DEBATE: NUEVOS TRATAMIENTOS EN CÁNCER DE MAMA POSICIONAMIENTO Y ALGORITMO TERAPÉUTICO CÁNCER DE MAMA HER 2 POSITIVO
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1 DEBATE: NUEVOS TRATAMIENTOS EN CÁNCER DE MAMA POSICIONAMIENTO Y ALGORITMO TERAPÉUTICO CÁNCER DE MAMA HER 2 POSITIVO
2 DEBATE: NUEVOS TRATAMIENTOS EN CÁNCER DE MAMA POSICIONAMIENTO Y ALGORITMO TERAPÉUTICO CÁNCER DE MAMA HER 2 POSITIVO ENFERMEDAD AVANZADA
3 PFS & OS EN EVOLUCIÓN HISTÓRICA Meses Slamon D. et al, NEJM 2001 Marty M. et al, JCO 2005 Swain S. Et al, ESMO 2014
4 ESTRATEGIAS TERAPÉUTICAS
5 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Slamon D. et al, NEJM 2001
6 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Marty M. et al, JCO 2005 Docetaxel + Trastuzumab vs. Docetaxel
7 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Andersson M. et al, JCO 2010 Docetaxel + Trastuzumab vs. Vinorelbina + Trastuzumab
8 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Lapatinib es inferior a QT + Trastuzumab en Primera Línea Paclitaxel + Trastuzumab vs. Paclitaxel + Lapatinib Gelmon K, et al. ASCO 2012
9 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Tras Progresión a 1ª Línea Lapatinib + Capecitabina Geyer CE. et al, NEJM 2006
10 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Tras Progresión a 1ª Línea Lapatinib + Capecitabina Trastuz. + Capecitabina Von Minckwitz. G, et al, JCO 2009
11 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? Qué Sabemos? : 2014 QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Tras Progresión a 1ª Línea Lapatinib + Capecitabina Trastuz. + Capecitabina
12 1ª Línea de Tratamiento
13 Pertuzumab HER2-positive MBC centrally confirmed (N = 808) 1:1 n = 406 Placebo + trastuzumab Docetaxel* 6 cycles Pertuzumab + trastuzumab PD PD n = 402 Docetaxel* 6 cycles Baselga J, et al, NEJM 2011
14 Pertuzumab Baselga J, et al, NEJM 2011
15 OS (%) Pertuzumab n at risk Ptz + T + D Pla + T + D HR % CI = 0.56, 0.84 p = Final OS Analysis Median follow-up 50 months Time (months) Ptz + T + D Pla + T + D Swain S, et al, ESMO 2014
16 OS (%) Pertuzumab n at risk Ptz + T + D Pla + T + D Median follow-up 50 months HR % CI = 0.56, 0.84 p = Final OS Analysis Time (months) Δ 15.7 months Ptz + T + D Pla + T + D Swain S, et al, ESMO 2014
17 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Qué Sabemos? : 2014 Taxano + Trastuzumab + Pertuzumab es Superior en Primera Línea Tras Progresión a 1ª Línea Lapatinib + Capecitabina Trastuz. + Capecitabina
18 2ª Línea de Tratamiento
19 T-DM1 T-DM1 Desarrollo Clínico. Fase III. (EMILIA). HER2+ (central) LABC or MBC (N=980) T-DM1 3.6 mg/kg q3w IV PD Prior taxane and trastuzumab Progression on metastatic tx or within 6 mos of adjuvant tx 1:1 Capecitabine 1000 mg/m 2 orally bid, days 1 14, q3w + Lapatinib 1250 mg/day orally qd PD Verma S, et al, NEJM 2012
20 Proportion progression-free T-DM PFS (IRC) Median (mos) No. events Cap + Lap T-DM Stratified HR=0.650 (95% CI, 0.55, 0.77) P< Time (mos) Verma S, et al, NEJM 2012
21 Proportion surviving T-DM Overall Survival Confirmatory Analysis Median (months) No. of events Cap + Lap T-DM % Stratified HR=0.682 (95% CI, 0.55, 0.85); P= Efficacy stopping boundary P= or HR= % 64.7% 51.8% Time (months)
22 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Tras Progresión a 1ª Línea Qué Sabemos? : 2014 Taxano + Trastuzumab + Pertuzumab es Superior en Primera Línea Tras Progresión a 1ª Línea Lapatinib + Capecitabina Trastuz. + Capecitabina T-DM1 es Superior a Lapatinib + Capecitabina
23 T-DM1 HER2-positive (central) advanced BC a (N=600) 2 T-DM1 3.6 mg/kg q3w IV (n=400) PD 2 prior HER2-directed therapies for advanced BC Prior treatment with trastuzumab, lapatinib, and a taxane 1 Treatment of physician s choice (TPC) b (n=200) PD T-DM1 (optional crossover) Krop IE, et al. Lancet Oncol 2014
24 T-DM1 T-DM1 Desarrollo Clínico. Fase III. (TH3RESA). TPC treatment category Combination with HER2-directed agent, % Chemotherapy b + trastuzumab Lapatinib + trastuzumab Hormonal therapy + trastuzumab Chemotherapy b + lapatinib TPC (n=184 a ) T-containing 80.4 Single-agent chemotherapy, b % 16.8 a Includes patients who received study treatment. b The most common chemotherapy agents used were vinorelbine, gemcitabine, eribulin, paclitaxel, and docetaxel. Krop IE, et al. Lancet Oncol 2014
25 Proportion progression-free T-DM1 Desarrollo Clínico. Fase III. (TH3RESA). T-DM1 TPC (n=198) T-DM1 (n=404) Median (months) No. of events Stratified HR=0.528 (95% CI, 0.422, 0.661) P< Krop IE, et al. Lancet Oncol Time (months)
26 Proportion surviving T-DM1 Desarrollo Clínico. Fase III. (TH3RESA). T-DM1 1.0 Observed 21% of targeted events Time (months) Krop IE, et al. Lancet Oncol 2014 TPC (n=198) T-DM1 (n=404) Median (months) 14.9 NE No. of events Stratified HR=0.552 (95% CI, 0.369, 0.826); P= Efficacy stopping boundary HR<0.363 or P<
27 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Tras Progresión a 1ª Línea Qué Sabemos? : 2014 Taxano + Trastuzumab + Pertuzumab es Superior en Primera Línea Tras Progresión a 1ª Línea Lapatinib + Capecitabina Trastuz. + Capecitabina T-DM1 es Superior a Lapatinib + Capecitabina T-DM1 es activo en Politratadas
28 ESTRATEGIAS TERAPÉUTICAS
29 Lapatinib + Trastuzumab Blackwell KL, et al. JCO 2012
30 Lapatinib + Trastuzumab Blackwell KL, et al. JCO 2012
31 Lapatinib + Trastuzumab Blackwell KL, et al. JCO 2012
32 Lapatinib + Trastuzumab Blackwell KL, et al. JCO 2012
33 Lapatinib + Trastuzumab
34 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Tras Progresión a 1ª Línea Qué Sabemos? : 2014 Taxano + Trastuzumab + Pertuzumab es Superior en Primera Línea Tras Progresión a 1ª Línea Lapatinib + Capecitabina Trastuz. + Capecitabina T-DM1 es Superior a Lapatinib + Capecitabina Lapatinib + Trastuzumab es activo sin QT T-DM1 es activo en Politratadas
35 ESTRATEGIAS TERAPÉUTICAS
36 Everolimus
37 Everolimus
38 ESTRATEGIAS TERAPÉUTICAS Qué Sabíamos? QT + Trastuzumab es el Tratamiento de Elección en Primera Línea Tras Progresión a 1ª Línea Qué Sabemos? : 2014 Taxano + Trastuzumab + Pertuzumab es Superior en Primera Línea Tras Progresión a 1ª Línea Lapatinib + Capecitabina Trastuz. + Capecitabina T-DM1 es Superior a Lapatinib + Capecitabina Lapatinib + Trastuzumab es activo sin QT T-DM1 es activo en Politratadas Everólimus + Trastuzumab
39 Crosstalk EGFR/HER2 P P p21ras Raf Núcleo p42/44 MAPK p38 MAPK pp90rsk Mek Tam RE RE P P AIB1 CBP Crecimiento independiente de hormonas c-jun c-fos Proliferación celular MAPK
40 HT + Trastuzumab Pacientes posmenopáusicas con CMM HER2+ (IHC 3+ y/o FISH+) RE positivo y/ o RP positivo Permitido Tamoxifeno en adyuvancia y 1ª línea de CMM No QT previa para CMM ECOG 0-1 FEVI basal >50%, HER2-positivo, RH-positivo CMM (n=208) Diseño estudio TAnDEM R Anastrozol 1 mg diario + Trastuzumab 4 mg/kg (carga) 2 mg/kg/semana hasta progresión de la enfermedad Anastrozol 1 mg diario hasta progresión de la enfermedad Ofrecido cruce a trastuzumab a todas las pacientes que progresaron a anastrozol en monoterapia RH, receptor hormonal; CMM, cáncer de mama metastásico; R, randomización Kaufman B, et al. JCO 2009
41 HT + Trastuzumab Probabilidad Supervivencia libre de progresión Events Median PFS 4.8 months 2.4 months 95% CI 3.7, , 4.6 p value Probabilidad Supervivencia global Events Median OS 28.5 months 23.9 months 95% CI 22.8, , 37.4 p value No. at risk A + H A Meses CI, confidence interval PFS = time from randomisation to date of progressive disease or death No. at risk A + H A Meses /104 pacientes (70%) recibieron H posteriormente Kaufman B, et al. JCO 2009
42 HT + Lapatinib
43 Lapatinib o Trastuzumab + Hormonoterapia ESTRATEGIAS TERAPÉUTICAS Opción en pacientes HER2 pos / RH pos Everólimus + Trastuzumab
44 DEBATE: NUEVOS TRATAMIENTOS EN CÁNCER DE MAMA POSICIONAMIENTO Y ALGORITMO TERAPÉUTICO CÁNCER DE MAMA HER 2 POSITIVO TRATAMIENTO ADYUVANTE
45 TRATAMIENTO ADYUVANTE Qué Sabemos? Trastuzumab + QT Adyuvante incrementa la SLE y la SG (en N+ y N-)
46 TRATAMIENTO ADYUVANTE Qué Sabemos? Trastuzumab + QT Adyuvante incrementa la SLE y la SG (en N+ y N-)
47 TRATAMIENTO ADYUVANTE Qué Sabemos? Trastuzumab + QT Adyuvante incrementa la SLE y la SG (en N+ y N-) La duración óptima del tratamiento es de 1 año PHARE Trial HERA Trial
48 TRATAMIENTO ADYUVANTE Qué Sabemos? Trastuzumab + QT Adyuvante incrementa la SLE y la SG (en N+ y N-) La duración óptima del tratamiento es de 1 año Trastuzumab concurrente con QT es preferible a la administración secuencial NCCTG N9831
49 DEBATE: NUEVOS TRATAMIENTOS EN CÁNCER DE MAMA POSICIONAMIENTO Y ALGORITMO TERAPÉUTICO CÁNCER DE MAMA HER 2 POSITIVO TRATAMIENTO NEOADYUVANTE
50 TRATAMIENTO NEOADYUVANTE Qué Sabemos? Trastuzumab + QT es el Tratamiento Estándar Gianni, Lancet 2010 Probability, DFS H + CT CT Patients Events HR a % CI p a
51 TRATAMIENTO NEOADYUVANTE Qué Sabemos? Trastuzumab + QT es el Tratamiento Estándar La prc predice mejor PFS y OS
52 TRATAMIENTO NEOADYUVANTE Qué Sabemos? Trastuzumab + QT es el Tratamiento Estándar La prc predice mejor PFS y OS El doble bloqueo HER2 incrementa la tasa de pcr Neosphere Trial
53 TRATAMIENTO NEOADYUVANTE Qué Sabemos? Trastuzumab + QT es el Tratamiento Estándar La prc predice mejor PFS y OS El doble bloqueo HER2 incrementa la tasa de pcr SIN EMBARGO: No existen datos maduros que permitan recomendar el doble bloqueo como tratamiento estándar. NeoAltto: No dif. en PFS ni OS NeoSphere: pte
54 CONCLUSIONES
PROGNOSTICO DE PACIENTES COM CA DE MAMA METASTATICO HER2+: PODEMOS FAZER MAIS? TDM-1 AND BEYOND!
II Simpósio Internacional de Câncer de Mama para o Oncologista Clínico PROGNOSTICO DE PACIENTES COM CA DE MAMA METASTATICO HER2+: PODEMOS FAZER MAIS? TDM-1 AND BEYOND! INGRID A. MAYER, MD, MSCI Assistant
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