Zenda Sadamoto, Akimoto Tetsuo, Mizumoto Masashi, Hayashi Ryuichi, Arahira Satoko, Okumura Toshiyuki, Sakurai Hideyuki
Department of Radiation Oncology, National Cancer Center Hospital East, Japan.
Department of Radiation Oncology, National Cancer Center Hospital East, Japan.
Radiother Oncol. 2016 Feb;118(2):267-71. doi: 10.1016/j.radonc.2015.10.025. Epub 2015 Nov 4.
The aim of this phase II study was to assess the clinical benefit of proton beam therapy for mucosal melanoma of the nasal cavity and para-nasal sinuses.
N0M0 mucosal melanoma of the nasal cavity and para-nasal sinuses were enrolled. Proton therapy was delivered three times per week with a planned total dose of 60 GyE in 15 fractions. Primary endpoint was local control rate at 1 year after treatment. Based on the results of a pilot study, the local control rate was estimated at 75%.
Thirty-two patients were enrolled from June 2008 through October 2012. Patient characteristics were as follows: median age 73 years (range, 36-89 years); male/female ratio, 12/20; and T stage 3/4, 11/21. Local control rate at 1 year was 75.8% (95% CI: 63.8-92.4%). With a median follow-up period of 36.4 months, 3-year overall survival rate was 46.1%. The most frequent pattern of first failure was distant metastasis. The main cause of death was cancer death due to distant metastases (93.3%).
Proton beam therapy showed sufficient local control benefits for mucosal melanoma as an alternative treatment of surgery.
本II期研究旨在评估质子束治疗鼻腔和鼻窦黏膜黑色素瘤的临床获益。
纳入鼻腔和鼻窦N0M0期黏膜黑色素瘤患者。质子治疗每周进行3次，计划总剂量为60 GyE，分15次给予。主要终点为治疗后1年的局部控制率。根据一项前期研究结果，估计局部控制率为75%。
2008年6月至2012年10月共纳入32例患者。患者特征如下：年龄中位数73岁（范围36 - 89岁）；男女比例为12/20；T分期3/4期，11/21。1年局部控制率为75.8%（95%CI：63.8 - 92.4%）。中位随访期为36.4个月，3年总生存率为46.1%。首次失败最常见的模式是远处转移。主要死亡原因是远处转移导致的癌症死亡（93.3%）。
质子束治疗对黏膜黑色素瘤显示出足够的局部控制获益，可作为手术的替代治疗方法。
