Raadpleeg ook de lijst van niet-toxische ondersteuning bij prostaatkanker van arts-bioloog drs. Engelbert Valstar.

En als donateur kunt u ook korting krijgen bij verschillende bedrijven, waaronder bij Medpro voor o.a. prostasol een veelgebruikt natuurlijk middel bij prostaatkanker als alternatief voor hormoontherapie.

Zie ook in gerelateerde artikelen

19 oktober 2023: Bron: N Engl J Med 2023; 389:1453-1465 18 oktober 2023

Uit de EMBARK fase III studie met totaal 1068 patienten uit maar liefst 224 ziekenhuizen in 17 verschillende landen blijkt dat wanneer prostaatkankerpatiënten waarvan hun PSA binnen 9 maanden na de operatie of bestraling al weer begint op te lopen een combinatiebehandeling krijgen van dagelijks enzalutamide (160mg dagelijks) plus hormoontherapie met leuprolide / leuproreline een beduidend langere ziektevrije tijd hadden in vergelijking met alleen leuprolide / leuproreline plus placebo of alleen enzalutamide. Verschil in metastasevrije overleving tussen combinatiebehandeling en alleen hormoontherapie was op 5-jaars meting 87,3 procent versus 71,4 procent.
En vooral de patiënten die enzalutamide kregen hadden veel minder last van vervelende bijwerkingen die hormoontherapie meestal wel geeft.

Resultaten vertaald uit het abstract:

In totaal ondergingen 1068 patiënten randomisatie: 355 patiënten werden toegewezen aan de combinatiegroep van enzalutamide plus leuprolide / leuproreline, 358 patiënten aan de groep met alleen leuprolide / leuproreline en 355 patiënten aan alleen enzalutamide.
De patiënten werden gemiddeld 60,7 maanden gevolgd.

Na 5 jaar was de metastasevrije overleving 87,3% (95% betrouwbaarheidsinterval , 83,0 tot 90,6) in de combinatiegroep, 71,4% (95% BI, 65,7 tot 76,3) in de groep met alleen leuprolide / leuproreline en 80,0%. (95% BI, 75,0 tot 84,1) in de monotherapiegroep met alleen enzalutamide.

Met betrekking tot de metastasevrije overleving was enzalutamide plus leuprolide superieur aan leuprolide alleen (hazard ratio voor metastase of overlijden, 0,42; 95% BI, 0,30 tot 0,61; P<0,001);
monotherapie met enzalutamide was ook superieur aan alleen leuprolide (hazard ratio voor metastase of overlijden, 0,63; 95% BI, 0,46 tot 0,87; P=0,005).

Er werden geen nieuwe veiligheidssignalen met meer bijwerkingen waargenomen en er waren geen substantiële verschillen tussen de groepen in maatregelen voor de kwaliteit van leven.

Het volledige studieverslag is tegen betaling in te zien. Hier het abstract:

Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer

Stephen J. Freedland, M.D.,
Murilo de Almeida Luz, M.D.,
Ugo De Giorgi, M.D., Ph.D.,
Martin Gleave, M.D.,
Geoffrey T. Gotto, M.D., M.P.H.,
Christopher M. Pieczonka, M.D.,
Gabriel P. Haas, M.D.,
Choung-Soo Kim, M.D.,
Miguel Ramirez-Backhaus, M.D.,
Antti Rannikko, M.D., Ph.D.,
Jamal Tarazi, M.D., M.P.A.,
Swetha Sridharan, M.B., B.S.,

Abstract

BACKGROUND

Patients with prostate cancer who have high-risk biochemical recurrence have an increased risk of progression. The efficacy and safety of enzalutamide plus androgen-deprivation therapy and enzalutamide monotherapy, as compared with androgen-deprivation therapy alone, are unknown.

METHODS

In this phase 3 trial, we enrolled patients with prostate cancer who had high-risk biochemical recurrence with a prostate-specific antigen doubling time of 9 months or less. Patients were randomly assigned, in a 1:1:1 ratio, to receive enzalutamide (160 mg) daily plus leuprolide every 12 weeks (combination group), placebo plus leuprolide (leuprolide-alone group), or enzalutamide monotherapy (monotherapy group). The primary end point was metastasis-free survival, as assessed by blinded independent central review, in the combination group as compared with the leuprolide-alone group. A key secondary end point was metastasis-free survival in the monotherapy group as compared with the leuprolide-alone group. Other secondary end points were patient-reported outcomes and safety.

RESULTS

A total of 1068 patients underwent randomization: 355 were assigned to the combination group, 358 to the leuprolide-alone group, and 355 to the monotherapy group. The patients were followed for a median of 60.7 months. At 5 years, metastasis-free survival was 87.3% (95% confidence interval , 83.0 to 90.6) in the combination group, 71.4% (95% CI, 65.7 to 76.3) in the leuprolide-alone group, and 80.0% (95% CI, 75.0 to 84.1) in the monotherapy group. With respect to metastasis-free survival, enzalutamide plus leuprolide was superior to leuprolide alone (hazard ratio for metastasis or death, 0.42; 95% CI, 0.30 to 0.61; P<0.001); enzalutamide monotherapy was also superior to leuprolide alone (hazard ratio for metastasis or death, 0.63; 95% CI, 0.46 to 0.87; P=0.005). No new safety signals were observed, with no substantial between-group differences in quality-of-life measures.

CONCLUSIONS

In patients with prostate cancer with high-risk biochemical recurrence, enzalutamide plus leuprolide was superior to leuprolide alone with respect to metastasis-free survival; enzalutamide monotherapy was also superior to leuprolide alone. The safety profile of enzalutamide was consistent with that shown in previous clinical studies, with no apparent detrimental effect on quality of life. (Funded by Pfizer and Astellas Pharma; EMBARK ClinicalTrials.gov number, NCT02319837. opens in new tab.)

QUICK TAKE VIDEO SUMMARYEnzalutamide for Biochemically Recurrent Prostate Cancer 02:17

Create your account to get 2 free subscriber-only articles each month.

GET FREE ACCESS NOW SUBSCRIBE FOR FULL ACCESS

Already have an account?

Print subscriber?

ACTIVATE YOUR ONLINE ACCESS.

Supported by Pfizer and Astellas Pharma.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank the patients and their families; all other investigators and investigational site members; Raj C. Patel, Pharm.D., Pfizer, for project management and editorial support with an earlier version of the manuscript; and Julie B. Stimmel, Ph.D., C.M.P.P., and Rosie Henderson, M.Sc., Onyx (a Prime Global Agency), for medical writing and editorial support with an earlier version of the manuscript.

Author Affiliations

From the Samuel Oschin Comprehensive Cancer Institute, Cedars–Sinai Medical Center, Los Angeles (S.J.F.); the Durham Veterans Affairs Health Care System, Durham, NC (S.J.F.); the Division of Urologic Oncology, Erasto Gaertner Hospital, Curitiba, Brazil (M.A.L.); IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy (U.D.G.); the Vancouver Prostate Centre, University of British Columbia, Vancouver (M.G.), and the Southern Alberta Institute of Urology, University of Calgary, Calgary (G.T.G.) — both in Canada; U.S. Urology Partners and Associated Medical Professionals of New York, Syracuse (C.M.P.); Global Development (G.P.H.) and Biostatistics (J.S.), Astellas Pharma, Northbrook, IL; Ewha Womans University Mokdong Hospital, Seoul, South Korea (C.-S.K.); Servicio de Urología, Fundación Instituto Valenciano de Oncología, Valencia, Spain (M.R.-B.); the Department of Urology and Research Program in Systems Oncology, University of Helsinki, and Helsinki University Hospital — both in Helsinki, Finland (A.R.); Global Product Development, Pfizer, Collegeville, PA (J.T.); the Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, NSW (S.S.), the Prostate Centre of Excellence, Sydney Adventist Hospital, Sydney, NSW (H.H.W.), and the College of Health and Medicine, Australian National University, Canberra, ACT (H.H.W.) — all in Australia; Global Product Development, Pfizer, San Francisco (Y.T.); Chesapeake Urology Research Associates, Towson, MD (R.F.T.); the Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, United Kingdom (B.V.); the Department of Urology, University of Lille, Claude Huriez Hospital, Centre Hospitalier Universitaire Lille, Lille, France (A.V.); Global Product Development, Pfizer, Cambridge, MA (F.Z.); and the Carolina Urologic Research Center and GenesisCare US, Myrtle Beach, SC (N.D.S.).

Dr. Shore can be contacted at nshore@gsuro.com or at the Carolina Urologic Research Center, GenesisCare US, 823 82nd Parkway, Myrtle Beach, SC, 29572.

EDITORIAL

OCT 19, 2023Biochemical Recurrence in Prostate Cancer — Tilting the ScaleA. Aparicio

prostaatkanker, radiotherapie, bestraling, PSA, hormoontherapie, leuprolide, ziektevrije overleving, enzalutamide, EMBARK fase III studie, leuproreline