Changhai Hospital, Shanghai, China.
Sun Yat-Sen University Cancer Center, Guangzhou, China.
Asia Pac J Clin Oncol. 2021 Dec;17(6):462-470. doi: 10.1111/ajco.13479. Epub 2020 Oct 13.
Radium-223, a targeted alpha therapy, is approved widely for the treatment of patients with metastatic castrate-resistant prostate cancer, based on a pivotal phase 3 study in predominantly white patients. We investigated the efficacy and safety of radium-223 in Asian patients with castrate-resistant prostate cancer and metastatic bone disease.
This multicenter, prospective, single-arm, open-label phase 3 trial evaluated the efficacy and safety of the standard radium-223 regimen (55 kBq/kg every 4 weeks for six cycles) in patients from Asian countries. The primary endpoints were the safety and overall survival.
A total of 226 patients were enrolled and received at least one dose of radium-223. Median overall survival was 14.0 months (95% confidence interval [CI], 11.2-17.4). Median time to total alkaline phosphatase and prostate-specific antigen progression were 7.5 (95% CI, 6.8-7.7) and 3.6 (95% CI, 3.1-3.7) months, respectively. Median skeletal-related event-free survival was 26.0 months (95% CI, 12.6-not reached). Grade ≥3 treatment-emergent adverse events were reported in 103 (46%) of 226 patients, with anemia being the most common event (34 [15%] patients). Grade ≥3 drug-related treatment-emergent adverse events occurred in 39 (17%) of 226 patients. Serious treatment-emergent adverse events were reported in 65 (29%) of 226 patients. Seven (3%) patients had an adverse event leading to death; none were considered to be related to radium-223.
The results of this study support the use of the standard radium-223 regimen for the treatment of Asian patients with castrate-resistant prostate cancer and symptomatic bone metastases.
镭-223 是一种靶向 α 疗法，广泛批准用于治疗转移性去势抵抗性前列腺癌患者，基于主要为白人患者的关键 3 期研究。我们研究了镭-223 在亚洲去势抵抗性前列腺癌和转移性骨疾病患者中的疗效和安全性。
这项多中心、前瞻性、单臂、开放标签的 3 期试验评估了镭-223 标准方案（每 4 周 55 kBq/kg，共 6 个周期）在来自亚洲国家的患者中的疗效和安全性。主要终点是安全性和总生存期。
共纳入 226 例患者，并至少接受了一次镭-223 治疗。中位总生存期为 14.0 个月（95%置信区间[CI]，11.2-17.4）。中位碱性磷酸酶和前列腺特异性抗原总进展时间分别为 7.5 个月（95%CI，6.8-7.7）和 3.6 个月（95%CI，3.1-3.7）。中位骨骼相关事件无进展生存期为 26.0 个月（95%CI，12.6-未达到）。226 例患者中有 103 例（46%）报告了≥3 级治疗后出现的不良事件，贫血是最常见的事件（34 例[15%]患者）。226 例患者中有 39 例（17%）发生了≥3 级与药物相关的治疗后出现的不良事件。226 例患者中有 65 例（29%）报告了严重的治疗后出现的不良事件。7 例（3%）患者发生了导致死亡的不良事件；均与镭-223 无关。
这项研究的结果支持使用标准的镭-223 方案治疗亚洲去势抵抗性前列腺癌和有症状的骨转移患者。
