TY - JOUR
T1 - A prospective trial of abiraterone acetate plus prednisone in Black and White men with metastatic castrate-resistant prostate cancer
AU - George, Daniel J.
AU - Halabi, Susan
AU - Heath, Elisabeth I.
AU - Sartor, A. Oliver
AU - Sonpavde, Guru P.
AU - Das, Devika
AU - Bitting, Rhonda L.
AU - Berry, William
AU - Healy, Patrick
AU - Anand, Monika
AU - Winters, Carol
AU - Riggan, Colleen
AU - Kephart, Julie
AU - Wilder, Rhonda
AU - Shobe, Kellie
AU - Rasmussen, Julia
AU - Milowsky, Matthew I.
AU - Fleming, Mark T.
AU - Bearden, James
AU - Goodman, Michael
AU - Zhang, Tian
AU - Harrison, Michael R.
AU - McNamara, Megan
AU - Zhang, Dadong
AU - LaCroix, Bonnie L.
AU - Kittles, Rick A.
AU - Patierno, Brendon M.
AU - Sibley, Alexander B.
AU - Patierno, Steven R.
AU - Owzar, Kouros
AU - Hyslop, Terry
AU - Freedman, Jennifer A.
AU - Armstrong, Andrew J.
N1 - Publisher Copyright:
© 2021 American Cancer Society
PY - 2021/8/15
Y1 - 2021/8/15
N2 - Background: Retrospective analyses of randomized trials suggest that Black men with metastatic castration-resistant prostate cancer (mCRPC) have longer survival than White men. The authors conducted a prospective study of abiraterone acetate plus prednisone to explore outcomes by race. Methods: This race-stratified, multicenter study estimated radiographic progression-free survival (rPFS) in Black and White men with mCRPC. Secondary end points included prostate-specific antigen (PSA) kinetics, overall survival (OS), and safety. Exploratory analysis included genome-wide genotyping to identify single nucleotide polymorphisms associated with progression in a model incorporating genetic ancestry. One hundred patients self-identified as White (n = 50) or Black (n = 50) were enrolled. Eligibility criteria were modified to facilitate the enrollment of individual Black patients. Results: The median rPFS for Black and White patients was 16.6 and 16.8 months, respectively; their times to PSA progression (TTP) were 16.6 and 11.5 months, respectively; and their OS was 35.9 and 35.7 months, respectively. Estimated rates of PSA decline by ≥50% in Black and White patients were 74% and 66%, respectively; and PSA declines to <0.2 ng/mL were 26% and 10%, respectively. Rates of grade 3 and 4 hypertension, hypokalemia, and hyperglycemia were higher in Black men. Conclusions: Multicenter prospective studies by race are feasible in men with mCRPC but require less restrictive eligibility. Despite higher comorbidity rates, Black patients demonstrated rPFS and OS similar to those of White patients and trended toward greater TTP and PSA declines, consistent with retrospective reports. Importantly, Black men may have higher side-effect rates than White men. This exploratory genome-wide analysis of TTP identified a possible candidate marker of ancestry-dependent treatment outcomes.
AB - Background: Retrospective analyses of randomized trials suggest that Black men with metastatic castration-resistant prostate cancer (mCRPC) have longer survival than White men. The authors conducted a prospective study of abiraterone acetate plus prednisone to explore outcomes by race. Methods: This race-stratified, multicenter study estimated radiographic progression-free survival (rPFS) in Black and White men with mCRPC. Secondary end points included prostate-specific antigen (PSA) kinetics, overall survival (OS), and safety. Exploratory analysis included genome-wide genotyping to identify single nucleotide polymorphisms associated with progression in a model incorporating genetic ancestry. One hundred patients self-identified as White (n = 50) or Black (n = 50) were enrolled. Eligibility criteria were modified to facilitate the enrollment of individual Black patients. Results: The median rPFS for Black and White patients was 16.6 and 16.8 months, respectively; their times to PSA progression (TTP) were 16.6 and 11.5 months, respectively; and their OS was 35.9 and 35.7 months, respectively. Estimated rates of PSA decline by ≥50% in Black and White patients were 74% and 66%, respectively; and PSA declines to <0.2 ng/mL were 26% and 10%, respectively. Rates of grade 3 and 4 hypertension, hypokalemia, and hyperglycemia were higher in Black men. Conclusions: Multicenter prospective studies by race are feasible in men with mCRPC but require less restrictive eligibility. Despite higher comorbidity rates, Black patients demonstrated rPFS and OS similar to those of White patients and trended toward greater TTP and PSA declines, consistent with retrospective reports. Importantly, Black men may have higher side-effect rates than White men. This exploratory genome-wide analysis of TTP identified a possible candidate marker of ancestry-dependent treatment outcomes.
KW - African American
KW - abiraterone acetate
KW - castration resistant
KW - hormone therapy
KW - metastatic prostate cancer
KW - prednisone
KW - prostate-specific antigen (PSA)
KW - race
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U2 - 10.1002/cncr.33589
DO - 10.1002/cncr.33589
M3 - Article
C2 - 33951180
AN - SCOPUS:85105103629
SN - 0008-543X
VL - 127
SP - 2954
EP - 2965
JO - Cancer
JF - Cancer
IS - 16
ER -