Bautista Francisco, Gallego Soledad, Cañete Adela, Mora Jaume, Díaz de Heredia Cristina, Cruz Ofelia, Fernández José María, Rives Susana, Berlanga Pablo, Hladun Raquel, Juan Ribelles Antonio, Madero Luis, Ramírez Manuel, Fernández Delgado Rafael, Pérez-Martínez Antonio, Mata Cristina, Llort Anna, Martín Broto Javier, Cela María Elena, Ramírez Gema, Sábado Constantino, Acha Tomás, Astigarraga Itziar, Sastre Ana, Muñoz Ascensión, Guibelalde Mercedes, Moreno Lucas
Unidad de Investigación Clínica CNIO-HNJ, Servicio de Hematología, Oncología y Trasplante de Progenitores Hematopoyéticos, Hospital Infantil Universitario Niño Jesús, Madrid, España.
Unidad de Oncología Pediátrica, Hospital Vall d'Hebron, Barcelona, España.
An Pediatr (Barc). 2017 Sep;87(3):155-163. doi: 10.1016/j.anpedi.2016.07.007. Epub 2017 Mar 6.
Cancer is the leading cause of death between the first year of life and adolescence, and some types of diseases are still a major challenge in terms of cure. There is, therefore, a major need for new drugs. Recent findings in cancer biology open the door to the development of targeted therapies against individual molecular changes, as well as immunotherapy. Promising results in adult anti-cancer drug development have not yet been translated into paediatric clinical practice. A report is presented on the activity in early paediatric oncology trials (phase I-II) in Spain.
All members of the Spanish Society of Paediatric Haematology Oncology (SEHOP) were contacted in order to identify early clinical trials in paediatric cancer opened between 2005 and 2015.
A total of 30 trials had been opened in this period: 21 (70%) in solid tumours, and 9 (30%) in malignant haemopathies. A total of 212 patients have been enrolled. The majority was industry sponsored (53%). Since 2010, four centres have joined the international consortium of Innovative Therapies for Children with Cancer (ITCC), which has as its aim to develop novel therapies for paediatric tumours. A significant number of new studies have opened since 2010, improving the treatment opportunities for our children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents, and their benefits.
The activity in clinical trials has increased in the years analysed. The SEHOP is committed to develop and participate in collaborative academic trials, in order to help in the advancement and optimisation of existing therapies in paediatric cancer.
癌症是1岁至青春期儿童死亡的主要原因，某些类型的疾病在治愈方面仍然是一项重大挑战。因此，对新药有重大需求。癌症生物学的最新发现为针对个体分子变化的靶向治疗以及免疫治疗的发展打开了大门。成人抗癌药物研发取得的喜人成果尚未转化为儿科临床实践。本文介绍了西班牙儿科肿瘤学早期试验（I-II期）的开展情况。
联系了西班牙儿科血液学与肿瘤学会（SEHOP）的所有成员，以确定2005年至2015年期间开展的儿科癌症早期临床试验。
在此期间共开展了30项试验：21项（70%）针对实体瘤，9项（30%）针对恶性血液病。共有212名患者入组。大多数试验由行业赞助（53%）。自2010年以来，有四个中心加入了儿童癌症创新疗法国际联盟（ITCC），其目标是开发针对儿科肿瘤的新型疗法。自2010年以来开展了大量新研究，改善了我们儿童的治疗机会。最近结束的试验结果显示了西班牙研究人员的贡献、分子靶向药物的引入及其益处。
在所分析的年份中，临床试验活动有所增加。SEHOP致力于开展并参与合作性学术试验，以帮助推动和优化儿科癌症现有疗法。
