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    Prostate-specific antigen nadir and cancer-control outcomes in real-world apalutamide-treated metastatic hormone-sensitive prostate cancer patients: a single-center analysis
    (ELSEVIER, 2024) Wenzel M, Cano Garcia C, Humke C, Hoeh B, Steuber T.; Merseburger AS, Kluth LA, Chun FKH, Mandel P.; Tilki, Derya; School of Medicine; Koç University Hospital
    Background and objective Currently available post hoc phase 3 trial–derived data suggest better cancer-control outcomes in apalutamide-treated metastatic hormone-sensitive prostate cancer (mHSPC) patients achieving an (ultra)low prostate-specific antigen (PSA) nadir. This study aims to validate ultralow PSA nadir cutoffs. Methods Relying on an institutional prostate cancer database, 107 eligible patients were yielded. The currently available PSA nadir cutoffs (SWOG trial: <0.2 ng/ml; ultralow TITAN trial: ≤0.02 vs 0.02–0.2 vs >0.2 ng/ml) and PSA responses (≥99%) were tested for time to castration-resistant prostate cancer (ttCRPC) and overall survival (OS) in mHSPC patients treated with apalutamide. Finally, comparisons were made against abiraterone mHSPC treatment. Key findings and limitations Overall, 107 mHSPC patients treated with apalutamide at a median age of 68 yr and baseline PSA of 29 ng/ml were included. The highest proportion of included patients (40.2%) achieved an ultralow PSA nadir of ≤0.02 ng/ml. Patients reaching the SWOG 9346–defined PSA nadir of <0.2 ng/ml and ultralow PSA nadir of ≤0.02 ng/ml harbored the longest time to metastatic castration-resistant prostate cancer (mCRPC) and OS (all p < 0.05). Moreover, 80% of mHSPC patients treated with apalutamide achieved a PSA response of ≥99%. These patients also harbored better time to mCRPC and OS outcomes, relative to patients with a <99% PSA response (both p < 0.05). In the second step of analyses, a comparison against abiraterone patients showed a significantly higher rate of achieving an ultralow PSA nadir of ≤0.02 ng/ml: 40.2% versus 8.8% for apalutamide versus abiraterone, resulting in a significantly longer ttCRPC for the apalutamide-treated (37 mo) than for the abiraterone-treated (22 mo) group (p = 0.001), even after multivariable adjustment and in sensitivity analyses for high-risk mHSPC patients only. The study is limited by its retrospective design. Conclusions and clinical implications In the real-world setting, most mHSPC patients treated with apalutamide achieve an ultralow PSA nadir, which is associated with better cancer-control outcomes. Moreover, a PSA response of ≥99% predicts better outcomes. In head-to-head comparisons, apalutamide achieves better PSA kinetics and ttCRPC outcomes than abiraterone. Patient summary A prostate-specific antigen (PSA) nadir of <0.02 ng/ml and PSA responses ≥99% are associated with better cancer-control outcomes in metastatic hormone-sensitive prostate cancer patients treated with apalutamide.
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    The 2019 Genitourinary Pathology Society (GUPS) white paper on contemporary grading of prostate cancer
    (College of American Pathologists, 2021) Epstein, Jonathan I.; Amin, Mahul B.; Fine, Samson W.; Algaba, Ferran; Aron, Manju; Beltran, Antonio Lopez; Brimo, Fadi; Cheville; John C.; Colecchia, Maurizio; Comperat, Eva; Cunha, Isabela Werneck da; Delprado, Warick; DeMarzo, Angelo M.; Giannico, Giovanna A.; Gordetsky, Jennifer B.; Guo, Charles C.; Hansel, Donna E.; Hirsch, Michelle S.; Humphrey, Jiaoti HuangPeter A.; Jimenez, Rafael E.; Khani, Francesca; Kong, Qingnuan; N. Kryvenko, Oleksandr; Kunju, L. Priya; Lal, Priti; Latour, Mathieu; Lotan, Tamara; Maclean, Fiona; Magi-Galluzzi, Cristina; Mehra, Rohit; Menon, Santosh; Miyamoto, Hiroshi; Montironi, Rodolfo; J. Netto, George; Nguyen, Jane K.; O. Osunkoya, Adeboye; Parwani, Anil; Robinson, Brian D.; Rubin, Mark A.; Shah, Rajal B.; So, Jeffrey S.; Takahashi, Hiroyuki; Tavora, Fabio; Tretiakova, Maria S.; True, Lawrence; Wobker, Sara E.; Yang, Ximing J.; Zhou, Ming; Zynger, Debra L.; Trpkov, Kiril; Baydar, Dilek Ertoy; Faculty Member; School of Medicine; 8025
    Context.—Controversies and uncertainty persist in prostate cancer grading. Objective.—To update grading recommendations. Data Sources.—Critical review of the literature along with pathology and clinician surveys. Conclusions.—Percent Gleason pattern 4 (%GP4) is as follows: (1) report %GP4 in needle biopsy with Grade Groups (GrGp) 2 and 3, and in needle biopsy on other parts (jars) of lower grade in cases with at least 1 part showing Gleason score (GS) 4 þ 4 ¼ 8; and (2) report %GP4: less than 5% or less than 10% and 10% increments thereafter. Tertiary grade patterns are as follows: (1) replace ‘‘tertiary grade pattern’’ in radical prostatectomy (RP) with ‘‘minor tertiary pattern 5 (TP5),’’ and only use in RP with GrGp 2 or 3 with less than 5% Gleason pattern 5; and (2) minor TP5 is noted along with the GS, with the GrGp based on the GS. Global score and magnetic resonance imaging (MRI)targeted biopsies are as follows: (1) when multiple undesignated cores are taken from a single MRI-targeted lesion, an overall grade for that lesion is given as if all the involved cores were one long core; and (2) if providing a global score, when different scores are found in the standard and the MRI-targeted biopsy, give a single global score (factoring both the systematic standard and the MRI-targeted positive cores). Grade Groups are as follows: (1) Grade Groups (GrGp) is the terminology adopted by major world organizations; and (2) retain GS 3 þ 5 ¼ 8 in GrGp 4. Cribriform carcinoma is as follows: (1) report the presence or absence of cribriform glands in biopsy and RP with Gleason pattern 4 carcinoma. Intraductal carcinoma (IDC-P) is as follows: (1) report IDC-P in biopsy and RP; (2) use criteria based on dense cribriform glands (.50% of the gland is composed of epithelium relative to luminal spaces) and/or solid nests and/or marked pleomorphism/necrosis; (3) it is not necessary to perform basal cell immunostains on biopsy and RP to identify IDC-P if the results would not change the overall (highest) GS/GrGp part per case; (4) do not include IDC-P in determining the final GS/GrGp on biopsy and/or RP; and (5) ‘‘atypical intraductal proliferation (AIP)’’ is preferred for an intraductal proliferation of prostatic secretory cells which shows a greater degree of architectural complexity and/or cytological atypia than typical high-grade prostatic intraepithelial neoplasia, yet falling short of the strict diagnostic threshold for IDC-P. Molecular testing is as follows: (1) Ki67 is not ready for routine clinical use; (2) additional studies of active surveillance cohorts are needed to establish the utility of PTEN in this setting; and (3) dedicated studies of RNA-based assays in active surveillance populations are needed to substantiate the utility of these expensive tests in this setting. Artificial intelligence and novel grading schema are as follows: (1) incorporating reactive stromal grade, percent GP4, minor tertiary GP5, and cribriform/intraductal carcinoma are not ready for adoption in current practice. © 2021 College of American Pathologists. All rights reserved.