RECIST 1.1 in NSCLC patients with EGFR mutations treated with EGFR tyrosine kinase inhibitors: comparison with RECIST 1.0.
RECIST 1.1 in NSCLC patients with EGFR mutations treated with EGFR tyrosine kinase inhibitors: comparison with RECIST 1.0.
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DOI：
10.2214/ajr.12.9668
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发表时间：
2013-07
期刊：
影响因子：
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通讯作者：
Johnson BE
中科院分区：
文献类型：
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作者：
Nishino M;Cardarella S;Jackman DM;Ramaiya NH;Rabin MS;Hatabu H;Jänne PA;Johnson BE
实体瘤疗效评价标准（RECIST）1.1已在临床试验中迅速被接受，作为评估肿瘤治疗疗效的标准指标，预计将改善疗效评估，尤其是在基因组定义的患者中。在接受EGFR酪氨酸激酶抑制剂治疗的伴致敏表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者中，比较了RECIST 1.1与RECIST 1.0的影响。回顾性研究了70例携带致敏EGFR突变的晚期NSCLC患者，这些患者接受了一线EGFR酪氨酸激酶抑制剂治疗。使用RECIST 1.0和RECIST 1.1进行肿瘤测量和缓解评估。比较了RECIST 1.1和RECIST 1.0之间的靶病灶数量、初始随访时的百分比变化、最佳缓解和至进展时间。与使用RECIST 1.0相比，使用RECIST 1.1识别的靶病变数量显著较低（平均值分别为2.7和2.0; p < 0.0001;配对Student t检验），31例患者（44%）减少。靶病灶测量值的初始比例变化在两个标准之间具有高度相关性（R2 = 0.8070），66例患者（94%）的疗效评估一致。最佳反应显示几乎完全一致（κw = 0.970）。52例患者（74%）的两种标准的至疾病进展时间（TTP）无差异，15例患者（21%）的至疾病进展时间（TTP）较长，3例患者（4%）的至疾病进展时间（TTP）较短。在接受EGFR酪氨酸激酶抑制剂治疗的携带致敏EGFR突变的晚期NSCLC患者中，与RECIST 1.0相比，RECIST 1.1提供了高度一致的缓解评估，靶病灶数量减少。与RECIST 1.0相比，RECIST 1.1改变了25%患者的TTP。
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 has been rapidly accepted in clinical trials as a standard measure to assess tumor response to therapy and is expected to improve response assessment, especially in genomically defined patients. The impact of RECIST 1.1 was compared with RECIST 1.0 in non–small cell lung cancer (NSCLC) patients with sensitizing epidermal growth factor receptor (EGFR) mutations treated with EGFR tyrosine kinase inhibitors. Seventy patients with advanced NSCLC harboring sensitizing EGFR mutations treated with a first-line EGFR tyrosine kinase inhibitor were retrospectively studied. Tumor measurements and response assessment were performed using RECIST 1.0 and RECIST 1.1. The number of target lesions, the percentage change at the initial follow-up, best response, and time to progression were compared between RECIST 1.1 and RECIST 1.0. The number of target lesions identified using RECIST 1.1 was significantly lower compared with that using RECIST 1.0 (mean, 2.7 and 2.0, respectively; p < 0.0001; paired Student t test), with a decrease in 31 patients (44%). The initial proportional changes of the target lesion measurements had high correlation between the two criteria (R2 = 0.8070), with concordant response assessment in 66 patients (94%). The best response showed almost perfect agreement (κw = 0.970). Time to progression (TTP) did not differ between the two criteria in 52 patients (74%), was longer by RECIST 1.1 in 15 patients (21%), and was shorter by RECIST 1.1 in three patients (4%). RECIST 1.1 provided highly concordant response assessment with a decreased number of target lesions compared with RECIST 1.0 in advanced NSCLC patients harboring sensitizing EGFR mutations treated with an EGFR tyrosine kinase inhibitor. RECIST 1.1 altered TTP in 25% of patients compared with RECIST 1.0.