Based on a third data reassessment by the German Institute for Quality and Efficiency in Health Care, enzalutamide (Xtandi) provided an added benefit for men with high-risk non-metastatic castration-resistant prostate cancer.
According to the third data release by the German Institute for quality and efficiency in Health Care (IQWiG) researchers found a "hint" of added benefit in terms of mortality due to the longer overall survival with the drug enzalutamide (Xtandi) to treat men with high-risk non-metastatic castration-resistant prostate cancer.
Xtandi has been evaluated twice before, once in 2018 and then in 2019 to see if there was an advantage compared to the appropriate comparator therapy. Both the first and second data cut-offs for the PROSPER study found no additional benefit from the drug to when used 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 based on the third data cut-off of the study, which had been completed in the meantime."
Regarding morbidity and health-related-quality, no new findings existed when compared to the first assessment of the drug. As a result, no added benefit was determined for these outcome categories.
That differed was in terms of mortality for the third data cut-off compared to the first assessment. The data found that men in the Xtandi arm survived considerably longer than men in the comparator arm.
For drug side effects, the researchers explained that the results are mixed. For renal and urinary disorders, there were signs of a major advantage for patients, although it's unclear whether these are a result of the disease's treatment or symptoms.
More signs of disadvantages were found for enzalutamide than watchful waiting while maintaining ongoing conventional androgen deprivation therapy.
Regardless, the disadvantages did not raise doubt about the advantages, resulting in the overall assessment of the use of Xtandi. These additional findings show a possible added benefit of Xtandi compared to the appropriate comparator therapy.
Reference:
Castration-resistant prostate cancer at high risk of metastasis: enzalutamide has added benefit [news release]. Published August 19, 2020. https://www.eurekalert.org/pub_releases/2020-08/ifqa-cpc081920.php. Accessed October 7, 2020/
https://www.cancernetwork.com/view/enzalutamide-induces-added-benefit-for-patients-with-castration-resistant-prostate-cancer
