Phase II study of Radium‐223 dichloride combined with hormonal therapy for hormone receptor‐positive, bone‐dominant metastatic breast cancer

Autor: Naoto T. Ueno, Rie K. Tahara, Takeo Fujii, James M. Reuben, Hui Gao, Babita Saigal, Anthony Lucci, Toshiaki Iwase, Nuhad K. Ibrahim, Senthil Damodaran, Yu Shen, Diane D. Liu, Gabriel N. Hortobagyi, Debu Tripathy, Bora Lim, Beth A. Chasen
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Cancer Medicine, Vol 9, Iss 3, Pp 1025-1032 (2020)
Druh dokumentu: article
ISSN: 2045-7634
DOI: 10.1002/cam4.2780
Popis: Abstract Background Radium‐223 dichloride (Ra‐223) is a targeted alpha therapy that induces localized cytotoxicity in bone metastases. We evaluated the efficacy and safety of Ra‐223 plus hormonal therapy in hormone receptor‐positive (HR+), bone‐dominant metastatic breast cancer. Methods In this single‐center phase II study, 36 patients received Ra‐223 (55 kBq/kg intravenously every 4 weeks) up to 6 cycles with endocrine therapy. The primary objective was to determine the clinical disease control rate at 9 months. Secondary objectives were to determine (a) tumor response rate at 6 months, (b) progression‐free survival (PFS) durations, and (c) safety. Results The median number of prior systemic treatments for metastatic disease was 1 (range, 0‐4). The disease control rate at 9 months was 49%. The tumor response rate at 6 months was 54% (complete response, 21%; partial, 32%). The median PFS was 7.4 months (95% CI, 4.8‐not reached [NR]). The median bone‐PFS was 16 months (95% CI, 7.3‐NR). There were no grade 3/4 adverse events. Conclusions Ra‐223 with hormonal therapy showed possible efficacy in HR+ bone‐dominant breast cancer metastasis, and adverse events were tolerable. We plan to further investigate the clinical application of Ra‐223 in these patients. (NCT02366130).
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