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第一代表皮生长因子受体酪氨酸激酶抑制剂单药用于晚期非小细胞肺癌患者超过5年的预测因素的相对重要性:台湾多中心TIPS-5研究

The relative importance of predictive factors for single first-generation EGFR-TKI use for more than 5 years in patients with advanced non-small cell lung cancer: Taiwan multicenter TIPS-5 study.

作者信息

Huang Yen-Hsiang, Hung Jen-Yu, Ko How-Wen, Su Po-Lan, Lai Chun-Liang, Chang Huang-Chih, Hsia Te-Chun, Lin Sheng-Hao, Wu Kuan-Li, Yang Cheng-Ta, Su Wu-Chou, Chu Yi-Chun, Wang Chin-Chou, Liao Wei-Yu, Lin Yen-Ting, Lin Ching-Hsiung, Lin Meng-Chih, Hsu Kuo-Hsuan, Tseng Jeng-Sen, Yang Tsung-Ying, Chen Kun-Chieh, Lee Mei-Hsuan, Yu Sung-Liang, Ho Chao-Chi, Chang Gee-Chen

机构信息

Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung.

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung.

出版信息

Ther Adv Med Oncol. 2021 May 22;13:17588359211018022. doi: 10.1177/17588359211018022. eCollection 2021.

Abstract

BACKGROUND

The relative importance of predictive factors for advanced non-small cell lung cancer (NSCLC) patients on epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) treatment remains unclear.

MATERIALS AND METHODS

We retrospectively enrolled advanced NSCLC patients with single first-generation EGFR-TKI treatment for ⩾5 years (Y) in Taiwan. Clinical data was collected and compared with those of another cohort with single first-line EGFR-TKI treatment for <5 Y. Plasma cell-free DNA (cfDNA) samples were collected from patient subsets, pre- and post-TKI, in the >5 Y group.

RESULTS

Overall, 128 and 278 patients were enrolled in the ⩾5 Y and <5 Y groups, respectively. Significant factors in the multivariate analysis of patients' characteristics including Eastern Cooperative Oncology Group performance status 0-1, postoperative recurrence, without brain metastasis, oligometastasis (each score of 2), female sex, erlotinib use, and without bone metastasis (each score of 1), were incorporated into a risk scoring system. The area under the receiver operating characteristic curve was 0.82 [95% confidence interval (CI): 0.78-0.86]. Of the plasma cfDNA samples from 33 patients in the ⩾5 Y group, only 1 had a T790M in 25 patients without progressive disease. In 27 patients with single agent use for ⩾96 months, 22 (81.5%) received local treatment (surgery or radiotherapy) for the primary lung tumor before and during TKI treatment.

CONCLUSION

For NSCLC patients with single first-generation EGFR-TKI use for ⩾5 Y, factors with different relative importance exist and the risk-scoring model is feasible with modest accuracy. The role of local treatment for primary tumors in patients with long-term TKI use requires further investigation.

摘要

背景

对于晚期非小细胞肺癌(NSCLC)患者,表皮生长因子受体(EGFR)-酪氨酸激酶抑制剂(TKI)治疗的预测因素的相对重要性仍不清楚。

材料与方法

我们回顾性纳入了台湾地区接受第一代EGFR-TKI单药治疗≥5年(Y)的晚期NSCLC患者。收集临床数据,并与另一组接受一线EGFR-TKI单药治疗<5年的患者进行比较。从≥5年组的患者亚组中,在TKI治疗前和治疗后收集血浆游离DNA(cfDNA)样本。

结果

总体而言,≥5年组和<5年组分别纳入了128例和278例患者。在对患者特征的多因素分析中,包括东部肿瘤协作组体能状态0-1、术后复发、无脑转移、寡转移(每项评分为2)、女性、使用厄洛替尼以及无骨转移(每项评分为1)等显著因素被纳入风险评分系统。受试者工作特征曲线下面积为0.82 [95%置信区间(CI):0.78-0.86]。在≥5年组的33例患者的血浆cfDNA样本中,在25例无疾病进展的患者中只有1例检测到T790M。在27例单药使用≥96个月的患者中,22例(81.5%)在TKI治疗前和治疗期间对原发性肺肿瘤接受了局部治疗(手术或放疗)。

结论

对于接受第一代EGFR-TKI单药治疗≥5年的NSCLC患者,存在相对重要性不同的因素,且风险评分模型可行,准确性适中。长期使用TKI患者中原发性肿瘤的局部治疗作用需要进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b2a0/8142001/f2d0ff4de3d4/10.1177_17588359211018022-fig1.jpg

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