Von Hoff D D, Casper J, Bradley E, Sandbach J, Jones D, Makuch R
Am J Med. 1981 May;70(5):1027-41. doi: 10.1016/0002-9343(81)90859-7.
An in vitro tumor colony-forming assay was utilized to measure the sensitivity of 800 individual patients' tumors to a variety of antineoplastic agents. Thirty-six separate histologic types of cancer were represented. Only 199 of the 800 patients' tumors (25 percent) both formed colonies in vitro and had enough cells in the biopsy or fluid specimen to perform drug sensitivity assays. In 123 instances the drug tested in vitro against the tumor was also used clinically to treat the patient. The clinician caring for the patient did not know the results of the in vitro test. When analyzed in a retrospective manner, the probability of a positive prediction from the assay, given the patient responded clinically, was 0.88. The probability for a negative prediction of the assay given the patient did not respond, was 0.94. Associations of in vitro and in vivo results in the 123 correlations were highly significant (p less than 0.001). We conclude that, as now constituted, the human tumor colony-forming assay can provide useful sensitivity information for only about 25 percent of the general oncology patients. Secondly, a prospective clinical trial of the assay is needed to insure that the assay is indeed predictive of which drug will produce a patient response and that it is not merely an indicator that a particular patient's tumor is highly responsive in vivo.
采用体外肿瘤集落形成试验来测定800例个体患者肿瘤对多种抗肿瘤药物的敏感性。涵盖了36种不同的癌症组织学类型。800例患者的肿瘤中只有199例（25%）在体外形成了集落，并且活检或体液标本中有足够的细胞来进行药敏试验。在123例病例中，体外针对肿瘤所测试的药物也用于临床治疗该患者。负责该患者的临床医生不知道体外试验的结果。当进行回顾性分析时，假设患者临床有反应，试验阳性预测的概率为0.88。假设患者无反应，试验阴性预测的概率为0.94。123例相关性分析中体外和体内结果的关联性非常显著（p小于0.001）。我们得出结论，就目前的情况而言，人肿瘤集落形成试验仅能为约25%的普通肿瘤患者提供有用的敏感性信息。其次，需要对该试验进行前瞻性临床试验，以确保该试验确实能预测哪种药物会使患者产生反应，而不仅仅是表明特定患者的肿瘤在体内具有高反应性的一个指标。
