| Summary: | Qian Geng,1,* Hua Shen,2,* Wenyu Zhu,1 Yingzhi Lu,3 Mengjie Wang,1 Hua Jiang,1 Dongqing Li1 1Cancer Center, The Affiliated Changzhou No. 2 People’s Hospital of Nanjing Medical University, Changzhou 213000, People’s Republic of China; 2Sir Run Run Hospital, Nanjing Medical University, Nanjing 210029, People’s Republic of China; 3Oncology Department, Lianyungang No. 2 People’s Hospital, Lianyungang 222000, People’s Republic of China*These authors contributed equally to this workCorrespondence: Hua JiangCancer Center, The Affiliated Changzhou No. 2 People’s Hospital of Nanjing Medical University, Changzhou 213000, People’s Republic of ChinaEmail czeyzlk@hotmail.comDongqing LiCancer Center, The Affiliated Changzhou No. 2 People’s Hospital of Nanjing Medical University, Changzhou 213000, People’s Republic of ChinaEmail lidongq1823@163.comBackground: Lung squamous-cell carcinoma (SqCC) is the second most common histology in non-small-cell lung carcinomas (NSCLCs). The treatment options for advanced lung SqCC are still an unmet medical need. Apatinib, a small-molecule inhibitor of vascular endothelial growth factor receptor-2 (VEGFR-2), is beneficial in the therapy of advanced NSCLC patients. This study aimed to preliminarily assess the efficacy and safety of low-dosage apatinib in patients with advanced lung SqCC.Methods: In this single-arm, open-label, investigator-initiated phase II prospective study (ChiCTR1800019808), we enrolled patients aged 54– 80 years with platinum-refractory or chemotherapy rejected advanced lung squamous-cell carcinoma. Key exclusion criteria included major blood vessel involvement and gross hemoptysis with an amount of more than 20 mL. Apatinib at an initial dose of 250 mg was administered to patients once daily until disease progression, unacceptable toxicity, withdrawal, or death. The primary endpoint was progression-free survival (PFS) in all patients. We assessed the adverse events according to the treatment received.Results: Thirty-eight patients were enrolled between June 11, 2015 and August 29, 2018. Two patients failed to evaluate treatment efficacy for personal reasons, and thus 36 patients were eligible for evaluation of tumor response to apatinib. Median PFS was 4.9 months (95% CI: 3.0– 6.8 months). Six patients achieved partial response (PR); the objective response rate (ORR) was 16.7% (6/36), and the total disease control rate (DCR) was 77.8% (28/36). Followed up to March 2020, 35 of the 38 patients were dead, and the 1-year survival rate was 21.1% (8/38). The median overall survival (OS) was 6.9 months (95% CI: 5.2– 8.5 months). The most common adverse events included fatigue (50.0%), hypertension (42.1%), proteinuria (23.7%), loss of appetite (23.1%) and hand-foot reaction (21.1%). No grade 4 adverse effect or drug-related mortality occurred.Conclusions: Low-dose apatinib monotherapy might be an option for patients with advanced lung squamous-cell carcinoma.Keywords: apatinib, lung squamous-cell carcinoma, VEGF, efficacy, safety
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