Phase 2 study of cabazitaxel as second-line treatment in patients with HER2-negative metastatic breast cancer previously treated with taxanes—a Hellenic Cooperative Oncology Group (HeCOG) Trial
Open Access
- 3 June 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in British Journal of Cancer
- Vol. 123 (3), 355-361
- https://doi.org/10.1038/s41416-020-0909-4
Abstract
Background Cabazitaxel is a novel taxane that might be active in breast cancer resistant to first-generation taxanes. Methods The purpose of the current multicentre phase II trial was to evaluate the activity and safety of cabazitaxel, as second-line treatment, in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) previously treated with taxanes. The primary endpoint was objective response rate (ORR). Results Eighty-four patients were enrolled between October 2012 and November 2016. Taxane resistance to previous treatment was detected in 43 cases. The ORR was 22.6% in the intent-to-treat population, 23.3% in taxane-resistant and 20.5% in taxane-non-resistant cases. At a median follow-up of 39.6 months, the median progression-free survival and overall survival were 3.7 months (95% CI 2.2–4.4) and 15.2 months (95% CI 11.3–19.4), respectively. Regarding toxicity, grade 3–4 neutropenia was reported in 22.6% and febrile neutropenia in 6% of the patients, respectively. Two fatal events (one febrile neutropenia and one sepsis) were reported as being related to study treatment. Conclusions This phase II trial suggests that cabazitaxel is active as second-line treatment in taxane-pretreated patients with HER2-negative MBC, with manageable toxicity.Keywords
This publication has 16 references indexed in Scilit:
- 4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)Annals of Oncology, 2018
- Preclinical profile of cabazitaxelDrug Design, Development and Therapy, 2014
- Antiproliferative Mechanism of Action of the Novel Taxane Cabazitaxel as Compared with the Parent Compound Docetaxel in MCF7 Breast Cancer CellsMolecular Cancer Therapeutics, 2014
- Cabazitaxel in patients with advanced solid tumours: Results of a Phase I and pharmacokinetic studyEuropean Journal of Cancer, 2013
- A multicentre dose-escalating study of cabazitaxel (XRP6258) in combination with capecitabine in patients with metastatic breast cancer progressing after anthracycline and taxane treatment: A phase I/II studyEuropean Journal of Cancer, 2011
- Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trialThe Lancet, 2010
- Phase I and Pharmacokinetic Study of XRP6258 (RPR 116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3 Weeks in Patients with Advanced Solid TumorsClinical Cancer Research, 2009
- A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patientsAnnals of Oncology, 2008
- Impact of chemotherapy beyond the first line in patients with metastatic breast cancerBreast Cancer Research and Treatment, 2007
- Extending Survival with Chemotherapy in Metastatic Breast CancerThe Oncologist, 2005