Translational andrology and urology · 2026
Real world outcomes of darolutamide activity and safety in treating hormone-sensitive prostate cancer.
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Liang Shuo, Zhang Xuyu, Lu Tong, Wu Zhigang, Guo Hongqian, Zhuang Junlong
Аннотация
BACKGROUND: Darolutamide is a next-generation androgen receptor (AR) inhibitor, used in the treatment of prostate cancer. There is currently limited real-world data available on its activity and safety. In our research, we collected real-world data to evaluate the effectiveness and safety of darolutamide in patients with castration-sensitive prostate cancer.
METHODS: This study retrospectively collected baseline information from patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and metastatic hormone-sensitive prostate cancer (mHSPC) who received darolutamide treatment at Nanjing Drum Tower Hospital between January 2022 and January 2024. We recorded the time at which patients reached their lowest prostate-specific antigen (PSA) levels and documented information of treatment discontinuation, dosage reduction, and adverse events during the treatment.
RESULTS: A total of 188 patients were included: 71% (n=133) with nmHSPC and 29% (n=55) with mHSPC. Both groups reached the lowest PSA levels in a median of 5 months, with most patients achieving a PSA90 reduction. At 12 months, biochemical progression-free survival (bPFS) rates were 72.8% for nmHSPC and 91% for mHSPC. Discontinuation due to voluntary choice was 2.3% (n=3) for nmHSPC and 1.8% (n=1) for mHSPC; due to insufficient efficacy, 0.8% (n=1) for nmHSPC and 7% (n=4) for mHSPC. Adverse events led to dose reductions in 4.5% (n=6) of nmHSPC and 1.8% (n=1) of mHSPC patients. Among the 51.1% (n=68) of nmHSPC patients with available surgical data, 81% (n=55) had negative margins, and 28% (n=19) achieved pathological complete response (pCR) or minimal residual disease (MRD). Common side effects included rash, fatigue, hot flushes, and sweating, with 7.4% (n=14) experiencing grade 2 adverse events and 0.5% (n=1) with grade 3.
CONCLUSIONS: Our real-world data demonstrate the activity and safety of darolutamide in patients with nmHSPC or mHSPC.
METHODS: This study retrospectively collected baseline information from patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and metastatic hormone-sensitive prostate cancer (mHSPC) who received darolutamide treatment at Nanjing Drum Tower Hospital between January 2022 and January 2024. We recorded the time at which patients reached their lowest prostate-specific antigen (PSA) levels and documented information of treatment discontinuation, dosage reduction, and adverse events during the treatment.
RESULTS: A total of 188 patients were included: 71% (n=133) with nmHSPC and 29% (n=55) with mHSPC. Both groups reached the lowest PSA levels in a median of 5 months, with most patients achieving a PSA90 reduction. At 12 months, biochemical progression-free survival (bPFS) rates were 72.8% for nmHSPC and 91% for mHSPC. Discontinuation due to voluntary choice was 2.3% (n=3) for nmHSPC and 1.8% (n=1) for mHSPC; due to insufficient efficacy, 0.8% (n=1) for nmHSPC and 7% (n=4) for mHSPC. Adverse events led to dose reductions in 4.5% (n=6) of nmHSPC and 1.8% (n=1) of mHSPC patients. Among the 51.1% (n=68) of nmHSPC patients with available surgical data, 81% (n=55) had negative margins, and 28% (n=19) achieved pathological complete response (pCR) or minimal residual disease (MRD). Common side effects included rash, fatigue, hot flushes, and sweating, with 7.4% (n=14) experiencing grade 2 adverse events and 0.5% (n=1) with grade 3.
CONCLUSIONS: Our real-world data demonstrate the activity and safety of darolutamide in patients with nmHSPC or mHSPC.