Indirect Comparison of Darolutamide versus Apalutamide and Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer
| Autor: | A. Reginald Waldeck, Viviana Garcia-Horton, Neal D. Shore, Emi Terasawa, Susan Halabi, Rajeev Ayyagari, Shan Jiang |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Oncology
Male medicine.medical_specialty Urology 030232 urology & nephrology Castration resistant Dizziness law.invention 03 medical and health sciences chemistry.chemical_compound Prostate cancer 0302 clinical medicine Randomized controlled trial law Internal medicine Nitriles Phenylthiohydantoin Androgen Receptor Antagonists Medicine Enzalutamide Humans Cognitive Dysfunction Fatigue business.industry Apalutamide Exanthema Middle Aged medicine.disease Indirect comparison Prostatic Neoplasms Castration-Resistant Darolutamide Fractures Spontaneous chemistry Thiohydantoins Benzamides Pyrazoles Accidental Falls business |
| Zdroj: | The Journal of urology. 206(2) |
| ISSN: | 1527-3792 |
| Popis: | No published head-to-head randomized trials have compared the safety and efficacy of darolutamide vs apalutamide or enzalutamide in nonmetastatic castration-resistant prostate cancer. This study compares prespecified adverse events and metastasis-free survival associated with darolutamide vs apalutamide, and darolutamide vs enzalutamide, via matching-adjusted indirect comparisons.Individual patient data from the phase III ARAMIS trial (NNo differences in metastasis-free survival hazard ratios were found after matching in either comparison. However, fall, fracture and rash rates were statistically significantly lower in favor of darolutamide vs apalutamide. Fall, dizziness, mental impairment, fatigue and severe fatigue rates were statistically significantly lower in favor of darolutamide vs enzalutamide.While metastasis-free survival did not differ across drugs in these cross-trial indirect comparisons, darolutamide showed a favorable safety and tolerability profile in prespecified adverse events vs apalutamide and enzalutamide. Consideration of these adverse events is important in clinical decision-making and treatment selection in nonmetastatic castration-resistant prostate cancer. |
| Databáze: | OpenAIRE |
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