npj Breast Cancer (Oct 2023)

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
https://doi.org/10.1038/s41523-023-00584-5
Journal volume & issue
Vol. 9, no. 1
pp. 1 – 8

Abstract

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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.