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James N, et al. ASCO 2017. LBA5003 and Oral Abstract Session
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James, N. D. et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Survival results from an
adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 387, 1163–1177 (2016).
Relapsing after previous RP or RT with ≥1 of: • PSA ≥4ng/ml and rising with
doubling time <6m • PSA ≥20ng/ml • Node-positive • Metastatic
Newly-diagnosed Any of: • Metastatic • Node-Positive • ≥2 of: Stage T3/4
PSA≥40ng/ml Gleason 8-10
ADT = 71 m (IQR 32 to not reached) ADT + DCT = 81 m (41 to not reached) HR 0.78, 95% CI 0·66–0·93; p=0·006
James, N. D. et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Survival results from an
adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 387, 1163–1177 (2016).
James, N. D. et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Survival results from an
adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 387, 1163–1177 (2016).
James, N. D. et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 387, 1163–1177 (2016).
DEPREPRIVACIÓN ANDROGÉNICA (ADT)
CÁNCER DE PRÓSTATA METASTÁSICO SENSIBLE A CASTRACIÓN RECIENTE
DIAGNÓSTICO
DOCETAXEL / A. ZOLENDRÓNICO
CHAARTED
Sweeney, C. J. et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N. Engl. J. Med. 2015; 373, 737–746
DEPREPRIVACIÓN ANDROGÉNICA
CARCINOMA DE PRÓSTATA METASTÁSICO SENSIBLE A CASTRACIÓN RECIENTE
DIAGNÓSTICO
DOCETAXEL ALTO VOLUMEN:
Visceral metastases or
≥4 bone lesions with ≥1 beyond the vertebral
bodies and pelvis
N = 790
mFOLLOW UP = 29m
Sweeney, C. J. et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N. Engl. J. Med. 373, 737–746 (2015).
Sweeney, C. J. et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N. Engl. J. Med. 373, 737–746 (2015).
James, N. D. et al. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N. Engl. J. Med. NEJMoa1702900 (2017).
doi:10.1056/NEJMoa1702900
HR 0.63 95% CI 0.52 to 0.76 P-value 0.00000115
HR 0.29 95% CI 0.25 to 0.34 P-value 0.377x10-61
N= 1917
Median follow-up = 40m.
3-year survival: 83% vs 76% James, N. D. et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Survival results from an
adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 387, 1163–1177 (2016).
James, N. D. et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Survival results from an
adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 387, 1163–1177 (2016).
James, N. D. et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Survival results from an
adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 387, 1163–1177 (2016).
MULTINACIONAL, ALEATORIZADO, DOBLE CIEGO,
CONTROLADO CON PLACEBO, FASE 3
- Adc Próstata M1 RECIENTE DIAGNÓSTICO: SENSIBLE CASTRACIÓN
- ALTO RIESGO. 2 de: - GLEASON 8 -10 - 3 O MÁS LESIONES
ÓSEAS - METÁSTASIS
VISCERALES (MEDIBLES)
RAMDOM 1:1
ADT + PLACEBO
VS
ADT + ABIRATERONA 1000 mg + PREDNISONA
5mg
OP: - mOS - SLP RADIOGRÁFICA.
OS: - TIEMPO A :
- EVENTO ESQUELÉTICO,
- PROGRESIÓN PSA, - SIGUIENTE
TRATAMIENTO - QT - PROGRESIÓN DEL
DOLOR
Fizazi, K. et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N. Engl. J. Med. NEJMoa1704174 (2017). doi:10.1056/NEJMoa1704174
FIRST INTERIM ANALYSIS Median follow-up of 30.4m
ABIRATERONA +ADT : NR ADT: 34.7m
ABIRATERONA +ADT : 33m ADT: 14.8
Fizazi, K. et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N. Engl. J. Med. NEJMoa1704174 (2017). doi:10.1056/NEJMoa1704174
Fizazi, K. et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N. Engl. J. Med. NEJMoa1704174 (2017). doi:10.1056/NEJMoa1704174
Fizazi, K. et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N. Engl. J. Med. NEJMoa1704174 (2017). doi:10.1056/NEJMoa1704174
Fizazi, K. et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N. Engl. J. Med. NEJMoa1704174 (2017). doi:10.1056/NEJMoa1704174
*PREDNISONA 5mg
ENSAYO CHAARTED STAMPEDE 1 STAMPEDE 2 LATITUDE
ADT VS DOCETAXEL DOCETAXEL ABIRATERONA ABIRATERONA
METASTÁSICOS 100% 61% 50% 100%
ALTO RIESGO/VOLUMEN 64% X X 100%
HR OS TODOS 0.61 0.78 0.63 0.62
HR OS METASTÁSICOS 0.61 0.61 0.61 0.62
TOX 3-4 28.30% 52% 47% 63%
Conclusiones
Agonista LHRH + Abiraterona: Tratamiento estándar en Ca
Próstata Metastásico… Opinable: Extendible al paciente M0
Atentos a lo que ocurra con más seguimiento y en los ensayos M0
Papel de Docetaxel: Peace I y
Abido