Toffart Anne-Claire, Moro-Sibilot Denis, Couraud Sébastien, Merle Patrick, Perol Maurice, Girard Nicolas, Souquet Pierre-Jean, Mastroianni Bénédicte, Ferretti Gilbert R, Romand Philippe, Chatellain Patrick, Vesin Aurélien, Brambilla Elisabeth, Brambilla Christian, Timsit Jean-François
Université Grenoble 1 INSERM U 823-Institut A Bonniot-Université J Fourier, Rond-point de la Chantourne, 38706 La Tronche Cedex, France.
BMC Cancer. 2014 Dec 20;14:989. doi: 10.1186/1471-2407-14-989.
Response Evaluation Criteria in Solid Tumors (RECIST) are widely used to assess the effect of chemotherapy in patients with cancer. We hypothesised that the change in unidimensional tumour size handled as a continuous variable was more reliable than RECIST in predicting overall survival (OS).
The prospective Pharmacogenoscan study enrolled consecutive patients with non-small-cell lung cancer (NSCLC) at any stage seen between 2005 and 2010 at six hospitals in France, given chemotherapy. After exclusion of patients without RECIST or continuous-scale tumour size data and of those with early death, 464 patients were left for the survival analyses. Cox models were built to assess relationships between RECIST 1.1 categories or change in continuous-scale tumour size and OS. The best model was defined as the model minimising the Akaike Information Criterion (AIC).
OS was 14.2 months (IQR, 7.3-28.9 months). According to RECIST 1.1, 146 (31%) patients had a partial or complete response, 245 (53%) stable disease, and 73 (16%) disease progression. RECIST 1.1 predicted better OS than continuous-scale tumour in early (<6 months) predicted survival analyses (p = 0.03) but the accuracy of the two response evaluation methods was similar in late (≥6 months) predicted survival analyses (p = 0.15).
In this large observational study, change in continuous-scale tumour size did not perform better than RECIST 1.1 in predicting survival of patients given chemotherapy to treat NSCLC.
NCT00222404.
实体瘤疗效评价标准（RECIST）被广泛用于评估癌症患者化疗的效果。我们假设将一维肿瘤大小的变化作为连续变量处理在预测总生存期（OS）方面比RECIST更可靠。
前瞻性药物基因组扫描研究纳入了2005年至2010年间在法国6家医院就诊的连续非小细胞肺癌（NSCLC）患者，均接受了化疗。排除无RECIST或连续尺度肿瘤大小数据的患者以及早期死亡患者后，464例患者留作生存分析。构建Cox模型以评估RECIST 1.1分类或连续尺度肿瘤大小变化与OS之间的关系。最佳模型定义为使赤池信息准则（AIC）最小化的模型。
OS为14.2个月（四分位间距，7.3 - 28.9个月）。根据RECIST 1.1，146例（31%）患者有部分或完全缓解，245例（53%）疾病稳定，73例（16%）疾病进展。在早期（<6个月）预测生存分析中，RECIST 1.1预测的OS优于连续尺度肿瘤大小（p = 0.03），但在晚期（≥6个月）预测生存分析中，两种疗效评估方法的准确性相似（p = 0.15）。
在这项大型观察性研究中，在预测接受化疗治疗NSCLC患者的生存方面，连续尺度肿瘤大小的变化并不比RECIST 1.1表现更好。
NCT00222404。
