Association of human papillomavirus and p16 status with mucositis and dysphagia for head and neck cancer patients treated with radiotherapy with or without cetuximab: Assessment from a phase 3 registration trial.
Association of human papillomavirus and p16 status with mucositis and dysphagia for head and neck cancer patients treated with radiotherapy with or without cetuximab: Assessment from a phase 3 registration trial.
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DOI：
10.1016/j.ejca.2016.05.008
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发表时间：
2016-09
影响因子：
8.4
通讯作者：
Rosenthal, David I.
中科院分区：
文献类型：
--
作者：
Bonner, James A.;Giralt, Jordi;Harari, Paul M.;Baselga, Jose;Spencer, Sharon;Bell, Diana;Raben, David;Liu, Joyce;Schulten, Jeltje;Ang, Kian K.;Rosenthal, David I.
粘膜炎和吞咽困难是局部晚期头颈部鳞状细胞癌(LA-SCCHN)放疗(RT)的常见不良反应。RT加化疗可提高存活率，但会导致更严重的粘膜炎和吞咽困难。这项分析的目的是评估在IMCL-9815期试验中接受RT±西妥昔单抗治疗的LA-SCCHN患者中p16状态对粘膜炎、吞咽困难和喂养管使用的影响。患者接受每周一次的RT加西妥昔单抗或单独接受RT。对p16阳性(n=75)和p16阴性(n=106)口咽癌(OPC)患者进行亚组分析。用Kaplan-Meier曲线和对数等级检验显示治疗组的黏膜炎和吞咽困难的发病时间和持续时间以及p16状态。用Fisher精确检验计算粘膜炎和吞咽困难发生率的P值。根据患者报告使用的百分比来评估喂养管的使用情况。在p16阳性和p16阴性的OPC亚组中，接受RT±西妥昔单抗治疗的患者的基线特征相似。P16阳性OPC亚组中的患者有更高的Karnofsky评分，更有可能患有T1-T3期癌症，并且来自美国。无论p16状态如何，接受RT加西妥昔单抗治疗的患者与单纯接受RT治疗的患者相比，3/4级粘膜炎或吞咽困难的发病或持续时间没有差异。在总体人群以及p16阳性和p16阴性的OPC亚群中，接受RT加西妥昔单抗的患者与单独接受RT的患者相比，喂养管的使用没有区别。无论p16状态如何，西妥昔单抗加用RT不会改变粘膜炎和吞咽困难的发生率、发病时间、严重程度或持续时间，也不会影响喂养管的使用频率。
Mucositis and dysphagia are common adverse effects of radiotherapy (RT) treatment of locally advanced squamous cell cancer of the head and neck (LA-SCCHN). Chemotherapy added to RT increases survival rates but causes worse mucositis and dysphagia. The aim of this analysis was to assess the impact of p16 status on mucositis, dysphagia, and feeding tube use in LA-SCCHN among patients treated with RT ± cetuximab in the phase 3 IMCL-9815 trial. Patients received RT plus weekly cetuximab or RT alone. Subgroup analyses were conducted on patients with p16-positive (n = 75) or p16-negative (n = 106) oropharyngeal cancer (OPC), as determined by immunohistochemical analysis. The onset and duration of mucositis and dysphagia by treatment arm and p16 status were displayed using Kaplan–Meier curves and the log-rank test. P values for the incidence of mucositis and dysphagia were calculated using the Fisher exact test. Feeding tube use was assessed as the percent of patients reporting use. The baseline characteristics of patients treated with RT ± cetuximab were similar in both the p16-positive and p16-negative OPC subgroups. Patients within the p16-positive OPC subgroup had higher Karnofsky scores and were more likely to have stage T1–T3 cancer and be from the United States. Regardless of p16 status, there was no difference in the onset or duration of grade 3/4 mucositis or dysphagia in patient receiving RT plus cetuximab compared with those receiving RT alone. In the overall population, and the p16-positive and p16-negative OPC subpopulations, feeding tube use was not different for patients receiving RT plus cetuximab compared with RT alone. Regardless of p16 status, the addition of cetuximab to RT did not alter the incidence, time to onset, severity, or duration of mucositis and dysphagia and did not impact the frequency of feeding tube use.
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影响因子：
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