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Neoadjuvant exemestane or exemestane plus docetaxel and cyclophosphamide tailored by clinicopathological response to 12 weeks' exemestane exposure in patients with estrogen receptor‐positive breast cancer: A multicenter, open‐label, phase II study
- Source :
- Cancer Medicine, Vol 8, Iss 12, Pp 5468-5481 (2019), Cancer Medicine
- Publication Year :
- 2019
- Publisher :
- Wiley, 2019.
-
Abstract
- Our aim was to investigate the efficacy and safety of initial neoadjuvant endocrine therapy with exemestane alone followed by tailored treatment, either continued exemestane monotherapy or exemestane plus docetaxel–cyclophosphamide (TC) combination therapy, in postmenopausal patients with primary invasive estrogen receptor–positive, human epidermal growth factor receptor 2–negative, stage I‐IIIA breast cancer and Ki67 labeling index ≤30%. In this open‐label phase II study, patients initially received exemestane 25 mg/d for 12 weeks. Responders were defined as patients who achieved complete response (CR), partial response (PR) with Ki67 labeling index ≤5% after treatment, or stable disease with Ki67 labeling index ≤5% both before and after treatment. For the subsequent 12 weeks, exemestane monotherapy was continued for responders (group A), whereas nonresponders received exemestane plus four cycles of TC (docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 every 3 weeks) (group B). Clinical response rate (ie the proportion of patients with CR or PR) at 24 weeks was the primary endpoint. Of 64 patients provisionally enrolled between December 2010 and May 2016, 58 (median age 60 years) started the study treatment. Five patients discontinued treatment in the initial exemestane monotherapy period, and 39 completed the study treatment. Clinical response rates at 8‐12 and 24 weeks were 71% (10/14, 95% confidence interval [CI] 41.9%‐91.6%) and 57% (8/14, 95% CI 28.9%‐82.3%), respectively, in group A, and 16% (4/25, 95% CI 4.5%‐36.1%) and 56% (14/25, 95% CI 34.9%‐75.6%), respectively, in group B. Grade ≥3 adverse events were reported in 8% (1/15) and 53% (20/38) in group A and group B, respectively. The tailored treatment maintained the favorable clinical response to exemestane alone in responders and improved clinical response in nonresponders. Trial number UMIN000004752 (UMIN Clinical Trials Registry).<br />Change in Ki67 labeling index over the course of the study in patients receiving continued exemestane monotherapy (A) and those receiving exemestane plus docetaxel–cyclophosphamide) (B).
- Subjects :
- 0301 basic medicine
Cancer Research
medicine.medical_specialty
Cyclophosphamide
Combination therapy
Phases of clinical research
Ki67 labeling index
Docetaxel
Gastroenterology
lcsh:RC254-282
Drug Administration Schedule
aromatase inhibitors
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Breast cancer
Exemestane
Internal medicine
medicine
Clinical endpoint
breast neoplasms
Humans
Radiology, Nuclear Medicine and imaging
Adverse effect
Aged
Original Research
business.industry
Clinical Cancer Research
Middle Aged
docetaxel and cyclophosphamide
medicine.disease
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Survival Analysis
Neoadjuvant Therapy
Tumor Burden
Androstadienes
Treatment Outcome
030104 developmental biology
Receptors, Estrogen
Oncology
chemistry
030220 oncology & carcinogenesis
Female
business
tailored therapy
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 20457634
- Volume :
- 8
- Issue :
- 12
- Database :
- OpenAIRE
- Journal :
- Cancer Medicine
- Accession number :
- edsair.doi.dedup.....c2093ba1fa60a6dcee8dc4acc75c23af