Found 1 Presentation For Request "244p"
244P - Eribulin combined with anlotinib for patients with HER2-negative metastatic breast cancer: A single-arm, multicenter, phase II study
- Yongmei Yin (Nanjing, China)
Abstract
Background
HER2-negative breast cancer is the most common breast cancer subtype and effective treatments for heavily pretreated patients with HER2-negative metastatic breast cancer are urgently needed. Eribulin mesylate is a non-taxane microtubule dynamics inhibitor with a distinct mode of action which could be used as a chemotherapeutic agent for HER2-negative breast cancer after failure of anthracycline and taxanes treatments. Anlotinib is a novel multitarget tyrosine kinase inhibitor targeting VEGFR, PDGFR, FGFR, and c-Kit. This study aimed to evaluate the efficacy and safety of combined treatment with eribulin and anlotinib in patients with HER2-negative metastatic breast cancer (NCT04624711).
Methods
This open-label, single-arm, phase II study enrolled females with HER2-neagtive breast cancer who underwent ≥1 line chemotherapy, including anthracyclines and taxanes, for metastatic breast cancer. Patients with hormone receptor positive breast cancer have undergone ≥1 line endocrine therapy. All patients were treated with Eribulin mesylate (1.4 mg/m2, administered intravenously on Days 1 and 8 of each 21-day cycle) and anlotinib (12 mg, administered orally once daily on Days 1-14 of each 21-day cycle). The primary endpoint was progression-free survival (PFS). Secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.
Results
From November 2020 to July 2022, 38 patients were enrolled in this study. Median follow-up was 6.87 months (95% CI 5.92-8.27). Median PFS was 4.7 months (95% CI 3.59-5.53). Of all the patients whose efficacy could be evaluated, no patient achieved complete response (CR); 17 (44.74%) and 15 (39.47%) patients got partial response (PR) and stable disease (SD), respectively. ORR was 44.74% and DCR was 86.84%. OS has not reached. The major treatment-related adverse events were fatigue (47.37%), neutropenia (44.74%), anemia (42.11%), platelet count decreased (34.21%), hypoalbuminemia (26.32%), elevated lactate dehydrogenase (26.32%), intraoral hemorrhage (15.79%) and epistaxis (13.16%). The most common grade 3/4 adverse events were neutropenia (18.42%). 21.05% of patients had dose reductions.
Conclusions
The combination of eribulin and anlotinib improved the survival of HER2-negative metastatic breast cancer patients and showed tolerable toxicities. Further studies enrolling more patients are still needed.
Clinical trial identification
NCT04624711.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.