Efficacy and safety of anlotinib in overall and disease-specific advanced gynecological cancer: A real-world study.

Abstract

5608 Background: 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. We conducted this study to address this issue in the real-world setting. Methods: Data from patients treated with anlotinib for persistent, recurrent or metastatic gynecological cancer including cervical, endometrial, and ovarian 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. 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 14.46 months. The overall ORR and DCR were 28.1% (95% 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 use was pain/arthralgia (18.3%). Conclusions: In conclusion, anlotinib holds promise in treating patients with advanced gynecological cancer, such as cervical, endometrial, and ovarian cancer, with reasonable efficacy and tolerable safety.