European urology oncology · 2025
Outcomes for [177Lu]Lu-PSMA-617 with and Without Concurrent Use of Androgen Receptor Pathway Inhibitors in Patients with Metastatic Castration-resistant Prostate Cancer.
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Muniz Miguel, Sartor Oliver, Orme Jacob J, Koch Regina M, Scharf Zachary, Heath Elisabeth I, Zarka Jabra G, Kase Adam M, Riaz Irbaz B, Andrews Jack R, Thorpe Matthew P, Tuba Kendi A, Bilgin Gokce Belge, Johnson Geoffrey B, Kwon Eugene D, Childs Daniel S
Аннотация
BACKGROUND AND OBJECTIVE: Large clinical trials, including VISION, have established the safety of combining [177Lu]Lu-PSMA-617 with an androgen receptor pathway inhibitor (ARPI). Most patients receiving [177Lu]Lu-PSMA-617 in the real-world setting have already progressed on an ARPI. This study aimed to assess the efficacy of [177Lu]Lu-PSMA-617 in patients with and without the concurrent use of an ARPI.
METHODS: We analyzed data from the Mayo Clinic Rochester radiopharmaceutical database, focusing on patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed after prior exposure to an ARPI and started treatment with [177Lu]Lu-PSMA-617 between March 2022 and March 2023. Patients receiving concurrent ARPIs (abiraterone, enzalutamide, apalutamide, or darolutamide) were identified. Baseline characteristics were compared using Mann-Whitney U test and chi-square test. Outcomes of interest included prostate-specific antigen (PSA) 50 response, median number of cycles, and overall survival (OS) from the start of [177Lu]Lu-PSMA-617, analyzed using Kaplan-Meier estimates and multivariate Cox regression.
KEY FINDINGS AND LIMITATIONS: Among 256 patients, 106 (41.4%) received an ARPI with [177Lu]Lu-PSMA-617. Those receiving an ARPI had lower baseline PSA levels (3.4 vs 29.7 ng/ml, p < 0.001) and lower rates of bone (77.4% vs 87.4%, p = 0.035) and visceral (18.9% vs 34%, p = 0.008) metastases. While patients on ARPIs were more likely to complete all six cycles of [177Lu]Lu-PSMA-617 (63.2% vs 48.7%, p < 0.001), PSA50 response rates were similar (49.1% vs 47.3%, p = 0.786). Median OS was longer with concurrent ARPI use (not reached vs 15.3 mo, p < 0.001), but this difference was not significant on a multivariate analysis (hazard ratio = 1.03 [95% confidence interval: 0.68-1.55], p = 0.891) after accounting for baseline differences in other prognostic variables. Limitations include its single-center, retrospective design and a lack of standardized radiographic response assessment.
CONCLUSIONS AND CLINICAL IMPLICATIONS: Among men with mCRPC previously exposed to an ARPI, continuation of the ARPI with [177Lu]Lu-PSMA-617 did not improve PSA50 response rates or OS after adjusting for cohort imbalances in known prognostic factors. Further post hoc analyses using large clinical trial data are needed.
METHODS: We analyzed data from the Mayo Clinic Rochester radiopharmaceutical database, focusing on patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed after prior exposure to an ARPI and started treatment with [177Lu]Lu-PSMA-617 between March 2022 and March 2023. Patients receiving concurrent ARPIs (abiraterone, enzalutamide, apalutamide, or darolutamide) were identified. Baseline characteristics were compared using Mann-Whitney U test and chi-square test. Outcomes of interest included prostate-specific antigen (PSA) 50 response, median number of cycles, and overall survival (OS) from the start of [177Lu]Lu-PSMA-617, analyzed using Kaplan-Meier estimates and multivariate Cox regression.
KEY FINDINGS AND LIMITATIONS: Among 256 patients, 106 (41.4%) received an ARPI with [177Lu]Lu-PSMA-617. Those receiving an ARPI had lower baseline PSA levels (3.4 vs 29.7 ng/ml, p < 0.001) and lower rates of bone (77.4% vs 87.4%, p = 0.035) and visceral (18.9% vs 34%, p = 0.008) metastases. While patients on ARPIs were more likely to complete all six cycles of [177Lu]Lu-PSMA-617 (63.2% vs 48.7%, p < 0.001), PSA50 response rates were similar (49.1% vs 47.3%, p = 0.786). Median OS was longer with concurrent ARPI use (not reached vs 15.3 mo, p < 0.001), but this difference was not significant on a multivariate analysis (hazard ratio = 1.03 [95% confidence interval: 0.68-1.55], p = 0.891) after accounting for baseline differences in other prognostic variables. Limitations include its single-center, retrospective design and a lack of standardized radiographic response assessment.
CONCLUSIONS AND CLINICAL IMPLICATIONS: Among men with mCRPC previously exposed to an ARPI, continuation of the ARPI with [177Lu]Lu-PSMA-617 did not improve PSA50 response rates or OS after adjusting for cohort imbalances in known prognostic factors. Further post hoc analyses using large clinical trial data are needed.
Предметные рубрики MeSH
HumansMaleProstatic Neoplasms, Castration-ResistantDipeptidesAgedHeterocyclic Compounds, 1-RingLutetiumAndrogen Receptor AntagonistsNitrilesMiddle AgedTreatment OutcomeRetrospective StudiesProstate-Specific AntigenNeoplasm MetastasisPhenylthiohydantoinAged, 80 and overBenzamidesThiohydantoinsRadioisotopes