Treatment with trastuzumab deruxtecan in patients with HER2-positive breast cancer and brain metastases and/or leptomeningeal disease (ROSET-BM)

Naoki Niikura; Takashi Yamanaka; Hironori Nomura; Kazuhiro Shiraishi; Hiroki Kusama; Mitsugu Yamamoto; Kazuo Matsuura; Kenichi Inoue; Sachiko Takahara; Shosuke Kita; Miki Yamaguchi; Tomoyuki Aruga; Nobuhiro Shibata; Akihiko Shimomura; Yuri Ozaki; Shuji Sakai; Yoko Kiga; Tadahiro Izutani; Kazuhito Shiosakai; Junji Tsurutani

doi:10.1038/s41523-023-00584-5

Treatment with trastuzumab deruxtecan in patients with HER2-positive breast cancer and brain metastases and/or leptomeningeal disease (ROSET-BM)

NPJ Breast Cancer. 2023 Oct 11;9(1):82. doi: 10.1038/s41523-023-00584-5.

Authors

Naoki Niikura¹, Takashi Yamanaka², Hironori Nomura³, Kazuhiro Shiraishi⁴, Hiroki Kusama⁵, Mitsugu Yamamoto⁶, Kazuo Matsuura⁷, Kenichi Inoue⁸, Sachiko Takahara⁹, Shosuke Kita¹⁰, Miki Yamaguchi¹¹, Tomoyuki Aruga¹², Nobuhiro Shibata¹³, Akihiko Shimomura¹⁴, Yuri Ozaki¹⁵, Shuji Sakai¹⁶, Yoko Kiga¹⁷, Tadahiro Izutani¹⁷, Kazuhito Shiosakai¹⁸, Junji Tsurutani¹⁹

Affiliations

¹ Department of Breast Oncology, Tokai University School of Medicine, Kanagawa, Japan. niikura@is.icc.u-tokai.ac.jp.
² Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Kanagawa, Japan.
³ First Department of Surgery, University of the Ryukyus, School of Medicine, Okinawa, Japan.
⁴ Department of Medical Oncology, Nagoya Medical Center, Nagoya, Aichi, Japan.
⁵ Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka, Japan.
⁶ Department of Breast Surgery, Hokkaido Cancer Center, Hokkaido, Japan.
⁷ Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
⁸ Division of Breast Oncology, Saitama Cancer Center, Saitama, Japan.
⁹ Department of Breast Surgery, Kitano Hospital, Osaka, Japan.
¹⁰ Department of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
¹¹ Department of Breast Surgery, JCHO Kurume General Hospital, Fukuoka, Japan.
¹² Department of Breast Surgery, Komagome Hospital, Tokyo, Japan.
¹³ Cancer Treatment Center, Kansai Medical University Hospital, Osaka, Japan.
¹⁴ Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo, Japan.
¹⁵ Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.
¹⁶ Department of Imaging Diagnosis and Nuclear Medicine, Tokyo Women's Medical University, Tokyo, Japan.
¹⁷ Oncology Medical Science Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
¹⁸ Data Intelligence Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
¹⁹ Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.

Abstract

Therapeutic options for breast cancer patients with brain metastases (BM)/leptomeningeal carcinomatosis (LMC) are limited. Here, we report on the effectiveness and safety of trastuzumab deruxtecan (T-DXd) in human epidermal growth factor receptor 2-positive breast cancer patients with BM. Data were analyzed for 104 patients administered T-DXd. Overall response rate (ORR), progression-free survival (PFS), overall survival (OS), intracranial (IC)-ORR, and IC-PFS were evaluated. ORR by investigator assessment was 55.7% (total population). Median PFS was 16.1 months; 12-month OS rate was 74.9% (total population). Median time-to-treatment failure was 9.7 months. In 51 patients with BM imaging, IC-ORR and median IC-PFS by independent central review were 62.7% and 16.1 months, respectively. In 19 LMC patients, 12-month PFS and OS rates were 60.7% and 87.1%, respectively. T-DXd showed effectiveness regarding IC-ORR, IC-PFS, PFS, and OS in breast cancer patients with BM/active BM, and sustained systemic and central nervous system disease control in LMC patients.Trial Registration: UMIN000044995.

Grants and funding

Not applicable/Daiichi Sankyo Company (Sankyo Company)