{
  "abstract": "Background and Importance Apalutamide, enzalutamide and darolutamide are oral treatments. They have been approved in combination with androgen deprivation therapy. The therapeutic efficacy and safety of darolutamide were established in two multicentre, randomised, placebo-controlled phase III studies in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) (ARAMIS) and metastatic hormone-sensitive prostate cancer (mHSPC) (ARASENS). Darolutamide was commercialised in 2020.Aim and Objectives To evaluate the therapeutic efficacy and safety of darolutamide in patients with mHSPC and nmCRPC in the routine clinical practice conditions.Material and Methods Retrospective observational multicentre study. All patients with darolutamida and with at least 3 months of clinical follow-up in 3 public hospitals in Spain (Huelva, Córdoba and Santa Cruz de Tenerife) were included. Data on age, diagnosis, disease volume (high/low), median PSA before darolutamide, median time from diagnosis to initiation of darolutamide, PSA decline after 3 y 12 months of darolutamide, patients continuing on treatment at 12 months, and reason for treatment discontinuation (toxicity or death/progression) were collected from digital medical records. A comprehensive descriptive statistical analysis was performed.Results 51 patients were included with a median age of 77(IQR=71-84) years. 14 patients started darolutamide for mHSPC and the rest for nmCRPC. In 24 patients, the disease volume at diagnosis was high and the rest had undergone some prior treatment. The median pre-treatment PSA was 4,2(IQR=1,5-13,3) ng/ml and the median time from diagnosis to darolutamide was 3,45(IQR=1,5-31,6) months. After 3 months of treatment with darolutamide, 54,9% of patients achieved >90% reduction in baseline PSA and 82,4% achieved >50% reduction in PSA in real-world condition. After 12 months, 22 patients continued with darolutamide, 15 patients achieved >90% reduction in baseline PSA. Only 7 patients discontinued treatment due to: disease progression(4), death(1), other reasons (1) and gastrointestinal toxicity(1).Conclusion and Relevance Darolutamide shows high efficacy, reduction of PSA >90% after 3 and 12 months of treatment, with an acceptable toxicity profile in routine clinical practice conditions. The inclusion of patients with and without metastases reinforces its therapeutic versatility and the possibility of integrating the drug into different stages of management.This study provides real data from three Spanish public hospitals, providing local evidence on the efficacy and safety of darolutamide.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Juan Ramón Jiménez, Hospital Pharmacy, Huelva, Spain"
      ],
      "name": "DS Loreto"
    },
    {
      "affiliations": [
        "Hospital Juan Ramón Jiménez, Hospital Pharmacy, Huelva, Spain"
      ],
      "name": "T Blanco-Espeso"
    },
    {
      "affiliations": [
        "Hospital Universitario Reina Sofia, Hospital Pharmacy, Cordoba, Spain"
      ],
      "name": "B Aparicio-Castellano"
    },
    {
      "affiliations": [
        "Hospital Universitario Nuestra Señora De Candelaria, Hospital Pharmacy, Santa Cruz De Tenerife, Spain"
      ],
      "name": "J Esquivel Negrín"
    },
    {
      "affiliations": [
        "Hospital Juan Ramón Jiménez, Hospital Pharmacy, Huelva, Spain"
      ],
      "name": "I Corriente Gordón"
    },
    {
      "affiliations": [
        "Hospital Juan Ramón Jiménez, Hospital Pharmacy, Huelva, Spain"
      ],
      "name": "E Paradela García"
    }
  ],
  "title": "4CPS-223 Efficacy and safety of darolutamide in the routine clinical practice conditions",
  "uid": "efecfc70-678c-524a-9b54-0e375181caae"
}