NEOCENT: a randomised feasibility and translational study comparing neoadjuvant endocrine therapy with chemotherapy in ER-rich postmenopausal primary breast cancer

Palmieri, C, Cleator, S, Kilburn, L S, Kim, S B, Ahn, S H, Beresford, M, Gong, G, Mansi, J, Mallon, E, Reed, S, Mousa, K, Fallowfield, L, Cheang, M, Morden, J, Page, K, Guttery, D S, Rghebi, B, Primrose, L, Shaw, J A, Thompson, A M, Bliss, J M and Coombes, R C (2014) NEOCENT: a randomised feasibility and translational study comparing neoadjuvant endocrine therapy with chemotherapy in ER-rich postmenopausal primary breast cancer. Breast Cancer Research and Treatment, 148 (3). pp. 581-590. ISSN 0167-6806

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Abstract

Neoadjuvant endocrine therapy is an alternative to chemotherapy for women with oestrogen receptor (ER)-positive early breast cancer (BC). We aimed to assess feasibility of recruiting patients to a study comparing chemotherapy versus endocrine therapy in postmenopausal women with ER-rich primary BC, and response as well as translational endpoints were assessed. Patients requiring neoadjuvant therapy were randomised to chemotherapy: 6 x 3-weekly cycles FE100C or endocrine therapy: letrozole 2.5 mg, daily for 18-23 weeks. Primary endpoints were recruitment feasibility and tissue collection. Secondary endpoints included clinical, radiological and pathological response rates, quality of life and translational endpoints. 63/80 patients approached were eligible, of those 44 (70, 95 % CI 57-81) were randomised. 12 (54.5, 95 % CI 32.2-75.6) chemotherapy patients showed radiological objective response compared with 13 (59.1, 95 % CI 36.4-79.3) letrozole patients. Compared with baseline, mean Ki-67 levels fell in both groups at days 2-4 and at surgery [fold change: 0.24 (95 % CI 0.12-0.51) and 0.24; (95 % CI 0.15-0.37), respectively]. Plasma total cfDNA levels rose from baseline to week 8 [fold change: chemotherapy 2.10 (95 % CI 1.47-3.00), letrozole 1.47(95 % CI 0.98-2.20)], and were maintained at surgery in the chemotherapy group [chemotherapy 2.63; 95 % CI 1.56-4.41), letrozole 0.95 (95 % CI 0.71-1.26)]. An increase in plasma let-7a miRNA was seen at surgery for patients with objective radiological response to chemotherapy. Recruitment and tissue collection endpoints were met; however, a larger trial was deemed unfeasible due to slow accrual. Both regimens were equally efficacious. Dynamic changes were seen in Ki-67 and circulating biomarkers in both groups with increases in cfDNA and let-7a miRNA persisting until surgery for chemotherapy patients.

Item Type: Article
Keywords: Breast, neoadjuvant therapy, Ki-67, cfDNA, miRNA
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: R Medicine > RC Internal medicine
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens > RC0280 By region, system, or organ of the body, or type of tumor, A-Z > RC0280.B8 Breast. Mammary glands
R Medicine > RM Therapeutics. Pharmacology > RM0260 Chemotherapy
Depositing User: Kathryn Monson
Date Deposited: 08 Dec 2014 14:46
Last Modified: 08 Dec 2014 14:46
URI: http://sro.sussex.ac.uk/id/eprint/51639
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