抗癌药物评定标准:统计学差异还是临床获益?

Evaluation criteria for anticancer drugs:statistical differences or clinical benefits?

2012—2016年PubMed上发表的肿瘤相关性RCT研究超过10 000项,较2000—2004年的发表量翻了1倍。如何评价如此庞杂的研究结果,将这些成果应用于临床决策,是一个值得思考的问题。抗癌药物价值的评判不仅包括其对患者生存的影响,还包括不良反应、经济因素等。因此,临床亟待新的标准全面评判抗肿瘤药物的临床获益。近期,欧洲临床肿瘤协会(the European Society for Medical Oncology,ESMO)与美国临床肿瘤学会(the American Society of Clinical Oncology)相继出台了评价肿瘤患者临床获益的标准,即ESMO-MCBS(Magnitude of Clinical Benefit Scale)、ASCO-VF(Value Framework)。采用以上标准后显示,在评价临床研究结果时,单凭统计学差异是不够的。抗癌药物临床研究的评价应以统计学差异为基础,以临床获益为目标,以期切实改善肿瘤患者的生存。

In recent years, there have been more and more randomized controlled trials （RCTs） on cancer treatment. The number of tumor-related RCTs published on PubMed from 2012 to 2016 exceeded 10 000, twice as many publications as in 2000-2004. How to evaluate such complex research results and apply these results to clinical decision-making is a question worth considering. The evaluation of the value of anti-cancer drugs includes not only its influence on the survival of patients, but also adverse reactions and economic factors. Therefore, we urgently need new standards to comprehensively evaluate the clinical benefits of anti-cancer drugs. Recently, the European Society for Medical Oncology （ESMO） and the American Society of Clinical Oncology have successively issued a standard for assessing clinical benefits, that is, Magnitude of Clinical Benefit Scale （ESMO-MCBS） and Value Framework （ASCO-VF）. Through the above criteria, we have found that when evaluating clinical research results, statistical differences alone are not enough. The evaluation of clinical studies of anticancer drugs should be based on statistical differences, and aim at clinical benefit, in order to improve the survival of tumor patients.