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

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

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。

OBJECTIVE To evaluate the effictiveness and safety of recombinant human endostatin combined with afatinib and teggio in the treatment of advanced lung squamous cell carcinoma.METHODS A 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.RESULTS The 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 levelⅢorⅣadverse events related to treatment were leukopenia(20%)and rash(12%),with no reported treatment-related deaths.CONCLUSION Recombinant 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.