Real world data of apalutamid in the treatment of prostate cancer: Data of the German multicenter AmPel trial.

Abstract

e17073 Background: Apalutamide (Apa) is a competitive inhibitor of the androgen receptor binding directly to the ligand-binding domain. In metastatic castration-sensitive prostate cancer (mCSPC) as well as non-metastatic castration-resistant prostate cancer (nmCRPC) Apa demonstrated a survival benefit in Phase-III trials. Nevertheless Real World data are still lacking. Methods: In the retrospective, multicenter AmPel trial (Apalutamid in prostate cancer in middle-Hessen) data of mCSPC and nmCRPC pat were collected before and during Apa treatment in routine clinical practice. Beside pat and tumor specific data side-effects, dose-modifications, response and subsequent therapies were assessed. Results: To date 100 pat were included since 11/2021. General data are summarized in table 1. mCSPC (n = 74): mFU 10 month (1-30). 75% showed mets at initial diagnosis: 56% with osseous, 15% with viszeral and 29% with oss/visz mets. PSA before therapy 13.5 ng/ml decreased to 0.2 ng/ml (-98.9%) after 3 mo. 77.4% showed a PSA decrease > 90% and 49% a PSA level of < 0.2 ng/ml after 6 mo. AEs ≥ 3: 12.3%. In 12.3% dose reduction was necessary. In 21% therapy was stopped due to toxicity (10.9%), progression (5.5%) and patient will (5.5%). 3 patients died: 1 due to PCA progression. PFS is not reached. nmCRPC (n = 26): mFU 15 month (3-30). Time after initial diagnosis: 6 y (1-22). PSA-Doubling time 3.9 mo (1-10). PSA before therapy 7.2 ng/ml with a decrease of 94.7% after 3 mo (0.45 ng/ml) and 62.5% with a PSA decrease > 90%. AEs ≥3: 5%. In 15.4% dose-reduction was necessary. In 24% therapy was stopped due to toxicity (5%), progression (9.5%) and patient will (9.5%). MFS is not reached. No increased adverse events were observed in case of statin and anticoagulant medication. Conclusions: Compared to Phase III trials this first real-world data of the AmPel-trial showed treatment of older and more co-morbid mCSPC and nmCRPC patients in clinical practice. Apa treatment resulted in a rapid PSA-response, was safe and effective with tolerable and manageable side effects in real world unselected patients. PSMA-PET/CT is not used in daily practice as well as Conference decisions before therapy. Updated data of the ongoing AmPel trial will be presented. [Table: see text]