experiencia y futuro del tratamiento con enzalutamida
TRANSCRIPT
Experiencia y Futuro del tratamiento con
Enzalutamida
Desarrollo clínico en cáncer próstata
Time
PSA
Metastatic
Symptoms
Castration Resistant
Non-Metastatic
Asymptomatic
Castration Sensitive
MetastaticNon-metastatic
Castration resistantCastration sensitive
First-line hormonal therapy/
castration
Docetaxel + prednisone
Localtherapy
Second-line hormonal therapies
Bicalutamide,flutamide,
nilutamide, etc.
Cabazitaxel + prednisone
Enzalutamide
Abiraterone acetate + prednisone
Sipuleucel-T
Abiraterone acetate + prednisone
AFFIRM
3
0 2 4 6 8 10 12
0
20
40
60
80
100
Time to event (months)
PF
S %
Supervivencia libre de enfermedad
Progresión por PSA: aumento >25% sobre nadir
Mediana 5.25 m
Uso Expandido 2012: HSCSP + Htal Asturias. T progresión por PSA
Acceso Expandido: Htal Asturias + HSCSP: Respuesta PSA
-100
-80
-60
-40
-20
0
20
40
60
80
100
1
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
Perfil de PSA en el tiempo. % sobre el basal
%
Semanas
*FDHT: 16β-18F-fluoro-5α-dihidrotestosteronaScher HI, et al. Lancet. 375:1437, 2010
Fase I/II: Inhibición del AR y farmacocinética
Farmacocinética de dosis múltiples
Conc. pre-dosis (Cmín)
Respuesta precoz y supervivencia?
Caffo et al. Fut Oncol 2014; 985
Desarrollo clínico en cáncer próstata
Time
PSA
Metastatic
Symptoms
Castration Resistant
Non-Metastatic
Asymptomatic
Castration Sensitive
MetastaticNon-metastatic
Castration resistantCastration sensitive
First-line hormonal therapy/
castration
Docetaxel + prednisone
Localtherapy
Second-line hormonal therapies
Bicalutamide,flutamide,
nilutamide, etc.
Cabazitaxel + prednisone
Enzalutamide
Abiraterone acetate + prednisone
Sipuleucel-T
Abiraterone acetate + prednisone
AFFIRM
ABIRATERONA ---- ENZALUTAMIDA
Enza tras Abi
N=137Median duration of Rx: 4 months
Enzalutamide in progressive mCRPC previously treated with abiraterone
Planned evaluations•rPFS•OS•PSA response•Time to PSA progression•Safety•Objective response rate•QoL•Time to start other antineoplastic therapy
ADT=androgen-deprivation therapy; ECOG PS=Eastern Cooperative Oncology Group performance status; mCRPC=metastatic castration-resistant prostate cancer; OS=overall survival; PFS=progression-free survival; PSA=prostate-specific antigen; QoL=quality of life; rPFS=radiographic PFS.EudraCT 2013-002271-17. Available at https://www.clinicaltrialsregister.eu. Last accessed: April 2014.
Enzalutamide (160 mg QD)
n=200
Progressive mCRPC
Testosterone ≤50 ng/dL
Ongoing ADT
≥6 months prior treatment
with abiraterone
Asymptomatic/mildly
symptomatic
ECOG PS 0–1
• A Phase 4 multicentre, single-arm study• Primary endpoint: rPFS
11
Ongoing trials
Desarrollo clínico en cáncer próstata
Time*Phase 1b; †Phase 2; ‡Phase 3.
PSA
Metastatic
Symptoms
Castration Resistant
Non-Metastatic
Asymptomatic
Castration Sensitive
MetastaticNon-metastatic
Castration resistantCastration sensitive
First-line hormonal therapy/
castration
Docetaxel + prednisone
Localtherapy
Second-line hormonal therapies
Bicalutamide,flutamide,
nilutamide, etc.
Cabazitaxel + prednisone
Enzalutamide
Abiraterone acetate + prednisone
Sipuleucel-T
Abiraterone acetate + prednisone
PREVAIL
AFFIRM
PREVAILCPRC metastásicoNO: Quimioterapia,
ketoconazole, o abirateroneECOG 0-1
BPI (Brief Pain Inventory):
Asintomático (0- 1) o casi asintomático
(2-3)Metástasis viscerales
permitidasPacientes NYHA I-II
NO riesgo de convulsión pero SÎ con medicaciones que bajen el dintel
convulsivoCorticoides permitidos
Objetivos
Co-primarios:
• SG
• rPFS
Enzalutamida160 mg/día
(capsulas) n=872
Placebon=845
RANDOMIZADO
1:1
CRPCm=Cáncer de Próstata resistente a castración metastásico SG=Supervivencia Global; rPFS=Supervivencia Libre de Progresión Radiográfica.
Beer TM, et al. ASCO-GU 2014; Oral presentation; ClinicalTrials.gov identifier: NCT01212991.
Características Enzalutamida (n=872)
Placebo (n=845)
Edad, mediana (rango), a 72 (43−93) 71 (42−93)
PSA, mediana, ng/mL 54.1 44.2
Gleason ≥8 50.6% 52.4%
Puntuación ECOG = 0 67.0% 69.2%
Dolor al inicio 0–1 BPI-SF 66.2% 67.5%
Uso de corticoides al inicio 4.0% 4.3%
Beer TM, et al. ASCO-GU 2014; Oral presentation.
Enfermedad ósea 85.0% 81.7%
Enfermedad de tejidos blandos 59.3% 59.6%
Enfermedad visceral (hepática y/o pulmonar) 11.2% 12.5%
RECIST
Enzalutamida(n=872)
Placebo(n=845) Valor P
Pacientes con enfemedad de tejidos blandos medibles al inicio
396 381
Respuesta Objetiva (RC + RP) 58.8% 5.0% <0.0001
Best overall response
RC 19.7% 1.0%
RP 39.1% 3.9%
Categorías de respuesta según criterios RECIST 1.1.
RC=respuesta completa; RP=Respuesta parcial; RECIST=Response Evaluation Criteria in Solid Tumors.
Beer TM, et al. ASCO-GU 2014; Oral presentation.
Supervivencia libre de Progresión Radiográfica
3 6 15 18 2112
100
80
60
40
20
00
rPF
S (
%)
Meses9
514 256 5 1 034832 128Enzalutamida, n
305 79 0 0 05801 20Placebo, n
Placebo
Enzalutamida
HR=0.186 (95% CI: 0.15–0.23); p<0.0001
Beer TM, et al. ASCO-GU 2014; Oral presentation.
Estimated Mediana estimada de rPFS, meses (95% IC): Enzalutamida: NYR (13.8, NYR); Placebo: 3.9 (3.7, 5.4)
Subgrupo
Nº de pacientesenzalutamida /
placeboHazard ratio
(95% IC)
Todos los pacientes 832 / 801 0.19 (0.15–0.23)
ECOG performance status at baseline = 0 557 / 549 0.15 (0.11–0.20)
ECOG performance status at baseline = 1 275 / 252 0.27 (0.19–0.37)
Edad <75 529 / 517 0.20 (0.15–0.26)
Edad ≥75 303 / 284 0.17 (0.12–0.24)
Región geográfica – North America 214 / 204 0.17 (0.12–0.25)
Región geográfica – Europe 456 / 435 0.21 (0.15–0.28)
Región geográfica – Rest of world 162 / 162 0.14 (0.08–0.25)
Enfermedad visceral (hepática y/o pulmonar) al screening– Sí 97 / 101 0.28 (0.16–0.49)
Enfermedad visceral (hepática y/o pulmonar) al screening– No 735 / 700 0.17 (0.14–0.22)
SLPr: Análisis de subgrupos
0 0.5 1.0 1.5
A favorenzalutamida
A favor placebo
ECOG=European Co-operative Group.
Beer TM, et al. ASCO-GU 2014; Oral presentation.
Beer TM, et al. ASCO-GU 2014; Oral presentation.
% de pacientes que recibieron tratamientos posteriores
Docetaxel 32.8% 56.7%
Abiraterona 20.5% 45.6%
Cabazitaxel 5.8% 13.0%
Enzalutamida 1.0% 4.4%
Sipuleucel-T 1.4% 1.2%
Enzalutamida(n=872)
Placebo (n=845)
Tratamiento: Duración media (m) 16.6 4.6
Duración ≥ 12 ms 67.9% 18.0%
Tratamiento activo al corte 42.1% 7.2%
% con al menos 1 tratamiento posterior que prolonga la vida
40.3% 70.3%
Supervivencia Global
3 6 30 33 3612
100
80
60
40
20
00
Su
pe
rviv
enci
a (%
)
Meses9
863 850 33 2 0797872 824Enzalutamida, n
835 781 27 2 0701845 744Placebo, n
Placebo
Enzalutamida
HR=0.706 (95% CI: 0.60–0.84); p<0.0001
15
745
644
18
566
484
21
395
328
24
244
213
27
128
102
Beer TM, et al. ASCO-GU 2014; Oral presentation.
Mediana estimada de SG, meses (95% IC): Enzalutamida: 32.4 (30.1, NYR); Placebo: 30.2 (28.0, NYR)
T a progresión por PSA
Respuesta PSA
Enzalutamida
(n=854)
Placebo
(n=777)
≥ 50% ≥ 90%
78.0%46.8%
3.5%1.2%
Otros beneficios asociados al tratamiento....
T a inicio de Quimioterapia
HR=0.35 (95% CI: 0.30–0.40); p<0.0001
Toxicidad
Todos los Grados (%) Acontecimientos Grado ≥3 (%)
Enzalutamida(n=871)
Placebo(n=844)
Enzalutamida(n=871)
Placebo(n=844)
Fatiga 35.6 25.8 1.8 1.9
Dolor de espalda 27.0 22.2 2.5 3.0
Estreñimiento 22.2 17.2 0.5 0.4
Artralgia 20.3 16.0 1.4 1.1
Eventos Cardiacos 10.1 7.8 2.8 2.1
Hipertensión 13.4 4.1 6.8 2.3
Aumento ALT 0.9 0.6 0.2 0.1
Convulsiones 0.0† 0.1 0.0† 0.0
*Al menos 20% en enzalutamida y ≥2% más que en placebo; † Unaconvulsión ocurió después de la fecha de cutoff.
ALT=alanina aminotransferasa.
Beer TM, et al. ASCO-GU 2014; Presentación Oral.
Desarrollo clínico en cáncer próstata
Time *Phase 1b; †Phase 2; ‡Phase 3.
PSA
Metastatic
Symptoms
Castration Resistant
Non-Metastatic
Asymptomatic
Castration Sensitive
MetastaticNon-metastatic
Castration resistantCastration sensitive
First-line hormonal therapy/
castration
Docetaxel + prednisone
Localtherapy
Second-line hormonal therapies
Bicalutamide,flutamide,
nilutamide, etc.
Cabazitaxel + prednisone
Enzalutamide
Abiraterone acetate + prednisone
Sipuleucel-T
Abiraterone acetate + prednisone
Neoadjuvant†
TERRAIN†
Monotherapy†
STRIVE†
M0 CRPC ‡
PREVAIL
Enzalutamide post abiraterone†
AFFIRM
PRESIDE
PREMIERE
PLATO
UPWARD
ALLIANCE
Desarrollo clínico en cáncer próstata
Time*Phase 1b; †Phase 2; ‡Phase 3.
PSA
Metastatic
Symptoms
Castration Resistant
Non-Metastatic
Asymptomatic
Castration Sensitive
MetastaticNon-metastatic
Castration resistantCastration sensitive
First-line hormonal therapy/
castration
Docetaxel + prednisone
Localtherapy
Second-line hormonal therapies
Bicalutamide,flutamide,
nilutamide, etc.
Cabazitaxel + prednisone
Enzalutamide
Abiraterone acetate + prednisone
Sipuleucel-T
Abiraterone acetate + prednisone
Neoadjuvant†
TERRAIN†
Monotherapy†
STRIVE†
M0 CRPC ‡
Enzalutamide post abiraterone†
AFFIRM
PRESIDE
PREMIERE
PLATO
UPWARD
ALLIANCE
PRESIDE: Continued enzalutamide treatment beyond progression in combination with docetaxel in
chemotherapy-naïve mCRPC
Planned evaluations•rPFS, time to PSA progression, PSA response, objective response, time to pain progression, time to first SRE, QoL
ADT=androgen-deprivation therapy; BID=twice daily; ECOG PS=Eastern Cooperative Oncology Group performance status; mCRPC=metastatic castration-resistant prostate cancer; PSA=prostate-specific antigen; QD=once daily; QoL=quality of life; R=randomisation; rPFS=radiographic progression-free survival.
• A Phase 3b randomised, double-blind placebo-controlled study• Primary endpoint: PFS
25
n=500
Chemotherapy-naïve mCRPC after ADT
failure
Testosterone ≤50 ng/dL
Progressive disease with ongoing ADT
Asymptomatic/mildly symptomatic
ECOG PS 0–1
Open-label enzalutamide
160 mg QDSafety follow-up
Enzalutamide (160 mg QD) +
docetaxel 75 mg/m2/3 weeks + prednisone (5
mg BID)
Placebo QD + docetaxel 75 mg/m2/
3 weeks + prednisone (5 mg BID)
R1:1
PLATO: Continued enzalutamide treatment beyond progression in combination with abiraterone in
chemotherapy-naïve mCRPC
Planned evaluations•PFS, time to PSA progression, PSA response, safety
ADT=androgen-deprivation therapy; BID=twice daily; ECOG PS=Eastern Cooperative Oncology Group performance status; mCRPC=metastatic castration-resistant prostate cancer; PFS=progression-free survival; PSA=prostate-specific antigen; QD=once daily; R=randomisation.NCT01995513. Available at http://clinicaltrials.gov. Last accessed: April 2014.
• A Phase 4 randomised, double-blind placebo-controlled study• Primary endpoint: PFS
26
Recruiting
n=500
Chemotherapy-naïve mCRPC
after ADT failure
ECOG PS 0–1
Estimated life expectancy >12 months
Open-label enzalutamide
160 mg QDSafety follow-up
Enzalutamide (160 mg QD) + abiraterone (1000
mg QD) + prednisone (5 mg BID)
Placebo (QD) + abiraterone
(1000 mg QD) + prednisone (5 mg BID)
PSA RISE
R1:1
PROGRESSION
Ongoing trials
ALLIANCE: Study on enzalutamide with or without abiraterone in mCRPC
Planned evaluations•OS•Safety, Grade ≥3 AEs•Decline in PSA•PFS•Objective response•rPFS•Tumour burden and bone activity
Timing•Estimated primary completion December 2019
ADT=androgen deprivation therapy; AE=adverse event; BID=twice daily; ECOG PS=Eastern Cooperative Oncology Group performance status; mCRPC=metastatic castration-resistant prostate cancer; OS=overall survival; PFS=progression-free survival; PSA=prostate-specific antigen; QD=once daily; R=randomisation; rPFS=radiographic PFS.NCT01949337. Available at http://clinicaltrials.gov. Last accessed: April 2014.
Enzalutamide (160 mg QD)
Enzalutamide (160 mg QD) +
abiraterone (1000 mg QD) +
prednisone(5 mg BID)
R2:1
n=1224
Chemotherapy-naïve mCRPC
No prior ketoconazole
Progression after ADT
ECOG PS 0–1
• A Phase 3 randomised, double-blind, placebo-controlled trial
• Primary endpoint: Metastatic-free survival
27
Recruiting
Ongoing trials
Abiraterona + Enzalutamida
PEACE: EORTC: Comparing Radium-223 and Enzalutamide vs Enzalutamide
Abi=abiraterone; ADC=apparent diffusion coefficient; ADT=androgen-deprivation therapy; BPI=Brief Pain Inventory; CRPC=castration-resistant prostate cancer; ECOG=Eastern Cooperative Oncology Group; FPI=first patient in; ORR=overall response rate; P=prednisone; PFS=progression-free survival; QD=once daily; R=randomisation.
Planned evaluations•Primary endpoint: sPFS 1•Secondary endpoints:
– PFS 2– ORR T1, T2– Predictive value bone markers and
ADC (Diff coeff)
Safety analysis•At 25, 50, 100 patients•At least two cycles or end of treatment
Statistical analysis•233 events (Month 51)•90% power•9 month difference (17 vs. 26 months)•1-sided type 1 error 0.025
Ongoing trials
Enzalutamide (160 mg QD)
+ ADT
n=510
Asymptomatic/mildly symptomatic
Metastatic CRPC (≥2 bone mets)
Visceral mets –ve
Lymph node ±ve
Maximum one line of treatment (chemo-naïve)
BPI pain ≤4 (none to mild)
Schedule for docetaxel, abi/P, enzalutamide
ECOG 0–1
• A Phase 3 multicentre study• Primary endpoint: sPFS 1
Recruiting (subject to revision)FPI Q2/3 2014
Radium-223 50kBq/kg
monthly, for 6 months +
enzalutamide 160 mg QD
+ ADT
R
Desarrollo clínico en cáncer próstata
Time*Phase 1b; †Phase 2; ‡Phase 3.
PSA
Metastatic
Symptoms
Castration Resistant
Non-Metastatic
Asymptomatic
Castration Sensitive
MetastaticNon-metastatic
Castration resistantCastration sensitive
First-line hormonal therapy/
castration
Docetaxel + prednisone
Localtherapy
Second-line hormonal therapies
Bicalutamide,flutamide,
nilutamide, etc.
Cabazitaxel + prednisone
Enzalutamide
Abiraterone acetate + prednisone
Sipuleucel-T
Abiraterone acetate + prednisone
Neoadjuvant†
TERRAIN†
Monotherapy†
STRIVE†
M0 CRPC ‡
PREVAIL
Enzalutamide post abiraterone†
AFFIRM
PRESIDE
PROSPER
PLATO
UPWARD
ALLIANCE
STRIVE: A study of Enzalutamide vs Bicalutamide in men with prostate cancer that failed primary ADT
Planned evaluations•Biochemical or radiographic PFS •Time to PSA progression•PSA response (≥50% decline from baseline)•Time to radiographic progression•QoL (FACT-P)•Safety
Timing•Estimated study completion June 2015
ADT=androgen-deprivation therapy; FACT-P=Functional Assessment of Cancer Therapy-Prostate; PFS=progression-free survival; PSA=prostate-specific antigen; PSADT=PSA doubling time; QD=once daily; QoL=quality of life; R=randomisation.NCT01664923. Available at http://clinicaltrials.gov. Last accessed: April 2014.
n=400Progressive
prostate cancer on first-line ADT*
PSA ≥5 ng/mL or PSADT
≤10 months if PSA 2 to <5 ng/mL
R1:1
Enzalutamide
160 mg QD
Bicalutamide 50 mg QD
Enrolment complete
• STRIVE is a Phase 2, randomised, double-blind, active-controlled trial
• Stratified by stage: M0N0, M0N1, or M1• Primary endpoint: PFS (biochemical or
radiographic)
32
Ongoing trials
TERRAIN: A study of Enzalutamide vs Bicalutamide in castrate men with metastatic prostate cancer
Planned evaluations•Radiographic PFS•Time to first SRE•Initiation of cytotoxic chemotherapy•QoL (FACT-P, EQ-5D)•PSA progression•Pain palliation (BPI-SF)•Safety (AEs, vital signs, physical exam, lab evaluations, ECG)•PKs
Timing•Estimated study completion December 2014
• TERRAIN is a Phase 2, randomised, double-blind, active-controlled trial
• Primary endpoint: PFS
n=370 mCRPC
Asymptomatic or mildly symptomatic
Progression after first-line ADT
Enzalutamide 160 mg QD
Bicalutamide 50 mg QD
R1:1
Enrolment complete
PROSPER: An efficacy and safety study of Enzalutamide in patients with non-metastatic CRPC
Planned evaluations•Metastatic-free survival•OS•Time to pain progression•Time to opiate use for prostate cancer pain•Time to first use of cytotoxic chemotherapy•Time to first use of new antineoplastic therapy•Time to PSA progression•PSA response rates•QoLTiming•Estimated study completion August 2017
ADT=androgen-deprivation therapy; CRPC=castration-resistant prostate cancer; EORTC=European Organisation for Research and Treatment of Cancer; FACT-P=Functional Assessment of Cancer Therapy-Prostate; OS=overall survival; PFS=progression-free survival; PSA=prostate-specific antigen; PSADT=PSA doubling time; QD=once daily; QLQ=Quality of Life Questionnaire; QoL=quality of life; R=randomisation.NCT02003924. Available at http://clinicaltrials.gov. Last accessed: April 2014.
Enzalutamide 160 mg QD
Placebo QD
R2:1
n=1560
Non-metastatic (M0) CRPC
Testosterone ≤50 ng/dL
Progressive disease with ongoing ADT
Asymptomatic
PSADT ≤10 months
• M0 CRPC is a Phase 3, randomised, double-blind, placebo-controlled trial
• Primary endpoint: Metastatic-free survival
34
Recruiting
Enzalutamida en pacientes con cáncer de próstata sin tratamiento hormonal previo1,2
• Estudio fase 2 que evalua la eficacia y seguridad de enzalutamida en monoterapia en pacientes con cáncer de próstata localizado, localmente avanzado o mestastásico que no hayan recibido previamente tratamientos hormonales o quimioterapia.
*Patients must have an ECOG performance status of 0, life expectancy of >1 year. †If patients exhibited clinical benefit at Week 25, enzalutamide treatment was continued until disease progression or unacceptable toxicity.ADT=androgen-deprivation therapy; ECOG=Eastern Cooperative Oncology Group; mCRPC=metastatic castration-resistant prostate cancer; PK=pharmacokinetics; PSA=prostate-specific antigen; QD=once daily; QoL=quality of life. 1.Tombal B, et al. ASCO-GU 2013; Poster presentation 18.2.Smith MR, et al. ECC 2013; Oral presentation 2852.
Patient population
Patients with hormone-naïve prostate cancer (all
stages)
Non-castrate levels of testosterone (≥230 ng/dL)
PSA ≥2 ng/mL
Rising PSA requiring ADT
ECOG performance status 0 at screening
Life expectancy ≥12 months
(N=67)*
Enzalutamide 160 mg QD
for 25 weeks†
Primary endpoint:
PSA response (≥80% decline) at Week 52
Secondary endpoints:
Enzalutamide PK
PSA kinetics
Changes in hormone levels
Metabolic changes
QoL
Safety/tolerability
Respuesta PSA semana 25
*Analysis was restricted to patients who completed the 25-week study period. Four patients who discontinued before Week 25 (for any reason) were considered non-responders; †≥80% decrease in PSA level. PSA=prostate-specific antigen.Tombal B, et al. ASCO-GU 2013; Poster presentation 18.
• 92.5% of patients (n=62*) experienced a PSA response†
(95% CI: 86.2%–98.8%)• Median decrease in PSA was 99.6% (range: –100 to –86.5%)
36
Max
imu
m d
ecli
ne
in
PS
A a
s p
erc
enta
ge
chan
ge
fro
m b
asel
ine
1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58Observations
10080604020
0–20–40–60–80
–10061 64 67
Cinética de la Respuesta por PSA
Cinética de las concetraciones séricas de LH y testosterona durante Enzalutamida
• Aumento medio de 185% en LH desde el basal a la semana 25• Aumento medio de 114% en la testosterona desde basal a la semana 25
LH=luteinising hormone.Tombal B, et al. ASCO-GU 2013; Poster presentation 18.
185%(n=58)
114%(n=63)
450
400
350
300
250
200
150
100
50
0
Co
nce
ntr
atio
n (
%)
1 2 5 9 13 17 21 25Time (weeks)
LHTestosterone
Neoadjuvant study: A study of Enzalutamide as a neoadjuvant therapy for patients undergoing
prostatectomy for localised PC
Planned evaluations•Pathological CR•Downstage/surgical margins•PSA, DHT, testosterone nadir, time to and duration of nadir•Pharmacodynamic markers (proliferative index, apoptotic index, tumoural DHT, AR signalling markers, etc.)•Safety and tolerability
Timing•Study completed
*Intermediate risk: T2b or T2c clinical stage or PSA at screening 10–20 ng/mL or Gleason Score of 7; high risk: T3 clinical stage or PSA at screening >20 ng/mL or Gleason Score 8–10 AR=androgen receptor; CR=complete response; DHT=dihydrotestosterone; ECOG PS=Eastern Cooperative Oncology Group performance status; PSA=prostate-specific antigen; QD=once daily; Q3MOS=once every three months; R=randomisation; SC=subcutaneous.NCT01547299. Available at http://clinicaltrials.gov. Last accessed: April 2014.
n=52
Intermediate to high risk prostate
cancer*
≥3 positive cores
ECOG PS 0–1
R1:1
6 months ofenzalutamide 160 mg
QD + dutasteride 0.5 mg QD + leuprolide
22.5 mg SC Q3MOS prior to radical prostatectomy
6 months of enzalutamide 160 mg QD
prior to radical prostatectomy
• Phase 2, open-label, randomised study• Stratified based on intermediate and high risk*• Primary endpoint: Pathological CR rate
39
Completed
RESISTENCIA A ENZALUTAMIDA: LIGADA O NO AL RA
RESISTENCIA A ENZALUTAMIDA: LIGADA O NO AL RA
Conclusiones
• Enzalutamida es hoy una parte fundamental en el manejo del CPRC
• Enzalutamida, por su perfil de toxicidad, mínimo, lo hace idóneo para su aplicación en fases precoces de la enfermedad y en combinación
• Además de su incorporación a fases precoces de la enfermedad, optimizar la duración del
tratamiento profundizando en los mecanismos de resistencia
| Presentation Title | Presenter Name | Date | Subject | Business Use Only
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