Abstract 5771
Background
Final analysis of our experience with 177Lutetium-labeled prostate-specific membrane antigen-ligand (177Lu-PSMA-I&T) for systemic radioligand therapy in 100 consecutive patients with metastatic castration-resistant prostate cancer (mCRPC).
Methods
Patients were treated under a review board-approved compassionate use protocol. Eligibility criteria for 177Lu-PSMA-I&T therapy included previous treatment with abiraterone or enzalutamide, taxane-based chemotherapy or unsuitability for taxanes as well as positive 68Ga-PSMA tracer uptake of metastases in a prior PET-scan. Intravenous treatment with 177Lu-PSMA-I&T was given 6- to 8-weekly with an activity of 7.4GBq up to 6 cycles in patients without clinical or radiographic progression. We report prostate-specific antigen (PSA) decline, clinical progression-free survival (cPFS), overall survival (OS), subgroupanalysis and toxicity.
Results
Median age was 72 years (range 46-85) and median PSA level was 165 ng/ml (range 0-6178). Bone, lymph node and visceral metastases were present in 96%, 87% and 35% of patients. The median number of previous treatment regimens for mCRPC was 3 (range 1-6) and 82% of patients were pretreated with chemotherapy. At the time of evaluation, 319 cycles with 177Lu-PSMA-I&T were applied (median 2 cycles per patient, range 1-6). No treatment was ongoing. 4 and 6 cycles were applied in 44 and 20 patients. PSA decline ≥30%, ≥50% and ≥90% was achieved in 47%, 38% and 11% of patients. Median cPFS was 4.1 months (95%CI 2.5-5.7) and median OS was 12.9 months (95%CI 9.9-15.9). In the subgroupanalysis visceral metastases were associated with a worse prognosis concerning PSA decline >50% (26 vs. 44%, p = 0.06), median cPFS (3.1 vs. 5.9 months, p < 0.01) and median OS (8.0 vs. 14.0%, p = <0,05). Treatment-emergent hematologic grade 3/4 toxicities were anemia (9%), thrombocytopenia (4%) and neutropenia (6%). Grade 3/4-non-hematologic toxicities were not observed. The main non-hematologic grade 1/2 toxicities were dry mouth (24%), fatigue (20%) and loss of appetite (10%).
Conclusions
Radioligand therapy with 177Lu-PSMA I&T appears to be safe and active in late-stage mCRPC.
Clinical trial identification
Legal entity responsible for the study
Klinikum rechts der Isar, Technical University Munich.
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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