National Center for Tumor Diseases (NCT), University of Heidelberg, Germany.
BMC Cancer. 2011 Jun 24;11:266. doi: 10.1186/1471-2407-11-266.
18-Fluorodeoxyglucose-PET (18F-FDG-PET) can be used for early response assessment in patients with locally advanced adenocarcinomas of the oesophagogastric junction (AEG) undergoing neoadjuvant chemotherapy. It has been recently shown in the MUNICON trials that response-guided treatment algorithms based on early changes of the FDG tumor uptake detected by PET are feasible and that they can be implemented into clinical practice. Only 40%-50% of the patients respond metabolically to therapy. As metabolic non-response is known to be associated with a dismal prognosis, metabolic non-responders are increasingly treated with alternative neoadjuvant chemotherapies or chemoradiation in order to improve their clinical outcome. We plan to investigate whether PET can be used as response assessment during radiochemotherapy given as salvage treatment in early metabolic non-responders to standard chemotherapy.
METHODS/DESIGN: The HICON trial is a prospective, non-randomized, explorative imaging study evaluating the value of PET as a predictor of histopathological response in metabolic non-responders. Patients with resectable AEG type I and II according to Siewerts classification, staged cT3/4 and/or cN+ and cM0 by endoscopic ultrasound, spiral CT or MRI and FDG-PET are eligible. Tumors must be potentially R0 resectable and must have a sufficient FDG-baseline uptake. Only metabolic non-responders, showing a < 35% decrease of SUV two weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to intensified taxane-based RCT (chemoradiotherapy (45 Gy) before surgery. 18FDG-PET scans will be performed before ( = Baseline) and after 14 days of standard neoadjuvant therapy as well as after the first cycle of salvage docetaxel/cisplatin chemotherapy (PET 1) and at the end of radiochemotherapy (PET2). Tracer uptake will be assessed semiquantitatively using standardized uptake values (SUV). The percentage difference ΔSUV = 100 (SUV Baseline - SUV PET1)/SUV Baseline will be calculated and assessed as an early predictor of histopathological response. In a secondary analysis, the association between the difference SUV PET1 - SUV PET2 and histopathological response will be evaluated.
The aim of this study is to investigate the potential of sequential 18FDG-PET in predicting histopathological response in AEG tumors to salvage neoadjuvant radiochemotherapy in patients who do not show metabolic response to standard neoadjuvant chemotherapy.
18 氟脱氧葡萄糖正电子发射断层扫描（18F-FDG-PET）可用于接受新辅助化疗的局部晚期胃食管结合部腺癌（AEG）患者的早期疗效评估。最近的 MUNICON 试验表明，基于 PET 检测到的 FDG 肿瘤摄取早期变化的反应指导治疗算法是可行的，并可将其应用于临床实践。只有 40%-50%的患者对治疗有代谢反应。由于代谢无反应与预后不良有关，因此越来越多的代谢无反应患者接受替代新辅助化疗或放化疗，以改善其临床结局。我们计划研究在标准化疗代谢无反应的早期患者中，作为挽救性治疗，PET 是否可用于评估放化疗期间的疗效。
方法/设计：HICON 试验是一项前瞻性、非随机、探索性影像学研究，旨在评估 PET 作为代谢无反应患者的组织病理学反应预测因子的价值。符合 Siewerts 分类的可切除 AEG Ⅰ型和Ⅱ型、内镜超声、螺旋 CT 或 MRI 及 FDG-PET 分期为 cT3/4 和/或 cN+和 cM0 的患者有资格参加。肿瘤必须具有潜在的 R0 可切除性，且必须有足够的 FDG 基线摄取。只有代谢无反应者（在新辅助化疗开始后 2 周 SUV 下降<35%）才有资格参加研究，并接受强化紫杉烷类 RCT（放疗（45 Gy）联合手术前化疗。在标准新辅助治疗前（=基线）和 14 天以及首次挽救性多西他赛/顺铂化疗后（PET1）和放化疗结束时（PET2）进行 18FDG-PET 扫描。使用标准化摄取值（SUV）进行半定量摄取评估。计算 SUV 基线-SUV PET1）/SUV 基线的百分比差异 ΔSUV = 100（SUV 基线-SUV PET1），并将其作为组织病理学反应的早期预测因子进行评估。在二次分析中，评估 SUV PET1-SUV PET2 的差异与组织病理学反应之间的相关性。
本研究的目的是研究在标准新辅助化疗代谢无反应的患者中，挽救性新辅助放化疗期间，连续 18FDG-PET 在预测 AEG 肿瘤组织病理学反应中的潜力。
