*.- Yondelis Reduce el Riesgo de Progresión de la Enfermedad o de Mortalidad en un 45%, comparado con los pacientes que recibieron Dacarbazina (índice de riesgo [IR] = 0,550; P 0,0001; mediana [M] 4,2 frente a 1,5 meses, respectivamente), con Resultados Validados Mediante Auditoría por Radiólogos Independientes.
*.- Esta Mejora en el Tratamiento se observó de manera Consistente en todos los Subgrupos Clínicos de Pacientes y fue a su vez Respaldada por una Mayor Tasa de Respuesta Objetiva, unas Respuestas más Duraderas y un Beneficio Clínico Superior en Comparación con el Grupo de Dacarbazina.
*.- El Análisis Final de OS se realizó en la fecha de corte clínico de 5 de enero de 2015, después se habían producido 381 muertes, con una Supervivencia Media de Seguimiento de 21 Meses.
*.- La Mediana de OS fue de 13,7 Meses para el grupo Trabectedin vs 13,1 Meses para el grupo Dacarbazine .
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The 217 patients enrolled in the study received a median of 6 cycles of trabectedin, with 56% of patients receiving ≥6 cycles, with some receiving a maximum of 44 cycles. The median treatment duration was 5.5 months and the median PFS was 5.5 months (95% CI, 4.8-7.1).
When comparing response by Choi criteria and RECIST, there was a staggering difference observed in PFS. By Choi criteria, the median PFS with trabectedin was 15.3 months (95% CI, 6.9-21.2) versus 8.1 months with RECIST (95% CI, 5.3-10.7).
The most common grade 3/4 AEs were neutropenia (17.9%) and transaminase increase (7.9%). Febrile neutropenia was reported in 2.7% of patients. The most common treatment-related AEs were fatigue (3.7%), nausea (1.4%), and vomiting (1.4%). One patient experienced a grade 5 pulmonary embolism.
“It was interesting to see how more than half of the patients receive 6 cycles or more of this treatment and 16.1% of the patients received the drug for 1 year or more," Penel said. "Given the manageable safety profile of trabectedin, the data underscore the clinical benefit for these patients.”
Data from the phase III study of trabectedin were submitted to European regulatory agencies, which moved the drug from an authorization under "exceptional circumstances" to a full approval on May 27, 2015. The treatment was first granted marketing authorization in September 2007.
In the United States, an application for trabectedin was submitted to the FDA for patients with advanced soft tissue sarcoma who received prior chemotherapy in late 2014. A final approval decision is expected from the FDA before the end of 2015.
