Takayuki Iwamoto
   Department   Kawasaki Medical School  Kawasaki Medical School, Department of Breast and Thyroid Surgery,
   Position   Assistant Professor
Article types 原著
Language English
Peer review Peer reviewed
Title Neoadjuvant Chemotherapy with or without Concurrent Hormone Therapy in Estrogen Receptor-Positive Breast Cancer: NACED-Randomized Multicenter Phase II Trial.
Journal Formal name:Acta medica Okayama
Abbreviation:Acta Med Okayama
ISSN code:0386300X/0386300X
Domestic / ForeginForegin
Volume, Issue, Page 69(5),pp.291-9
Author and coauthor Kumi Sugiu, Takayuki Iwamoto, Catherine M Kelly, Naoki Watanabe, Takayuki Motoki, Mitsuya Ito, Shoichiro Ohtani, Kenji Higaki, Takako Imada, Takeshi Yuasa, Masako Omori, Hiroshi Sonobe, Toshiyoshi Fujiwara, Junji Matsuoka
Authorship 2nd author
Publication date 2015
Summary Although in the neoadjuvant setting for estrogen receptor (ER)-positive breast cancers, chemotherapy or hormone therapy alone does not result in satisfactory tumor response, it is unknown whether concurrent chemo-endocrine therapy is superior to chemotherapy alone in clinical outcomes. We conducted a randomized phase II trial to test the responses of ER-positive patients to concurrent administration of chemo-endocrine therapy in the neoadjuvant setting. Women with stage II-III, ER-positive, invasive breast cancer (n=28) received paclitaxel followed by fluorouracil, epirubicin, cyclophosphamide (T-FEC) and were randomized to receive concurrent chemo-endocrine therapy consisting of goserelin administered subcutaneously for premenopausal women or an aromatase inhibitor for postmenopausal women. The primary endpoint was the pathological complete response (pCR) rate after neoadjuvant therapy. Twenty-eight patients were randomized. There were no significant differences in pCR rate between the concurrent group (12.5%;2/16) and the chemotherapy alone group (8.3%;1/12). Tumor size after therapy was significantly reduced in the concurrent therapy group (p=0.035), but not in the chemotherapy-alone group (p=0.622). Neoadjuvant chemotherapy with concurrent hormone therapy provided no significant improvement in pCR rate in ER-positive breast cancers. These preliminary results should be followed up by further studies.
DOI 10.18926/AMO/53675
PMID 26490026