%0 Multicenter Study
%T Real-World Evidence of Triplet Therapy in Metastatic Hormone-Sensitive Prostate Cancer: An Austrian Multicenter Study.
%A Kafka M
%A Giannini G
%A Artamonova N
%A Neuwirt H
%A Ofner H
%A Kramer G
%A Bauernhofer T
%A Luger F
%A Höfner T
%A Loidl W
%A Griessner H
%A Lusuardi L
%A Bergmaier A
%A Berger A
%A Winder T
%A Weiss S
%A Bauinger S
%A Krause S
%A Drerup M
%A Heinrich E
%A Schneider M
%A Madersbacher S
%A Vallet S
%A Stoiber F
%A Laimer S
%A Hruby S
%A Schachtner G
%A Nagele U
%A Lenart S
%A Ponholzer A
%A Pfuner J
%A Wiesinger C
%A Kamhuber C
%A Müldür E
%A Bektic J
%A Horninger W
%A Heidegger I
%J Clin Genitourin Cancer
%V 22
%N 2
%D 2024 04 4
%M 38267304
%F 3.121
%R 10.1016/j.clgc.2023.12.018
%X Two randomized trials demonstrated a survival benefit of triplet therapy (androgen deprivation therapy [ADT]) plus androgen receptor pathway inhibitor [ARPI] plus docetaxel) over doublet therapy (ADT plus docetaxel), thus changing treatment strategies in metastatic hormonesensitive prostate cancer (mHSPC).<BR>We conducted the first real-world analysis comprising 97 mHSPC patients from 16 Austrian medical centers, among them 79.4% of patients received abiraterone and 17.5% darolutamide treatment. Baseline characteristics and clinical parameters during triplet therapy were documented. Mann-Whitney U test for continuous or X²-test for categorical variables was used. Variables on progression were tested using logistic regression analysis and tabulated as hazard ratios (HR), 95% confidence interval (CI).<BR>Of 83.5% patients with synchronous and 16.5% with metachronous disease were included. 83.5% had high-volume disease diagnosed by conventional imaging (48.9%) or PSMA PET-CT (51.1%). While docetaxel and ARPI were administered consistent with pivotal trials, prednisolone, prophylactic gCSF and osteoprotective agents were not applied guideline conform in 32.5%, 37%, and 24.3% of patients, respectively. Importantly, a nonsimultaneous onset of chemotherapy and ARPI, performed in 44.3% of patients, was associated with significantly worse treatment response (P = .015, HR 0.245). Starting ARPI before chemotherapy was associated with significantly higher probability for progression (P = .023, HR 15.781) than vice versa. Strikingly, 15.6% (abiraterone) and 25.5% (darolutamide) low-volume patients as well as 14.4% (abiraterone) and 17.6% (darolutamide) metachronous patients received triplet therapy. Adverse events (AE) occurred in 61.9% with grade 3 to 5 in 15% of patient without age-related differences. All patients achieved a PSA decline of 99% and imaging response was confirmed in 88% of abiraterone and 75% of darolutamide patients.<BR>Triplet therapy arrived in clinical practice primarily for synchronous high-volume mHSPC. Regardless of selected therapy regimen, treatment is highly effective and tolerable. Preferably therapy should be administered simultaneously, however if not possible, chemotherapy should be started first.