A multicenter phase II trial of neoadjuvant letrozole plus low-dose cyclophosphamide in postmenopausal patients with estrogen receptor-positive breast cancer (JBCRG-07): therapeutic efficacy and clinical implications of circulating endothelial cells

Autor: Takayuki Ueno, Satoshi Morita, Shunji Kamigaki, Sunao Tanaka, Norikazu Masuda, Masakazu Toi, Hitoshi Tsuda, Masafumi Kurosumi, Yoshiki Mikami, Takashi Morimoto, Futoshi Akiyama
Rok vydání: 2018
Předmět:
0301 basic medicine
Oncology
Cancer Research
Estrogen receptor
Phases of clinical research
Multimodal Imaging
Breast cancer
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
Clinical endpoint
Original Research
Aged
80 and over
Letrozole
Middle Aged
Prognosis
metronomic therapy
Immunohistochemistry
Neoadjuvant Therapy
Treatment Outcome
Receptors
Estrogen
030220 oncology & carcinogenesis
Female
medicine.drug
medicine.medical_specialty
Cyclophosphamide
Breast Neoplasms
03 medical and health sciences
circulating endothelial cell
Internal medicine
Biomarkers
Tumor
medicine
Humans
Radiology
Nuclear Medicine and imaging
Aged
business.industry
neoadjuvant
Endothelial Cells
Clinical Cancer Research
medicine.disease
Metronomic Chemotherapy
Clinical trial
030104 developmental biology
Neoplasm Grading
chemo‐endocrine therapy
business
Follow-Up Studies
Zdroj: Cancer Medicine
ISSN: 2045-7634
Popis: Neoadjuvant endocrine therapy has been reported to decrease tumor size, which leads to increased breast conservation rates. To improve the clinical response, metronomic chemotherapy with endocrine therapy is a promising strategy. A multicenter phase II single‐arm neoadjuvant trial with letrozole and cyclophosphamide was conducted. Eligibility criteria included postmenopausal status, T2–4 N0–1, and estrogen receptor‐positive breast carcinoma. Letrozole (2.5 mg) plus cyclophosphamide (50 mg) was given orally once a day for 24 weeks. The primary endpoint was the clinical response rate (CRR). To investigate anti‐angiogenic effects, circulating endothelial cells (CECs) were quantified using the CellSearch system. From October 2007 to March 2010, 41 patients were enrolled. The CRR was 67.5% (52.0–80.0%), which was above the prespecified threshold (65%). The conversion rate from total mastectomy to breast‐conserving surgery was 64% (18/28). Grade 3 or greater nonhematological toxicity was not reported. Clinical response was associated with improved disease‐free survival (DFS) (P = 0.020). The increase in CEC counts at 8 weeks was observed in nonresponders (P = 0.004) but not in responders. Patients with higher CEC counts at baseline or post‐treatment showed worse DFS than those with lower counts (P
Databáze: OpenAIRE
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