A pilot trial of pre-operative (Neoadjuvant) letrozole in combination with bevacizumab in post-menopausal women with newly diagnosed estrogen and/or progesterone receptor positive breast cancer.
Document Type
Article
Department
Haematology and Oncology, East Africa
Abstract
Purpose: Tumor content or expression of vascular endothelial growth factor (VEGF) is associated with impaired efficacy of anti-estrogen adjuvant therapy. We designed a pilot study of neoadjuvant letrozole and bevacizumab (anti-VEGF) to assess feasibility and short term efficacy in post-menopausal women with stage II/III, ER/PR positive breast cancer.
Patients and Methods: Patients were treated with a neo-adjuvant regimen of letrozole, 2.5mg/day (P.O.) and bevacizumab 15mg/kg Q3 weeks (I.V.) for a total of 24 weeks prior to surgical treatment of their breast cancer. Patients were followed for toxicity at 3 week intervals and tumor assessment (physical exam and tumor ultrasound) at 6 week intervals. PET scans were carried out prior to therapy and 6 weeks after initiation of therapy. Surgery was done 4 weeks after the last dose of bevacizumab.
Results: Twenty five evaluable patients were treated. The regimen was well tolerated except for 2 patients who were taken off-study for difficult to control hypertension. Objective clinical response occurred in 17/25 patients (68%) including 16% CR and 52% PR. The 4 patients with clinical CR had pathologic CR in their breasts (16%) although one had residual tumor cells in axillary nodes. 8/25 patients (32%) attained stage 0 or 1 status. PET scan response at 6 weeks correlated with clinical CR and breast pathologic CR at 24 weeks (p < 0.0036).
Conclusion: Combination neo-adjuvant therapy with letrozole and bevacizumab was well tolerated and resulted in impressive clinical and pathologic responses. The Breast Cancer Translational Research Consortium has an ongoing randomized phase II trial of this regimen in this patient population.
Publication (Name of Journal)
Cancer Research
DOI
https://doi.org/10.1158/0008-5472.SABCS-09-1088
Recommended Citation
Forero, A.,
Saleh, M.,
Galleshaw, J.,
Jones, C.,
Shah, J.,
Percent, I.,
Nabell, L.,
Carpenter, J.,
Falkson, C.,
Krontiras, H.
(2009). A pilot trial of pre-operative (Neoadjuvant) letrozole in combination with bevacizumab in post-menopausal women with newly diagnosed estrogen and/or progesterone receptor positive breast cancer.. Cancer Research, 69(24).
Available at:
https://ecommons.aku.edu/eastafrica_fhs_mc_haematol_oncol/67
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Comments
This work was published before the author joined Aga Khan University.