I Blancas1, E Aguirre2, S Morales2, M L Gonzálvez3, S Servitja4, N Díaz5, S Del Barco6, A Barnadas7, M Margelí8, I García Carbonero9, A Llombart10. 1. Department of Medical Oncology, University Hospital San Cecilio, Av. De la Investigación s/n, 18016, Granada, Spain. iblancas@ugr.es. 2. Department of Medical Oncology, University Hospital Arnau de Vilanova, Lleida, Spain. 3. Department of Medical Oncology, University Hospital Arrixaca, Murcia, Spain. 4. Department of Medical Oncology, Hospital Del Mar, Barcelona, Spain. 5. Department of Medical Oncology, University Hospital San Juan de Alicante, Alicante, Spain. 6. Department of Medical Oncology, Institut Català d'Oncologia, Girona, Spain. 7. Department of Medical Oncology, University Hospital Sant Pau, Barcelona, Spain. 8. Department of Medical Oncology, Institut Català d'Oncologia, Badalona, Spain. 9. Department of Medical Oncology, Virgen de La Salud Hospital, Toledo, Spain. 10. Department of Medical Oncology, Arnau de Vilanova Hospital, Valencia, Spain.
Abstract
PURPOSE: To evaluate the efficacy and safety of oral weekly vinorelbine 60 mg/m2 for metastatic breast cancer (MBC) in patients previously treated with anthracyclines or taxanes in routine clinical practice. MATERIALS AND METHODS: Fifty-five patients were enrolled in a prospective multicentre study conducted in Spain. Women ≥ 18 years of age with locally advanced breast cancer who were not candidates for surgical treatment with a radical intention or patients with stage IV disease, and who had received a prior taxane or anthracycline regimen were eligible for participation. RESULTS: Median age was 67 years. Median progression-free survival was 3.7 months (95% CI 2.5-4.9), median overall survival 10 months (95% CI 6.6-13.5), and overall response rate and clinical benefit rate were 29.1% and 49.1%, respectively. Main grade 3 and 4 toxicities were neutropenia 9.1%, febrile neutropenia 3.6% and constipation 3.6%. In total, 86% of the patients received complete treatment without delays or dose reduction. Moreover, HER2-positive patients who received oral vinorelbine concomitantly with trastuzumab showed better response (complete response: HER2-positive 14.3% vs. HER2-negative 0%; partial response: HER2-positive 42.9% vs. HER2-negative 25.6%; p = 0.008), better disease control rate (HER2-positive 100% vs. HER2-negative 46.2%; p = 0.011), and better values for the remaining analysed variables than HER2-negative patients. CONCLUSION: Our study provides real-world data on the use of oral weekly vinorelbine, which proves an effective and well-tolerated regimen for MBC patients previously treated with taxanes or anthracyclines. Patients with HER2-positive disease could also benefit from this treatment in combination with trastuzumab.
PURPOSE: To evaluate the efficacy and safety of oral weekly vinorelbine 60 mg/m2 for metastatic breast cancer (MBC) in patients previously treated with anthracyclines or taxanes in routine clinical practice. MATERIALS AND METHODS: Fifty-five patients were enrolled in a prospective multicentre study conducted in Spain. Women ≥ 18 years of age with locally advanced breast cancer who were not candidates for surgical treatment with a radical intention or patients with stage IV disease, and who had received a prior taxane or anthracycline regimen were eligible for participation. RESULTS: Median age was 67 years. Median progression-free survival was 3.7 months (95% CI 2.5-4.9), median overall survival 10 months (95% CI 6.6-13.5), and overall response rate and clinical benefit rate were 29.1% and 49.1%, respectively. Main grade 3 and 4 toxicities were neutropenia 9.1%, febrile neutropenia 3.6% and constipation 3.6%. In total, 86% of the patients received complete treatment without delays or dose reduction. Moreover, HER2-positive patients who received oral vinorelbine concomitantly with trastuzumab showed better response (complete response: HER2-positive 14.3% vs. HER2-negative 0%; partial response: HER2-positive 42.9% vs. HER2-negative 25.6%; p = 0.008), better disease control rate (HER2-positive 100% vs. HER2-negative 46.2%; p = 0.011), and better values for the remaining analysed variables than HER2-negative patients. CONCLUSION: Our study provides real-world data on the use of oral weekly vinorelbine, which proves an effective and well-tolerated regimen for MBCpatients previously treated with taxanes or anthracyclines. Patients with HER2-positive disease could also benefit from this treatment in combination with trastuzumab.
Entities:
Keywords:
HER2 status; Metastatic breast cancer; Oral vinorelbine; Progression-free survival
Authors: Slavomir Krajnak; Thomas Decker; Lukas Schollenberger; Christian Rosé; Christian Ruckes; Tanja Fehm; Christoph Thomssen; Nadia Harbeck; Marcus Schmidt Journal: J Cancer Res Clin Oncol Date: 2021-03-20 Impact factor: 4.553