TY - JOUR
TI - 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
AU - Koutras, A.
AU - Zagouri, F.
AU - Koliou, G.-A.
AU - Psoma, E.
AU - Chryssogonidis, I.
AU - Lazaridis, G.
AU - Tryfonopoulos, D.
AU - Kotsakis, A.
AU - Res, E.
AU - Kentepozidis, N.K.
AU - Razis, E.
AU - Psyrri, A.
AU - Koumakis, G.
AU - Kalofonos, H.P.
AU - Dimopoulos, M.A.
AU - Fountzilas, G.
JO - British Journal of Cancer
PY - 2020
VL - 123
TODO - 3
SP - 355-361
PB - Springer Nature BV
SN - 0007-0920, 1532-1827
TODO - 10.1038/s41416-020-0909-4
TODO - alkaline phosphatase;  cabazitaxel;  gamma glutamyltransferase;  granulocyte colony stimulating factor;  lactate dehydrogenase;  cabazitaxel;  epidermal growth factor receptor 2;  ERBB2 protein, human;  taxoid, acute kidney failure;  adult;  aged;  anemia;  Article;  bone pain;  cancer chemotherapy;  cancer survival;  diarrhea;  drug activity;  drug dose reduction;  drug efficacy;  drug safety;  drug withdrawal;  dyspnea;  estrogen receptor negative breast cancer;  estrogen receptor positive breast cancer;  fatigue;  febrile neutropenia;  female;  follow up;  headache;  human;  human epidermal growth factor receptor 2 negative breast cancer;  hypermagnesemia;  hypertension;  hypokalemia;  intention to treat analysis;  leukopenia;  lymphocytopenia;  major clinical study;  metastatic breast cancer;  multicenter study;  multiple cycle treatment;  nausea;  necrotizing enterocolitis;  neutropenia;  neutropenic enterocolitis;  overall survival;  pain;  patient compliance;  peripheral neuropathy;  phase 2 clinical trial;  priority journal;  progesterone receptor positive breast cancer;  progression free survival;  sensory neuropathy;  sepsis;  side effect;  skin infection;  thrombocytopenia;  treatment response;  breast tumor;  clinical trial;  drug effect;  drug resistance;  genetics;  metastasis;  middle aged;  survival analysis;  treatment outcome, Adult;  Aged;  Breast Neoplasms;  Drug Resistance, Neoplasm;  Female;  Humans;  Middle Aged;  Neoplasm Metastasis;  Receptor, ErbB-2;  Survival Analysis;  Taxoids;  Treatment Outcome
TODO - 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. © 2020, The Author(s), under exclusive licence to Cancer Research UK.
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