Chen Hua-Jun, Tu Hai-Yan, Hu Yanping, Fan Yun, Wu Guowu, Cang Shundong, Yang Yi, Yang Nong, Ma Rui, Jin Gaowa, Xu Ximing, Liu Anwen, Tang Shubin, Cheng Ying, Yu Yan, Xu Chong-Rui, Zhou Qing, Wu Yi-Long
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Guangdong Lung Cancer Institute, Southern Medical University, Guangzhou, China.
Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, China.
J Hematol Oncol. 2025 Jan 5;18(1):3. doi: 10.1186/s13045-024-01656-0.
The study is to evaluate the efficacy and safety of combined anlotinib and EGFR-tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC) who had gradual, oligo, or potential progression after previous EGFR-TKIs treatment.
We conducted an open-label, single-arm, multicenter, phase II trial in China. Eligible patients were 18-75 years old with histologically or cytologically confirmed NSCLC who were EGFR mutation positive and showed gradual, oligo, or potential progression after EGFR-TKIs. Anlotinib (12 mg/day) was administered orally for 2 weeks and then off 1 week in a 3-week cycle. EGFR-TKIs were continue used. The primary endpoint was progression-free survival (PFS). The secondary endpoints included 6- and 12-month PFS rate, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.
From July 2019 to December 2022, 120 patients were enrolled. The median PFS (mPFS) was 9.1 months (95% CI 6.8-11.7). The PFS rates at 6 and 12 months was 68.5% and 38.8% respectively. For 86 patients with first-line 1st /2nd generation EGFR-TKIs, the mPFS was 9.2 months (95% CI 6.7-12.6). For 32 patients with first-line 3rd generation EGFR-TKIs, the mPFS was 10.3 months (95% CI 6.1-13.3). Overall ORR and DCR were 6.7% (95% CI 2.9-12.7) and 87.5% (95% CI 80.2-92.8), respectively. 52.5% of patients had grade 3 or higher treatment-emergent adverse events (TEAEs).
Anlotinib in combination with continuation of EGFR-TKIs prolonged the clinical benefit of EGFR-TKIs, demonstrating favorable survival outcomes and manageable toxicity in NSCLC treated with EGFR-TKIs and had specific progression modes, such as gradual progression.
NCT04007835.
本研究旨在评估安罗替尼联合表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）用于既往接受EGFR-TKIs治疗后出现缓慢、寡转移或潜在进展的晚期非小细胞肺癌（NSCLC）患者的疗效和安全性。
我们在中国开展了一项开放标签、单臂、多中心II期试验。符合条件的患者年龄在18至75岁之间，组织学或细胞学确诊为NSCLC，EGFR突变阳性，且在接受EGFR-TKIs治疗后出现缓慢、寡转移或潜在进展。安罗替尼（12毫克/天）口服给药2周，然后停药1周，每3周为一个周期。继续使用EGFR-TKIs。主要终点为无进展生存期（PFS）。次要终点包括6个月和12个月的PFS率、客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和安全性。
2019年7月至2022年12月，共纳入120例患者。中位PFS（mPFS）为9.1个月（95%CI 6.8-11.7）。6个月和12个月时的PFS率分别为68.5%和38.8%。对于86例一线使用第1/2代EGFR-TKIs的患者，mPFS为9.2个月（95%CI 6.7-12.6）。对于32例一线使用第3代EGFR-TKIs的患者，mPFS为10.3个月（95%CI 6.1-13.3）。总体ORR和DCR分别为6.7%（95%CI 2.9-12.7）和87.5%（95%CI 80.2-92.8）。52.5%的患者发生3级或更高等级的治疗中出现的不良事件（TEAE）。
安罗替尼联合继续使用EGFR-TKIs可延长EGFR-TKIs的临床获益，在接受EGFR-TKIs治疗的NSCLC患者中显示出良好的生存结果和可管理的毒性，且具有特定的进展模式，如缓慢进展。
NCT04007835。
