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晚期妇科癌症空间分割放射治疗前瞻性临床转化试验设计的国际共识

An International Consensus on the Design of Prospective Clinical-Translational Trials in Spatially Fractionated Radiation Therapy for Advanced Gynecologic Cancer.

作者信息

Amendola Beatriz E, Mahadevan Anand, Blanco Suarez Jesus Manuel, Griffin Robert J, Wu Xiaodong, Perez Naipy C, Hippe Daniel S, Simone Charles B, Mohiuddin Majid, Mohiuddin Mohammed, Snider James W, Zhang Hualin, Le Quynh-Thu, Mayr Nina A

机构信息

Innovative Cancer Institute, South Miami, FL 33143, USA.

Department of Radiation Oncology, New York University, Langone Health, New York, NY 10016, USA.

出版信息

Cancers (Basel). 2022 Aug 31;14(17):4267. doi: 10.3390/cancers14174267.

Abstract

Despite the unexpectedly high tumor responses and limited treatment-related toxicities observed with SFRT, prospective multi-institutional clinical trials of SFRT are still lacking. High variability of SFRT technologies and methods, unfamiliar complex dose and prescription concepts for heterogeneous dose and uncertainty regarding systemic therapies present major obstacles towards clinical trial development. To address these challenges, the consensus guideline reported here aimed at facilitating trial development and feasibility through a priori harmonization of treatment approach and the full range of clinical trial design parameters for SFRT trials in gynecologic cancer. Gynecologic cancers were evaluated for the status of SFRT pilot experience. A multi-disciplinary SFRT expert panel for gynecologic cancer was established to develop the consensus through formal panel review/discussions, appropriateness rank voting and public comment solicitation/review. The trial design parameters included eligibility/exclusions, endpoints, SFRT technology/technique, dose/dosimetric parameters, systemic therapies, patient evaluations, and embedded translational science. Cervical cancer was determined as the most suitable gynecologic tumor for an SFRT trial. Consensus emphasized standardization of SFRT dosimetry/physics parameters, biologic dose modeling, and specimen collection for translational/biological endpoints, which may be uniquely feasible in cervical cancer. Incorporation of brachytherapy into the SFRT regimen requires additional pre-trial pilot investigations. Specific consensus recommendations are presented and discussed.

摘要

尽管立体定向体部放疗(SFRT)显示出了出乎意料的高肿瘤反应率以及有限的治疗相关毒性,但仍缺乏关于SFRT的前瞻性多机构临床试验。SFRT技术和方法的高度变异性、对于非均匀剂量陌生的复杂剂量和处方概念以及全身治疗的不确定性,是临床试验发展的主要障碍。为应对这些挑战,本文报告的共识指南旨在通过预先协调治疗方法以及SFRT治疗妇科癌症试验的所有临床试验设计参数,促进试验发展和可行性。评估了妇科癌症的SFRT试点经验状况。成立了一个妇科癌症多学科SFRT专家小组,通过正式的小组审查/讨论、适宜性等级投票以及征求公众意见/审查来达成共识。试验设计参数包括入选标准/排除标准、终点指标、SFRT技术/技巧、剂量/剂量学参数、全身治疗、患者评估以及嵌入式转化科学。宫颈癌被确定为最适合进行SFRT试验的妇科肿瘤。共识强调了SFRT剂量学/物理参数、生物剂量建模以及用于转化/生物学终点指标的标本采集的标准化,这在宫颈癌中可能具有独特的可行性。将近距离放疗纳入SFRT方案需要额外的试验前试点研究。文中给出并讨论了具体的共识建议。

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