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 veel gebruikt natuurlijk middel bij prostaatkanker als alternatief voor hormoontherapie.


9 februari 2021: ASCO GI februari 2021

Uit de eindanalyse van de fase III studie ACIS blijkt dat  Apalutamide (Erleada)samen met abiraterone acetate plus prednison 31 procent minder risico geeft op overlijden voor patiënten met uitgezaaide hormoonresistente prostaatkanker in vergelijking met alleen abiraterone acetate plus prednison. Deze groep patiënten had ook geen chemo gehad maar alleen hormoontherapie tot ziekteprogressie optrad en met de behandelingen werd gestart.

Deze studie wordt komende week gepresenteerd op ASCO GI 2021: 

Final results from ACIS, a randomized, placebo (PBO)-controlled double-blind phase 3 study of apalutamide (APA) and abiraterone acetate plus prednisone (AAP) versus AAP in patients (pts) with chemo-naive metastatic castration-resistant prostate cancer (mCRPC).  

Authors:

Dana E. Rathkopf, Eleni Efstathiou, Gerhardt Attard, Thomas W. Flaig, Fabio Andre Franke, Oscar B. Goodman, Stephane Oudard, Thomas Steuber, Hiroyoshi Suzuki, Daphne Wu, Kesav Yeruva, Peter De Porre, Sabine Doris Brookman-May, Susan Li, Jinhui Li, Suneel Mundle, Sharon Anne McCarthy, Fred Saad, On behalf of the ACIS investigators; Memorial Sloan Kettering Cancer Center, New York, NY; The...

Research Funding:

Janssen Research and Development

Background:

As mCRPC is driven by activated androgen receptors and elevated intratumoral androgens, androgen annihilation may require dual inhibition. APA and AA are approved prostate cancer therapies that have distinct receptor inhibition and ligand suppression actions, respectively. ACIS compared radiographic progression-free survival (rPFS) of APA + AAP vs PBO + AAP in chemo-naive mCRPC.

Methods:mCRPC pts with ongoing androgen deprivation therapy (ADT) but no other life-prolonging treatment since diagnosis were randomized 1:1 to APA (240 mg po QD) + AA (1000 mg po QD) + P (5 mg po BID) or PBO + AAP (stratified by presence or absence of visceral metastases, Eastern Cooperative Oncology Group performance status 0 or 1, and geographic region). The primary end point was rPFS (investigator assessed; defined from randomization date to radiographic progression date or death). Secondary/other end points included prostate-specific antigen (PSA) response, overall survival (OS), safety, time to PSA progression, chronic opioid use, initiation of cytotoxic chemotherapy, and pain progression.

Results:982 pts were enrolled (Dec 2014 to Aug 2016). Median rPFS was extended 6 mos with APA + AAP (22.6 mos) vs AAP (16.6 mos) (HR 0.69 [95% CI 0.58-0.83]; p < 0.0001) at the final analysis for rPFS, coinciding with the first interim analysis of OS (median follow-up time 25.7 mo). At final analysis, treatment with APA + AAP vs AAP showed a significantly higher rate of confirmed ≥ 50% PSA decline. Although not statistically significant, treatment with APA + AAP vs AAP showed a longer median OS. Time to PSA progression, chronic opioid use, initiation of cytotoxic chemotherapy, and pain progression did not differ statistically significantly between arms. The safety profile was consistent with prior drug experience, with no new safety concerns. Grade 3/4 treatment-emergent adverse events (TEAEs) were reported in 63.3% (310/490) of APA + AAP–treated pts vs 56.2% (275/489) of AAP-treated pts, with more grade 3 (56.1%, 275/490 vs 45.6%, 223/489) and less grade 4 (7.1%, 35/490 vs 10.6%, 52/489) TEAEs, respectively. Results based on biomarker subpopulations and quality of life will be presented.

Conclusions:

The ACIS final analysis met the primary end point and demonstrated a 31% reduction in risk of radiographic progression or death in chemo-naive mCRPC pts treated with the combination of APA + AAP with ADT vs AAP with ADT. Funding: Janssen Research & Development. Trial registration: NCT02257736. Clinical trial information:

NCT02257736

End PointAPA + AAP
(n = 492)
AAP
(n = 490)
HR (95% CI)p Value
rPFS, median (95% CI), mo 22.6
(19.5-27.4)
16.6
(13.9-19.3)
0.69
(0.58-0.83)
< 0.0001
PSA response (≥ 50% decline), n (%) 391 (79.5) 357 (72.9) 1.09
(1.02-1.17)a
0.015
OS, median, mo 36.2 33.7 0.95
(0.81-1.11)
0.498

aRelative response.

This material on this page is ©2021 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org.




 



Plaats een reactie ...

Reageer op "Apalutamide en abiraterone acetaat plus prednison vermindert bij patiënten met chemo-naïeve uitgezaaide castratieresistente prostaatkanker met 31 procent het risico op overlijden dan met alleen abiraterone acetate plus prednison"


Gerelateerde artikelen
 

Gerelateerde artikelen

Apalutamide en abiraterone >> Abiraterone zonder hormoontherapie >> abiraterone acetate (Zytiga) >> abiraterone acetate (Zytiga) >> Abiraterone Acetate geeft >> Abiraterone Acetate door FDA >>