(Prostate Cancer) Is Darolutamide Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
- February 20, 2023
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On February 8, 2023, Silke Gillessen and colleagues from the EOC—Istituto Oncologico della Svizzera Italiana published the results of the SAKK 08/16 Phase II clinical trial in the Journal of Clinical Oncology. The study evaluated the efficacy and safety of Darolutamide as maintenance therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) following taxane-based chemotherapy.
This trial was a multicenter, randomized, double-blind Phase II study involving 92 patients with mCRPC who had previously received taxane-based chemotherapy. Participants were randomized to receive either Darolutamide (600 mg) or a placebo. The primary endpoint was the radiographic progression-free survival (rPFS) rate at 12 weeks. Secondary endpoints included time to progression, event-free survival (EFS), and overall survival (OS).
The results showed that the 12-week rPFS rate was 64.7% in the Darolutamide group compared to 52.2% in the placebo group, representing a significant improvement. The median progression-free survival (PFS) was 5.5 months for the Darolutamide group and 4.5 months for the placebo group. The median EFS was 5.4 months versus 2.9 months, and the median OS was 24 months versus 21.3 months, respectively. Regarding safety, the incidence of adverse events was similar between the two groups.
Based on the results of the SAKK 08/16 trial, Silke Gillessen and the research team stated that Darolutamide as maintenance therapy significantly improved the 12-week rPFS in patients with mCRPC following taxane-based chemotherapy. The treatment was well-tolerated, and if validated in larger trials, it is expected to become a new therapeutic option for this patient population.
Source: https://ascopubs.org/doi/full/10.1200/JCO.22.01726
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