Bajorin D, Katz A, Chan E, Geller N, Vogelzang N, Bosl G J
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY.
J Clin Oncol. 1988 May;6(5):786-92. doi: 10.1200/JCO.1988.6.5.786.
To evaluate the potential effect of patient selection on chemotherapy trials for patients with advanced germ cell tumors (GCT), four sets of eligibility criteria for poor risk trials were compared in 118 patients. A significant difference was found in the number of patients designated poor risk by the various criteria (P less than .005). Disagreement in the risk assignment by the various selection criteria was seen in 44% of patients. Initial complete response (CR) rates in patients designated poor risk by the various criteria ranged from 38% to 62%. Initial CR rates as high as 94% were seen in patients considered to be poor risk by one set of criteria, but good risk by another. Substantial differences in sensitivity, specificity, overall predictive value, and survival distributions were observed for the various selection criteria. Randomized trials will be necessary to reduce the influence of eligibility criteria on trial outcome and conclusions.
为评估患者选择对晚期生殖细胞肿瘤（GCT）患者化疗试验的潜在影响，对118例患者的四套不良风险试验入选标准进行了比较。不同标准指定为不良风险的患者数量存在显著差异（P小于0.005）。44%的患者在不同选择标准的风险分配上存在分歧。不同标准指定为不良风险的患者初始完全缓解（CR）率在38%至62%之间。在一组标准认为是不良风险但另一组标准认为是良好风险的患者中，初始CR率高达94%。观察到不同选择标准在敏感性、特异性、总体预测价值和生存分布方面存在实质性差异。有必要进行随机试验以减少入选标准对试验结果和结论的影响。
