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西妥昔单抗联合放疗治疗日本头颈癌患者的疗效及不良事件

The efficiency and adverse events of radiotherapy with cetuximab for Japanese head and neck cancer patients.

作者信息

Hirasawa Kazuhiro, Okamoto Isaku, Motohashi Ray, Sato Hiroki, Takase Soichiro, Agata Ayumi, Takeda Atsuo, Tsukahara Kiyoaki

机构信息

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.

出版信息

Auris Nasus Larynx. 2017 Dec;44(6):724-728. doi: 10.1016/j.anl.2017.01.005. Epub 2017 Feb 22.

Abstract

OBJECTIVES

Radiotherapy with cisplatin (Chemoradiotherapy, CRT) has long been one of the standard treatments for head and neck squamous cell cancer (HNSCC). Approval of cetuximab for the treatment of HNSCC has made radiotherapy with cetuximab (Bioradiotherapy, BRT) a new treatment option for HNSCC. Reports of BRT in the Japanese written in English up to now is only the phase II study, though it includes only 22 patients. Also on the nature of the clinical Phase II trial, sampling bias of cases may exist. Here we report the treatment completion rate, response rate and frequency of adverse events of BRT in Japanese patients with HNSCC in English for the first time. In association with this, we examine the issues related to BRT in Japanese patients.

PATIENTS AND METHODS

The subjects consisted of patients with HNSCC who underwent BRT as the first curative treatment (45 cases). Their treatment completion rate, response rate and frequency of adverse events were examined.

RESULTS

Of the 45patients, 42 were male and 3 were female. The mean age of the patients was 64 (range from 40 to 86). Adverse events of Grade3 or more were 12 cases (27%) of dermatitis, 31 cases (69%) of mucositis/stomatitis, 6 cases (13%) of interstitial pneumonia. The complication rate of pulmonary emphysema in those who developed interstitial pneumonia and those who did not were 83% and 21%, respectively. The BRT completion rate was 78%, and the response rate was 84%.

CONCLUSION

BRT is sufficiently tolerable and have high response rate even for the Japanese, but we should recognize that BRT is not a minimally invasive and easily manageable treatment.

摘要

目的

顺铂放疗(放化疗,CRT)长期以来一直是头颈部鳞状细胞癌(HNSCC)的标准治疗方法之一。西妥昔单抗获批用于治疗HNSCC,使得西妥昔单抗放疗(生物放疗,BRT)成为HNSCC的一种新治疗选择。到目前为止,用英文撰写的关于日本BRT的报告仅为II期研究,不过该研究仅纳入了22例患者。而且就临床II期试验的性质而言,可能存在病例的抽样偏差。在此,我们首次用英文报告日本HNSCC患者BRT的治疗完成率、缓解率及不良事件发生率。与此同时,我们探讨日本患者BRT相关问题。

患者与方法

研究对象为接受BRT作为首次根治性治疗的HNSCC患者(45例)。对其治疗完成率、缓解率及不良事件发生率进行了研究。

结果

45例患者中,男性42例,女性3例。患者的平均年龄为64岁(范围40至86岁)。3级及以上不良事件为:皮炎12例(27%),黏膜炎/口腔炎31例(69%),间质性肺炎6例(13%)。发生间质性肺炎者与未发生者的肺气肿并发症发生率分别为83%和21%。BRT完成率为78%,缓解率为84%。

结论

即使对于日本人,BRT也具有足够的耐受性且缓解率高,但我们应认识到BRT并非微创且易于管理的治疗方法。

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