ABSTRACT
Aim: Darolutamide significantly prolonged metastasis-free survival (MFS) versus placebo in the Phase III ARAMIS study. We analyzed outcomes in Spanish participants in ARAMIS. Patients & methods: Patients with high-risk nonmetastatic castration-resistant prostate cancer were randomized 2:1 to darolutamide 600 mg twice daily or placebo, plus androgen-deprivation therapy. The primary end point was MFS. Descriptive statistics are reported for this post hoc analysis. Results: In Spanish participants, darolutamide (n = 75) prolonged MFS versus placebo (n = 42): hazard ratio 0.345, 95% confidence interval 0.175-0.681. The incidence and type of treatment-emergent adverse events were comparable between treatment arms. Conclusion: For Spanish participants in ARAMIS, efficacy outcomes favored darolutamide versus placebo, with a similar safety profile, consistent with the overall ARAMIS population. Clinical Trials Registration: NCT02200614 (ClinicalTrials.gov).
Darolutamide is an oral treatment for a type of prostate cancer that has stopped responding to other treatments and is at risk of spreading to other parts of the body (termed "nonmetastatic castration-resistant prostate cancer" or "nmCRPC"). In the international ARAMIS study, patients treated with darolutamide lived longer without their cancer spreading than patients who were given placebo (sugar) pills. We wanted to know whether Spanish patients in ARAMIS had similar characteristics and treatment outcomes to other patients in the study. We found that the 75 Spanish patients who were treated with darolutamide had a significantly lower risk of their cancer spreading than the 42 Spanish patients who received placebo. The two groups of Spanish patients had similar side effects.
Subject(s)
Prostatic Neoplasms, Castration-Resistant , Male , Humans , Prostatic Neoplasms, Castration-Resistant/pathology , Androgen Receptor Antagonists/adverse effects , Androgen Antagonists/adverse effects , Pyrazoles/adverse effectsABSTRACT
OBJECTIVES: To review the various methods to predict the risk of having prostate cancer, or that localized disease may be cured or progress after a given treatment. METHODS: We performed a review of the various mathematic models known for the probability analysis of the event, with a critical analysis of weaknesses and strengths of each method. In a Medline update we review the most relevant papers referred to diagnosis and management of localized prostate cancer in its diagnosis and management sides, as well as the probability of developing metastatic disease and to die. RESULTS: There are multiple methods and models to predict the various events in a patient candidate to diagnosis of prostate cancer, as well as to analyze the possibilities of success of a specific treatment, in many cases with an important exactness. We emphasize the heterogeneity in the methods, data and variables used for the analysis, basically about retrospective studies. Many of the most sophisticated methods, Neural Network or cart, do not present greater exactness than classic methods like logistic regression. CONCLUSIONS: Predictive models are an important element for decision making in usual clinical practice, favoring the decision of a diagnosis or certain treatment is not taken in a random manner and therefore it is taken following scientific criteria. Waiting for more precise methods, we have to know no method is perfect, and therefore it is an important tool, which should not by pass personal knowledge or the experience of a specific working group.
