Aziz D C, Peter J B
Cytometrics, Division of Specialty Laboratories, Inc., San Diego, CA 92121-1201.
J Clin Lab Anal. 1991;5(6):422-38. doi: 10.1002/jcla.1860050611.
DNA ploidy and cell cycle analysis as measured by flow cytometry (FC) and image analysis (IA) have moved out of the realm of the research laboratory to become valid clinical tests used in the assessment of prognosis of the cancer patient. Although much information on the relationship of DNA ploidy/%S-phase analysis to patient prognosis is available in the literature, the data are not presented in such a way as to be helpful in clinical decision making. Because predictive values and confidence intervals, which measure the likelihood that a given clinical test will rule in or rule out a clinical outcome, were not calculated in previous reviews, conclusions about the clinical utility of these analyses were not possible. Using the available raw data on DNA ploidy and %S-phase analysis from previously published papers, predictive values and confidence limits were calculated for specific clinical presentations. In several such clinical situations (tumor type, stage, etc.), predictive value of greater than 90% was derived. We conclude that in these situations DNA ploidy and %S-phase analysis can be used to predict clinical outcome, to design treatment, and to guide patient management. The evaluation of the clinical utility of these tests must ultimately rest on prospective trials which show that randomized arms respond to treatment regimens dependent upon the DNA ploidy and %S-phase status.
通过流式细胞术（FC）和图像分析（IA）进行的DNA倍体和细胞周期分析已走出研究实验室领域，成为用于评估癌症患者预后的有效临床检测方法。尽管文献中有许多关于DNA倍体/%S期分析与患者预后关系的信息，但这些数据的呈现方式无助于临床决策。由于之前的综述未计算预测值和置信区间（用于衡量给定临床检测将确诊或排除临床结果的可能性），因此无法得出关于这些分析临床效用的结论。利用先前发表论文中关于DNA倍体和%S期分析的可用原始数据，针对特定临床表现计算了预测值和置信限。在几种此类临床情况（肿瘤类型、分期等）中，得出了大于90%的预测值。我们得出结论，在这些情况下，DNA倍体和%S期分析可用于预测临床结果、设计治疗方案以及指导患者管理。这些检测临床效用的评估最终必须基于前瞻性试验，该试验表明随机分组对取决于DNA倍体和%S期状态的治疗方案有反应。
