Home >  Urology >  Urology News >  Darolutamide improves...

Darolutamide improves survival in nonmetastatic prostate cancer patients: NEJM

Written By :  Medha Baranwal
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2020-09-12 04:00 GMT   |   Update On 2020-09-12 09:48 GMT
Advertisement

Delhi: The administration of Darolutamide in men with nonmetastatic, castration-resistant prostate cancer led to a significantly higher rate of survival, according to results from ARAMIS trial in the New England Journal of Medicine.

Darolutamide, a structurally distinct androgen-receptor inhibitor, is approved for the treatment of nonmetastatic, castration-resistant prostate cancer. Findings from the planned primary analysis of a phase 3 trial showed significantly higher median metastasis-free survival with Darolutamide (40.4 months) than with placebo (18.4 months). However, the primary analysis data lacked the data for the analysis of overall survival. 

To fill this knowledge gap, Karim Fizazi, head of the department of cancer medicine at Institut Gustave Roussy in Villejuif, France, and colleagues performed a double-blind, placebo-controlled trial. In the trial,1509 men were assigned in the ratio 2:1 to receive darolutamide (955 patients) or placebo (554 patients). They continued to receive androgen-deprivation therapy. They were followed for a median of 29.0 months.

Advertisement

Unblinding of the treatment assignments occurred, after the results of the primary end-point analysis were found to be positive, and patients in the placebo group were permitted to cross over to receive open-label darolutamide treatment. At the time of this prespecified final analysis, which had been planned to be performed after approximately 240 deaths had occurred, overall survival and all other secondary endpoints were evaluated.

The median follow-up time was 29.0 months. At the time of unblinding of the data, all 170 patients who were still receiving placebo crossed over to receive darolutamide; 137 patients who had discontinued placebo before unblinding had occurred received at least one other life-prolonging therapy. 

Key findings of the study include:

  • Overall survival at 3 years was 83% in the darolutamide group and 77% in the placebo group.
  • The risk of death was significantly lower, by 31%, in the darolutamide group than in the placebo group (hazard ratio for death, 0.69).
  • Darolutamide was also associated with a significant benefit with respect to all other secondary endpoints, including the time to the first symptomatic skeletal event and the time to the first use of cytotoxic chemotherapy.
  • The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.

"The percentage of patients who were alive at 3 years was significantly higher in men with nonmetastatic, castration-resistant prostate cancer who received darolutamide than among those who received a placebo. The incidence of adverse events was similar in the two groups," concluded the authors.

The study, "Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide," is published in the New England Journal of Medicine.

DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa2001342

Tags:    
Article Source : New England Journal of Medicine

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Medha Baranwal
Comments Policy
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News

UTIs Linked to Short-Term Increased Risk of Heart Attack and Stroke, reveals research

Higher BMI and Depression Linked to Greater Risk of Urinary Incontinence in Women: NHANES Study

Kidney Injury Significantly Increases Hypertension Risk, Study Finds

Prioritize Sustained decongestion over preserving kidney function in modest eGFR decline: Study

Study identifies Urinary EGF as Protective Biomarker Against CKD Progression

Polygenic Risk Score Outperforms PSA and MRI in Detecting Clinically Significant Prostate Cancer: NEJM

Longer Antibiotic Therapy and Early PCN Drainage Linked to Better Outcomes in Urosepsis with Upper Ureteral Stones: Study

Enzyme-Loaded Magnetic Robots Offer Promising Noninvasive Solution for Kidney Stone Treatment: Study Shows