Purpose <p>This study aimed to evaluate the real-world effectiveness, survival outcomes, and safety profile of [<sup>177</sup>Lu]Lu-PSMA radioligand therapy (PSMA RLT) in an Asian cohort of patients with metastatic castration-resistant prostate cancer (mCRPC).</p> Methods <p>This retrospective patient-based cohort study included 14 patients with mCRPC who underwent [<sup>177</sup>Lu]Lu-PSMA RLT between November 2020 and February 2025. Biochemical response was defined as a ≥ 50% PSA decline. Overall survival (OS) was estimated using Kaplan–Meier analysis. Statistical analyses were performed using SPSS version 23.0, with <i>p</i> &lt; 0.05 considered statistically significant. Adverse events were graded according to CTCAE v5.0.</p> Results <p>Fourteen patients (median age: 65 years) with a median of 4 prior therapy lines (range: 3–5) and a median follow-up of 14 months (range: 5–52) received 2–9 treatment cycles (median: 4), for a total of 63 cycles. The median administered activity was 7,400 MBq per cycle (range: 2,035–7,400 MBq), with a median cumulative administered activity of 27,935 MBq. PSA declines &gt; 30%, ≥ 50%, and ≥ 80% occurred in 57.1%, 50.0%, and 42.9% of patients, respectively. Median OS was significantly longer in PSA responders than non-responders (15.0 vs. 9.0 months; <i>p</i> = 0.037). Hematologic toxicities were predominantly grade 1–2, with one case of grade 4 thrombocytopenia.</p> Conclusion <p>[¹⁷⁷Lu]Lu-PSMA RLT demonstrated encouraging efficacy and tolerability in this real-world Asian mCRPC cohort. A ≥ 50% PSA decline was associated with improved OS. Favorable responses observed in selected patients receiving lower administered activities should be interpreted cautiously and considered hypothesis-generating, requiring validation in prospective studies.</p>

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Clinical Outcomes of [177Lu]Lu-PSMA Therapy in mCRPC: PSA Response as a Prognostic Marker and Considerations for Individualized Treatment

  • Hendra Budiawan,
  • Budi Darmawan,
  • Ferry Safriadi,
  • Indra Wijaya,
  • Arifudin Achmad,
  • Sawkar Vijay Pramod,
  • Aaron Tigor Sihombing,
  • Hadi Marzuki,
  • M. Arifin Fahmi,
  • Rian Hidayatullah,
  • William Korompis,
  • Andreas Lim,
  • Basuki Hidayat,
  • A. Hussein S. Kartamihardja

摘要

Purpose

This study aimed to evaluate the real-world effectiveness, survival outcomes, and safety profile of [177Lu]Lu-PSMA radioligand therapy (PSMA RLT) in an Asian cohort of patients with metastatic castration-resistant prostate cancer (mCRPC).

Methods

This retrospective patient-based cohort study included 14 patients with mCRPC who underwent [177Lu]Lu-PSMA RLT between November 2020 and February 2025. Biochemical response was defined as a ≥ 50% PSA decline. Overall survival (OS) was estimated using Kaplan–Meier analysis. Statistical analyses were performed using SPSS version 23.0, with p < 0.05 considered statistically significant. Adverse events were graded according to CTCAE v5.0.

Results

Fourteen patients (median age: 65 years) with a median of 4 prior therapy lines (range: 3–5) and a median follow-up of 14 months (range: 5–52) received 2–9 treatment cycles (median: 4), for a total of 63 cycles. The median administered activity was 7,400 MBq per cycle (range: 2,035–7,400 MBq), with a median cumulative administered activity of 27,935 MBq. PSA declines > 30%, ≥ 50%, and ≥ 80% occurred in 57.1%, 50.0%, and 42.9% of patients, respectively. Median OS was significantly longer in PSA responders than non-responders (15.0 vs. 9.0 months; p = 0.037). Hematologic toxicities were predominantly grade 1–2, with one case of grade 4 thrombocytopenia.

Conclusion

[¹⁷⁷Lu]Lu-PSMA RLT demonstrated encouraging efficacy and tolerability in this real-world Asian mCRPC cohort. A ≥ 50% PSA decline was associated with improved OS. Favorable responses observed in selected patients receiving lower administered activities should be interpreted cautiously and considered hypothesis-generating, requiring validation in prospective studies.