The efficacy and safety of metronomic vinorelbine combined with anlotinib in HER2-negative advanced breast cancer: a prospective, single-arm clinical study.
Xinli Wang, Ting Yang, Junmei Zhang, Jin Yang, Ruizhi Gong, Shusong Liu, Yan Xue
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Abstract
Background: In the era of chronic cancer management, second-line treatment for HER2-negative (HER2-) advanced breast cancer demands convenient and safe therapeutic options. Vinorelbine tartrate soft capsules are an oral chemotherapeutic agent, and anlotinib is an oral multi-target anti-angiogenic drug. The aim of this study is to investigate the efficacy and safety of metronomic vinorelbine combined with anlotinib in HER2- advanced breast cancer.
Methods: This is a prospective, single-arm, single center clinical study. Women with metastatic HER- breast cancer who had received one prior line of endocrine ± targeted therapy or chemotherapy ± immunotherapy were enrolled. Treatment consisted of vinorelbine tartrate soft capsules 30-50 mg orally three times weekly (every other day) plus anlotinib 12 mg once daily on days 1-14 of each 21-day cycle. The primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).
Results: Fifty-eight patients were enrolled. ORR was 63.8% and DCR 89.7%. Median PFS (mPFS) was 7.0 months [95% confidence interval (CI): 6.4-7.8]. Subgroup analyses showed that patients with prior PFS ≥6 months or Ki-67 ≤20% derived greater benefit: mPFS 7.5 vs. 6.0 months [hazard ratio (HR) 0.38, 95% CI: 0.16-0.91, P=0.03] and 8.5 vs. 6.7 months (HR 0.29, 95% CI: 0.10-0.82, P=0.02), respectively. All other subgroups demonstrated consistent PFS benefit. Any-grade AEs occurred in 56.9% of patients. Myelosuppression (mainly neutropenia and anemia; thrombocytopenia was uncommon) and gastrointestinal toxicities (nausea, vomiting, abdominal pain, diarrhea-mostly grade 1-2) were most frequent. Treatment interruption, modification, or discontinuation due to treatment-related AEs was uncommon (12.1%).
Conclusions: Metronomic vinorelbine plus anlotinib shows favorable efficacy in HER2- advanced breast cancer without increasing the risk of AEs.
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