novedades en el manejo del paciente con cprc m0 y su potencial ...€¦ · spartan & prosper...
TRANSCRIPT
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Coordinación científica: Dr. Fernando Rivera Hospital Universitario Marqués de Valdecilla,
Santander
Organizado por: Fundación para el progreso
de la oncología en Cantabria
Novedades en el manejo del paciente con CPRC M0
y su potencial aplicación en la clínica
Dr. Juan Fco Rodríguez Moreno Centro Integral Oncológico Clara Campal. Madrid
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M0 Prostate Cancer: A trending topic in GU oncology
www.thelancet.com/oncology Vol 19 April 2018
N Engl J Med 378;26 nejm.org June 28, 2018
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M0 Prostate Cancer: Definition and Review of the problem
1.1 million Prostate Cancers diagnosed annually in the world
Most of them in early stages with curative options of treatment
Relapses after local radical treatments (Surgery or Radiotherapy) could be only a Biochemical
Recurrence:
RISING SERUM PSA WITHOUT LOCOREGIONAL RECURRENCE OR DISTANT METASTASES
Androgen Deprivation Therapy, YES…..BUT
When to initiate ADT-Based Therapy?
Monotherapy?
Continuous versus intermittent androgen deprivation
Van den Bergh RC et al. Eur Urol. 2016:69(5):802
Crook et al. N Engl J Med 2012:367(10):895
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M0 Castration-Resistant Prostate Cancer: Definition and Review of the problem
US incidence of nmCRPC is approximately 50.000 to 60.000 cases per year.
Men with nmCRPC are not at risk for recurrence, are sick people in which metastatic disease will be
appear if don´t die for another cause.
In many cases of nmCRPC the median bone metastasis-free survival ranges from 25 to 30 months.
But, some prognostics features could select a high risk population for develop distant metastasis; like
PSA level, PSA DT, Gleason Score, etc.
Watchful waiting ??
Denosumab?
Atrasentan, Zibotentan, …
Clinical Trials: SPARTAN and PROSPER Smith MR et al. J Clin Oncol 2005; 23:2918-25
Smith MR et al. Cancer 2011. 117:2077-85
Smith MR et al. J Clin Oncol 2013:31:3800-6
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Smith MR et al. N Engl J Med Feb 2018;378:1408-18
M Hussain et al. N Engl J Med Jun 2018;378:2465-74
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Smith MR et al. N Engl J Med Feb 2018;378:1408-18
M Hussain et al. N Engl J Med Jun 2018;378:2465-74
*
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SPARTAN & PROSPER Trials: Common aspects
Big (1207 & 2874 pts) prospective Phase 3, double-blind, placebo-controlled, randomized (2:1) trials
M0 = Non-Metastatic Disease assessed by CT scan and Bone Scan
* N1 patients (pelvic lymph nodes less 2cm) were allowed in SPARTAN Trial
PSA DT ≤ 10 Months
Stratified according to:
* PSA DT > 6m vs ≤ 6m
* Use of bone-sparing agents
* and N0 vs N1 in the SPARTAN Trial
Primary end-point: Metastasis-free Survival
JA Beaver et al. N Engl J Med 378;26 nejm.org June 28, 2018
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SPARTAN & PROSPER Trials: Common aspects
Big (1207 & 2874 pts) prospective Phase 3, double-blind, placebo-controlled, randomized (2:1) trials
M0 = Non-Metastatic Disease assessed by CT scan and Bone Scan
* N1 patients (pelvic lymph nodes less 2cm) were allowed in SPARTAN Trial
PSA DT ≤ 10 Months
Stratified according to:
* PSA DT > 6m vs ≤ 6m
* Use of bone-sparing agents
* and N0 vs N1 in the SPARTAN Trial
Primary end-point: Metastasis-free Survival
JA Beaver et al. N Engl J Med 378;26 nejm.org June 28, 2018
Xie M, et al. J Clin Oncol, 2017
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SPARTAN Trial: Efficacy
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SPARTAN Trial:
Efficacy
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SPARTAN Trial:
Efficacy
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PROSPER Trial: Efficacy
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PROSPER
Efficacy
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PROSPER
Efficacy
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Enzalutamide Associated with Stable to Improved QOL by FACT-P
Presented By Alicia Morgans at 2018 ASCO Annual Meeting
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E.J Small. Poster. AUA Annual Meeting 2018
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TOXICITY
Fracture 17 vs 8%
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TOXICITY
Death principally related with Cardiovascular Events. More frequent in:
* Patients with personal history of cardiovascular disease
* Hypertension
* Diabetes Mellitus
* Hyperlipidemia
* 75 years of age or older
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So, in the clinic… SELECT AND MONITOR patients carefully
Really M0?? Try PET-Colina or PET-PSMA
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So, in the clinic… SELECT AND MONITOR patients carefully
Really M0?? Try PET-Colina or PET-PSMA
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So, in the clinic… SELECT AND MONITOR patients carefully
Really M0??
Agresive disease?? PSA DT <10m?? PSA DT <6m?? PSA level?? Gleason Score??
J Clin Oncol 36,2018(suppl; abst 5034
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So, in the clinic… SELECT AND MONITOR patients carefully
Really M0??
Agresive disease??
Patient fit for second generation AA??
* Cardiovascular comorbilities
* Neurological comorbilities
* Downton Scale <3
* Age??
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So, in the clinic… SELECT AND MONITOR patients carefully
Really M0??
Agresive disease??
Patient fit for second generation AA??
Close Monitoring, specially BONE HEALTH
* Increase the use of bone-sparing agents
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So, in the clinic… SELECT AND MONITOR patients carefully
Really M0??
Agresive disease??
Patient fit for second generation AA??
Close Monitoring, specially BONE HEALTH
Regulatory issues
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Coordinación científica: Dr. Fernando Rivera Hospital Universitario Marqués de Valdecilla,
Santander
Organizado por: Fundación para el progreso
de la oncología en Cantabria
Thank you for your attention!