Phase 2 randomized trial of primary endocrine therapy versus chemotherapy in postmenopausal patients with estrogen receptor‐positive breast cancer

Abstract

BACKGROUND.Few studies have compared primary neoadjuvant endocrine therapy with neoadjuvant chemotherapy in breast cancer patients. The need for preoperative chemotherapy with doxorubicin or taxanes may be reduced in postmenopausal patients with estrogen receptor (ER)‐positive and/or progesterone receptor (PgR)‐positive tumors. This randomized, controlled, phase 2 study evaluated the efficacy of neoadjuvant chemotherapy compared with endocrine treatment with aromatase inhibitors in postmenopausal women with ER‐positive and/or PgR‐positive breast cancer.METHODS.Eligible patients were randomly assigned to receive neoadjuvant anastrozole 1 mg/day (n = 61) or exemestane 25 mg/day (n = 60) for 3 months or doxorubicin 60 mg/m2 with paclitaxel 200 mg/m2 (four 3‐week cycles). Study end points included overall objective response determined by palpation, mammography, and ultrasound, and the number of patients who qualified for breast‐conserving surgery and radiotherapy.RESULTS.Clinical objective response was 64% in the endocrine therapy and chemotherapy treatment groups. Median time to clinical response was 57 and 51 days with aromatase inhibitors and chemotherapy, respectively (P > .05). Rates of pathological complete response (3% vs 6%) and disease progression (9% vs 9%) did not differ significantly in the endocrine therapy or chemotherapy group, respectively (P > .05). Rates of breast‐conserving surgery were slightly higher in the endocrine group (33% vs 24%; P = .058). The most frequent toxicities from chemotherapy were alopecia (79%), grade 3/4 neutropenia (33%), and grade 2 neuropathy (30%). Endocrine treatment was well tolerated. No deaths occurred during the preoperative treatment.CONCLUSIONS.Preoperative neoadjuvant endocrine therapy with aromatase inhibitors was well tolerated and resulted in rates similar to chemotherapy in overall objective response and breast‐conserving surgery in postmenopausal women with ER‐positive and/or PgR‐positive tumors. Cancer 2007. © 2007 American Cancer Society.

Preoperative chemotherapy is safe in early breast cancer, even after 10 years of follow-up; clinical and translational results from the EORTC trial 10902

“…These patients may benefit more from preoperative hormonal therapy. In a study of 239 postmenopausal breast cancer patients with hormonal positive disease, preoperative chemotherapy (doxorubicin with paclitaxel) was compared with preoperative hormonal therapy (anastrozole or exemestane), both for 3 months [34]. Clinical objective response, time to clinical response, rates of pCR and PD were similar between both treatment groups.…”

Estrogen receptor‐positive/human epidermal growth factor receptor 2‐negative breast tumors

“…[3][4][5][6] In a study on the role of 18 F-FDG PET in predicting a complete response to NAC that involved different breast cancer subtypes, only 1 of 53 patients with ERþ/HER2À disease achieved a pCR. 8 Thus, the authors could not evaluate the role of 18 F-FDG PET in that subgroup.…”

“…Because patients with luminal A tumors are less likely to respond, neoadjuvant endocrine therapy may be an alternative to chemotherapy. 4 It is noteworthy that Future studies also should focus on neoadjuvant endocrine therapy, especially for luminal A breast cancer. If our study is replicated in this setting, then use of the preoperative endocrine prognostic index (PEPI) score, which has been correlated with patient outcomes, 35 should be preferred to the Sataloff scale.…”

“…3 Chemosensitivity of ERþ/HER2À tumors is variable and mostly limited. [3][4][5][6] Therefore, factors that may help in predicting chemosensitivity are required.…”

“…3 Chemosensitivity of ERþ/HER2À tumors is variable and mostly limited. [3][4][5][6] Therefore, factors that may help in predicting chemosensitivity are required.Positron emission tomography/computed tomography (PET/CT) with 18 F-fluorodeoxyglucose ( 18 F-FDG) is gaining importance for the staging of patients with large or locally advanced breast cancer. 7 Also, an early change in 18 F-FDG…”