Characteristics, tolerance and effectiveness of patients aged more or less than 75 years treated with [177Lu]Lu-PSMA-617 as part of France’s early access program

Background[177Lu]Lu-PSMA-617 (Lu-PSMA) is a treatment available in France as part of France’s early access program. Lu-PSMA is available for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) expressing PSMA, previously treated with at least 1 taxane chemotherapy and 1 next generation hormonal agent. Its safety profile in the elderly is not known. This retrospective study compares tpts aged >75 years old (yo) treated compared to pts ≤75yo.MethodsFrom 01.12.2021 to 31.01.2024, 1696 pts were included. Recommended administration schedule was 6 intravenous injections of Lu-PSMA (7.4 GBq) every 6 weeks. Pts characteristics, efficacy, and safety data were collected during the 6 follow-up visits.Results645 pts >75yo (39.7%) and 981 pts ≤75 yo (60.3%) were included. Pts >75yo had the following characteristics (vs pts ≤75yo) : ECOG score [0-1] 84.1% vs 89.2 (p<0.001); Median PSA 64.5 ng/ml vs 52.6 ng/ml (p=0.23); metastases by site: bone 92.9% vs 93.9% (p=0.42); lymph nodes 57.8% vs 61.5% (p=0.14); hepatic 9.8% vs 8.9%(p=0.54); number of systemic treatment lines ≥ 3 77.5% vs 78.4%; pain management by opioids 21.6% vs 31.3% (p<0.001). Between 01.12.2021 and 30.04.2023, 790 pts received at least 1 Lu-PSMA infusion and underwent clinical, biological and radiological evaluations, of whom 294 pts >75 yo (37.2%). Median follow-up time period was approx. 7 mo. The median time to imaging PFS was not statistically different 6.93 mo [5.78 - 7.66] for pts<75 yo vs 7.98 mo [6.11 - 8.21] for pts >75 yo. 82.9% of pts>75 yo and 80.8% of pts ≤75 yo had a controlled PSA level (decrease or stabilization). Over this period, 85 pts ≤75yo and 68 pts>75 yo had dose adaptation (p=0.039). There was no significant difference between the 2 populations regarding reasons for discontinuing treatment, progression of the disease, serious adverse effects or death.ConclusionsPts treated in the France's early access program with Lu-PSMA for mCRPC shows few differences for pts >75 yo compared to pts ≤75 yo concerning pts characteristics and safety. However, no differences in terms of radiological and biological response were observed. These data suggest that age alone should not preclude the use of Lu-PSMA in pts >75 yo.Legal entity responsible for the studyAdvanced Accelerator Applications - Novartis.FundingAdvanced Accelerator Applications - Novartis.DisclosureD. Tonnelet: Financial Interests, Other: AAA-Novartis, Astellas. J. Farce: Financial Interests, Other: Boston Scientific. C. Merlin: Financial Interests, Other: Astellas, Curium, AAA-Novartis, Janssen, Pfizer, Bayer, AstraZeneca, BMS, Telix, Gilead. A. Cottereau: Financial Interests, Other: AAA-Novartis. S. Chene: Financial Interests, Full or part-time Employment: AAA-Novartis. C. BAILLY: Financial Interests, Advisory Board: Boston Scientific, AAA-Novartis, Sirtex Medical, Telix Radiopharmaceuticals. L. Mourey: Financial Interests, Advisory Role: Astellas, Janssen, MSD, BMS, Ipsen, AstraZeneca, Pfizer, Merck, AAA-Novartis; Financial Interests, Speaker, Consultant, Advisor: Sanofi. All other authors have declared no conflicts of interest.