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S-1同步放化疗用于II期(T2N0M0)咽喉部鳞状细胞癌患者的II期研究

Phase II study of concurrent chemoradiotherapy with S-1 in patients with stage II (T2N0M0) squamous cell carcinoma of the Pharynx or Larynx.

作者信息

Taguchi Takahide, Takahashi Masahiro, Nishimura Goshi, Shiono Osamu, Komatsu Masanori, Sano Daisuke, Sakuma Yasunori, Tanigaki Yuji, Kubota Akira, Taguri Masataka, Hata Masaharu, Oridate Nobuhiko

机构信息

Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University School of Medicine, Yokohama

Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University School of Medicine, Yokohama.

出版信息

Jpn J Clin Oncol. 2014 Dec;44(12):1158-63. doi: 10.1093/jjco/hyu154. Epub 2014 Sep 29.

DOI:10.1093/jjco/hyu154
PMID:25267992
Abstract

OBJECTIVE

The goals of treatment for head and neck cancer are cure and organ-function preservation. For organ preservation, primary treatment via radiotherapy alone is thought to be insufficient for Stage II squamous cell carcinoma of the larynx, oropharynx or hypopharynx. The objective of the present study was to investigate the efficacy and safety of concurrent chemoradiotherapy with S-1 for patients with Stage II squamous cell carcinoma of the pharynx or larynx for primary organ preservation.

METHODS

Previously untreated patients with Stage II squamous cell carcinoma of the larynx, oropharynx or hypopharynx received three courses of S-1 (40 or 50 mg twice a day; 2 weeks of administration followed by 1 week of rest every 3 weeks) during conventional radiotherapy (a single daily fraction of 1.8 Gy) to a total dose of 70.2 Gy. The primary endpoint was the local control rate at 3 years.

RESULTS

From August 2009 to October 2012, 37 patients were evaluated for the study. The overall response rate was 100%. The 3-year local control rate was 89.0% (95% confidence interval, 78.9-99.2%), and the 3-year overall survival rate was 97.2% (95% confidence interval, 91.8-100%). Mucositis and dermatitis in the radiation field were the most common acute adverse events observed. The rates of Grade 3 mucositis and dermatitis were 27 and 35%, respectively. No patients experienced Grade 4 acute adverse events. The treatment completion rate was 89.2%.

CONCLUSION

Concurrent chemoradiotherapy with S-1 was safe and effective in improving local control for Stage II squamous cell carcinoma of the pharynx or larynx.

摘要

目的

头颈癌的治疗目标是治愈疾病并保留器官功能。对于器官保留而言,单纯放疗作为主要治疗手段被认为对于喉、口咽或下咽的II期鳞状细胞癌是不够的。本研究的目的是探讨S-1同步放化疗用于II期咽喉部鳞状细胞癌患者进行原发器官保留的疗效和安全性。

方法

未经治疗的喉、口咽或下咽II期鳞状细胞癌患者在常规放疗(每日单次剂量1.8 Gy)期间接受三个疗程的S-1治疗(40或50 mg,每日两次;给药2周,然后每3周休息1周),总剂量达70.2 Gy。主要终点是3年时的局部控制率。

结果

2009年8月至2012年10月,37例患者纳入本研究进行评估。总缓解率为100%。3年局部控制率为89.0%(95%置信区间,78.9 - 99.2%),3年总生存率为97.2%(95%置信区间,91.8 - 100%)。放射野内的黏膜炎和皮炎是观察到的最常见急性不良事件。3级黏膜炎和皮炎的发生率分别为27%和35%。无患者发生4级急性不良事件。治疗完成率为89.2%。

结论

S-1同步放化疗对于改善II期咽喉部鳞状细胞癌的局部控制是安全有效的。

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Int J Clin Oncol. 2016 Oct;21(5):869-874. doi: 10.1007/s10147-016-0964-2. Epub 2016 Feb 23.