Fairchild Alysa, Langendijk Johannes A, Nuyts Sandra, Scrase Christopher, Tomsej Milan, Schuring Danny, Gulyban Akos, Ghosh Sunita, Weber Damien C, Budach Wilfried
Department of Radiation Oncology, Cross Cancer Institute, 11560 University Avenue, T6G 1Z2, Edmonton, AB, Canada.
Department of Radiation Oncology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Radiat Oncol. 2014 Nov 26;9:248. doi: 10.1186/s13014-014-0248-9.
The phase III 22071-26071 trial was designed to evaluate the addition of panitumumab to adjuvant chemotherapy plus intensity modulated radiotherapy (IMRT) in locally advanced resected squamous cell head and neck cancer. We report the results of the dummy run (DR) performed to detect deviations from protocol guidelines.
DR datasets consisting of target volumes, organs at risk (OAR) and treatment plans were digitally uploaded, then compared with reference contours and protocol guidelines by six central reviewers. Summary statistics and analyses of potential correlations between delineations and plan characteristics were performed.
Of 23 datasets, 20 (87.0%) GTVs were evaluated as acceptable/borderline, along with 13 (56.5%) CTVs and 10 (43.5%) PTVs. All PTV dose requirements were met by 73.9% of cases. Dose constraints were met for 65.2-100% of mandatory OARs. Statistically significant correlations were observed between the subjective acceptability of contours and the ability to meet dose constraints for all OARs (p ≤ 0.01) except for the parotids and spinal cord. Ipsilateral parotid doses correlated significantly with CTV and PTV volumes (p ≤ 0.05).
The observed wide variations in treatment planning, despite strict guidelines, confirms the complexity of development and quality assurance of IMRT-based multicentre studies for head and neck cancer.
III期22071 - 26071试验旨在评估在局部晚期切除的头颈部鳞状细胞癌中，将帕尼单抗添加到辅助化疗加调强放疗（IMRT）中的效果。我们报告了为检测与方案指南的偏差而进行的预试验（DR）结果。
由靶区体积、危及器官（OAR）和治疗计划组成的DR数据集被数字化上传，然后由六位中心审查员与参考轮廓和方案指南进行比较。进行了描述和计划特征之间潜在相关性的汇总统计和分析。
在23个数据集中，20个（87.0%）大体肿瘤体积（GTV）被评估为可接受/临界，13个（56.5%）临床靶体积（CTV）和10个（43.5%）计划靶体积（PTV）也是如此。73.9%的病例满足了所有PTV剂量要求。65.2% - 100%的强制性OAR满足了剂量限制。除了腮腺和脊髓外，在轮廓的主观可接受性与所有OAR满足剂量限制的能力之间观察到统计学上的显著相关性（p≤0.01）。同侧腮腺剂量与CTV和PTV体积显著相关（p≤0.05）。
尽管有严格的指南，但观察到的治疗计划存在广泛差异，这证实了基于IMRT的头颈部癌多中心研究的开发和质量保证的复杂性。
