Raadpleeg ook onze lijst van niet-toxische ondersteuning bij prostaatkanker. :
Als donateur kunt u ook korting krijgen bij verschillende bedrijven, waaronder bij Medpro voor o.a. prostasol een veel gebruikt natuurlijk middel bij prostaatkanker als alternatief voor hormoontherapie18 januari 2021: Bron: Prostate Cancer Prostatic Dis. 2020; 23(3): 517–526.
Uit een grote langjarige fase III studie bij mannen met uitgezaaide hormoonresistente prostaatkanker blijkt dat immuuntherapie met provenge - sipuleucel-T Afro-Amerikaanse mannen een opmerkelijk betere overall overleving hadden dan blanke mannen. 35.3 maanden versus 25.8 maanden. Vooral mannen met een lage PSA bij de start van de immuuntherapie deden het onder de Afro-Amerikaanse mannen veel beter.
Bij alle patiënten was de basislijn-PSA aanzienlijk hoger bij Afro-Amerikaanse patiënten (33,0 versus 13,9 ng / ml bij blanken). Afro-Amerikanen vertoonden een lager hemoglobinegehalte, een langere tijd van diagnose tot sipuleucel-T-behandeling en een lagere kans op eerdere chemotherapie, ongeacht of we naar de totale populatie of naar PSA-gematchte cohorten keken (Table 1).
De meest gebruikte behandelingen na de immuuntherapie die de overleving verlengden na Provenge - sipuleucel-T waren abiraterone, enzalutamide en docetaxel voor beide rassen (Table 4). Terwijl bij alle patiënten mCRPC werd vastgesteld, hadden Afro-Amerikanen meer kans om hormonale middelen te krijgen, terwijl blanken iets meer kans hadden om met chemotherapie te worden behandeld (53% Afro-Amerikanen en 66% blanken ontvingen chemotherapie).
Uit de introductie van de studie:
Provenge - Sipuleucel-T, een ook in Nederland geregistreerde vorm van een autologe cellulaire immuuntherapie voor mannen met asymptomatische / minimaal symptomatische gemetastaseerde castratieresistente prostaatkanker (mCRPC), wordt aanbevolen als een eerste optie voor behandeling door de National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for Prostaatkanker op basis van categorie 1 bewijs [1]
Sipuleucel-T verbeterde de mediane totale overleving (OS) met 4,1 maanden ten opzichte van placebo in deIMPACT trial (NCT00065442), met een afzonderlijke post-hocanalyse die een OS-voordeel van 13 maanden aantoonde bij mensen met prostaatspecifiek antigeen (PSA) -niveaus onder de mediaan van 22,1 ng / ml bij aanvang van de behandeling.[2, 3].
In de klinische praktijk toonden gegevens van het PROVENGE-register voor observatie, verzameling en evaluatie van ervaringsgegevens (PROCEED; NCT01306890) dat mCRPC-patiënten die werden behandeld met Provenge - sipuleucel-T een mediane OS hadden van 30,7 maanden; met een mediane follow-up van 46,6 maanden en een OS van 47,7 maanden (95% betrouwbaarheidsinterval , 43,5-50,7 maanden) in het laagste PSA-kwartiel bij aanvang (≤5,27 ng / ml) [4].
Omdat het studierapport gratis volledig is in te zien en te downloaden, met heel veel meer grafieken en cijfers geef ik hier alleen een link en het abstract met referentielijst onderaan artikel.
Prostate Cancer Prostatic Dis. 2020; 23(3): 517–526.
Published online 2020 Feb 28. doi: 10.1038/s41391-020-0213-7
PMCID: PMC7423504
PMID: 32111923
Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry
Oliver Sartor,
#1 Andrew J. Armstrong,#2 Chiledum Ahaghotu,3 David G. McLeod,4,5 Matthew R. Cooperberg,6 David F. Penson,7 Philip W. Kantoff,8 Nicholas J. Vogelzang,9 Arif Hussain,10 Christopher M. Pieczonka,11 Neal D. Shore,12 David I. Quinn,13 Eric J. Small,14 Elisabeth I. Heath,15 Ronald F. Tutrone,16 Paul F. Schellhammer,17 Matthew Harmon,18 Nancy N. Chang,18 Nadeem A. Sheikh,18 Bruce Brown,18 Stephen J. Freedland,19,20 and Celestia S. Higano21
#1 Andrew J. Armstrong,#2 Chiledum Ahaghotu,3 David G. McLeod,4,5 Matthew R. Cooperberg,6 David F. Penson,7 Philip W. Kantoff,8 Nicholas J. Vogelzang,9 Arif Hussain,10 Christopher M. Pieczonka,11 Neal D. Shore,12 David I. Quinn,13 Eric J. Small,14 Elisabeth I. Heath,15 Ronald F. Tutrone,16 Paul F. Schellhammer,17 Matthew Harmon,18 Nancy N. Chang,18 Nadeem A. Sheikh,18 Bruce Brown,18 Stephen J. Freedland,19,20 and Celestia S. Higano21Abstract
Purpose
African Americans experience greater prostate cancer risk and mortality than do Caucasians. An analysis of pooled phase III data suggested differences in overall survival (OS) between African American and Caucasian men receiving sipuleucel-T. We explored this in PROCEED (NCT01306890), an FDA-requested registry in over 1900 patients with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T.
Patients and methods
OS for patients who received ≥1 sipuleucel-T infusion was compared between African American and Caucasian men using an all patient set and a baseline prostate-specific antigen (PSA)-matched set (two Caucasians to every one African American with baseline PSAs within 10% of each other). Univariable and multivariable analyses were conducted. Survival data were examined using Kaplan–Meier and Cox proportional hazard methodologies.
Results
Median follow-up was 46.6 months. Overall survival differed between African American and Caucasian men with hazard ratios (HR) of 0.81 (95% confidence interval : 0.68–0.97, P = 0.03) in the all patient set and 0.70 (95% CI: 0.57–0.86, P < 0.001) in the PSA-matched set. Median OS was longer in African Americans than in Caucasian men for both analysis sets, e.g., 35.3 and 25.8 months, respectively, in the PSA-matched set. Similar results were observed in the all patient set. Differences were larger when treatment began at lower baseline PSA; curves were more similar among patients with higher baseline PSA. In patients with baseline PSA below the median, the HR was 0.52 (95% CI: 0.37–0.72, P < 0.001), with median OS of 54.3 versus 33.4 months. Known prognostic factors and African American race (multivariable analyses; HR: 0.60, 95% CI: 0.48–0.74, P < 0.001) were independently associated with OS. Use of post-sipuleucel-T anticancer interventions was balanced between races.
Conclusion
In this exploratory analysis of a registry including nearly 12% African American men with mCRPC, OS was significantly different between African Americans and Caucasians, indicating further research is warranted.
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