Continuous Anlotinib Combined with Oral Vinorelbine has Shown Anti-Tumor Efficiency in Refractory HER2 Negative Advanced Breast Cancer

Jia-Yi Huang,1,* Yan Zhang,2,* Cai-Wen Du1 1Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, Guangdong, 518116, People’s Republic of China; 2Department of Emergency, Shenzhen Longhua District People’s Hospital, Shenzhen, Guangdong, 518109, People’s Republic of China*These authors contributed equally to this workCorrespondence: Cai-Wen Du, Email [email protected]: To explore the efficacy and safety of continuous administration of anlotinib combined with oral vinorelbine in refractory human epidermal growth factor-2 (HER2) negative advanced breast cancer (ABC).Patients and Methods: This retrospective study included 41 HER2 negative ABC patients who received anlotinib (8mg orally per day without interruption) plus oral vinorelbine during November 2019 and February 2023. These patients have received at least two treatments in the past. The efficacy and adverse events (AEs) of these patients need to be evaluated.Results: The median follow-up time for this study was 35.6 months. Among 41 patients with HER2 negative ABC, 16 were HR positive/HER2 negative and 25 were triple negative breast cancer (TNBC). The median progression free survival (PFS) and overall survival (OS) were 6.7 months (95% CI, 4.9– 8.5 months) and 28.3 months (95% CI, 10.6– 46.0 months). There were no statistical differences in PFS (p=0.200) and OS (p=0.494) between the HR positive/HER2 negative and TNBC subgroups. The objective response rate (ORR), clinical benefit rate (CBR) and disease control rate (DCR) were 22.0%, 61.0% and 82.9%, respectively. Forty patients (97.6%) experienced varying grades of AEs and 31.7% of patients for grades 3– 4. The most common grade 3– 4 AEs that we observed were neutropenia (17.1%), leukopenia (9.8%) and diarrhea (9.8%).Conclusion: Continuous administration of anlotinib combined with oral vinorelbine demonstrates to be efficacious and well tolerated for refractory HER2 negative ABC.Keywords: anlotinib, anti-angiogenesis therapy, oral vinorelbine, advanced breast cancer