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• W4361951409 abstract "<div>Abstract<p><b>Purpose:</b> To assess the efficacy of a single infusion of radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 (lutetium-177; ¹⁷⁷Lu) by prostate-specific antigen (PSA) decline, measurable disease response, and survival.</p><p><b>Experimental Design:</b> In this dual-center phase II study, two cohorts with progressive metastatic castration-resistant prostate cancer received one dose of ¹⁷⁷Lu-J591 (15 patients at 65 mCi/m², 17 at 70 mCi/m²) with radionuclide imaging. Expansion cohort (<i>n</i> = 15) received 70 mCi/m² to verify response rate and examine biomarkers.</p><p><b>Results:</b> Forty-seven patients who progressed after hormonal therapies (55.3% also received prior chemotherapy) received ¹⁷⁷Lu-J591. A total of 10.6% experienced ≥50% decline in PSA, 36.2% experienced ≥30% decline, and 59.6% experienced any PSA decline following their single treatment. One of 12 with measurable disease experienced a partial radiographic response (8 with stable disease). Sites of prostate cancer metastases were targeted in 44 of 47 (93.6%) as determined by planar imaging. All experienced reversible hematologic toxicity, with grade 4 thrombocytopenia occurring in 46.8% (29.8% received platelet transfusions) without significant hemorrhage. A total of 25.5% experienced grade 4 neutropenia, with one episode of febrile neutropenia. The phase I maximum tolerated dose (70 mCi/m²) resulted in more 30% PSA declines (46.9% vs. 13.3%, <i>P</i> = 0.048) and longer survival (21.8 vs. 11.9 months, <i>P</i> = 0.03), but also more grade 4 hematologic toxicity and platelet transfusions. No serious nonhematologic toxicity occurred. Those with poor PSMA imaging were less likely to respond.</p><p><b>Conclusion:</b> A single dose of ¹⁷⁷Lu-J591 was well tolerated with reversible myelosuppression. Accurate tumor targeting and PSA responses were seen with evidence of dose response. Imaging biomarkers seem promising. <i>Clin Cancer Res; 19(18); 5182–91. ©2013 AACR</i>.</p></div>" @default.
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• W4361951409 date "2023-03-31" @default.
• W4361951409 modified "2023-10-16" @default.
• W4361951409 title "Data from Phase II Study of Lutetium-177–Labeled Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody J591 for Metastatic Castration-Resistant Prostate Cancer" @default.
• W4361951409 doi "https://doi.org/10.1158/1078-0432.c.6522521.v1" @default.
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