TY - JOUR
T1 - Improved Surgical Outcomes for Breast Cancer Patients Receiving Neoadjuvant Aromatase Inhibitor Therapy
T2 - Results from a Multicenter Phase II Trial
AU - Olson, John A.
AU - Budd, G. Thomas
AU - Carey, Lisa A.
AU - Harris, Lyndsay A.
AU - Esserman, Laura J.
AU - Fleming, Gini F.
AU - Marcom, Paul K.
AU - Leight, George S.
AU - Giuntoli, Therese
AU - Commean, Paul
AU - Bae, Kyongtae
AU - Luo, Jingqin
AU - Ellis, Matthew J.
N1 - Funding Information:
Supported by National Cancer Institute (NCI) grant R01 CA095614 and Avon NCI Partners in Progress Award 3P50 CA68438-07S2.
Funding Information:
Disclosure Information: Dr Ellis received honoraria, consulting fees and research grants from both Novartis and AstraZeneca as speaker, ad hoc consultant, and scientist on grants, and a consulting fee from Pfizer as an ad hoc consultant. Dr Budd received a research grant as investigator and a consulting fee is an advisory board member for Novartis, and received a fee as an ad hoc consultant for Pfizer. Dr Marcom is a consulting independent contractor for AstraZeneca Pharmaceuticals LP; and received grant support and consulting fees as investigator and contract teaching for Novartis. All other authors have nothing to disclose.
PY - 2009/5
Y1 - 2009/5
N2 - Background: Neoadjuvant aromatase inhibitor therapy has been reported to improve surgical outcomes for postmenopausal women with clinical stage II or III hormone receptor-positive breast cancer. A multicenter phase II clinical trial was conducted to investigate the value of this approach for US surgical practice. Study Design: One hundred fifteen postmenopausal women with >2 cm, estrogen receptor (ER) or progesterone receptor (PgR)-positive breast cancer were enrolled in a trial of 16 to 24 weeks of letrozole 2.5 mg daily before operation. Results: One hundred six patients were eligible for primary analysis, 96 underwent operations, 7 received chemotherapy after progressive disease, and 3 did not undergo an operation. Baseline surgical status was marginal for breast-conserving surgery (BCS) in 48 (45%), 47 were definitely ineligible for BCS (44%), and 11 were inoperable by standard mastectomy (10%). Overall Response Evaluation Criteria In Solid Tumors clinical response rate in the breast was 62%, with 12% experiencing progressive disease. Fifty percent underwent BCS, including 30 of 46 (65%) patients who were initially marginal for BCS and 15 of 39 (38%) patients who were initially ineligible for BCS. All 11 inoperable patients successfully underwent operations, including 3 (27%) who had BCS. Nineteen percent of patients undergoing mastectomy had a pathologic T1 tumor, suggesting that some highly responsive tumors were overtreated surgically. Conclusions: Neoadjuvant aromatase inhibitor improves operability and facilitates BCS, but there was considerable variability in responsiveness. Better techniques to predict response, determine residual tumor burden before operation, and greater willingness to attempt BCS in responsive patients could additionally improve the rate of successful BCS.
AB - Background: Neoadjuvant aromatase inhibitor therapy has been reported to improve surgical outcomes for postmenopausal women with clinical stage II or III hormone receptor-positive breast cancer. A multicenter phase II clinical trial was conducted to investigate the value of this approach for US surgical practice. Study Design: One hundred fifteen postmenopausal women with >2 cm, estrogen receptor (ER) or progesterone receptor (PgR)-positive breast cancer were enrolled in a trial of 16 to 24 weeks of letrozole 2.5 mg daily before operation. Results: One hundred six patients were eligible for primary analysis, 96 underwent operations, 7 received chemotherapy after progressive disease, and 3 did not undergo an operation. Baseline surgical status was marginal for breast-conserving surgery (BCS) in 48 (45%), 47 were definitely ineligible for BCS (44%), and 11 were inoperable by standard mastectomy (10%). Overall Response Evaluation Criteria In Solid Tumors clinical response rate in the breast was 62%, with 12% experiencing progressive disease. Fifty percent underwent BCS, including 30 of 46 (65%) patients who were initially marginal for BCS and 15 of 39 (38%) patients who were initially ineligible for BCS. All 11 inoperable patients successfully underwent operations, including 3 (27%) who had BCS. Nineteen percent of patients undergoing mastectomy had a pathologic T1 tumor, suggesting that some highly responsive tumors were overtreated surgically. Conclusions: Neoadjuvant aromatase inhibitor improves operability and facilitates BCS, but there was considerable variability in responsiveness. Better techniques to predict response, determine residual tumor burden before operation, and greater willingness to attempt BCS in responsive patients could additionally improve the rate of successful BCS.
UR - http://www.scopus.com/inward/record.url?scp=64949102825&partnerID=8YFLogxK
U2 - 10.1016/j.jamcollsurg.2009.01.035
DO - 10.1016/j.jamcollsurg.2009.01.035
M3 - Article
C2 - 19476859
AN - SCOPUS:64949102825
SN - 1072-7515
VL - 208
SP - 906
EP - 914
JO - Journal of the American College of Surgeons
JF - Journal of the American College of Surgeons
IS - 5
ER -