Analysis of the efficacy and tolerance or darolutamide in combination with chemotherapy and ADT in patients with metastatic castration-sensitive prostate cancer (mCSPC) in the Spanish population in a daily clinic.

e17069 Background: Darolutamide is an inhibitor of the androgen receptor signaling pathway that increases overall survival both in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and in patients with high-volume mCSPC Smith et al. N Eng J Med 2022. Our objective is to analyze the efficacy and tolerance of darolutamide, in combination with chemotherapy and ADT (triplet therapy), in real-life data in several Spanish hospitals. Methods: A multicentric, observational, prospective study was performed in patients with mCSPC which started treatment with triplet therapy including darolutamide between 2022 and 2023 in some Spanish hospitals. A statistical analysis has been carried out with the SPSS v19 platform. Results: Between 2022 and 2023, 11 patients have been included, of which 10 have been analyzed. The mean age was 64 years (57-75 years), most patients with ECOG = 0 (60%) and ECOG = 1 (10%); the mean PSA diagnosis was 1025 ng/ml (12-4735 ng/ml). The majority of patients had a Gleason 9 (70%), 60% with extra regional lymph node metastases (M1a), 70% with bone metastases (M1b) and 60% with visceral metastases (M1c). The median time from diagnosis to statistical analysis was 580 days (366-700 days). The first patient was included in January 2022 and the last one was included in April 2023. Most patients started docetaxel and darolutamide was added a few weeks later. All patients achieved progression-free survival (PFS) with median of 14,5 months. The overall survival (OS) has not been reached. The median response time to 50% PSA was 3 months (2-8 months) and the median response time to 90% was 6 months (2-9 months); 30% of patients achieved complete PSA response. In relation to the objective response evaluation, 70% of the patients achieved a partial response, 30% stable disease and 11% presented disease progression; no complete radiological responses have been observed. Only 2 patients became castration resistant (one in 1 month and another in 11 months). Regarding adverse effects, 5 patients (50%) presented asthenia, 4 patients (40%) hematological toxicity (20% grade 3 neutropenia), 3 patients (30%) hot flashes, 2 patients (20%) elevated transaminases and 1 patient (10%) hyperglycemia; no patient had high blood pressure, weight gain, urinary tract infection or falls. Conclusions: The results of this analysis of real-life data confirm the efficacy of darolutamide within the triplet combination with chemotherapy and ADT in mCSPC patients, similar to the results of the already published phase III trial. Treatment with darolutamide was well tolerated. This analysis is limited by the retrospective nature and the small number of patients included.