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

Cancer Medicine

Shinji Ohno¹  Takayuki Ueno²  Satoshi Morita³  Chizuko Kanbayashi⁴  Koji Kaneko⁴  Nobuaki Sato⁴  Takashi Morimoto⁵  Shigehira Saji⁶  Hironobu Sasano⁷  Masakazu Toi⁸  Hiroyuki Yasojima⁹  Norikazu Masuda⁹ 

[1] Breast Oncology Center Cancer Institute Hospital Tokyo Japan;Breast Surgical Oncology, Breast Oncology Center Cancer Institute Hospital Tokyo Japan;Department of Biomedical Statistics and Bioinformatics Kyoto University Graduate School of Medicine Kyoto Japan;Department of Breast Oncology Niigata Cancer Center Hospital Niigata Japan;Department of Breast Surgery Yao Municipal Hospital Osaka Japan;Department of Medical Oncology Fukushima Medical University Fukushima Japan;Department of Pathology Tohoku University Miyagi Japan;Department of Surgery (Breast Surgery), Graduate School of Medicine Kyoto University Kyoto Japan;Department of Surgery, Breast Oncology National Hospital Organization Osaka National Hospital Osaka Japan;

关键词: aromatase inhibitors;    breast neoplasms;    docetaxel and cyclophosphamide;    Ki67 labeling index;    tailored therapy;   

DOI  :  10.1002/cam4.2423

来源: DOAJ

【 摘 要 】

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).

【 授权许可】

Unknown