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Cáncer de próstata hormonosensible de alto riesgo: definición y alternativas terapéuticas

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Cáncer de próstata hormonosensible de alto

riesgo: definición y alternativas terapéuticas

Docetaxel

Abiraterona

CONCLUSIONES

Docetaxel

Abiraterona

CONCLUSIONES

El BUENO: STAMPEDE

El FEO: CHAARTED

El MALO: GETUG

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).

mCSPC

mCSPC

Docetaxel

Abiraterona

CONCLUSIONES

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

Docetaxel

Abiraterona

CONCLUSIONES

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

Thank you!!!