Department of Radiotherapy and Radiooncology, University Medicine Göttingen, Göttingen, Germany.
Strahlenther Onkol. 2010 May;186(5):262-8. doi: 10.1007/s00066-010-2136-z. Epub 2010 Apr 26.
To test for a possible correlation between high-grade acute organ toxicity during primary radio(chemo)therapy and treatment outcome in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
From 05/1994 to 01/2009, 216 HNSCC patients were treated with radio(chemo)therapy in primary approach. They received normofractionated (2 Gy/fraction) irradiation including associated nodal drainage sites to a cumulative dose of 70 Gy. 151 patients received additional concomitant chemotherapy (111 patients 5-fluorouracil/mitomycin C, 40 patients cisplatin-based). Toxicity during treatment was monitored weekly according to the Common Toxicity Criteria (CTC), and any toxicity grade CTC >or= 3 of mucositis, dysphagia or skin reaction was assessed as high-grade acute organ toxicity for later analysis.
A statistically significant coherency between high-grade acute organ toxicity and overall survival as well as locoregional control was found: patients with CTC >or= 3 acute organ toxicity had a 5-year overall survival rate of 44% compared to 8% in patients without (p < 0.01). Thereby, multivariate analyses revealed that the correlation was independent of other possible prognostic factors or factors that may influence treatment toxicity, especially concomitant chemotherapy and radiotherapy technique or treatment-planning procedure.
These data indicate that normal tissue and tumor tissue may behave similarly with respect to treatment response, as high-grade acute organ toxicity during radio(chemo)therapy showed to be an independent prognostic marker in the own patient population. However, the authors are aware of the fact that a multivariate analysis in a retrospective study generally has statistical limitations. Therefore, their hypothesis should be further analyzed on biomolecular and clinical levels and other tumor entities in prospective trials.
检测原发性放化疗过程中发生的高级别急性器官毒性与局部晚期头颈部鳞癌（HNSCC）患者治疗结果之间是否存在相关性。
1994 年 5 月至 2009 年 1 月，216 例 HNSCC 患者采用原发性放化疗方式进行治疗。所有患者均接受常规分割（2 Gy/次）照射，包括相关的淋巴结引流区，照射总剂量为 70 Gy。151 例患者接受了附加同期化疗（111 例采用氟尿嘧啶/丝裂霉素 C，40 例采用顺铂方案）。根据通用毒性标准（CTC）每周监测治疗期间的毒性，任何黏膜毒性 CTC 分级>或=3、吞咽困难或皮肤反应均被评估为高级别急性器官毒性，用于后续分析。
发现高级别急性器官毒性与总生存及局部区域控制之间存在显著一致性：发生 CTC 分级>或=3 级急性器官毒性的患者 5 年总生存率为 44%，而无此类毒性的患者为 8%（p<0.01）。多变量分析显示，这种相关性独立于其他可能的预后因素或影响治疗毒性的因素，尤其是同期化疗、放疗技术或治疗计划程序。
这些数据表明，正常组织和肿瘤组织在治疗反应方面可能具有相似性，因为放化疗过程中的高级别急性器官毒性是本患者人群中的一个独立预后标志物。然而，作者意识到，回顾性研究中的多变量分析通常存在统计学局限性。因此，他们的假设应在生物分子和临床水平上，并在前瞻性试验中对其他肿瘤实体进行进一步分析。
