Assouline Sarit, Meyer Ralph M, Infante-Rivard Claire, Connors Joseph M, Belch Andrew, Crump Michael, Kouroukis C Tom, Eisenhauer Elizabeth
Jewish General Hospital, McGill University, Montreal, QC, Canada.
Leuk Lymphoma. 2007 Mar;48(3):513-20. doi: 10.1080/10428190601078126.
RECIST (response evaluation criteria in solid tumours) uses a unidimensional approach to tumour measurement and has been widely adopted for assessing the response rate of new therapies in solid tumour clinical trials. For lymphoma, the IWC (International Workshop Criteria), based on bidimensional product assessment, is generally utilised. We adapted RECIST for use in lymphoma and compared responses with the IWC in three Phase II lymphoma trials (n = 115). Measures of agreement estimated the concordance between the adapted RECIST and the IWC response assessments. A Pearson's coefficient estimated the correlation between changes in uni- and bidimensional measurements in a subset of patients (n = 75). All measures of agreement were very high [kappa = 0.86 (95% CI: 0.76 - 0.95), percent agreement 0.93 (95% CI: 0.87 - 0.97), positive agreement 0.90 (95% CI: 0.87 - 0.98), negative agreement 0.92 (95% CI: 0.89 - 0.98)]. Pearson's coefficient was 0.92 (95% CI: 0.87, 0.95). The lymphoma-adapted RECIST is simpler to apply than the IWC and yields near identical response rates. The adapted RECIST should be considered for inclusion into any new draft of the IWC.
实体瘤疗效评价标准（RECIST）采用一维方法进行肿瘤测量，已被广泛用于评估实体瘤临床试验中新疗法的缓解率。对于淋巴瘤，通常采用基于二维乘积评估的国际研讨会标准（IWC）。我们对RECIST进行了调整以用于淋巴瘤，并在三项II期淋巴瘤试验（n = 115）中比较了其与IWC的疗效评估结果。一致性测量估计了调整后的RECIST与IWC疗效评估之间的一致性。皮尔逊系数估计了一部分患者（n = 75）一维和二维测量变化之间的相关性。所有一致性测量结果都非常高[kappa = 0.86（95% CI：0.76 - 0.95），一致百分比0.93（95% CI：0.87 - 0.97），阳性一致性0.90（95% CI：0.87 - 0.98），阴性一致性0.92（95% CI：0.89 - 0.98）]。皮尔逊系数为0.92（95% CI：0.87，0.95）。调整后的用于淋巴瘤的RECIST比IWC更易于应用，且缓解率几乎相同。应考虑将调整后的RECIST纳入IWC的任何新草案中。
