Xu Chong'an, Liu Jiali, Xing Lili, Liu Shu
Department of Oncology Medicine, the Fourth Affiliated Hospital of China Medical University, Shenyang 110032, China.
Zhongguo Fei Ai Za Zhi. 2010 Oct;13(10):954-61. doi: 10.3779/j.issn.1009-3419.2010.10.05.
RECIST (Response Evaluation Criteria in Solid Tumors) criteria could not be used to detect viable tumor tissue and is not an accurate tool for evaluation of objective response (OR) in non-small cell lung cancer (NSCLC) patients without measurable lesions. The aim of this study is to detect the pre- and post-chemotherapy serum cytokeratin 19 fragment (CYFRA21-1) expression levels in advanced NSCLC patients to evaluate the clinical value of CYFRA21-1 in the prediction of chemotherapy response and prognosis in NSCLC patients.
A automatic electrochemiluminescence immunoassay analyzer was applied to detect the pre- and post-chemotherapy serum CYFRA21-1 expression levels in 112 cases of initial treatment patients with NSCLC. Application of receiver operating characteristics curve (ROC) curve in evaluation the significance of serum CYFRA21-1 response in the diagnosis of OR and its correlation with prognosis.
After 2 cycles of platinum-based combined chemotherapy, post-chemotherapy serum CYFRA21-1 significantly decreased compared with baseline levels. 80 patients were evaluable for radiological and serological efficacy, and 26.3% (21/80) patients achieved radiological OR. The decrease ratio of post-chemotherapy serum CYFRA21-1 with CYFRA21-1 response was 40.0% (32/80). There was significant correlation between serum CYFRA21-1 response and OR (P < 0.001). The median survival time of all patients was 9.9 months; the survival of patients with CYFRA21-1 response were significantly longer than those without CYFRA21-1 responders (12.3 months vs 8.9 months, P < 0.001). Univariate survival analysis showed that PS score, OR, baseline serum CYFRA21-1 level and CYFRA21-1 response were important prognostic factors. Cox multivariate survival analysis confirmed that only the PS score, serum CYFRA21-1 baseline levels and CYFRA21-1 response were independent prognostic factors of NSCLC patients; OR was not an independent prognostic factor.
Serum CYFRA21-1 level can be sensitive to reflect changes in tumor volume, which may be a reliable substitution index for evaluation the chemotherapy efficacy in advanced NSCLC patients and a good indicator for prediction the prognosis of survival.
实体瘤疗效评价标准（RECIST）无法用于检测存活的肿瘤组织，对于无可测量病灶的非小细胞肺癌（NSCLC）患者而言，并非评估客观缓解（OR）的准确工具。本研究旨在检测晚期NSCLC患者化疗前后血清细胞角蛋白19片段（CYFRA21-1）的表达水平，以评估CYFRA21-1在预测NSCLC患者化疗反应及预后方面的临床价值。
应用全自动电化学发光免疫分析仪检测112例初治NSCLC患者化疗前后血清CYFRA21-1的表达水平。应用受试者工作特征曲线（ROC）评估血清CYFRA21-1反应在OR诊断中的意义及其与预后的相关性。
经过2周期铂类联合化疗后，化疗后血清CYFRA21-1较基线水平显著降低。80例患者可进行影像学和血清学疗效评估，其中26.3%（21/80）的患者达到影像学OR。化疗后血清CYFRA21-1下降且有CYFRA21-1反应的比例为40.0%（32/80）。血清CYFRA21-1反应与OR之间存在显著相关性（P < 0.001）。所有患者的中位生存时间为9.9个月；有CYFRA21-1反应的患者生存时间显著长于无CYFRA21-1反应的患者（12.3个月对8.9个月，P < 0.001）。单因素生存分析显示，PS评分、OR、基线血清CYFRA21-1水平及CYFRA21-1反应是重要的预后因素。Cox多因素生存分析证实，只有PS评分、血清CYFRA21-1基线水平及CYFRA21-1反应是NSCLC患者的独立预后因素；OR不是独立预后因素。
血清CYFRA21-1水平可敏感反映肿瘤体积变化，可能是评估晚期NSCLC患者化疗疗效的可靠替代指标及预测生存预后的良好指标。
