PharmaMar Recibe el Ok de la FDA Para Iniciar Fase I con PM54 en Combi con Inmuno Para Posible Tratamiento . PARA EI RELEVO DE LURBINECTEDIN ESTABAN PM184 Y PM14 AMBOS RETIRADOS POR LA CIA. AHORA HAY OTROS DOS FÁRMACOS EN FASE I EN EL INTENTO DE RELEVAR A LURBINECTEDIN : PM54 Y PM534 ... EL PROBLEMA ES QUE AMBOS AÚN ESTAN EN FASE I CON TODO LO QUE ESTO IMPLICA EN CUESTIÓN DE PLAZOS ... YA QUE PARA REALUZAR 3 FASES CLÍNICAS HACEN FALTA DE 12 A 15 AÑOS ... NOS IRÍAMOS AL 2040.
07 junio 2007
Yondelis ( ET-743 ) , evidence of activity in advanced, pretreated soft tissue and bone sarcoma patients.
Huygh G, Clement PM, Dumez H, Schöffski P, Wildiers H, Selleslach J, Jimeno JM, Wever ID, Sciot R, Duck L, Van Oosterom AT.
2006 Dec 31.
Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium.
Purpose. To evaluate the activity and safety of ecteinascidin (ET-743) in pretreated patients with advanced or metastatic soft tissue and bone sarcoma. Patients or subjects. Eighty-nine patients received ET-743 as a 24-hour continuous infusion at a dose of 900-1500 mug/m(2) every 3 weeks. Results. We observed one complete remission, 5 partial remissions, one minimal response, and 16 patients with a disease stabilization of 6 months or more. The objective response rate was 6.7% and the clinical benefit rate at 3 and 6 months was 37.7% and 23.4%, respectively. Responses were noted in patients with lipo-, leiomyo-, osteo-, and myogenic sarcoma, with a median duration of 9.85 months. Toxicity mainly involved an asymptomatic elevation of transaminases and neutropenia. Estimated 1- and 2-year survival rates were 39.4% and 15.8%. Median overall survival was 8.25 months. Discussion. This retrospective analysis confirms that ET-743 induces objective responses and progression arrest in a clinically relevant proportion of patients.
2006 Dec 31.
Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium.
Purpose. To evaluate the activity and safety of ecteinascidin (ET-743) in pretreated patients with advanced or metastatic soft tissue and bone sarcoma. Patients or subjects. Eighty-nine patients received ET-743 as a 24-hour continuous infusion at a dose of 900-1500 mug/m(2) every 3 weeks. Results. We observed one complete remission, 5 partial remissions, one minimal response, and 16 patients with a disease stabilization of 6 months or more. The objective response rate was 6.7% and the clinical benefit rate at 3 and 6 months was 37.7% and 23.4%, respectively. Responses were noted in patients with lipo-, leiomyo-, osteo-, and myogenic sarcoma, with a median duration of 9.85 months. Toxicity mainly involved an asymptomatic elevation of transaminases and neutropenia. Estimated 1- and 2-year survival rates were 39.4% and 15.8%. Median overall survival was 8.25 months. Discussion. This retrospective analysis confirms that ET-743 induces objective responses and progression arrest in a clinically relevant proportion of patients.
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