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 Ticeo in second-line treatment of advanced lung squamous cell carcinoma

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

Key words:  Lung squamous cell carcinoma  Recombinant human endostatin  Afatinib  Teggio  Second-line treatment

摘要:

目的：本研究旨在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(PFS)、总生存期(OS)、疾病控制率(DCR)、客观缓解率(ORR)、不良反应(AE)。结果：25例患者接受了至少2个周期的入组方案二线治疗,数据截至2022年12月31日,其中4例患者病情部分缓解(PR),17例患者病情稳定(SD),4例患者病情进展(PD)。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3级或4级不良事件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对于晚期肺鳞癌患者的二线治疗有效且相对安全,值得进一步探究。

Abstract:

Objective: This study was to evaluate the efficacy and safety of recombinant human endostatin combined with afatinib and Tighio in the treatment of advanced lung squamous cell carcinoma. How: 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 Tighio as scheduled. Progression-free survival (PFS), overall survival (OS), disease control rate (DCR), objective response rate (ORR), and adverse reactions (AE) were observed and analyzed. Results: Twenty-five patients received at least two cycles of second-line therapy with the enrolling regimen, with data as of December 31, 2022, including four patients with partial response (PR), 17 patients with stable disease (SD), and four patients with progressive disease (PD). The investigator-confirmed ORR was 16%(95%CI, 4.5%-36.1%), the DCR was 84%(95%CI, 63.9%-95.5%), the median PFS was 5.3 months (95%CI, 3.5-6.9 months), and the median OS was not yet reached. Treatment-related grade 3 or 4 adverse events were most commonly leukopenia (20%) and rash (12%), and no treatment-related deaths were reported. Conclusion: Recombinant human endostatin combined with afatinib and Digio is an effective and relatively safe second-line treatment for patients with advanced lung squamous cell carcinoma, which is worthy of further exploration.