Green S, Weiss G R
Southwest Oncology Group Statistical Center, Seattle, Washington 98104.
Invest New Drugs. 1992 Nov;10(4):239-53. doi: 10.1007/BF00944177.
The Southwest Oncology Group, in cooperation with the National Cancer Institute and the other major cooperative oncology groups, has participated in the development of new toxicity criteria for reporting the results of cancer clinical trials. The new criteria (NCI Common Toxicity Criteria) respond to a recognized need to: (1) report toxicities consistently among cooperative groups, particularly for shared 'intergroup' clinical trials; (2) strive for comparability in toxicity reporting among clinical trials; and (3) recognize new toxicities accompanying new classes of anticancer treatment modalities. The Southwest Oncology Group has extended the toxicity criteria, incorporating additional new criteria for biological agents, radiation therapy, surgery, and hormonal agents. In addition, endpoint definitions and response criteria are discussed. These have been developed in response to previous uncertainties in clinical trials objectives, to limitations in the resolution of imaging methods, and to demands for greater rigor in response and endpoint definitions. Toxicity criteria, endpoint definitions, and response criteria are tabulated.
西南肿瘤协作组与美国国立癌症研究所及其他主要的肿瘤协作组合作，参与制定了用于报告癌症临床试验结果的新毒性标准。新的标准（美国国立癌症研究所通用毒性标准）满足了人们已认识到的以下需求：（1）在各协作组之间一致地报告毒性，特别是对于共同开展的“组间”临床试验；（2）力求临床试验间毒性报告具有可比性；（3）认识到新型抗癌治疗方式所伴随的新毒性。西南肿瘤协作组扩展了毒性标准，纳入了针对生物制剂、放射治疗、手术及激素制剂的额外新标准。此外，还讨论了终点定义和反应标准。这些标准是针对以往临床试验目标存在的不确定性、成像方法分辨率的局限性以及对反应和终点定义更严格要求而制定的。毒性标准、终点定义和反应标准均已制成表格。
