Definitions for Response and Progression in Ovarian Cancer Clinical Trials Incorporating RECIST 1.1 and CA 125 Agreed by the Gynecological Cancer Intergroup (GCIG)
Definitions for Response and Progression in Ovarian Cancer Clinical Trials Incorporating RECIST 1.1 and CA 125 Agreed by the Gynecological Cancer Intergroup (GCIG)
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DOI：
10.1097/igc.0b013e3182070f17
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发表时间：
2011-02-01
影响因子：
4.8
通讯作者：
Vermorken, Jan
中科院分区：
文献类型：
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作者：
Rustin, Gordon John Sampson;Vergote, Ignace;Vermorken, Jan
妇科癌症国际组（GCIG）先前已就临床试验方案中应使用的定义一线治疗后无进展生存期的标准以及使用血清标志物CA 125定义复发性疾病治疗应答的标准达成共识，并规定了应使用这些标准的情况。然而，这些出版物没有包括详细的定义，也没有编写以适应目前可用的新版实体瘤疗效评价标准（RECIST）标准（版本1.1）。因此，我们建议将稍后详细描述的定义纳入临床试验方案中，以保持一致性。定义进展的标准现在在复发性疾病的临床试验中是可接受的，因为它们已经得到验证（Pujade-Lauraine，个人交流，2010）。GCIG要求将所有使用这些定义的临床试验数据提供给GCIG试验中心，以便持续验证和改进。这些定义是从分析接受细胞毒性化疗的患者中得出的，尚未在接受分子靶向药物的患者中得到验证。
The Gynecological Cancer Intergroup (GCIG) has previously reached consensus regarding the criteria that should be used in clinical trial protocols to define progression-free survival after first-line therapy as well as the criteria to define response to treatment in recurrent disease using the serum marker CA 125 and has specified the situations where these criteria should be used. However, the publications did not include detailed definitions, nor were they written to accommodate the new version of Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) now available. Thus, we recommend that the definitions described later in detail are incorporated into clinical trial protocols to maintain consistency. The criteria for defining progression are now acceptable in clinical trials of recurrent disease as they have since been validated (Pujade-Lauraine, personal communication, 2010). The GCIG requests that data from all clinical trials using these definitions are made available to GCIG trial centers so that continual validation and improvement can be accomplished. These definitions were developed from analyzing patients receiving cytotoxic chemotherapy and have not yet been validated in patients receiving molecular targeting agents.