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Deep, rapid, and du...
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
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- Chowdhury, S. (författare)
- King's College London
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- Bjartell, A. (författare)
- Lund University,Lunds universitet,Urologisk cancerforskning, Malmö,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Urological cancer, Malmö,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Skåne University Hospital
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- Agarwal, N. (författare)
- Huntsman Cancer Institute
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- Chung, B. H. (författare)
- Yonsei University
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- Given, R. W. (författare)
- Eastern Virginia Medical School
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Pereira de Santana Gomes, A. J. (författare)
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- Merseburger, A. S. (författare)
- University Medical Center Schleswig-Holstein
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- Özgüroğlu, M. (författare)
- Istanbul University
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Juárez Soto, Soto (författare)
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- Uemura, H. (författare)
- Kindai University Hospital
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- Ye, D. (författare)
- Fudan University Shanghai Cancer Center (FUSCC)
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- Brookman-May, S. D. (författare)
- Janssen Research & Development, Belgium,Ludwig-Maximilian University of Munich
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- Londhe, A. (författare)
- Janssen Research & Development, Belgium
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- Bhaumik, A. (författare)
- Janssen Research & Development, Belgium
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- Mundle, S. D. (författare)
- Janssen Research & Development, Belgium
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- Larsen, J. S. (författare)
- Janssen Research & Development, Belgium
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- McCarthy, S. A. (författare)
- Janssen Research & Development, Belgium
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Chi, K. N. (författare)
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(creator_code:org_t)
- Elsevier BV, 2023
- 2023
- Engelska 9 s.
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Ingår i: Annals of Oncology. - : Elsevier BV. - 0923-7534. ; 34:5, s. 477-485
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
Nyckelord
- castration resistance
- mCSPC
- overall survival
- PSA progression
- radiographic progression-free survival
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- ref (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Chowdhury, S.
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Bjartell, A.
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Agarwal, N.
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Chung, B. H.
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Given, R. W.
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Pereira de Santa ...
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visa fler...
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Merseburger, A. ...
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Özgüroğlu, M.
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Juárez Soto, Sot ...
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Uemura, H.
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Ye, D.
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Brookman-May, S. ...
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Londhe, A.
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Bhaumik, A.
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Mundle, S. D.
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Larsen, J. S.
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McCarthy, S. A.
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Chi, K. N.
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