Final results of a phase II study of paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer.
Clin Transl Oncol
; 17(2): 160-6, 2015 Feb.
Article
in En
| MEDLINE
| ID: mdl-25119930
ABSTRACT
BACKGROUND:
Efficacy and safety data for combining bevacizumab, gemcitabine, and paclitaxel for locally advanced/metastatic breast cancer are limited. PATIENTS ANDMETHODS:
AVALUZ trial evaluates the combination of bevacizumab 10 mg/kg, gemcitabine 2,000 mg/m(2) plus paclitaxel 150 mg/m(2), on days 1 and 15 of each 28-day course in previously untreated HER-2 negative patients.RESULTS:
Median progression-free survival (PES) 12.3 months. The overall response and clinical benefit rate (CR + PR + SD) were 72 % (95 % CI 60.9-82.0 %) and 89 % (95 % CI 80.3-95.3 %), respectively. Median overall survival 27.4 mo. Baseline circulating tumor cell (CTCs) ≥2 versus CTCs <2 was associated with lower PFS, p = 0.046. Overall response was significantly greater in patients with intense angiotensin type 1 receptor (AGTR1) expression (99 vs. 60 % [p = 0.021]). The most frequent grade 3/4 adverse events were neutropenia (10 %); febrile neutropenia (1 %); sensory neuropathy (13 %); and asthenia (6 %). Grade 3 adverse events of interest with bevacizumab included bleeding (1 %) and hypertension (4 %). One patient developed cardiac ischemia (1 %).CONCLUSIONS:
Adding bevacizumab to chemotherapy appeared feasible and well tolerated, producing toxicity comparable to other effective combined first-line regimens. Baseline circulating endothelial cells and AGTR1 expression are predictive of PFS and response.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Breast Neoplasms
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Antineoplastic Combined Chemotherapy Protocols
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Receptor, ErbB-2
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Receptor, Angiotensin, Type 1
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Neoplastic Cells, Circulating
Type of study:
Observational_studies
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Prognostic_studies
/
Risk_factors_studies
Limits:
Adult
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Aged
/
Aged80
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Female
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Humans
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Middle aged
Language:
En
Journal:
Clin Transl Oncol
Year:
2015
Document type:
Article