Wang Yan, Liu Yu, Zhao Chao, Li Xuefei, Wu Chunyan, Hou Likun, Zhang Shijia, Jiang Tao, Chen Xiaoxia, Su Chunxia, Gao Guanghui, Li Wei, Wu Fengying, Li Aiwu, Ren Shengxiang, Zhou Caicun, Zhang Jun
Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, PR China.
Department of Radiotherapy, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, PR China.
Lung Cancer. 2016 Apr;94:28-34. doi: 10.1016/j.lungcan.2016.01.014. Epub 2016 Jan 25.
Histological tissues are preferred for anaplastic lymphoma kinase (ALK) fusion detection in non-small cell lung cancer (NSCLC). The aim of this study was to evaluate the feasibility of cytological sample as an alternative specimen for ALK fusion testing in patients with advanced NSCLC.
Advanced NSCLC patients with cytological specimens or tumor tissue who had their ALK fusion status detected by the method of reverse transcriptase polymerase chain reaction (RT-PCR) in Shanghai Pulmonary Hospital, Tongji University were included into this study. The efficacy was evaluated in those with ALK fusion positive and received the therapy of crizotinib.
1274 patients were included in this study. Among them, 108 patients were ALK RT-PCR positive and 69 of them received crizotinib treatment. Among 1002 patients with cytological specimens, the average concentration of RNA extracted from cytological specimens was 60.99 ng/μl (95% confidence interval [CI], 55.56-66.60) and the incidence rate of ALK fusion was 8.3% (83/1002), which were similar to 63.16 ng/μl (95% CI, 51.88-76.34) (p=0.727) and 9.2% (25/272, p=0.624) in 272 patients with tumor tissue. Also, there were no statistically significant differences regarding to the objective response rate (ORR) (62.0% vs. 42.1%, p=0.177) and the median progression free survival (mPFS) [8.6 months (95% CI 7.30-9.84) vs. 7.0 months (95% CI 4.54-9.47), p=0.736] in patients of cytological group and tissue group after the treatment of crizotinib.
Cytological specimens showed a high feasibility to detect ALK fusion status, which could be regarded as alternative samples for ALK fusion detection by the method of RT-PCR in patients with advanced NSCLC.
在非小细胞肺癌（NSCLC）中，组织学组织是检测间变性淋巴瘤激酶（ALK）融合的首选。本研究旨在评估细胞学样本作为晚期NSCLC患者ALK融合检测替代标本的可行性。
纳入在同济大学附属上海市肺科医院通过逆转录聚合酶链反应（RT-PCR）方法检测ALK融合状态的有细胞学标本或肿瘤组织的晚期NSCLC患者。对ALK融合阳性并接受克唑替尼治疗的患者评估疗效。
本研究共纳入1274例患者。其中，108例患者ALK RT-PCR检测呈阳性，69例接受了克唑替尼治疗。在1002例有细胞学标本的患者中，从细胞学标本中提取的RNA平均浓度为60.99 ng/μl（95%置信区间[CI]，55.56 - 66.60），ALK融合发生率为8.3%（83/1002），这与272例有肿瘤组织的患者中的63.16 ng/μl（95% CI，51.88 - 76.34）（p = 0.727）和9.2%（25/272，p = 0.624）相似。此外，克唑替尼治疗后，细胞学组和组织组患者的客观缓解率（ORR）（62.0%对42.1%，p = 0.177）和中位无进展生存期（mPFS）[8.6个月（95% CI 7.30 - 9.84）对7.0个月（95% CI 4.54 - 9.47），p = 0.736]也无统计学显著差异。
细胞学标本在检测ALK融合状态方面显示出高度可行性，可被视为晚期NSCLC患者通过RT-PCR方法进行ALK融合检测的替代样本。
