Bueno Muíño Coralia, García-Sáenz José Angel, López Tarruella Sara, Rodríguez Lajustica Laura, Díaz-Rubio Eduardo
Servicio de Oncología Médica, Hospital Clínico Universitario San Carlos, Madrid, Spain.
Clin Transl Oncol. 2006 Aug;8(8):581-7. doi: 10.1007/s12094-006-0063-3.
Clinical cancer investigation is performed through clinical trials. Development and measurement of clinical efficacy of new target-based agents differs from classic cytotoxic drugs. Whereas the aim of chemotherapy drugs is to destroy tumoral cells, new agents try to inhibit cell profileration without a clear tumor shrinkage. The main endpoint for phase I trials is to determine the optimal biological response with the least toxicity; oncopharmacogenomic studies must be performed in tumoral biopsies to assess the target inhibition. Time to progression and biological activity are the endpoints for phase II studies. Finally, phase III trials will determine overall survival.
临床癌症研究是通过临床试验进行的。新型靶向药物临床疗效的开发和衡量与传统细胞毒性药物不同。化疗药物的目的是破坏肿瘤细胞，而新型药物则试图抑制细胞增殖，却没有明显的肿瘤缩小。I期试验的主要终点是确定具有最低毒性的最佳生物学反应；必须在肿瘤活检中进行肿瘤药物基因组学研究以评估靶点抑制情况。疾病进展时间和生物学活性是II期研究的终点。最后，III期试验将确定总生存期。
