日本去势抵抗性前列腺癌伴骨转移患者中氯化镭-223的上市后监测——聚焦骨折的3年延长随访最终分析

Post-marketing surveillance of radium-223 chloride in Japanese patients with castration-resistant prostate cancer with bone metastasis-final analysis of 3-year extended follow-up focusing on bone fractures.

作者信息

Masumori Naoya, Hosono Makoto, Takahashi Shunji, Kakehi Yoshiyuki, Uemura Hirotsugu, Sunaya Toshiyuki, Shimotsumagari Kako, Matsuba Yasuhiro, Adachi Masatoshi, Kakiuchi Haruka, Kinuya Seigo

机构信息

Department of Urology, Sapporo Medical University School of Medicine, S1, W16, Chuo-ku, Sapporo, 060-8543, Japan.

Department of Radiology, Faculty of Medicine, Kindai University, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan.

出版信息

Int J Clin Oncol. 2025 Aug 8. doi: 10.1007/s10147-025-02846-7.

DOI:10.1007/s10147-025-02846-7

PMID:40779218

Abstract

BACKGROUND

A post-marketing surveillance (PMS) study was conducted in Japan to assess real-world outcomes with radium-223 treatment in men with metastatic castration-resistant prostate cancer (mCRPC). Results from the treatment period showed that radium-223 was generally well tolerated. Follow-up was subsequently extended to 3 years to collect data on fracture events. Results of the extended follow-up are now reported.

METHODS

This prospective, non-interventional, multicenter, single-cohort PMS study enrolled men with CRPC and bone metastases treated with radium-223 under clinical practice. Extended follow-up lasted until 3 years after the first administration of radium-223. Data on clinical fractures and survival were collected.

RESULTS

A total of 334 patients were enrolled, with a median follow-up of 15.3 months (range 1-50). The overall incidence proportion of fractures reported as adverse events was 7.76% (95% confidence interval [CI] 5.09-11.25%), with a fracture incidence rate of 5.22 patients [with fracture]/100 person-years (PY). Patients who received bone-modifying agents (BMAs) had a numerically lower incidence of fractures (5.85%; 3.46/100PY vs 9.93%; 7.92/100PY). Median overall survival was 26.32 months (95% CI 21.65-not reached).

CONCLUSION

Compared with existing reference data, there was no obvious increase in the incidence of clinical fractures in Japanese patients with mCRPC who were treated with radium-223 under clinical practice. As is already well known for androgen deprivation, BMAs may also be useful in reducing bone fracture after radium-223.

摘要

背景

在日本开展了一项上市后监测（PMS）研究，以评估镭-223治疗转移性去势抵抗性前列腺癌（mCRPC）男性患者的真实世界疗效。治疗期结果显示，镭-223总体耐受性良好。随后将随访期延长至3年，以收集骨折事件的数据。现将延长随访的结果报告如下。

方法

这项前瞻性、非干预性、多中心、单队列PMS研究纳入了在临床实践中接受镭-223治疗的CRPC和骨转移男性患者。延长随访持续至首次给予镭-223后3年。收集临床骨折和生存数据。

结果

共纳入334例患者，中位随访时间为15.3个月（范围1 - 50个月）。报告为不良事件的骨折总体发生率为7.76%（95%置信区间[CI]5.09 - 11.25%），骨折发生率为5.22例[骨折患者]/100人年（PY）。接受骨改良剂（BMA）治疗的患者骨折发生率在数值上较低（5.85%；3.46/100PY对比9.93%；7.92/100PY）。中位总生存期为26.32个月（95%CI 21.65 - 未达到）。