Lieming Ding, Xiaobin Yuan, Yang Wang, Min Yang, Pengxiang Wu, Hui Chen, Yu Yun, Zhilin Shen, Dong Ji, Yongbin Ma
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Outcome analysis included the demographic characteristics, tumor response, progression-free survival (PFS), and treatment-related adverse events (TRAE).</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Among the 49 patients, the majority were under 65 years old (73.5%), non-smokers (85.7%), had an Eastern Cooperative Oncology Group Performance Status of 0–1 (77.6%), and were at stage IV (71.4%). All patients were included in the efficacy and safety analysis. Seven PFS events were reported in cohort A while no patients experienced PFS events in cohort B. The median PFS was not estimable for both cohorts. In cohort A, the objective response rate (ORR) was 63.9%, and the disease control rate (DCR) was 83.3%. In the cohort B, the ORR was 76.9% and the DCR was 100.0%. Rash was the only TRAE reported in the cohort A (8.3%) and cohort B (23.1%). No patients had grade 3 or higher TRAE.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Ensartinib has been tentatively proven favorable efficacy and tolerability in the treatment of patients with ALK-positive advanced LUSC or LASC in the real-world. However, confirmatory studies are still needed in larger sample sizes.</p>\n </section>\n </div>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":"20 6","pages":"700-706"},"PeriodicalIF":1.4000,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Ensartinib in the treatment of anaplastic lymphoma kinase-positive locally advanced or metastatic patients with lung squamous or adenosquamous carcinoma: A real-world, retrospective study\",\"authors\":\"Lieming Ding, Xiaobin Yuan, Yang Wang, Min Yang, Pengxiang Wu, Hui Chen, Yu Yun, Zhilin Shen, Dong Ji, Yongbin Ma\",\"doi\":\"10.1111/ajco.14091\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Aim</h3>\\n \\n <p>To report the efficacy and safety of ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, in treating patients with ALK-positive advanced lung squamous cell carcinoma (LUSC) or lung adenosquamous carcinoma (LASC) in China.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>This retrospective study analyzed data for 36 advanced-stage patients with ALK-positive LUSC (cohort A) and 13 patients with ALK-positive LASC (cohort B) between December 16, 2020 and December 16, 2021. 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引用次数: 0
摘要
目的:报告安赛替尼(一种非典型淋巴瘤激酶(ALK)抑制剂)治疗中国ALK阳性晚期肺鳞状细胞癌(LUSC)或肺腺鳞癌(LASC)患者的疗效和安全性:这项回顾性研究分析了2020年12月16日至2021年12月16日期间36例ALK阳性晚期肺鳞癌患者(队列A)和13例ALK阳性晚期肺腺癌患者(队列B)的数据。所有患者均接受每日一次的恩沙替尼 225 毫克治疗。结果分析包括人口统计学特征、肿瘤反应、无进展生存期(PFS)和治疗相关不良事件(TRAE):在49名患者中,大多数患者年龄在65岁以下(73.5%)、不吸烟(85.7%)、东部合作肿瘤学组表现状态为0-1(77.6%)、处于IV期(71.4%)。所有患者均纳入疗效和安全性分析。队列 A 中报告了 7 例 PFS 事件,队列 B 中没有患者出现 PFS 事件。A 组患者的客观反应率(ORR)为 63.9%,疾病控制率(DCR)为 83.3%。在队列 B 中,客观反应率为 76.9%,疾病控制率为 100.0%。皮疹是 A 组(8.3%)和 B 组(23.1%)中唯一报告的 TRAE。没有患者出现3级或以上TRAE:在现实世界中,恩沙替尼治疗ALK阳性晚期LUSC或LASC患者的疗效和耐受性已得到初步证实。然而,仍需进行更大样本量的确证研究。
Ensartinib in the treatment of anaplastic lymphoma kinase-positive locally advanced or metastatic patients with lung squamous or adenosquamous carcinoma: A real-world, retrospective study
Aim
To report the efficacy and safety of ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, in treating patients with ALK-positive advanced lung squamous cell carcinoma (LUSC) or lung adenosquamous carcinoma (LASC) in China.
Methods
This retrospective study analyzed data for 36 advanced-stage patients with ALK-positive LUSC (cohort A) and 13 patients with ALK-positive LASC (cohort B) between December 16, 2020 and December 16, 2021. All patients received once-daily ensartinib 225 mg. Outcome analysis included the demographic characteristics, tumor response, progression-free survival (PFS), and treatment-related adverse events (TRAE).
Results
Among the 49 patients, the majority were under 65 years old (73.5%), non-smokers (85.7%), had an Eastern Cooperative Oncology Group Performance Status of 0–1 (77.6%), and were at stage IV (71.4%). All patients were included in the efficacy and safety analysis. Seven PFS events were reported in cohort A while no patients experienced PFS events in cohort B. The median PFS was not estimable for both cohorts. In cohort A, the objective response rate (ORR) was 63.9%, and the disease control rate (DCR) was 83.3%. In the cohort B, the ORR was 76.9% and the DCR was 100.0%. Rash was the only TRAE reported in the cohort A (8.3%) and cohort B (23.1%). No patients had grade 3 or higher TRAE.
Conclusion
Ensartinib has been tentatively proven favorable efficacy and tolerability in the treatment of patients with ALK-positive advanced LUSC or LASC in the real-world. However, confirmatory studies are still needed in larger sample sizes.
期刊介绍:
Asia–Pacific Journal of Clinical Oncology is a multidisciplinary journal of oncology that aims to be a forum for facilitating collaboration and exchanging information on what is happening in different countries of the Asia–Pacific region in relation to cancer treatment and care. The Journal is ideally positioned to receive publications that deal with diversity in cancer behavior, management and outcome related to ethnic, cultural, economic and other differences between populations. In addition to original articles, the Journal publishes reviews, editorials, letters to the Editor and short communications. Case reports are generally not considered for publication, only exceptional papers in which Editors find extraordinary oncological value may be considered for review. The Journal encourages clinical studies, particularly prospectively designed clinical trials.