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Kafka, M; Giannini, G; Artamonova, N; Neuwirt, H; Ofner, H; Kramer, G; Bauernhofer, T; Luger, F; Höfner, T; Loidl, W; Griessner, H; Lusuardi, L; Bergmaier, A; Berger, A; Winder, T; Weiss, S; Bauinger, S; Krause, S; Drerup, M; Heinrich, E; Schneider, M; Madersbacher, S; Vallet, S; Stoiber, F; Laimer, S; Hruby, S; Schachtner, G; Nagele, U; Lenart, S; Ponholzer, A; Pfuner, J; Wiesinger, C; Kamhuber, C; Müldür, E; Bektic, J; Horninger, W; Heidegger, I.
Real-World Evidence of Triplet Therapy in Metastatic Hormone-Sensitive Prostate Cancer: An Austrian Multicenter Study.
Clin Genitourin Cancer. 2024; 22(2):458-466.e1
Doi: 10.1016/j.clgc.2023.12.018
Web of Science
PubMed
FullText
FullText_MUG
- Führende Autor*innen der Med Uni Graz
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Kafka Mona
- Co-Autor*innen der Med Uni Graz
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Bauernhofer Thomas
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- Abstract:
- INTRODUCTION: 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). PATIENTS AND METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.
- Find related publications in this database (using NLM MeSH Indexing)
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Humans - administration & dosage
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Male - administration & dosage
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Androgen Antagonists - therapeutic use
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Antineoplastic Combined Chemotherapy Protocols - therapeutic use
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Austria - administration & dosage
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Docetaxel - therapeutic use
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Hormones - administration & dosage
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Positron Emission Tomography Computed Tomography - administration & dosage
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Prostatic Neoplasms - drug therapy, pathology
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Randomized Controlled Trials as Topic - administration & dosage
- Find related publications in this database (Keywords)
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Abiraterone
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Darolutamide
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Personalized treatment
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Treatment efficacy
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Triplet therapy tolerability