Τίτλος:
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
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Koutras, A.
Zagouri, F.
Koliou, G.-A.
Psoma, E.
Chryssogonidis, I.
Lazaridis, G.
Tryfonopoulos, D.
Kotsakis, A.
Res, E.
Kentepozidis, N.K.
Razis, E.
Psyrri, A.
Koumakis, G.
Kalofonos, H.P.
Dimopoulos, M.A.
Fountzilas, G.
Περιοδικό:
British Journal of Cancer
Εκδότης:
Springer Nature BV
Λέξεις-κλειδιά:
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
DOI:
10.1038/s41416-020-0909-4
