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PURPOSE: To investigate the activity of letrozole plus/minus oral metronomic cyclophosphamide as primary systemic treatment (PST) in elderly breast cancer patients. METHODS: One hundred fourteen consecutive elderly women with T2-4 N0-1 and estrogen receptor-positive breast cancer were randomly assigned to primary letrozole therapy (2.5 mg daily for 6 months) or a combination of letrozole plus oral cyclophosphamide (50 mg/daily for 6 months) in an open-labeled, randomized phase II trial. Tumor response was assessed clinically, and tumor Ki67 index and vascular endothelial growth factor (VEGF) -A levels were measured before and after treatment. RESULTS: Overall response rate was 71.9% (95% CI, 60.0 to 83.8) in the 57 patients randomly assigned to receive primary letrozole and 87.7% (95% CI, 78.6 to 96.2) in the 57 patients randomly assigned to receive letrozole plus cyclophosphamide. The difference in activity between treatment arms was predominantly confined to patients with ductal histology. There was a significantly greater suppression of Ki67 and VEGF-A expression in the letrozole/cyclophosphamide-treated group than in the letrozole-treated group, leading to lower Ki67 and VEGF expression at post-treatment residual histology (P = .03 and P = .002, respectively). CONCLUSION: Both letrozole and letrozole plus cyclophosphamide treatments appeared active as PST in elderly breast cancer patients. Metronomic scheduling of cyclophosphamide may have an antiangiogenic effect and the combination of letrozole plus cyclophosphamide warrants testing in a randomized phase III trial.

Original publication

DOI

10.1200/JCO.2005.04.5773

Type

Journal article

Journal

J Clin Oncol

Publication Date

01/08/2006

Volume

24

Pages

3623 - 3628

Keywords

Aged, Aged, 80 and over, Angiogenesis Inhibitors, Antineoplastic Agents, Alkylating, Antineoplastic Combined Chemotherapy Protocols, Aromatase Inhibitors, Biomarkers, Tumor, Breast Neoplasms, Cyclophosphamide, Drug Administration Schedule, Female, Humans, Ki-67 Antigen, Middle Aged, Neoplasm Staging, Nitriles, Treatment Outcome, Triazoles, Vascular Endothelial Growth Factor A