Neoadjuvant everolimus plus letrozole versus fluorouracil, epirubicin and cyclophosphamide for ER-positive, HER2-negative breast cancer: a randomized pilot trial

Autor:	Liang Jin, Heran Deng, Nanyan Rao, Jiewen Chen, Yandan Yao, Yaping Yang, Zhanghai He, Yan Nie, Wei Wu, Jieqiong Liu, Fengxi Su
Jazyk:	angličtina
Rok vydání:	2021
Předmět:	Adult 0301 basic medicine Oncology Cancer Research medicine.medical_specialty Epirubicin and cyclophosphamide (FEC) Receptor ErbB-2 Biopsy Breast Neoplasms Pilot Projects 03 medical and health sciences 0302 clinical medicine Breast cancer Positive axillary lymph node Internal medicine Antineoplastic Combined Chemotherapy Protocols Biomarkers Tumor Genetics medicine Humans Everolimus Randomized neoadjuvant pilot trial ER-positive and HER2-negative breast cancer Cyclophosphamide RC254-282 Aged Epirubicin business.industry Research Letrozole Everolimus plus letrozole Neoplasms. Tumors. Oncology. Including cancer and carcinogens Middle Aged medicine.disease Primary tumor Treatment Outcome 030104 developmental biology Receptors Estrogen Tolerability Fluorouracil 030220 oncology & carcinogenesis Female business medicine.drug
Zdroj:	BMC Cancer, Vol 21, Iss 1, Pp 1-12 (2021) BMC Cancer
ISSN:	1471-2407
Popis:	BackgroundHere we evaluated the feasibility, efficacy, tolerability, and treatment-mediated immune modulation of neoadjuvant everolimus plus letrozole versus chemotherapy in treating postmenopausal patients with ER-positive, HER2-negative breast cancer.MethodsPostmenopausal women with ER-positive, HER2-negative breast cancer who had a primary tumor > 2 cm or positive axillary lymph node(s) proofed by biopsy were randomly (1,1) enrolled to receive neoadjuvant everolimus plus letrozole for 18 weeks or fluorouracil, epirubicin plus cyclophosphamide (FEC) for 6 cycles before surgery. Primary outcome was feasibility of the trial. Secondary outcome included ultrasound response rate, pathological complete response rate, breast-conserving surgery rate, toxicities, treatment-mediated immune modulation and biomarkers.ResultsForty patients were randomized. Completion rate was 90.0% in the neoadjuvant endocrine therapy (NET) arm but 70.0% in the neoadjuvant chemotherapy (NAC) arm. The ultrasound response rate was 65.0% in NET arm and 40.0% in FEC arm, respectively. In terms of the adverse events, clearly favored NET arm. Everolimus plus letrozole increased the ratio of peripheral Tregs to CD4+T cells and tumor PD-L1 expression, and decreased Ki67 index and tumor-infiltrating Tregs, and patients with a greater increase of tumor-specific CTLs showed more sensitive to NET.ConclusionThis pilot trial showed that neoadjuvant everolimus plus letrozole might achieve a favorable ultrasound response rate with low toxicities in treating postmenopausal ER-positive, HER2-negative breast cancer patients. Everolimus plus letrozole might have positive antitumoral immunity effects. Further large randomized controlled trials are needed to confirm our findings.Trail registrationA Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer, registered on 07/04/2016 and first posted on 18/04/2016,NCT02742051.
Databáze:	OpenAIRE
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