Labadie Brian W, Morris David S, Bryce Alan H, Given Robert, Zhang Jingsong, Abida Wassim, Chowdhury Simon, Patnaik Akash
Section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, IL, USA.
Urology Associates, P.C., Nashville, TN, USA.
Cancer Manag Res. 2022 Feb 17;14:673-686. doi: 10.2147/CMAR.S335962. eCollection 2022.
The US Food and Drug Administration has recently granted accelerated approval of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib as treatment for men with metastatic castration-resistant prostate cancer (mCRPC) associated with a deleterious germline or somatic or (BRCA) alteration. As the safety profile of this new addition to the mCRPC treatment landscape may be unfamiliar to clinicians and patients, we summarize the data from the literature and provide practical guidelines for the management of treatment-emergent adverse events (TEAEs) that may occur during rucaparib treatment.
Safety data were identified from PubMed and congress publications of trials involving men with mCRPC treated with oral rucaparib monotherapy (600 mg twice daily). Management guidelines for TEAEs were developed based on trial protocols, prescribing information, oncology association guidance, and the authors' clinical experience.
In clinical trials of men with mCRPC who received rucaparib (n = 193), TEAEs observed were consistent with that of other PARP inhibitors. The most frequent any-grade TEAEs included gastrointestinal events, asthenia/fatigue, anemia, increased alanine/aspartate aminotransferase, rash, and thrombocytopenia; the most frequent grade ≥3 TEAE was anemia. The majority of TEAEs were self-limiting and did not require treatment modification or interruption. Here, we provide recommendations on management of the most common TEAEs reported with rucaparib as well as other TEAEs of interest.
Rucaparib's recent approval for treatment of BRCA-mutant mCRPC is practice changing. Proper management of TEAEs will allow maximum treatment benefit for patients receiving rucaparib.
美国食品药品监督管理局最近加速批准了聚（ADP - 核糖）聚合酶（PARP）抑制剂鲁卡帕尼，用于治疗患有有害种系或体细胞BRCA改变的转移性去势抵抗性前列腺癌（mCRPC）男性患者。由于临床医生和患者可能对mCRPC治疗领域这一新增药物的安全性概况尚不熟悉，我们总结了文献数据，并为鲁卡帕尼治疗期间可能发生的治疗突发不良事件（TEAE）的管理提供实用指南。
从PubMed以及涉及接受口服鲁卡帕尼单药治疗（每日两次，每次600mg）的mCRPC男性患者的试验会议出版物中识别安全性数据。基于试验方案、处方信息、肿瘤学协会指南以及作者的临床经验制定了TEAE的管理指南。
在接受鲁卡帕尼治疗的mCRPC男性患者的临床试验中（n = 193），观察到的TEAE与其他PARP抑制剂一致。最常见的任何级别TEAE包括胃肠道事件、乏力/疲劳、贫血、丙氨酸/天冬氨酸转氨酶升高、皮疹和血小板减少症；最常见的≥3级TEAE是贫血。大多数TEAE是自限性的，不需要调整治疗或中断治疗。在此，我们针对鲁卡帕尼报告的最常见TEAE以及其他相关TEAE的管理提供建议。
鲁卡帕尼最近被批准用于治疗BRCA突变的mCRPC，这改变了临床实践。对TEAE进行恰当管理将使接受鲁卡帕尼治疗的患者获得最大治疗益处。
