pre-treatment EQ-5D-5L utility value, along with albumin and CEA, was an independent efficacy predictor and prognostic factor in patients with UPC treated with first-line GnP. Their usefulness should be validated in future studies.
背景:在不可切除的晚期胰腺癌(UPC)化疗中,治疗前健康评估问卷(EQ-5D-5L和G8)的临床实用性尚不清楚。本研究旨在填补这一空白:这项多中心、前瞻性、观察性研究调查了EQ-5D-5L和G8与吉西他滨联合纳布-紫杉醇(GnP)一线治疗UPC的临床结果之间的关系。生存率差异采用对数秩检验进行分析,多变量分析采用考克斯比例危险模型:结果:2022年4月至2023年9月期间,共有60名患者入组,并对其数据进行了分析。根据EQ-5D-5L效用值中位数(0.824)将患者分为两组,EQ-5D-5L效用值高的患者无进展生存期(PFS)和总生存期(OS)明显长于效用值低的患者(中位PFS为7.0个月 vs. 4.7个月,P 结论:EQ-5D-5L效用值高的患者无进展生存期(PFS)和总生存期(OS)明显长于效用值低的患者(中位PFS为7.0个月 vs. 4.7个月):治疗前的EQ-5D-5L效用值与白蛋白和CEA一样,是UPC一线GnP治疗患者的独立疗效预测指标和预后因素。未来的研究应验证它们的实用性。
期刊介绍:
The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.