Wstępne wyniki bk PROSPER - Enzalutamid w nmCRPC

Wstępne wyniki bk PROSPER - Enzalutamid w nmCRPC

Nieprzeczytany postautor: zosia bluszcz » 10 lip 2018, 02:52

Artykul dot. wstepnej oceny wynikow finansowanego przez Pfizer i Astellas Pharma badania PROSPER (clinicaltrials.gov NCT02003924 https://clinicaltrials.gov/ct2/show/NCT02003924), oficjalny polski tytul -
Międzynarodowe, randomizowane, prowadzone metodą podwójnie ślepej próby, kontrolowane placebo badanie fazy III, dotyczące skuteczności i bezpieczeństwa stosowania enzalutamidu u chorych z nieprzerzutowym rakiem prostaty opornym na kastracje.
Badanie bylo prowadzone w latach 2013-2018, rowniez przez kilka osrodkow w Polsce.


Krotko:

1. Grupa pacjentow biorących Enzalutamid byla dwa razy liczniejsza od grupy placebo.

2. Mediana przezycia bez przerzutow -
-> 36.6 miesięcy w grupie enzalutamidu
-> 14.7 miesięcy w grupie placebo

3. Mediana czasu, ktory uplynął miedzy terapią enzalutamidem a koniecznoscią zastosowania kolejnej terapii antynowotworowej -
-> 39.6 miesięcy grupa enzalutamidu
-> 17.7 months grupa placebo

4. Przezycie calkowite - zarejestrowano zgon
-> 103 pacjentow (11%) z grupy enzalutamidu
-> 62 (13%) z grupy placebo




Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer

Maha Hussain, Karim Fizazi, Fred Saad, Per Rathenborg, Neal Shore, Ubirajara Ferreira, Petro Ivashchenko, Eren Demirhan, Katharina Modelska, De Phung, Andrew Krivoshik, Cora N Sternberg
New England Journal of Medicine 2018 June 28, 378 (26): 2465-2474

BACKGROUND: Men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising prostate-specific antigen (PSA) level are at high risk for metastasis. We hypothesized that enzalutamide, which prolongs overall survival among patients with metastatic, castration-resistant prostate cancer, would delay metastasis in men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising PSA level.

METHODS: In this double-blind, phase 3 trial, we randomly assigned, in a 2:1 ratio, men with nonmetastatic, castration-resistant prostate cancer and a PSA doubling time of 10 months or less who were continuing androgen-deprivation therapy to receive enzalutamide (at a dose of 160 mg) or placebo once daily. The primary end point was metastasis-free survival (defined as the time from randomization to radiographic progression or as the time to death without radiographic progression).

RESULTS: A total of 1401 patients (median PSA doubling time, 3.7 months) underwent randomization.
As of June 28, 2017, a total of 219 of 933 patients (23%) in the enzalutamide group had metastasis or had died, as compared with 228 of 468 (49%) in the placebo group.

The median metastasis-free survival was 36.6 months in the enzalutamide group versus 14.7 months in the placebo group (hazard ratio for metastasis or death, 0.29; 95% confidence interval, 0.24 to 0.35; P<0.001).

The time to the first use of a subsequent antineoplastic therapy was longer with enzalutamide treatment than with placebo (39.6 vs. 17.7 months; hazard ratio, 0.21; P<0.001; such therapy was used in 15% vs. 48% of patients) as was the time to PSA progression (37.2 vs. 3.9 months; hazard ratio, 0.07; P<0.001; progression occurred in 22% vs. 69% of patients).

At the first interim analysis of overall survival, 103 patients (11%) receiving enzalutamide and 62 (13%) receiving placebo had died.
Adverse events of grade 3 or higher occurred in 31% of the patients receiving enzalutamide, as compared with 23% of those receiving placebo.

CONCLUSIONS: Among men with nonmetastatic, castration-resistant prostate cancer with a rapidly rising PSA level, enzalutamide treatment led to a clinically meaningful and significant 71% lower risk of metastasis or death than placebo. Adverse events were consistent with the established safety profile of enzalutamide. (Funded by Pfizer and Astellas Pharma; PROSPER ClinicalTrials.gov number, NCT02003924 .).

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