Clinical cases presentation of advanced NSCLC patients treated … III Clinical Trial Phase II...
Transcript of Clinical cases presentation of advanced NSCLC patients treated … III Clinical Trial Phase II...
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Clinical cases presentation of advanced NSCLC patients treated with the EGF based therapeutic vaccine
Phase III Clinical TrialPhase II Clinical Trial Vaccine-Chemotherapy-
Vaccine
4th CIMAvax EGF Global MeetingNovember 22-23th, 2011
Elia Neninger Vinagera M.D.Hernanos Ameijeiras HospitalCiudad de la Habana
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Ensayo Clínico Fase III vacuna EGF
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Ensayo Clínico VQV
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Ensayo Clínico Vacuna EGF Combinación terapéuticaProtocol IIC RD-EC111Paciente TPC--2727Sexo : FemeninoEdad: 37 añosHistoria tabáquica: 30 cigarrillos por día durante 20 añosSintomas: Tosedora habitual, hemoptisis y dolor en hemitórax derechoDiagnostico histologico: Carcinoma de células no pequeñasFecha de diagnóstico:29.05.09Localización: Lóbulo superiorderechoEstadio: IIIB Masa tumoral del lóbulo superior derecho segmento anteriorQue compromete al mediastino compresión de la VCS Adenopatias mediastinales ipsilateralesECOG: 1Fecha de inclusión:05.06.09Fecha de comienzo tto. Con vacuna EGF: 12.06.09Primer ciclo de quimioterapia: 07.07.09
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CASO no. 1 cont….Evaluación después de la Quimioterapia:Remisión parcial: disminución diámetros tumor primario, necrosisDisminución de los síntomas hasta desaparecerEventos adversos:Relacionados vacuna: grado/1Relacionados Quimioterapia: digestivos g/2Mantiene ECOG 0En seguimiento se observa respuesta completa en el tiempo
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Mayo 2009Supervivencia esperada: 9-10 meses
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EVALUACIÓN-3
/0
/7
/14
/21
/28
CPM
QUIMIOTERAPIA (4-6 CICLOS)
VACUNA EGFVACUNA EGFVACUNA EGF
BSC
Inicio tto:Esquema optimización terapéutica
2 dosis Cimavax EgfQuimioterapia de régimen platino: 4 ciclos
RECIST RP
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Septiembre 2009
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19.03.2010
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Marzo 2010 Tratamiento continuadoRECIST RP
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06.09.2010
No se aprecia tumor
Se considera RC
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Noviembre 2011ECOG 0
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Ensayo Clínico Vacuna EGF Combinación terapéuticaProtocol IIC RD-EC111Paciente JRNY-12Sexo : MasculinoEdad: 79 añosHistoria tabáquica: Exfumador 20 cigarrillos por día durante 51 añosSintomas: Hemoptisis en dos ocasionesDiagnostico histologico: Carcinoma de células no pequeñasFecha de diagnóstico:23.03.09Localización: Lóbulo superior derechoEstadio: IIIB Masa tumoral del lóbulo superior izquierdo segmento posterioren íntimo contacto con la Aorta descendente. Adenopatias mediastinales bilateralesECOG: 1Fecha de inclusión:26.03.09Fecha de comienzo tto. Con vacuna EGF: 03.04.09Primer ciclo de quimioterapia: 06.05.09Radioterapia: 60 Gy
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CASO no. 2 cont….Evaluación después de la Quimioterapia:Remisión parcial: disminución diámetros tumor primarioNo síntomasECOG 0Eventos adversos:Relacionados vacuna: g ½ en las primeras dosisRelacionados quimioterapia: Digestivos g/2, hematológicos g/2En seguimiento se observa mantenimiento de la respuestaMantiene ECOG 0Supervivencia 27,73 meses
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17,03.2009
AL DIAGNÓSTICO
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POST- QUIMIOTERAPIA
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TAC 06.10.2010
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JRNYOCTUBRE 2011
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•Respuesta Objetiva•Supervivencia libre de progresión prolongada•Desaparición de síntomas•Calidad de vida óptima