Real-world data on the efficacy and safety of weekly oral vinorelbine in breast cancer patients previously treated with anthracycline or taxane-based regimens
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.
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.
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.
KeywordsMetastatic breast cancer Oral vinorelbine HER2 status Progression-free survival
This study was funded by Laboratoires Pierre Fabre. Medical writing support was provided by Dr. Almudena Fuster-Matanzo of Medical Statistics Consulting S.L. (Valencia). The authors would like to give special thanks to the patients and their families.
Compliance with ethical standards
Conflict of interest
The authors had no conflict of interest in this study.
The protocol of this trial and informed consent were approved by the ethics committee of each participating hospital and met the ethical principles stated in the Declaration of Helsinki. This study was classified by the Spanish Agency of Medicines and Health Products (AEMPS).
Written informed consent was obtained from all individual participants included in the study.
- 4.Cancer B. Fact sheet. 2016. http://www.moph.gov.lb/Campaigns/Materials/FactSheet.pdf. Accessed 07 May 2018.
- 5.Heinemann V, Di Gioia D, Vehling-Kaiser U, Harich HD, Heinrich B, Welt A, et al. A prospective multicenter phase II study of oral and i.v. vinorelbine plus trastuzumab as first-line therapy in HER2-overexpressing metastatic breast cancer. Ann Oncol. 2011;22(3):603–8. https://doi.org/10.1093/annonc/mdq409.CrossRefGoogle Scholar
- 6.National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology V. 1. 2010. http://www.nccn.org/professionals/physician_gls/PDF/breast.pdf.
- 9.Potier P. The synthesis of Navelbine prototype of a new series of vinblastine derivatives. Semin Oncol. 1989;16(2 Suppl 4):2–4.Google Scholar
- 15.Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92(3):205–16.CrossRefGoogle Scholar
- 21.Steger GG, Dominguez A, Dobrovolskaya N, Giotta F, Tubiana-Mathieu N, Pecherstorfer M, et al. Single-agent oral vinorelbine as first-line chemotherapy for endocrine-pretreated breast cancer with bone metastases and no visceral involvement: NORBREAST-228 Phase II Study. Clin Breast Cancer. 2018;18(1):e41–7. https://doi.org/10.1016/j.clbc.2017.05.012.CrossRefGoogle Scholar
- 22.Cazzaniga ME, Cortesi L, Ferzi A, Scaltriti L, Cicchiello F, Ciccarese M, et al. Metronomic chemotherapy with oral vinorelbine (mVNR) and capecitabine (mCAPE) in advanced HER2-negative breast cancer patients: is it a way to optimize disease control? Final results of the VICTOR-2 study. Breast Cancer Res Treat. 2016;160(3):501–9. https://doi.org/10.1007/s10549-016-4009-3.CrossRefGoogle Scholar
- 26.Andersson M, Lidbrink E, Bjerre K, Wist E, Enevoldsen K, Jensen AB, et al. Phase III randomized study comparing docetaxel plus trastuzumab with vinorelbine plus trastuzumab as first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer: the HERNATA study. J Clin Oncol. 2011;29(3):264–71. https://doi.org/10.1200/JCO.2010.30.8213.CrossRefGoogle Scholar
- 29.Barni S, Freier B, Garau I, Mouysset JL, Sediva M, Zamagni C, et al. Burden of advanced breast cancer for patients and caregivers in Europe: comparison of two treatment forms of vinorelbine, oral and intravenous. Curr Med Res Opin. 2016;32(11):1807–12. https://doi.org/10.1080/03007995.2016.1211518.CrossRefGoogle Scholar
- 30.Welt A, Meldgaard P, Martoni A, Hansen O, Gebbia V, Fischer von Weikersthal L, et al. Improving chemotherapy capacity by switching from IV to oral vinorelbine. Eur J Oncol Pharm. 2010;4(3):14–8.Google Scholar