Raimondi Alessandra, Sepe Pierangela, Claps Melanie, Maccauro Marco, Aliberti Gianluca, Pagani Filippo, Apollonio Giulia, Randon Giovanni, Peverelli Giorgia, Seregni Ettore, Verzoni Elena, Procopio Giuseppe
Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Department of Nuclear Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Tumori. 2020 Oct;106(5):406-412. doi: 10.1177/0300891620905646. Epub 2020 Mar 2.
Therapeutic decision-making in metastatic castration-resistant prostate cancer (mCRPC) represents an open challenge. Radium-223 is approved for patients with symptomatic bone metastases, no visceral involvement, progressing after at least 2 lines of systemic therapy, or ineligible for any other systemic treatment.
We performed a retrospective, observational study on patients with mCRPC treated with radium-223 at our institution outside of clinical trials, to assess the safety and activity in a real-world population. Data regarding baseline patient/disease characteristics and treatment outcomes (number of cycles, treatment-related adverse events [AEs], cause of discontinuation, and best response) were collected.
Overall, 41 patients were treated from September 2015 to September 2018. Median age was 73 years; baseline Eastern Cooperative Oncology Group Performance Status (ECOG PS) was 0, 1, or 2 in 15%, 80%, and 5% of cases, respectively; and 3%, 41%, 44%, and 12% of patients had <6, 6-20, >20, and superscan bone lesions, respectively. A median number of 5 cycles (interquartile range 3-6) with median dose 19.52 MBq (interquartile range 12.87-24.83) was received. Treatment schedule was completed in 49% of cases; discontinuations due to AEs, disease-related death, or disease progression occurred in 24%, 33%, and 43% of patients, respectively. Any-grade AEs occurred in 73% and grade 3/4 treatment-related AEs occurred in 29% of patients, mainly anemia, decreased platelet count, and fatigue. No skeletal-related events or treatment-related deaths were recorded. After treatment, 66%, 2%, and 32% of patients had a stable, improved, or deteriorated ECOG PS versus baseline, respectively, and 24%, 61%, and 15% reported a stable, improved, or worsened pain symptom control. Post-treatment versus baseline alkaline phosphatase was reduced or stable in 46% and increased in 54% of patients, whereas prostate-specific antigen was decreased or stable in 83% and increased in 17% of patients.
Our study provides clinically useful real-world data on radium-223, highlighting the importance of multidisciplinary patient management to guarantee the best continuum of care for patients with mCRPC.
转移性去势抵抗性前列腺癌（mCRPC）的治疗决策是一项公开的挑战。镭-223被批准用于有症状性骨转移、无内脏受累、在至少2线全身治疗后病情进展或不符合任何其他全身治疗条件的患者。
我们对在我们机构接受镭-223治疗的mCRPC患者进行了一项回顾性观察研究（非临床试验），以评估真实世界人群中的安全性和活性。收集了有关基线患者/疾病特征和治疗结果（周期数、治疗相关不良事件[AEs]、停药原因和最佳反应）的数据。
总体而言，2015年9月至2018年9月期间共治疗了41例患者。中位年龄为73岁；基线东部肿瘤协作组体能状态（ECOG PS）为0、1或2的病例分别占15%、80%和5%；分别有3%、41%、44%和12%的患者有<6个、6 - 20个、>20个和全身骨扫描显示骨病变。患者接受的中位周期数为5个（四分位间距3 - 6），中位剂量为19.52 MBq（四分位间距12.87 - 24.83）。49%的病例完成了治疗计划；分别有24%、33%和43%的患者因AE、疾病相关死亡或疾病进展而停药。73%的患者发生了任何级别的AE，29%的患者发生了3/4级治疗相关AE，主要为贫血、血小板计数减少和疲劳。未记录到骨相关事件或治疗相关死亡。治疗后，分别有66%、2%和32%的患者ECOG PS相对于基线稳定、改善或恶化，分别有24%、61%和15%的患者报告疼痛症状控制稳定、改善或恶化。治疗后与基线相比，46%的患者碱性磷酸酶降低或稳定，54%的患者升高，而83%的患者前列腺特异性抗原降低或稳定，17%的患者升高。
我们的研究提供了关于镭-223的临床有用的真实世界数据，强调了多学科患者管理对于保证mCRPC患者获得最佳连续护理的重要性。
