欧洲常规临床实践中镭-223的药物利用情况（DIRECT）：一项上市后安全性研究。
Drug Utilisation of Radium-223 Under Routine Clinical Practice (DIRECT) in Europe: A Post-Authorisation Safety Study.
作者信息
Weinrib Rachel, Fortuny Joan, Martinez David, Kollhorst Bianca, Haug Ulrike, Kousholt Astrid, Ehrenstein Vera, Iversen Peter, Mortensen Jann, Bosch Dianne, Kuppen Malou, Pisa Federica, Vassilev Zdravko
机构信息
Department of Pharmacoepidemiology and Risk Management, RTI Health Solutions, Av. Diagonal, 605, 9-1, 08028, Barcelona, Spain.
Department of Biostatistics, RTI Health Solutions, Barcelona, Spain.
出版信息
Oncol Ther. 2025 Jun 16. doi: 10.1007/s40487-025-00344-4.
INTRODUCTION
Radium-223 is indicated for adults with metastatic castration-resistant prostate cancer (mCRPC) and symptomatic bone metastases, without visceral metastases, who progress after at least (≥) two lines of or are ineligible for other systemic therapies (besides luteinising hormone-releasing hormone analogues). Radium-223 is contraindicated in combination with abiraterone acetate and prednisone/prednisolone. Point 2 and the contraindication above were added to the 2018 European Medicines Agency (EMA) label. In the observational cohort study reported here, we evaluated compliance with the 2018 revised label.
METHODS
The proportion of patients with mCRPC who initiated radium-223 in the Netherlands, Germany and Denmark was analysed descriptively before (2013-2017) and after (2019-2020) the label change, allowing ≥ 6 months of follow-up. No a priori hypotheses were evaluated.
RESULTS
A total of 1070 patients were included in this observational cohort study (before/after the label change: Netherlands [243/53]; Germany [580/71]; Denmark [60/63]). Radium-223 use with abiraterone acetate or other systemic mCRPC therapies was limited and decreased after the label change in the Netherlands and Germany; in Denmark, combined use was not observed before the label change and was observed only rarely after the label change. After the label change, radium-223 use without ≥ 2 prior lines of systemic mCRPC therapy decreased in all countries, despite remaining relatively common in the Netherlands and Germany.
CONCLUSIONS
Radium-223 use in combination with abiraterone acetate or other systemic mCRPC therapies largely aligned with the 2018 EMA label change. However, after the label change, radium-223 use without ≥ 2 prior lines of systemic mCRPC therapy remained relatively common in the Netherlands and Germany, possibly because radium-223 was previously recommended as first-line treatment for frail patients, and doctors still may consider it for use in these cases. We could not assess patients' eligibility for other systemic mCRPC therapies; therefore, these findings may partly reflect radium-223 on-label use in patients with contraindications for other systemic therapies.
EMA STUDY IDENTIFICATION NUMBER
EUPAS37163.
引言
镭-223适用于患有转移性去势抵抗性前列腺癌（mCRPC）且有症状性骨转移、无内脏转移、在至少两线治疗后病情进展或不符合其他全身治疗（除促黄体激素释放激素类似物外）条件的成年患者。镭-223禁止与醋酸阿比特龙和泼尼松/泼尼松龙联合使用。上述第2点和禁忌内容已添加到2018年欧洲药品管理局（EMA）的药品标签中。在本报告的观察性队列研究中，我们评估了对2018年修订标签的依从性。
方法
对荷兰、德国和丹麦在标签更改前（2013 - 2017年）和更改后（2019 - 2020年）开始使用镭-223的mCRPC患者比例进行描述性分析，随访时间≥6个月。未评估先验假设。
结果
本观察性队列研究共纳入1070例患者（标签更改前后：荷兰[243/53]；德国[580/71]；丹麦[60/63]）。在荷兰和德国，镭-223与醋酸阿比特龙或其他全身性mCRPC治疗联合使用的情况有限，且在标签更改后有所减少；在丹麦，标签更改前未观察到联合使用情况，标签更改后仅偶尔观察到。标签更改后，在所有国家，未接受至少两线全身性mCRPC治疗就使用镭-223的情况有所减少，尽管在荷兰和德国仍然相对常见。
结论
镭-223与醋酸阿比特龙或其他全身性mCRPC治疗联合使用的情况在很大程度上与2018年EMA标签更改一致。然而，标签更改后，在荷兰和德国，未接受至少两线全身性mCRPC治疗就使用镭-223的情况仍然相对常见，可能是因为镭-223此前被推荐作为体弱患者的一线治疗药物，医生在这些情况下可能仍会考虑使用。我们无法评估患者是否符合其他全身性mCRPC治疗的条件；因此，这些发现可能部分反映了镭-223在有其他全身治疗禁忌证患者中的标签内使用情况。
EMA研究识别号：EUPAS37163
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