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Intensification of ADT in Hormone-Sensitive Metastatic Prostate Cancer: An Evolving Paradigm
For most patients with hormone-sensitive metastatic prostate cancer (HSMPC), androgen deprivation therapy (ADT) intensification with docetaxel, abiraterone, enzalutamide, or apalutamide is the standard of care, based on compelling survival benefit demonstrated in phase III studies. The PEACE-1 trial provided evidence of benefit for the addition of abiraterone to ADT plus docetaxel in high-risk patients with metastatic disease at initial presentation (Ann Oncol 2021; 32:suppl 5:S1283).
In the industry-sponsored, international, phase III ARASENS trial, investigators randomized men with HSMPC to receive darolutamide or placebo in addition to ADT plus docetaxel. Randomization was stratified according to the TNM metastasis stage. The primary endpoint was overall survival.
Of 1306 patients, 80% had bone and 18% had visceral metastases, and 86% had metastatic disease at initial presentation. At the time of data cutoff, the median treatment duration was 41.0 months in the darolutamide group compared with 16.7 months in the placebo arm. Approximately 87% of patients in both arms completed six cycles of docetaxel.
The risk of death was 32.5% lower in the darolutamide group than in the placebo group (hazard ratio, 0.68; P<0.001). Overall survival at 4 years was 62.7% in the darolutamide group and 50.4% in the placebo group. Of note, 76% of patients in the placebo group subsequently received potentially life-prolonging therapies. Grade 3 or 4 adverse events occurred in 66.1% and 63.5% of the darolutamide and placebo groups, respectively, most commonly neutropenia (approximately 34%).
These findings provide additional support to those from PEACE-1 for the use of androgen receptor pathway inhibitors to further intensify ADT plus docetaxel in selected patients with HSMPC. All the participants in PEACE-1 and the majority in ARASENS were men with de novo metastatic presentations who were fit to receive docetaxel. More data will be required to assess the potential benefit in other subsets of men with HSMPC.
Smith MR et al.
Title: Darolutamide and survival in metastatic, hormone-sensitive prostate cancer.
Source: N Engl J Med 2022 Feb 17; [e-pub]. (Abstract/FREE Full Text)