Efficacy and safety of rechallenge [177Lu]Lu-PSMA-617 RLT after initial partial remission in patients with mCRPC: evaluation of a prospective registry (REALITY study).

IF 8.6 1区 医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING European Journal of Nuclear Medicine and Molecular Imaging Pub Date : 2024-11-01 Epub Date: 2024-07-15 DOI:10.1007/s00259-024-06825-4
Florian Rosar, Joelle Schuler, Caroline Burgard, Arne Blickle, Mark Bartholomä, Stephan Maus, Sven Petto, Fadi Khreish, Andrea Schaefer, Samer Ezziddin
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Abstract

Aim: Rechallenge of [177Lu]Lu-PSMA-617 radioligand therapy (RLT) was proposed for patients who initially responded to PSMA-RLT experiencing partial remission, but relapsed into progression after a certain period of remission. However, only limited data is available regarding this approach. In this study, we analyzed the efficacy and safety profile of one or more series of [177Lu]Lu-PSMA-617 RLT rechallenge in patients from a prospective registry (REALITY Study, NCT04833517) after they initially benefited from PSMA-RLT.

Methods: Forty-seven patients with metastatic castration-resistant prostate cancer (mCRPC) who had biochemical response to initial [177Lu]Lu-PSMA-617 RLT followed by disease progression received at least one (up to three) series of [177Lu]Lu-PSMA-617 RLT rechallenge. Biochemical response rates based on prostate-specific antigen (PSA) serum value, PSA-based progression-free survival (PFS) and overall survival (OS) were calculated. Adverse events of the treatment were assessed according to 'common terminology criteria for adverse events' (CTCAE).

Results: After one series of RLT rechallenge, a PSA decline of at least 50% was achieved in 27/47 patients (57.4%). The median PFS of all patients was 8.7 mo and the median OS was 22.7 mo, each calculated from the administration of the first rechallenge series. Patients who responded (PSA decline > 50%) to the rechallenge showed a median OS of 27.3 mo. Regarding PFS, a significant correlation (r = 0.4128, p = 0.0323) was found for these patients comparing initial and rechallenge RLT. Ten patients received a second and 3 patients received a third rechallenge series with 8/10 and 3/3 patients responding to repeated RLT rechallenge. No severe deterioration of adverse events rated by CTCAE criteria was observed.

Conclusion: [177Lu]Lu-PSMA-617 RLT rechallenge is associated with significant PSA response and encouraging survival outcome as well as a very favourable safety profile and should therefore be considered as a straight-forward treatment option in mCRPC patients, who previously benefited from PSMA-RLT.

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mCRPC患者初次部分缓解后再次挑战[177Lu]Lu-PSMA-617 RLT的有效性和安全性:前瞻性登记评估(REALITY研究)。
目的:有人建议对那些最初对 PSMA-RLT 有反应并出现部分缓解,但在缓解一段时间后又复发、病情恶化的患者重新进行[177Lu]Lu-PSMA-617 放射配体治疗(RLT)。然而,有关这种方法的数据非常有限。在本研究中,我们分析了前瞻性注册研究(REALITY 研究,NCT04833517)中的患者在最初从 PSMA-RLT 中获益后进行一系列或多次 [177Lu]Lu-PSMA-617 RLT 再挑战的疗效和安全性:47例转移性耐受阉割前列腺癌(mCRPC)患者在首次接受[177Lu]Lu-PSMA-617 RLT治疗后出现生化反应,随后疾病进展,这些患者至少接受了一次(最多三次)[177Lu]Lu-PSMA-617 RLT再治疗。根据前列腺特异性抗原(PSA)血清值计算生化反应率,并计算基于PSA的无进展生存期(PFS)和总生存期(OS)。根据 "不良事件通用术语标准"(CTCAE)对治疗的不良事件进行了评估:经过一系列RLT再挑战治疗后,27/47名患者(57.4%)的PSA下降了至少50%。所有患者的中位 PFS 为 8.7 个月,中位 OS 为 22.7 个月,均从首次再挑战系列开始计算。对再挑战有反应(PSA下降>50%)的患者的中位OS为27.3个月。在 PFS 方面,这些患者的初始 RLT 与再挑战 RLT 相比,发现了明显的相关性(r = 0.4128,p = 0.0323)。10名患者接受了第二次再挑战,3名患者接受了第三次再挑战,8/10和3/3名患者对重复RLT再挑战有反应。根据CTCAE标准,未观察到不良反应严重恶化的情况:结论:[177Lu]Lu-PSMA-617 RLT再挑战与显著的PSA反应和令人鼓舞的生存结果以及非常有利的安全性相关,因此应被视为mCRPC患者的一种直接治疗选择,这些患者曾受益于PSMA-RLT。
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来源期刊
CiteScore
15.60
自引率
9.90%
发文量
392
审稿时长
3 months
期刊介绍: The European Journal of Nuclear Medicine and Molecular Imaging serves as a platform for the exchange of clinical and scientific information within nuclear medicine and related professions. It welcomes international submissions from professionals involved in the functional, metabolic, and molecular investigation of diseases. The journal's coverage spans physics, dosimetry, radiation biology, radiochemistry, and pharmacy, providing high-quality peer review by experts in the field. Known for highly cited and downloaded articles, it ensures global visibility for research work and is part of the EJNMMI journal family.
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