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子宫内膜癌的临床研究:妇科癌症协作组的共识建议。

Clinical research in endometrial cancer: consensus recommendations from the Gynecologic Cancer InterGroup.

机构信息

Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.

Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea.

出版信息

Lancet Oncol. 2024 Sep;25(9):e420-e431. doi: 10.1016/S1470-2045(24)00192-X.

Abstract

The Gynecologic Cancer InterGroup (GCIG) Endometrial Cancer Consensus Conference on Clinical Research (ECCC) was held in Incheon, South Korea, Nov 2-3, 2023. The aims were to develop consensus statements for future trials in endometrial cancer to achieve harmonisation on design elements, select important questions, and identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and finalisation of 18 statements within four topic groups, addressing adjuvant treatment in high-risk disease; treatment for metastatic and recurrent disease; trial designs for rare endometrial cancer subgroups and special circumstances; and specific methodology and adaptation for trials in low-resource settings. In addition, eight areas of unmet need were identified. This was the first GCIG Consensus Conference to include patient advocates and an expert on inclusion, diversity, equity, and access to take part in all aspects of the process and output. Four early-career investigators were also selected for participation, ensuring that they represented different GCIG member groups and regions. Unanimous consensus was obtained for 16 of the 18 statements, with 97% concordance for the remaining two. Using the described methodology from previous Ovarian Cancer Consensus Conferences, this conference did not require even one minority statement. The high acceptance rate following active involvement in the preparation, discussion, and refinement of the statements by all representatives confirmed the consensus progress within a global academic setting, and the expectation that the ECCC will lead to greater harmonisation, actualisation, inclusion, and resolution of unmet needs in clinical research for individuals living with and beyond endometrial cancer worldwide.

摘要

2023 年 11 月 2 日至 3 日,妇科癌症国际协作组(GCIG)子宫内膜癌共识会议(ECCC)在韩国仁川举行。会议旨在制定子宫内膜癌未来试验的共识声明,以实现设计要素的协调一致,选择重要问题,并确定未满足的需求。所有 33 个 GCIG 成员组都参与了四项主题组内 18 项声明的制定、完善和最终确定,涵盖高危疾病的辅助治疗;转移性和复发性疾病的治疗;罕见子宫内膜癌亚组和特殊情况下的试验设计;以及资源有限环境下试验的具体方法和适应性。此外,还确定了 8 个未满足的需求领域。这是 GCIG 第一次共识会议,包括患者倡导者和一位包容性、多样性、公平性和获取性专家,参与了整个过程和结果的所有方面。还选择了四名早期职业研究人员参与,确保他们代表不同的 GCIG 成员组和地区。18 项声明中有 16 项获得了一致共识,其余两项有 97%的一致性。使用以前卵巢癌共识会议描述的方法,本次会议甚至不需要一项少数派声明。所有代表积极参与声明的准备、讨论和完善,使接受率很高,这证实了在全球学术环境中达成共识的进展,预计 ECCC 将导致更大的协调、实际化、包容性和解决全球范围内子宫内膜癌患者和幸存者的未满足需求。

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