Presentazione standard di PowerPoint - AIOM€¦ · Statistical Design: History of CHAARTEDIntent...
Transcript of Presentazione standard di PowerPoint - AIOM€¦ · Statistical Design: History of CHAARTEDIntent...
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
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
Il quesito
1. Ci sono dati a favore di un cambiamento dello stato dell’arte nel trattamento del mHSPC? • DOC+SOC?
• ABT+SOC?
Le questioni metodologiche
1. Valutare la qualità dei risultati ottenuti
2. Descrivere il rapporto beneficio/danno • Nei confronti diretti e indiretti a disposizione
mHSPC mCRPC
nmHNPC nmCRPC
DOCETAXEL
Comparison of study PICOs
Overall survival
Failure-free survival
Vale, Lancet Oncol 2016
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
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
Primary endpoint: Overall survival
CHAARTED Overall
High burden Low burden
CHAARTED by tumor burden
Low precision
mHSPC mCRPC
nmHNPC nmCRPC
ABIRATERONE
Comparison of study PICOs
mHNPC mCRPC
nmHNPC nmCRPC
ABI vs DOCE
Slide 20
Grade 3–5 AEs in ≥2% of patients
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
QOL FACT-P: CHAARTED
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
LATITUDE: QOL FACT-P results
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
Comparison of study PICOs
Slide 32
Presented By Nicholas James at 2017 ASCO Annual Meeting
Slide 38
Presented By Nicholas James at 2017 ASCO Annual Meeting
Network meta-analyses of aggregate data suggest “abiraterone” better
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
Backup Slides
MAIN INCLUSION CRITERIA
Presented By Gwenaelle Gravis at 2015 Genitourinary Cancers Symposium
Slide 13
Presented By Gwenaelle Gravis at 2015 Genitourinary Cancers Symposium
Presented By Christopher Sweeney at 2014 ASCO Annual Meeting
Risk of performance bias
STAMPEDE Trial
Presented By Nicholas James at 2017 ASCO Annual Meeting
Presented By Nicholas James at 2017 ASCO Annual Meeting
Presented By Nicholas James at 2017 ASCO Annual Meeting
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)
Docetaxel: Survival
Presented By Nicholas James at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
Slide 25
Presented By Nicholas James at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
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
Objective
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
Overall study design of LATITUDE
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
Statistically significant 53% risk reduction of radiographic progression or death
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
Statistically significant 38% risk reduction of death
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
Summary of adverse events
Presented By Karim Fizazi at 2017 ASCO Annual Meeting
Slide 1
Presented By Nicholas James at 2017 ASCO Annual Meeting
Abiraterone comparison: patients
Presented By Nicholas James at 2017 ASCO Annual Meeting
Inclusion criteria
Presented By Nicholas James at 2017 ASCO Annual Meeting
Slide 30
Presented By Nicholas James at 2017 ASCO Annual Meeting
Slide 22
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
Current accrual in PEACE-1
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care
Cost of early docetaxel vs abiraterone
Presented By Nicholas Van As at 2018 Genitourinary Cancers Symposium: Translating Evidence to Multidisciplinary Care