乳腺癌新辅助治疗对新药研发价值分析

Focus on the role of neoadjuvant treatment of breast cancer in the development of new drugs

目的:探讨新辅助治疗在新药研发中的价值,阐述其主要研究领域。方法:应用PubMed及万方数据库检索系统,以乳腺癌、新辅助治疗、新药研发为检索词,检索1997-01-2012-10的相关文献,共检索到文献327条。纳入标准:1)乳腺癌新辅助治疗加速新药研发;2)新辅助治疗的主要研究领域。符合分析的文献32篇。结果:新辅助治疗主要通过以下3点促进新药的研发:1)新辅助治疗中达到病理学完全缓解的乳腺癌患者,预后较好,且新辅助治疗与辅助治疗疗效具有一致性,这提示可以通过新辅助治疗迅速评估药效,故可利用新辅助治疗模型开展治疗方案疗效测定的研究;2)利用分子生物技术以及基因芯片等方法分析新辅助治疗前、中、后的组织和血液标本,评估肿瘤在结构、蛋白、基因等层面的变化,进行相关治疗方案的疗效预测及其作用机制的研究,从而促进对药物机制以及耐药机制更全面的理解;3)新辅助临床研究可促进个体化分子生物学标志的发现,根据分子生物标志预测药物敏感性从而指导治疗方案的制定更为可行。结论:新辅助治疗在迅速评估药物疗效、深入阐述药物机制、发现新型分子生物指标等领域发挥重要作用,故需重视其在乳腺癌新药研发中的价值。

OBJECTIVE：To describe the role of neoadjuvant treatment of breast cancer in new drugs development. METHORDS： Database of PubMed and Wanfang database were searched using key words ＂breast cancer,neoadjvant treatment,the development of new drugs＂ from 01,1997 to 10,2012. A number of 327 searching records were screened,and 32 eligible articles were included. Inclusion criteria were： the role of breast cancer neoadjvant treatment on accelerating the new drug development ; main research fields. RESULTS： Pathologic complete remission after neoadjuvant treatment in patients with breast cancer is associated with an excellent long-term prognosis. The curative effect of neoadjuvant therapy in accordance with that of adjuvant therapy and, therefore, we can launch the research of drug efficacy. Because tumor tissue is available before treatment,at the moment of surgery, and possibly during treatment, the research of drug efficacy and mechanism can be promoted. With the development of raolecular technology and gene microarrays, the changes of the tumor tissue after neoadjuvant therapy in micro structure, proteins and genes can be analyzed. Neoadjuvant setting can also promote the discovery of new biomarkers to predict the responsiveness to certain treatments. Neoadjuvant therapy can be considered as an important step in breast cancer drug development. CONCLUSIONS： Neoadjuvant model plays an impor- tant role in fast valuating the efficacy of drugs,further understanding the mechanism of the drugs and the discovery of new molecular biomarkers,which ultimately benefits patients. In conclusion, it＇s necessary to attach importance to the role of neoadjuvant treatment of breast cancer in the development of new drugs. [