オノ　マキコ   ONO Makiko   小野　麻紀子    所属   医学部 医学科（東京女子医科大学病院）    職種   准教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Efficacy and prognostic predictors of primary systemic therapy for de novo Stage IV breast cancer. Exploratory analysis of JCOG1017 PRIM-BC.
掲載誌名	正式名：Breast cancer (Tokyo, Japan) 略　 称：Breast Cancer ISSNコード：18804233/13406868
巻・号・頁	33(2),pp.396-406
著者・共著者	Tadahiko Shien, Makoto Ishitobi, Keita Sasaki, Kiyo Tanaka, Akihiko Shimomura, Takahiro Tsukioki, Yasuaki Sagara, Yuri Kimura, Kaori Terata, Takayuki Ishiba, Hiroyuki Yasojima, Makiko Ono, Kyoko Goda, Yoichi Naito, Tomomi Fujisawa, Fumikata Hara, Gakuto Ogawa, Haruhiko Fukuda, Hiroji Iwata,
発行年月	2026/03
概要	The optimal initial systemic therapy for de novo Stage IV breast cancer (BC) is critical, particularly to assess early drug efficacy. In the JCOG1017 trial, untreated de novo Stage IV BC patients received 3 months of subtype-based systemic therapy before randomization for primary tumor resection. Among 569 treated patients, the overall non-progression disease (non-PD: no 10% or more increase in maximum diameter) rate was 77.2%, and the objective response rate (ORR) was 29.0%. By subtype, non-PD/ORR rates were TN (78.2%/36.4%), Luminal (75.4%/13.4%), HER2 (92.9%/81.0%), and Luminal-HER2 (66.7%/40.3%). Multivariable analysis revealed higher non-PD rates in postmenopausal patients (odds ratio (OR) 1.673, p = 0.024) and those with PgR-positive tumors (OR 2.391, p = 0.0019). Endocrine therapy was more effective for patients with PgR-positive tumors (OR 3.258, p < 0.0001) and less practical in those with visceral metastasis (OR 0.605, p = 0.0334). HPD (Trastuzumab, Pertuzumab, Docetaxel)/HPTX (Trastuzumab, Paclitaxel) therapies (non-PD rate: 92.7%) were highly effective for visceral metastasis (OR = 15.818, p = 0.0030). Patients without progression at 3 months had significantly better overall survival (HR 0.508, 95% CI [0.398, 0.648]). These findings emphasize that initial therapy must align with subtype, and endocrine monotherapy is suboptimal for ER + HER2 + BC. Effective strategies are needed for those with early progression.
DOI	10.1007/s12282-025-01821-4
PMID	41619104