Chung Yih-Lin, Pui Newman N M
Department of Radiation Oncology, Koo Foundation Sun Yat-Sen Cancer Center, No. 125 Lih-Der Road, Pei-Tou District, Taipei, 112, Taiwan.
Sunny Pharmtech Inc., New Taipei City, Taiwan.
Support Care Cancer. 2017 Sep;25(9):2743-2751. doi: 10.1007/s00520-017-3684-x. Epub 2017 Mar 28.
The aim of this study was to identify patient-centered, mucositis-associated adverse impact factors and events that might confound physician-assessed oral mucositis (OM) in head and neck cancer (HNC) patients receiving chemoradiotherapy.
This was a post hoc analysis of a previously conducted randomized trial to determine the efficacy of 5% phenylbutyrate mouthwash in preventing chemoradiotherapy-induced OM. This analysis identified patient-centered symptomatic, observable, and measurable factors that may confound physician scoring of the severity of OM during chemoradiotherapy. Confounding factors were then combined with physician-rated OM scores according to World Health Organization (WHO) and OM Assessment Scale (OMAS) criteria to investigate the therapeutic implications of OM treatment.
The original analysis found no significant differences between experimental and placebo groups with respect to the cumulative incidence of physician-recorded severe OM (WHO ≥3 or OMAS ≥2), patient-reported adverse events, and opioid use. However, patients in the experimental arm had relatively lower rates of OM-associated adverse clinical issues including unplanned short radiation breaks, skipping of chemotherapy, nausea/vomiting, late loss of body weight, and early opioid use, all of which could potentially interfere with physician-assessed OM scoring. When WHO OM grade (functional impact and pain), OMAS ulceration size (organic impact), and prolonged radiation treatment time (cancer treatment impact) were combined, there were significantly fewer interruptions of chemoradiotherapy treatment in symptomatic OM patients in the experimental compared to the placebo group. The benefits conferred by reducing the amount of chemoradiotherapy-related, OM-associated adverse impacts in the experimental group were reflected by better 5-year locoregional recurrence-free survival.
This exploratory study raises questions as to whether the severity reflected by physician-rated OM scores is in concordance with OM-induced adverse impacts on HNC patients. Further investigations are warranted to identify patient-related and cancer-associated symptom burdens that may affect tolerance, compliance, and outcome of chemoradiotherapy and confound the evaluation of therapeutic effects on chemoradiotherapy-induced OM.
本研究旨在确定以患者为中心的、与口腔黏膜炎相关的不良影响因素和事件，这些因素和事件可能会混淆接受放化疗的头颈癌（HNC）患者中医生评估的口腔黏膜炎（OM）情况。
这是一项对先前进行的随机试验的事后分析，以确定5%苯丁酸钠漱口水预防放化疗引起的OM的疗效。该分析确定了以患者为中心的症状性、可观察和可测量的因素，这些因素可能会混淆医生对放化疗期间OM严重程度的评分。然后，根据世界卫生组织（WHO）和口腔黏膜炎评估量表（OMAS）标准，将混杂因素与医生评定的OM评分相结合，以研究OM治疗的治疗意义。
原始分析发现，在医生记录的严重OM（WHO≥3或OMAS≥2）的累积发生率、患者报告的不良事件和阿片类药物使用方面，实验组和安慰剂组之间没有显著差异。然而，实验组患者与OM相关的不良临床问题发生率相对较低，包括计划外的短时间放疗中断、化疗漏用、恶心/呕吐、晚期体重减轻和早期阿片类药物使用，所有这些都可能干扰医生评估的OM评分。当将WHO OM分级（功能影响和疼痛）、OMAS溃疡大小（器质性影响）和延长的放疗时间（癌症治疗影响）相结合时，与安慰剂组相比，实验组中有症状的OM患者的放化疗治疗中断明显更少。实验组减少与放化疗相关的、与OM相关的不良影响所带来的益处体现在更好的5年局部区域无复发生存率上。
这项探索性研究提出了一个问题，即医生评定的OM评分所反映的严重程度是否与OM对HNC患者的不良影响一致。有必要进行进一步的研究，以确定可能影响放化疗耐受性、依从性和结果并混淆对放化疗引起的OM治疗效果评估的患者相关和癌症相关症状负担。
