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ES2677562T3 - Métodos para la predicción del resultado clínico para inhibidores del receptor del factor de crecimiento epidérmico para pacientes de cáncer - Google Patents

Métodos para la predicción del resultado clínico para inhibidores del receptor del factor de crecimiento epidérmico para pacientes de cáncer Download PDF

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ES2677562T3
ES2677562T3 ES15177716.6T ES15177716T ES2677562T3 ES 2677562 T3 ES2677562 T3 ES 2677562T3 ES 15177716 T ES15177716 T ES 15177716T ES 2677562 T3 ES2677562 T3 ES 2677562T3
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Marileila Varella Garcia
Paul A. Bunn, Jr.
Federico Cappuzzo
Wilbur A. Franklin
Fred R. Hirsch
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University of Colorado Boulder
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Abstract

Fármaco inhibidor de tirosina quinasa seleccionado de gefitinib, y cetuximab para el uso en un método para tratar el cáncer en un paciente, en el cual dicho método comprende: a) detectar en una muestra de células tumorales de un paciente, un cambio en el número de copias de un gen seleccionado del grupo que consiste en: i) la amplificación del gen del receptor de factor de crecimiento épidérmico (EGFR); ii) la polisomía del gen EGFR; iii) la amplificación del gen del receptor de tirosina quinasa humano (HER2); e iv) la polisomía del gen HER2; b) comparar el número de copias del gen EGFR y/o HER2 en la muestra de células tumorales del paciente con el número de copias del gen EGFR y/o HER2 en las células tumorales que son sensibles o resistentes a un inhibidor de EGFR y c) proporcionar un tratamiento con el fármaco inhibidor de tirosina quinasa si se identifica que el paciente tiene un número de copias del gen EGFR y/o HER2 en las células tumorales de dicho paciente, que es estadísticamente similar o mayor que el número de copias del gen EGFR y/o HER2 en las células tumorales que son sensibles a un inhibidor de EGFR.

Description

DESCRIPCIÓN
Características Total Modelo FISH Pacientes Grupo 1 Grupo 2 Disomía Baja Alta Baja Total Alta Amplificación Total Trisomía Trisomía Polisomía Polisomía de Gen Total No. 102 36 17 2 14 69 20 13 33 % 100 35.3 16.7 2.0 13.7 67.6 19.6 12.7 32.4 Respuesta total y No. 14 2 2 5 7 12 parcial % 13.7 100 2.9 25 53.8 36.4 Enfermedad estable No. 26 9 5 2 16 7 3 10 % 25.5 25.0 29.4 14.3 23.2 35 23.1 30.3 Enfermedad progresiva No. 62 27 12 12 51 8 3 11 % 60.8 75.0 70.6 85.7 73.9 40 23.1 33.3 Tasa de control de 39.2 25.0 29.4 100 14.3 26.1 60.0 76.9 66.7 enfermedad Tiempo medio de 2.9 2.5 3.6 9.3 2.1 2.5 6.6 6.0 6.3 progresión (meses)
% Pacientes sin 18.6 8.3 5.9 100 0 8.7 35.0 46.2 39.4 progresión de enfermedad a los 12 meses Media total de supervivencia (meses) 7.0 6.9 10.2 13.7 3.0 6.5 8.3 9.0 9.0 Tasa Media total de 45.1 38.9 41.2 100 14.3 36.2 65.0 61.5 63.6 supervivencia de más de 1 año
29
30
Deleciones Exón 19 Proteina EGFR 739 K I P V A I K E L R E A T S P K A N 756 SEQ ID NO:4 Gen EGFR 2215 AAA ATT CCC GTC GCT ATC AAG GAA TTA AGA GAA GCA ACA TCT CCG AAA GCC AAC 2268 SEQ ID NO:5 Paciente 15 AAA ATT CCC GTC GCT ATC AAG --- --- --- --- --- TCT CCG AAA GCC AAC SEQ ID NO:6 Pacientes 19, 30, 41 y AAA ATT CCC GTC GCT ATC AA. --- --- --- --- .A ACA TCT CCG AAA GCC AAC
35
53* SEQ ID NO:7 Paciente 57 AAA ATT CCC GTC GCT ATC AAG GAA T.. --- --- --- --- .CT CCG AAA GCC AAC SEQ ID NO:8 Paciente 75† AAA ATT CCC GTC GCT ATC AAG --- --- --- --- --- ACA TCT CCG AAA GCC AAC SEQ ID NO:9 Notas . Similar al paciente 1 en (11) t Similar a la Del-1b (12) Mutaciones Exón 21 Proteina EGFR 850 H V K I T D F G L A K L L G 863 SEQ ID NO:10 Gen EGFR 2538 CAT GTC AAG ATC ACA GAT TTT GGG CTG GCC AAA CTG CTG GGT 2589 SEQ ID NO:11 Pacientes 1,2, 16, 26, H V K I T D F G L A K L L G 31, 38, 100 SEQ ID NO:12 (sustitución 2573 T>G) CAT GTC AAG ATC ACA GAT TTT GGG CTG GCC AAA CTG CTG GGT ‡ SEQ ID NO:13 Paciente 3 (Sustitución H I K I T D F G L A K L L G 2541 G>A)# SEQ ID NO:14 CAT ATC AAG ATC ACA GAT TTT GGG CTG GCC AAA CTG CTG GGT SEQ ID NO:15 Notas ‡ Paciente 38 predominantemente mutante # Mutación del Paciente 3 no se ha informado en la base de datos SNP Marcadores utilizados para Análisis de Mutaciones Exón 18 hacia delante GACCCTTGTCTCTGTGTTCTTGT SEQ ID NO:16 Exón 18 opuesto hacia TATACAGCTTGCAAGGACTCTGG fuera SEQ ID NO:17 Exón 18 opuesto hacia CCAGACCATGAGAGGCCCTG dentro SEQ ID NO:18 Exón 19 hacia delante CACAATTGCCAGTTAACGTCTTC SEQ ID NO:19 Exón 19 opuesto hacia AGGGTCTAGAGCAGAGCAGC fuera SEQ ID NO:20 Exón 19 opuesto hacia GCCTGAGGTTCAGAGCCAT dentro SEQ ID NO:21 Exón 21 hacia delante CATGATGATCTGTCCCTCACAG SEQ ID NO:22 Exón 21 opuesto hacia CTGGTCCCTGGTGTCAGGAA fuera SEQ ID NO:23 Exón 21 opuesto hacia GCTGGCTACCTAAAGCCACC dentro SEQ ID NO:24
EGFR EGFR EGFRFEGFRFIEGFR EGFR M- PAKT+ PAKT - KRAS+ KRAS- IHC+ IHC - ISH + SH - M+ Hombre 68/121 45/79 30/59 77/124 18/43 72/113 72/127 30/57 25/36 57/102 (56%) (57%) (51%) (62%) (42%) (64%) (57%) (53%) (69%) (57%) Mujer 53/121 34/79 29/59 47/124 25/43 41/113 27/57 11/36 44/102 (44%) (43%) (49%) (38%) (58%) (36%) 55/127 (47%) (31%) (43%) (43%) Valor p Chi Valor p Chi Valor p Chi Valor p Chi cuadrado= Valor p Chi cuadrado= 0.915 cuadrado= 0.149 cuadrado= 0.014 0.608 cuadrado= 0.185 Fumador Actual 99/121 59/79 42/59 104/124 30/43 96/114 26/127 12/57 33/36 80/102 /antiguo (82%) (75%) (71%) (84%) (70%) (84%) (20%) (21%) (92%) (78%) No fumador 22/121 20/79 17/59 20/124 13/43 18/114 45/57 3/36 22/102 (18%) (25%) (29%) (16%) (30%) (16%) 101/127 (79%) (8%) (22%) (80%) valor p chi-valor p chi-valor p chi-valor p chi-cuadrado = valor p chi-cuadrado = 0.226 cuadrado = 0.046 cuadrado = 0.045 0.928 cuadrado = 0.076 Adenocarcinom58/120 38/78 31/58 54/124 24/42 58/112 59/126 26/57 21/36 45/101 a (48%) (49%) (53%) (44%) (57%) (52%) (47%) (46%) (58%) (45%) 36/120 27/78 15/58 43/124 13/42 27/112 43/126 19/57 14/36 29/101 BAC (30%) (35%) (26%) (35%) (31%) (24%) (34%) (33%) (39%) (29%) 1/120 1/78 1/58 1/124 0/42 1/112 1/126 1/57 0/36 1/101 Célula Grande (1%) (1%) (2%) (1%) (0%) (1%) (1%) (2%) (0%) (1%) 18/120 8/78 9/58 17/124 2/42 19/112 17/126 8/57 1/36 18/101 (15%) (10%) (16%) (14%) (5%) (17%) (13%) (14%) (3%) (18%) Célula 7/120 4/78 2/58 9/124 3/42 7/112 6/126 3/57 0/36 8/101 Escamosa (6%) (5%) (3%) (7%) (7%) (6%) (5%) (5%) (0%) (8%)
Indiferenciado valor p chi-valor p chi-valor p chi-valor p chi-cuadrado = valor p chi-cuadrado = 0.867 cuadrado = 0.536 cuadrado = 0.347 0.984 cuadrado = 0.051
Nº. OR DC TTP MS 1-año OS pacientes FISH + 59 (32%) 33% 65% 9 (5-10) 18 (14-21) 68% (56%-80%) FISH - 124 (68%) 6% 30% 3 (2-3) 8 (6-11) 37% (29%-46%) valor p< 0.001 valor p< 0.001 valor p< 0.001 valor p= 0.002 IHC + 121 (61%) 22% 56% 5 (3-7) 14 (11-21) 56% (47%-65%) IHC - 79 (40%) 5% 27% 3 (2-3) 7 (5-10) 37% (26%-48%) valor p= 0.002 valor p< 0.001 valor p= 0.006 valor p= 0.003 Mutación EGFR + 43 (28%) 39% 52% 3 (2-11) 13 (6-21) 52% (37%-68%) Mutación EGFR - 113 (72%) 7% 37% 3 (2-4) 11 (7-13) 46% (37%-55%) valor p< 0.001 valor p= 0.151 valor p= 0.180 valor p= 0.210 P-AKT + 127 (69%) 20% 49% 4 (3-5) 13 (10-16) 52% (43%-61%) P-AKT - 57 (31%) 2% 33% 3 (2-5) 8 (6-14) 41% (28%-54%) valor p= 0.005 valor p= 0.10 valor p= 0.09 valor p= 0.34 Mutación KRAS + 36 (26%) 7% 39% 3 (2-4) 11 (6-23) 49% (33%-66%) Mutación KRAS - 102 (74%) 19% 40% 3 (2-4) 12 (8-15) 50% (40%-60%) valor p= 0.237 valor p= 0.99 valor p= 0.890 valor p= 0.890
ES15177716.6T 2004-05-27 2005-05-26 Métodos para la predicción del resultado clínico para inhibidores del receptor del factor de crecimiento epidérmico para pacientes de cáncer Active ES2677562T3 (es)

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ES05755989.0T Active ES2553264T3 (es) 2004-05-27 2005-05-26 Métodos para la predicción del resultado clínico para inhibidores del receptor del factor de crecimiento epidérmico para pacientes de cáncer
ES15177716.6T Active ES2677562T3 (es) 2004-05-27 2005-05-26 Métodos para la predicción del resultado clínico para inhibidores del receptor del factor de crecimiento epidérmico para pacientes de cáncer

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ES05755989.0T Active ES2553264T3 (es) 2004-05-27 2005-05-26 Métodos para la predicción del resultado clínico para inhibidores del receptor del factor de crecimiento epidérmico para pacientes de cáncer

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US (3) US20080090233A1 (es)
EP (3) EP1751309B1 (es)
JP (2) JP5422120B2 (es)
AU (1) AU2005249492B2 (es)
CA (1) CA2567293C (es)
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WO (1) WO2005117553A2 (es)

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