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Results of the Pivotal Phase 3 PROSPER Study, Which Evaluated Treatment with Astellas Pharma Enzalutamide with Androgen deprivation (Adt) Compared to Placebo More Adt in Patients With Prostate Cancer non-metastatic castration-resistant (Crpc), were published in the New England Journal of Medicine . The article " Enzalutamide in men with non-metastatic castration-resistant prostate cancer " appears in the paper edition of the NEJM of 28 June. In the study, enzalutamide added to Adt significantly reduced the risk of developing metastases or death compared with Adt alone: 23 percent of patients in the enzalutamide arm and Adt had metastases or were dead, against 49 percent in the arm with only Adt. The median parameter median survival without metastases (MFS) was 36.6 months for men who received enzalutamide versus 14.7 months with only Adt.
"I am satisfied with the results of the PROSPER study, which confirm that men who received treatment with nonmetastatic Crpc with enzalutamide plus Adt were delayed by nearly two years in the onset of metastases or deaths from prostate cancer compared to those treated with Adt ", Maha Hussain MD, FACP, FASCO, Professor of Medicine at Genevieve Teuton, Robert H. Lurie Comprehensive Cancer Center of the Northwestern University and principal investigator of the study. In January 2018, based on the results of the PROSPER study, Astellas presented a Type II variant to the European Medicines Agency (EMA) to expand the indication of enzalutamide to patients with non-metastatic Crpc. Enzalutamide was approved by the European Commission in June 2013 for the treatment of adult males with metastatic, asymptomatic or mildly symptomatic Mcrc after failure of antiandrogenic therapy and in whom chemotherapy is not yet clinically indicated or indicated. whose disease has evolved or after therapy with docetaxel. Enzalutamide is currently not licensed in the European Union for the treatment of men with non-metastatic CRPC
PROSPER study results It is of a double-blind, controlled phase 3 study placebo conducted in 300 centers in 32 countries, randomizing 1,401 patients with non-metastatic Crpc and with a 10-month Psa doubling time or least, to receive respectively, with a ratio 2: 1, of enzalutamide once a day plus Adt (n = 993) or placebo plus Adt (n = 468). Among the secondary outcomes there was a statistically significant delay in the median time to first use of a new antineoplastic therapy (ACT) of 39.6 versus 17.7 months. In the first interim badysis of overall survival, 103 patients (11%) died in the enzalutamide group and 62 (13%) in the placebo group . Overall median survival was not achieved in either group. The most common adverse reactions of any grade in patients, with an incidence ≥10 percent and higher, for enzalutamide plus ADT versus ADT alone were: 33 fatigue vs. 14 percent, 13 vs 8 hot flashes for a hundred, nausea 11 versus 9 percent, hypertension 12 versus 5 percent, dizziness 10 versus 4 percent, falls 11 versus 4 percent and appetite decreased 10 versus 4 percent. The adverse events in this study were consistent with the known safety profile of enzalutamide. ( EUGENIA SERMONTI )
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