Thursday, May 5, 2022 (HealthDay News) – For patients with newly diagnosed metastatic hormone-sensitive prostate cancer, adding Arternel to androgen deprivation therapy (ADT) significantly improves progress-free survival but overall survival (OS). No. In a study published online April 21 Journal of Clinical Oncology.
Neeraj Agarwal, MD of the University of Utah Huntsman Cancer Institute in Salt Lake City, and colleagues randomly metastatic hormone-sensitive prostate cancer patients with orthorenal or ADT bicalutamide (638 and 64, respectively). The OS was compared to the primary objective, targeting a 33 percent improvement in moderate survival.
The researchers noticed a significant improvement in progression-free survival (moderate, 47.6 vs. 23.0 months; risk ratio, 0.58; 95 percent confidence interval, 0.51 to 0.67) after a follow-up of 4.9 years and at prostate-specific antigen levels. Seven months, but not in OS (81.1 vs. 70.2 months; risk ratio, 0.86; 95 percent confidence interval, 0.72 to 1.02). In the experimental vs. control arm, there were further grade 3/4 adverse events. 77.4 percent and 61.3 percent of patients received post-protocol life-longing therapy in control and experimental weapons, respectively.
“Although the approximately 11-month improvement in the median OS, including orteronel, appears to be clinically significant, it does not meet the prerequisite requirements for statistical significance,” the authors wrote.
The study was partially funded by Millennium Pharmaceuticals Inc. (Takeda Pharmaceutical Company Limited), the manufacturer of Orternell.
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