One-Year Postapproval Clinical Experience with Radium-223 Dichloride in Patients with Metastatic Castrate-Resistant Prostate Cancer
One-Year Postapproval Clinical Experience with Radium-223 Dichloride in Patients with Metastatic Castrate-Resistant Prostate Cancer
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DOI：
10.1089/cbr.2014.1802
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发表时间：
2015-06-01
影响因子：
3.4
通讯作者：
Conti, Peter S.
中科院分区：
文献类型：
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作者：
Jadvar, Hossein;Challa, Sudha;Conti, Peter S.
目的：我们报告了镭-223二氯化物用于治疗去势抵抗性前列腺癌骨转移的1年批准后临床经验。方法：回顾性分析25例原发性高血压患者的临床资料。确定血液学、胃肠道和其他不良事件的发生率，包括导致治疗停止或延迟的事件。评价骨痛、血清碱性磷酸酶和前列腺特异性抗原（PSA）水平的变化。结果如下：6例患者接受了所有6次预定剂量的镭-223二氯化物，2例完成了5次剂量，6例接受了4次剂量，2例完成了3次剂量，6例接受了2次剂量，3例接受了1次剂量，总计给药91次。9名患者在接受至少一剂药物后因疾病进展而停止治疗，5名患者需要输血，5名患者出现胃肠道症状，4名患者报告骨痛恶化，1名患者出现皮炎。血清碱性磷酸酶和PSA下降趋势分别见于11例和5例患者。结论：大约四分之一的队列完成了整个六剂治疗。软组织疾病进展是停止治疗的主要原因。不良事件较轻且可管理。血清碱性磷酸酶下降比PSA下降更常见。
Objectives: We report our 1-year postapproval clinical experience with Radium-223 dichloride for treatment of castrate-resistant prostate cancer with bone metastases. Methods: The clinical courses of the first 25 patients treated were reviewed retrospectively. Incidence of hematologic, gastrointestinal, and other adverse events were identified, including those events that led to cessation or delay in treatment. Alterations in bone pain and serum alkaline phosphatase and prostate-specific antigen (PSA) levels were evaluated. Results: Six patients received all 6 scheduled doses of Radium-223 dichloride, 2 completed 5 doses, 6 received 4 doses, 2 completed 3 doses, 6 patients had 2 doses, and 3 patients received one dose, for a total of 91 doses administered. Nine patients discontinued treatment after receiving at least one dose due to progressive disease, 5 required blood transfusions, 5 developed gastrointestinal symptoms, 4 reported worsening bone pain, and 1 developed dermatitis. Downward trends in serum alkaline phosphatase and PSA were seen in 11 and 5 patients, respectively. Conclusions: About one-quarter of cohort completed the entire six-dose treatment. Advancing soft tissue disease was the primary reason for cessation of therapy. The adverse events were mild and manageable. A decline in serum alkaline phosphatase was more common than a decline in PSA.