Cited 16 times in
Deep, rapid, and durable prostate-specific antigen decline with apalutamide plus androgen deprivation therapy is associated with longer survival and improved clinical outcomes in TITAN patients with metastatic castration-sensitive prostate cancer
DC Field | Value | Language |
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dc.contributor.author | 정병하 | - |
dc.date.accessioned | 2024-03-22T05:51:09Z | - |
dc.date.available | 2024-03-22T05:51:09Z | - |
dc.date.issued | 2023-05 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/198249 | - |
dc.description.abstract | Background: The first interim analysis of the phase III, randomized, double-blind, placebo-controlled, multinational TITAN study demonstrated improved overall survival (OS) and radiographic progression-free survival (rPFS) with apalutamide added to ongoing androgen deprivation therapy (ADT) in patients with metastatic castration-sensitive prostate cancer. The final analysis confirmed improvement in OS and other long-term outcomes. We evaluated prostate-specific antigen (PSA) kinetics and the association between PSA decline and outcomes in patients with metastatic castration-sensitive prostate cancer from TITAN. Patients and methods: Patients received apalutamide (240 mg/day) or placebo plus ADT (1: 1). This post hoc exploratory analysis evaluated PSA kinetics and decline in relation to rPFS (22.7 months’ follow-up) and OS, time to PSA progression, and time to castration resistance (44.0 months’ follow-up) in patients with or without confirmed PSA decline using a landmark analysis, the Kaplan–Meier method, and Cox proportional hazards model. Results: One thousand and fifty-two patients (apalutamide, 525; placebo, 527) were enrolled. Best confirmed PSA declines (≥50% or ≥90% from baseline or to ≤0.2 ng/ml) were achieved at any time during the study in 90%, 73%, and 68% of apalutamide-treated versus 55%, 29%, and 32% of placebo-treated patients, respectively. By 3 months of apalutamide treatment, best deep PSA decline of ≥90% or to ≤0.2 ng/ml occurred in 59% and 51% of apalutamide- and in 13% and 18% of placebo-treated patients, respectively. Achievement of deep PSA decline at landmark 3 months of apalutamide treatment was associated with longer OS [hazard ratio (HR) 0.35; 95% confidence interval (CI) 0.25-0.48), rPFS (HR 0.44; 95% CI 0.30-0.65), time to PSA progression (HR 0.31; 95% CI 0.22-0.44), and time to castration resistance (HR 0.38; 95% CI 0.27-0.52) compared with no decline (P < 0.0001 for all). Similar results were observed at landmark 6 and 12 months of apalutamide treatment. Conclusions: Apalutamide plus ADT demonstrated a robust (rapid, deep, and durable) PSA decline that was associated with improved clinical outcomes, including long-term survival. © 2023 The Authors | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Oxford University Press | - |
dc.relation.isPartOf | ANNALS OF ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Androgen Antagonists / therapeutic use | - |
dc.subject.MESH | Androgens / therapeutic use | - |
dc.subject.MESH | Castration | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Prostate-Specific Antigen* | - |
dc.subject.MESH | Prostatic Neoplasms, Castration-Resistant* | - |
dc.title | Deep, rapid, and durable prostate-specific antigen decline with apalutamide plus androgen deprivation therapy is associated with longer survival and improved clinical outcomes in TITAN patients with metastatic castration-sensitive prostate cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Urology (비뇨의학교실) | - |
dc.contributor.googleauthor | S Chowdhury | - |
dc.contributor.googleauthor | A Bjartell | - |
dc.contributor.googleauthor | N Agarwal | - |
dc.contributor.googleauthor | B H Chung | - |
dc.contributor.googleauthor | R W Given | - |
dc.contributor.googleauthor | A J Pereira de Santana Gomes | - |
dc.contributor.googleauthor | A S Merseburger | - |
dc.contributor.googleauthor | M Özgüroğlu | - |
dc.contributor.googleauthor | Á Juárez Soto | - |
dc.contributor.googleauthor | H Uemura | - |
dc.contributor.googleauthor | D Ye | - |
dc.contributor.googleauthor | S D Brookman-May | - |
dc.contributor.googleauthor | A Londhe | - |
dc.contributor.googleauthor | A Bhaumik | - |
dc.contributor.googleauthor | S D Mundle | - |
dc.contributor.googleauthor | J S Larsen | - |
dc.contributor.googleauthor | S A McCarthy | - |
dc.contributor.googleauthor | K N Chi | - |
dc.identifier.doi | 10.1016/j.annonc.2023.02.009 | - |
dc.contributor.localId | A03607 | - |
dc.relation.journalcode | J00171 | - |
dc.identifier.eissn | 1569-8041 | - |
dc.identifier.pmid | 36858151 | - |
dc.subject.keyword | PSA progression | - |
dc.subject.keyword | castration resistance | - |
dc.subject.keyword | mCSPC | - |
dc.subject.keyword | overall survival | - |
dc.subject.keyword | radiographic progression-free survival | - |
dc.contributor.alternativeName | Chung, Byung Ha | - |
dc.contributor.affiliatedAuthor | 정병하 | - |
dc.citation.volume | 34 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 477 | - |
dc.citation.endPage | 485 | - |
dc.identifier.bibliographicCitation | ANNALS OF ONCOLOGY, Vol.34(5) : 477-485, 2023-05 | - |
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