Resumen de Landscape of early clinical trials for childhood and adolescence cancer in Spain
F. J. Bautista Sirvent, Soledad Gallego Melcón, María Adela Cañete Nieto, Jaume Mora Graupera, C. Díaz de Heredia Rubio, Ofelia Cruz Martínez, José María Fernández Navarro, S. Rives Solà, Luis Madero López, Victoria Castel Sánchez, M. E. Cela de Julián, Gemma Ramírez Villar, Constantino Sábado Alvarez, Tomás Acha García, Itziar Astigarraga Aguirre, Ana Sastre Urgellés, A. Muñoz Mellado, Mercedes Guibelalde del Castillo, Lucas Moreno
Purpose Despite numerous advances, survival remains dismal for children and adolescents with poor prognosis cancers or those who relapse or are refractory to first line treatment. There is, therefore, a major unmet need for new drugs. Recent advances in the knowledge of molecular tumor biology open the door to more adapted therapies according to individual alterations. Promising results in the adult anticancer drug development have not yet been translated into clinical practice. We report the activity in early pediatric oncology trials in Spain.
Methods All members of the Spanish Society of Pediatric Hematology Oncology (SEHOP) were contacted to obtain information about early trials open in each center.
Results 22 phase I and II trials were open as of May 2015: 15 for solid tumors (68 %) and 7 for hematological malignancies (32 %). Fourteen (64 %) were industry sponsored. Since 2010, four centers have joined the Innovative Therapies For Children With Cancer, an international consortium whose aim is developing novel therapies for pediatric cancers. A substantial number of studies have opened in these 5 years, improving the portfolio of trials for children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents and their benefits.
Conclusions Clinical trials are the way to evaluate new drugs, avoiding the use of off-label drugs that carry significant risks. The Spanish pediatric oncology community through the SEHOP is committed to develop and participate in collaborative academic trials, to favor the advancement and optimization of existing therapies in pediatric cancer.
