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顺铂超选择性动脉内灌注联合放疗治疗局部晚期上颌窦癌的剂量探索与疗效确认试验(日本临床肿瘤学会1212):剂量探索阶段

Dose-finding and efficacy confirmation trial of the superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for locally advanced maxillary sinus cancer (Japan Clinical Oncology Group 1212): Dose-finding phase.

作者信息

Homma Akihiro, Onimaru Rikiya, Matsuura Kazuto, Shinomiya Hirotaka, Sakashita Tomohiro, Shiga Kiyoto, Tachibana Hiroyuki, Nakamura Kenichi, Mizusawa Junki, Kitahara Hideaki, Eba Junko, Fukuda Haruhiko, Fujii Masato, Hayashi Ryuichi

机构信息

Department of Otolaryngology - Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.

Department of Radiation Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.

出版信息

Head Neck. 2018 Mar;40(3):475-484. doi: 10.1002/hed.25001. Epub 2017 Nov 11.

DOI:10.1002/hed.25001
PMID:29130565
Abstract

BACKGROUND

We are currently undertaking a multi-institutional prospective trial of the superselective intra-arterial infusion of high-dose cisplatin with concomitant radiotherapy for patients with T4aN0M0 or T4bN0M0 locally advanced maxillary sinus squamous cell carcinomas (SCC). We herein report the results of the dose-finding phase.

METHODS

The dose-finding phase sought to evaluate the incidence of dose-limiting toxicities and determine the recommended number of cycles of the intra-arterial infusion of cisplatin. In this phase, 100 mg/m of cisplatin was administered intra-arterially weekly for 7 weeks with concomitant radiotherapy (70 Gy).

RESULTS

All 18 patients received a full dose of radiotherapy. The number of cycles of cisplatin was 7 in 13 patients and 6 in 5 patients. The dose-limiting toxicities were observed in 5 patients.

CONCLUSION

These results indicated that this therapy is safe and well-tolerated at 7 cycles of cisplatin, which was determined to be the recommended number of cycles for locally advanced maxillary sinus SCC.

摘要

背景

我们目前正在进行一项多机构前瞻性试验,针对T4aN0M0或T4bN0M0局部晚期上颌窦鳞状细胞癌(SCC)患者,采用高剂量顺铂超选择性动脉内灌注联合放射治疗。在此,我们报告剂量探索阶段的结果。

方法

剂量探索阶段旨在评估剂量限制性毒性的发生率,并确定顺铂动脉内灌注的推荐周期数。在此阶段,每周动脉内给予100mg/m²顺铂,共7周,同时进行放射治疗(70Gy)。

结果

所有18例患者均接受了全剂量放疗。13例患者顺铂的周期数为7个,5例患者为6个。5例患者出现了剂量限制性毒性。

结论

这些结果表明,顺铂7个周期的这种治疗方法是安全且耐受性良好的,这被确定为局部晚期上颌窦SCC的推荐周期数。

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