Anlotinib or Bevacizumab Combined with Taxane/Capecitabine for the Second-Line or Subsequent Treatment of HER-2 Negative Metastatic Breast Cancer: A Retrospective Cohort Study

Jinyu Xiang,1,* Ping Sun,1,* Zeyu Liu,1,* Qingyu Zhang,1 Lei Song,2 Jiannan Liu1 1Departments of Oncology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, People’s Republic of China; 2Departments of Geriatric Medicine, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, People’s Republic of China*These authors contributed equally to this workCorrespondence: Jiannan Liu, Email [email protected] Lei Song, Email [email protected]: Anlotinib and bevacizumab have demonstrated efficacy in treating HER-2 (human epidermal growth factor receptor 2)-negative metastatic breast cancer (MBC), yet no comparative studies have been conducted to access their effectiveness in MBC patients. Accordingly, this study aimed to evaluate the safety and effectiveness of anlotinib versus bevacizumab when combined with taxane/capecitabine for second-line or subsequent treatment of HER-2-negative MBC.Methods: Patients with pathologically confirmed HER-2-negative MBC that underwent second-line or subsequent treatment of anlotinib or bevacizumab plus taxane/capecitabine between April 2020 and October 2021 were retrospectively reviewed. Outcomes including the objective response rates (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) were analyzed.Results: A total of 130 patients were included for this study, with 67 in the anlotinib + chemotherapy group and 63 in the bevacizumab + chemotherapy group. The ORRs were 40.30% for the anlotinib + chemotherapy group and 30.16% for the bevacizumab + chemotherapy group (P = 0.27), while the DCRs were 86.57% and 69.84%, respectively (P = 0.03). Patients in the anlotinib + chemotherapy group showed significantly longer median PFS and OS compared to the bevacizumab + chemotherapy group (mPFS: 8.57 vs 5.90 months, HR 0.55 [95% CI 0.36– 0.85], P = 0.04; mOS: 22.76 vs 16.50 months, HR 0.63[95% CI 0.43– 0.93], P = 0.02). The most common treatment-related adverse events (TRAE) were grade 1/2 alopecia, peripheral neuropathy, hypertension, and granulocytopenia, with both groups exhibiting tolerable TRAE profiles.Conclusion: In this retrospective analysis, anlotinib combined with taxane/capecitabine demonstrated a manageable safety profile. This regimen was associated with improved DCR, PFS, and OS compared to bevacizumab plus chemotherapy in patients with HER2-negative MBC. These findings suggest that anlotinib may represent a promising therapeutic option for patients for whom ADC drugs are inaccessible or unsuitable; however, further prospective, randomized studies are warranted to confirm.Keywords: anlotinib, breast cancer, angiogenesis, taxane, capecitabine