Pediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
Department of Radiology, Children's National Medical Center, Washington, DC.
Neuro Oncol. 2018 Jan 10;20(1):13-23. doi: 10.1093/neuonc/nox087.
Lack of standard response criteria in clinical trials for medulloblastoma and other seeding tumors complicates assessment of therapeutic efficacy and comparisons across studies. An international working group was established to develop consensus recommendations for response assessment. The aim is that these recommendations be prospectively evaluated in clinical trials, with the goal of achieving more reliable risk stratification and uniformity across clinical trials. Current practices and literature review were performed to identify major confounding issues and justify subsequently developed recommendations; in areas lacking scientific investigations, recommendations were based on experience of committee members and consensus was reached after discussion. Recommendations apply to both adult and pediatric patients with medulloblastoma and other seeding tumors. Response should be assessed using MR imaging (brain and spine), CSF cytology, and neurologic examination. Clinical imaging standards with minimum mandatory sequence acquisition that optimizes detection of leptomeningeal metastases are defined. We recommend central review prior to inclusion in treatment cohorts to ensure appropriate risk stratification and cohort inclusion. Consensus recommendations and response definitions for patients with medulloblastomas and other seeding tumors have been established; as with other Response Assessment in Neuro-Oncology recommendations, these need to now be prospectively validated in clinical trials.
在临床试验中缺乏标准的反应标准,使得对成神经管细胞瘤和其他播种肿瘤的治疗效果评估和研究之间的比较变得复杂。成立了一个国际工作组来制定反应评估的共识建议。目的是在临床试验中前瞻性地评估这些建议,以期在临床试验中实现更可靠的风险分层和统一。进行了当前实践和文献回顾,以确定主要的混杂问题,并为随后制定的建议提供依据;在缺乏科学研究的领域,建议基于委员会成员的经验,并在讨论后达成共识。建议适用于成神经管细胞瘤和其他播种肿瘤的成人和儿童患者。应使用磁共振成像(脑和脊柱)、CSF 细胞学和神经检查来评估反应。定义了临床成像标准,包括最小强制性序列采集,以优化脑膜转移的检测。我们建议在纳入治疗队列之前进行中央审查,以确保适当的风险分层和队列纳入。已经为成神经管细胞瘤和其他播种肿瘤患者制定了共识建议和反应定义;与其他神经肿瘤反应评估建议一样,这些建议现在需要在临床试验中前瞻性验证。