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Efficacy of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy in pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer.
- Source :
-
Breast cancer research : BCR [Breast Cancer Res] 2020 May 27; Vol. 22 (1), pp. 54. Date of Electronic Publication: 2020 May 27. - Publication Year :
- 2020
-
Abstract
- Introduction: Neoadjuvant endocrine therapy (NET) has demonstrated efficacy in post-menopausal patients with hormone-responsive breast cancer. This trial was designed to compare the efficacy of neoadjuvant chemotherapy (NCT) with NET in pre-menopausal breast cancer.<br />Patients and Methods: In this prospective, randomised, phase III study, oestrogen receptor (ER)-positive, HER2-negative, and lymph node-positive pre-menopausal breast cancer patients were recruited from 7 hospitals in South Korea. Enrolled patients were randomly assigned (1:1) to receive 24 weeks of either NCT or NET with goserelin and tamoxifen. The primary purpose was to evaluate the non-inferiority of NET compared to NCT using clinical response, assessed by MRI. Besides, pathological complete response rate (pCR), changes in Ki-67 expression, breast conservation surgery (BCS) rate, and quality of life were included as secondary endpoints.<br />Results: A total of 187 patients were assigned to receive NCT (n = 95) or NET (n = 92), and 87 patients in each group completed treatments. More NCT patients had complete response or partial response than NET patients using MRI (NCT 83.7% vs. NET 52.9%, 95% CI 17.6-44.0, p < 0.001) and callipers (NCT 83.9% vs. NET 71.3%, 95% CI 0.4-24.9, p = 0.046). Three NCT patients (3.4%) and one NET patient (1.2%) showed pCR (p < 0.005). No difference existed in the conversion rate of BCS (13.8% for NCT vs. 11.5% for NET, p = 0.531) and Ki-67 change (p = 0.114) between the two groups. Nineteen NCT patients had treatment-related grade 3 or worse events compared with none in the NET group.<br />Conclusions: Better clinical responses were observed in pre-menopausal patients after 24 weeks of NCT compared to those observed after NET.<br />Trial Registration: Clinicaltrials.gov, NCT01622361. Registration June 19, 2012.
- Subjects :
- Adult
Breast Neoplasms metabolism
Breast Neoplasms pathology
Combined Modality Therapy
Cyclophosphamide administration & dosage
Docetaxel administration & dosage
Doxorubicin administration & dosage
Female
Follow-Up Studies
Goserelin administration & dosage
Humans
Lymph Nodes drug effects
Lymph Nodes metabolism
Middle Aged
Premenopause
Prognosis
Prospective Studies
Receptors, Progesterone metabolism
Trastuzumab administration & dosage
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Breast Neoplasms drug therapy
Lymph Nodes pathology
Receptor, ErbB-2 metabolism
Receptors, Estrogen metabolism
Subjects
Details
- Language :
- English
- ISSN :
- 1465-542X
- Volume :
- 22
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Breast cancer research : BCR
- Publication Type :
- Academic Journal
- Accession number :
- 32460816
- Full Text :
- https://doi.org/10.1186/s13058-020-01288-5