Aims

The De-ESCALaTE study showed an overall survival advantage for the administration of synchronous cisplatin chemotherapy with radiotherapy in low-risk oropharyngeal cancer when compared with synchronous cetuximab. During the trial, a radiotherapy quality assurance protocol amendment permitted centres to swap from the original radiotherapy contouring protocol (incorporating the whole oropharynx into the high-dose clinical target volume (CTV); anatomical protocol) to a protocol that incorporated the gross tumour volume with a 10 mm margin into the CTV (volumetric protocol). The purpose of this study was to examine both toxicity and tumour control related to this protocol amendment.

Materials and methods

Overall survival and recurrence at 2 years were used to compare tumour control in the two contouring cohorts. For toxicity, the cohorts were compared by both the number of severe (grades 3–5) and all grades acute and late toxicities. In addition, quality of life and swallowing were compared using EORTC-C30 and MD Anderson Dysphagia Inventory, respectively.

Results

Of 327 patients included in this study, 185 were contoured according to the anatomical protocol and 142 by the volumetric protocol. The two cohorts were well balanced, with the exception of significantly more patients in the anatomical cohort undergoing prophylactic feeding tube insertion (P < 0.001). With a minimum of 2 years of follow-up there was no significant difference in overall survival or recurrence between the two contouring protocols. Similarly, there was no significant difference in the rate of reported severe or all grades acute or late toxicity and no sustained significant difference in quality of life. However, there was a significant difference in favour of volumetric contouring in several domains of the MD Anderson Dysphagia Inventory questionnaire at 1 year, which persisted to 2 years in the dysphagia functional (P = 0.002), dysphagia physical (P = 0.009) and dysphagia overall function (P = 0.008) domains.

Conclusion

In the context of the unplanned post-hoc analysis of a randomised trial, measurable improvement in long-term dysphagia has been shown following a reduction in the CTV. Further reductions in the CTV should be subject to similar scrutiny within the confines of a prospective study.

中文翻译：

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De-ESCALaTE 研究中临床目标体积减少后吞咽困难结果的改善

宗旨

De-ESCALaTE 研究表明，与同步西妥昔单抗相比，同步顺铂化疗联合放疗在低危口咽癌中具有总体生存优势。在试验期间，放射治疗质量保证方案修正案允许中心从最初的放射治疗轮廓方案（将整个口咽部纳入高剂量临床靶体积 (CTV)；解剖方案）转换为将大体肿瘤体积与在 CTV 中留出 10 毫米的边缘（体积协议）。本研究的目的是检查与该方案修正案相关的毒性和肿瘤控制。

材料和方法

2 年时的总体生存率和复发率用于比较两个轮廓队列中的肿瘤控制情况。对于毒性，通过严重（3-5 级）和所有等级的急性和晚期毒性的数量对队列进行比较。此外，分别使用 EORTC-C30 和 MD Anderson 吞咽困难量表比较生活质量和吞咽。

结果

在这项研究中包括的 327 名患者中，185 名根据解剖方案绘制轮廓，142 名根据体积方案绘制轮廓。这两个队列非常平衡，除了解剖队列中接受预防性饲管插入的患者明显更多（P< 0.001)。经过至少 2 年的随访，两种轮廓方案之间的总生存率或复发率没有显着差异。同样，报告的严重或所有级别的急性或晚期毒性发生率也没有显着差异，生活质量也没有持续显着差异。然而，1 年时 MD 安德森吞咽困难量表问卷的几个领域有利于体积轮廓的显着差异，在功能性吞咽困难 (P = 0.002)、物理性吞咽困难 (P = 0.009) 和吞咽困难方面持续到2年总体功能 ( P = 0.008) 域。

结论

在一项随机试验的计划外事后分析的背景下，在 CTV 降低后，长期吞咽困难已显示出可测量的改善。CTV 的进一步降低应在前瞻性研究的范围内进行类似的审查。