A third data cutoff reevaluation carried out by the German Institute for Quality and Efficiency in Health Care revealed that enzalutamide induces an additional advantage for patients with high-risk non-metastatic castration-resistant prostate cancer.
The researchers discovered an indication of extra benefit in respect to mortality due to the extended overall survival with the drug enzalutamide (Xtandi) to treat adult patients with high-risk non-metastatic castration-resistant prostate cancer. This was revealed after a reevaluation by the German Institute for Quality and Efficiency in Health Care (IQWiG).
The drug had formerly been evaluated twice before in 2018 and 2019 to detect if there was a benefit in comparison with the proper comparator therapy. The first and second data cut-offs for the PROSPER research discovered no additional benefit for the drug to treat high-risk non-metastatic castration-resistant prostate cancer.
“Since the study was not yet completed, the Federal Joint Committee (G-BA) limited its corresponding decision,” the press release stated. “After expiry of the decision, IQWiG reassessed the drug on the basis of the third data cut-off of the study, which had been completed in the meantime.”
In regard to morbidity and health-related-quality, no new results occurred when correlated to the first examination of the drug. Due to this, no additional advantage was deduced for these outcome categories.
However, the difference that was detected was seen in regards to mortality for the third data cut-off when correlated to the first evaluation. The data pointed out that patients who used the enzalutamide survived extensively longer than patients who used the comparator.
In terms of the drug side effects, the researchers asserted that the results are diverse. In regards to renal and urinary disorders, there were indications of a crucial benefit for patients although its imprecise whether these are an outcome of treatment or symptoms of the disease. In addition, indications of harms were discovered for enzalutamide when related to watchful waiting while upholding ongoing regular androgen denial therapy.
Nonetheless, the harms did not bring about any doubt about the benefits of the drug, arising in the comprehensive evaluation finding an additional benefit of enzalutamide correlated to the proper comparator therapy.
Prostate cancer is known to be the most common form of cancer for men in the United States. In addition, the American Cancer Society calculates that approximately 190,000 men will be diagnosed with prostate cancer and more than 33,000 men in the United States will die from the cancer in the 2020.