Efficacy and Safety of Anlotinib in Overall and Disease-Specific Advanced Gynecological Cancer: A Real-World Study

Abstract

Xinyi Hong,1,* Shanhu Qiu,2,* Xia Wu,3 Sizhen Chen,4 Xiaoxiang Chen,5 Bei Zhang,6 Aiqin He,3 Yun Xu,7 Jianqing Wang,8 Yingchun Gao,9 Xizhong Xu,10 Li Sun,11 Yang Zhang,12 Libing Xiang,13 Jundong Zhou,14 Qun Guan,15 Yanling Zhu,16 Haiyan Liu,17 Hao Xu,18 Ying Zhou,19 Bingwei Chen,4 Yang Shen1 1Department of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, 210009, People’s Republic of China; 2Department of General Practice, Zhongda Hospital, Institute of Diabetes, School of Medicine, Southeast University, Nanjing, People’s Republic of China; 3Department of Gynecological Oncology, Tumor Hospital Affiliated to Nantong University, Nantong, Jiangsu, People’s Republic of China; 4Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, People’s Republic of China; 5Department of Gynecological Oncology, Jiangsu Cancer Hospital, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, People’s Republic of China; 6Department of Obstetrics and Gynecology, Xuzhou Central Hospital, Xuzhou, People’s Republic of China; 7Department of Obstetrics and Gynecology, The First People’s Hospital of Changzhou, Changzhou, People’s Republic of China; 8Department of Obstetrics and Gynecology, The Yancheng Clinical College of Xuzhou Medical University, The First People’s Hospital of Yancheng, Yancheng, People’s Republic of China; 9Department of Obstetrics and Gynecology, Huai’an First People’s Hospital, The Affiliated Huaian No.1 People’s Hospital of Nanjing Medical University, Huai’an, People’s Republic of China; 10Department of Obstetrics and Gynecology, The Affiliated Hospital of Jiangnan University, Wuxi, People’s Republic of China; 11Department of Gynecological Oncology, Qingdao Central Hospital, The Second Affiliated Hospital of Medical College of Qingdao University, Qingdao, People’s Republic of China; 12Gynecology Department, The First People’s Hospital of Lianyungang, Lianyungang, People’s Republic of China; 13Ovarian Cancer Program, Department of Gynecologic Oncology, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China; 14Radio-oncology Department, Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou, People’s Republic of China; 15Gynecology Department, Jiangsu Province Hospital of Chinese Medicine, Nanjing, People’s Republic of China; 16Gynecology Department, Xuzhou Cancer Hospital, Xuzhou, People’s Republic of China; 17Department of Obstetrics and Gynecology, Affiliated Hospital of Yangzhou University, Yangzhou, People’s Republic of China; 18Gynecology Department, Huangshi Love & Health Hospital Affiliated to Hubei Polytechnic University, Huangshi, People’s Republic of China; 19The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, People’s Republic of China*These authors contributed equally to this workCorrespondence: Yang Shen, Department of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, 210009, People’s Republic of China, Tel [phone], Fax +86 [phone], Email [email protected] Bingwei Chen, Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, 210009, People’s Republic of China, Email [email protected]: Anlotinib is a novel oral small-molecule multi-target tyrosine kinase inhibitor that has been approved for treating non-small cell lung cancer. However, its efficacy and safety among patients with advanced gynecological cancer have not been comprehensively evaluated. We conducted this study to address this issue in the real-world setting.Patients and Methods: Data from patients treated with Anlotinib for persistent, recurrent or metastatic gynecological cancer were collected from 17 centers from August 2018. The database lock-time was on March 2022. Anlotinib was administered orally on days 1– 14 every 3 weeks until disease progression, severe toxicity occurred, or death. In this study, disease-specific advanced gynecological cancer was mainly referred to cervical, endometrial, and ovarian cancer. The outcomes included objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS).Results: A total of 249 patients were analyzed, with a median follow-up of 14.5 months. The overall ORR and DCR were 28.1% [95% confidence interval (CI) 22.6% to 34.1%] and 80.7% (95% CI 75.3% to 85.4%), respectively. Specifically, the ORR varied from 19.7% to 34.4% and the DCR differed from 81.7% to 90.0% in disease-specific advanced gynecological cancer. The median PFS was 6.1 months and ranged from 5.6 to 10.0 months in the overall and disease-specific advanced gynecological cancer, respectively. Larger cumulative dosage of Anlotinib (> 700 mg) was in general associated with longer PFS in the overall and disease-specific advanced gynecological cancer. The most common adverse event related to Anlotinib treatment was pain/arthralgia (18.3%).Conclusion: In conclusion, Anlotinib holds promise in treating patients with advanced gynecological cancer including its disease-specific types, with reasonable efficacy and tolerable safety.Keywords: molecular-targeting therapy, angiogenesis inhibitors, real-world study

Keywords

• molecular-targeting therapy
• angiogenesis inhibitors
• real-world study