Presentazione standard di PowerPoint - AIOM€¦ · Statistical Design: History of CHAARTEDIntent...
Transcript of Presentazione standard di PowerPoint - AIOM€¦ · Statistical Design: History of CHAARTEDIntent...
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Pulci Statistiche
Valter Torri IRCCS – Istituto di ricerche farmacologiche
Mario Negri - Milano
Gestione ottimale del paziente con carcinoma della prostata - Milano, 25-26.09.18
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Survival remains disappointing in men presenting with M1 disease who are started on only long-term ADT, despite active treatments being available at first failure of ADT. Importantly, men with M1 disease now spend the majority of their remaining life in a state of castration-resistant relapse
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Il quesito
1. Ci sono dati a favore di un cambiamento dello stato dell’arte nel trattamento del mHSPC? • DOC+SOC?
• ABT+SOC?
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Le questioni metodologiche
1. Valutare la qualità dei risultati ottenuti
2. Descrivere il rapporto beneficio/danno • Nei confronti diretti e indiretti a disposizione
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mHSPC mCRPC
nmHNPC nmCRPC
DOCETAXEL
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Comparison of study PICOs
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Overall survival
Failure-free survival
Vale, Lancet Oncol 2016
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Statistical Design: History of CHAARTED<br />Intent to treat analysis, 80% power 1-sided alpha=2.5% to detect 33% improvement in median OS (with all versions)
Presented By Christopher Sweeney at 2014 ASCO Annual Meeting
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CHAARTED definition of risk
High volume
visceral mets and/or ≥4 bone mets (at last 1 beyond pelvis and spine)
Presented By Michael Morris at 2014 ASCO Annual Meeting
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Primary endpoint: Overall survival
CHAARTED Overall
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High burden Low burden
CHAARTED by tumor burden
Low precision
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mHSPC mCRPC
nmHNPC nmCRPC
ABIRATERONE
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Comparison of study PICOs
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mHNPC mCRPC
nmHNPC nmCRPC
ABI vs DOCE
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Slide 20
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Grade 3–5 AEs in ≥2% of patients
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
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QOL FACT-P: CHAARTED
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
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LATITUDE: QOL FACT-P results
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
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Comparison of study PICOs
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Slide 32
Presented By Nicholas James at 2017 ASCO Annual Meeting
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Slide 38
Presented By Nicholas James at 2017 ASCO Annual Meeting
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Network meta-analyses of aggregate data suggest “abiraterone” better
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
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Backup Slides
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MAIN INCLUSION CRITERIA
Presented By Gwenaelle Gravis at 2015 Genitourinary Cancers Symposium
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Slide 13
Presented By Gwenaelle Gravis at 2015 Genitourinary Cancers Symposium
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Presented By Christopher Sweeney at 2014 ASCO Annual Meeting
Risk of performance bias
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STAMPEDE Trial
Presented By Nicholas James at 2017 ASCO Annual Meeting
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Presented By Nicholas James at 2017 ASCO Annual Meeting
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Presented By Nicholas James at 2017 ASCO Annual Meeting
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HR (95% CI) SOC+ZA vs. SOC: 0.94 (0.79-1.11) SOC+DOC vs. SOC: 0.78 (0.66-0.93) SOC+ZA+DOC vs. SOC: 0.82 (0.69-0.97)
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Docetaxel: Survival
Presented By Nicholas James at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
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Slide 25
Presented By Nicholas James at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
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LATITUDE: A phase 3, double-blind, randomized trial of androgen deprivation therapy with abiraterone acetate plus prednisone or placebos <br />in newly diagnosed high-risk metastatic hormone-naïve prostate cancer patients
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
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Objective
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
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Overall study design of LATITUDE
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
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Statistically significant 53% risk reduction of radiographic progression or death
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
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Statistically significant 38% risk reduction of death
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
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Summary of adverse events
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
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Slide 1
Presented By Nicholas James at 2017 ASCO Annual Meeting
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Abiraterone comparison: patients
Presented By Nicholas James at 2017 ASCO Annual Meeting
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Inclusion criteria
Presented By Nicholas James at 2017 ASCO Annual Meeting
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Slide 30
Presented By Nicholas James at 2017 ASCO Annual Meeting
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Slide 22
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
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Current accrual in PEACE-1
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
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Cost of early docetaxel vs abiraterone
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care