医学
临床试验
医学物理学
淋巴瘤
可比性
淋巴结
实体瘤疗效评价标准
肿瘤科
内科学
放射科
临床研究阶段
数学
组合数学
作者
Bruce D. Cheson,Sandra J. Horning,B Coiffier,Margaret A. Shipp,Richard I. Fisher,Joseph M. Connors,Tim Lister,Julie M. Vose,Antonio J Grillo-López,Anton Hagenbeek,Fernando Cabanillas,Donald Klippensten,Wolfgang Hiddemann,Ronald A. Castellino,Nancy L. Harris,Jamés O. Armitage,William Carter,Richard T. Hoppe,George P. Canellos
标识
DOI:10.1200/jco.1999.17.4.1244
摘要
ABSTRACT: Standardized guidelines for response assessment are needed to ensure comparability among clinical trials in non-Hodgkin's lymphomas (NHL). To achieve this, two meetings were convened among United States and international lymphoma experts representing medical hematology/oncology, radiology, radiation oncology, and pathology to review currently used response definitions and to develop a uniform set of criteria for assessing response in clinical trials. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients—especially those with large-cell NHL—who may not have residual disease. Single-photon emission computed tomography gallium scans are encouraged as a valuable adjunct to assessment of patients with large-cell NHL, but such scans require appropriate expertise. Flow cytometric, cytogenetic, and molecular studies are not currently included in response definitions. Response rates may be the most important objective in phase II trials where the activity of a new agent is important and may provide support for approval by regulatory agencies. However, the goals of most phase III trials are to identify therapies that will prolong the progression-free survival, if not the overall survival, of the treated patients. We hope that these guidelines will serve to improve communication among investigators and comparability among clinical trials until clinically relevant laboratory and imaging studies are identified and become more widely available.
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