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免疫检查点抑制剂联合抗血管生成药物治疗晚期非鳞状细胞非小细胞肺癌的研究进展
引用本文:陈杨, 范国栋, 焦安男, 等. 重组人血管内皮抑制素联合阿法替尼及替吉奥二线治疗晚期肺鳞癌的单臂、多中心、前瞻性临床研究[J]. 中国现代应用药学, 2024, 41(10): 1388-1393. DOI: 10.13748/j.cnki.issn1007-7693.20231829
作者姓名:陈杨  范国栋  焦安男  李泽庚  童佳兵  方彪  姚素玲  王明琦  张梅  李平
作者单位:1.安徽医科大学第一附属医院中西医结合肿瘤科,合肥 230022;2.安徽中医药大学,合肥 230022;3.泾县中医院,安徽 宣城 242500;4.明光中医院,安徽 明光 239400
摘    要:目的

评价重组人血管内皮抑制素联合阿法替尼及替吉奥二线治疗晚期肺鳞癌患者的有效性和安全性。

方法

共25例驱动基因阴性晚期肺鳞癌患者被纳入这项单臂前瞻性研究,按期二线给予入组患者重组人血管内皮抑制素联合阿法替尼及替吉奥治疗,观察分析患者无进展生存期(progression-free-survival,PFS)、总生存期(overall survival,OS)、疾病控制率(disease control rate,DCR)、客观缓解率(objective response rate,ORR)和不良反应(adverse reaction,AR)。

结果

25例入组患者接受了≥2个周期的二线治疗方案,随访时间截至2023年3月31日,其中4例患者病情部分缓解,17例患者病情稳定,4例患者病情进展。经研究者确认的ORR为16%(95%CI,4.5%~36.1%),DCR为84%(95%CI,63.9%~95.5%),中位PFS为5.3个月(95%CI,3.5~6.9个月),中位OS尚未达到。全组患者治疗耐受良好,治疗相关的Ⅲ级或Ⅳ级AR最常见的是白细胞下降(20%)和皮疹(12%),没有与治疗相关的死亡报告。

结论

重组人血管内皮抑制素联合阿法替尼及替吉奥二线治疗晚期肺鳞癌可延长患者PFS且相对安全,值得进一步探究及推广。



关 键 词:肺鳞癌  重组人血管内皮抑制素  阿法替尼  替吉奥  二线治疗
收稿时间:2023-07-01

Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries
CHEN Yang, FAN Guodong, JIAO Annan, LI Zegeng, TONG Jiabing, FANG Biao, YAO Suling, WANG Mingqi, ZHANG Mei, LI Ping. Single-arm, Multi-center, Prospective Clinical Study of Recombinant Human Endostatin Combined with Afatinib and Teggio in Second-line Treatment of Advanced Lung Squamous Cell Carcinoma[J]. Chinese Journal of Modern Applied Pharmacy, 2024, 41(10): 1388-1393. DOI: 10.13748/j.cnki.issn1007-7693.20231829
Authors:CHEN Yang  FAN Guodong  JIAO Annan  LI Zegeng  TONG Jiabing  FANG Biao  YAO Suling  WANG Mingqi  ZHANG Mei  LI Ping
Affiliation:1.Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China;2.Anhui University of Chinese Medicine, Hefei 230022, China;3.Jingxian Hospital of Traditional Chinese Medicine, Xuancheng 242500, China;4.Mingguang Hospital of Traditional Chinese Medicine, Mingguang 239400, China
Abstract:OBJECTIVETo evaluate the effictiveness and safety of recombinant human endostatin combined with afatinib and teggio in the treatment of advanced lung squamous cell carcinoma. METHODSA total of 25 patients with driver-negative advanced lung squamous cell carcinoma were included in this single-arm prospective study, and the enrolled patients were treated with recombinant human endostatin combined with afatinib and teggio as scheduled. Progression-free survival(PFS), overall survival(OS), disease control rate(DCR), objective response rate(ORR), and adverse reactions(AR) were observed and analyzed. RESULTSThe 25 enrolled patients received at least 2 cycles of second-line treatment, and were followed up as of March 31, 2023. Among them, 4 patients had partial remission, 17 patients had stable disease, and 4 patients experienced progressive disease. The ORR confirmed by the researchers was 16%(95%CI, 4.5%−36.1%), DCR was 84%(95%CI, 63.9%−95.5%), and median PFS was 5.3 months(95%CI, 3.5−6.9 months). The median OS had not yet been achieved. The entire group of patients had good treatment tolerance, and the most common level Ⅲ or Ⅳ adverse events related to treatment were leukopenia(20%) and rash(12%), with no reported treatment-related deaths. CONCLUSIONRecombinant human endostatin combined with afatinib and teggio in the second line treatment of advanced lung squamous cell carcinoma can prolong the progression free survival period of patients and is relatively safe, which is worth further exploration and promotion.
Keywords:lung squamous cell carcinoma  recombinant human endostatin  afatinib  teggio  second-line treatment
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