■已知目标病变选择是RECIST1.1中读者间不一致的主要因素。这项研究的目的是评估目标病变的体积测量是否导致不同的反应分类,与标准的一维测量相反,并评估当不同的读者选择不同的目标病变集时,读者之间的反应分类协议的影响。
■50名患有实体瘤可测量疾病的患者,其中3位读者盲目且独立地选择了不同的靶病变组,随后达到了临床上显着的不一致反应分类(进行性疾病[PD]与本研究包括基于RECIST1.1分析的非进行性疾病[非PD])。所有目标病变的额外体积测量由相同的读取器在第二次读取中进行。使用Cohen的k统计数据评估标准一维测量(uRECIST)和体积测量(vRECIST)之间的读取器内一致性。Fleissk统计数据用于分析uRECIST和vRECIST结果的读者间协议。
■3位读者在33/50(66%)中根据uRECIST和vRECIST分配了相同的响应分类,42/50患者(84%),和44/50的患者(88%),分别。读取器间协议从使用uRECIST时的0%提高到使用vRECIST时的36%。
■与标准一维测量相比,目标病变的体积测量可以改善响应评估的读者间变异性。然而,在大约三分之二的患者中,无论测量方法如何,读者都不同意,这表明一组有限的靶病变可能不足以代表全身肿瘤负荷。
UNASSIGNED: Target lesion selection is known to be a major factor for inter-reader discordance in RECIST 1.1. The purpose of this study was to assess whether volumetric measurements of target lesions result in different response categorization, as opposed to standard unidimensional measurements, and to evaluate the impact on inter-reader agreement for response categorization when different readers select different sets of target lesions.
UNASSIGNED: Fifty patients with measurable disease from solid tumours, in which 3 readers had blindly and independently selected different sets of target lesions and subsequently reached clinically significant discordant response categorizations (progressive disease [PD] vs. non-progressive disease [non-PD]) based on RECIST 1.1 analyses were included in this study. Additional volumetric measurements of all target lesions were performed by the same readers in a second read. Intra-reader agreement between standard unidimensional measurements (uRECIST) and volumetric measurements (vRECIST) was assessed using Cohen\'s k statistics. Fleiss k statistics was used to analyse the inter-reader agreement for uRECIST and vRECIST results.
UNASSIGNED: The 3 readers assigned the same response classifications based on uRECIST and vRECIST in 33/50 (66%), 42/50 patients (84%), and 44/50 patients (88%), respectively. Inter-reader agreement improved from 0% when using uRECIST to 36% when using vRECIST.
UNASSIGNED: Volumetric measurement of target lesions may improve inter-reader variability for response assessment as opposed to standard unidimensional measurements. However, in about two-thirds of patients, readers disagreed regardless of the measurement method, indicating that a limited set of target lesions may not be sufficiently representative of the whole-body tumour burden.