Shafirstein Gal, Rigual Nestor R, Arshad Hassan, Cooper Michele T, Bellnier David A, Wilding Gregory, Tan Wei, Merzianu Mihai, Henderson Barbara W
Photodynamic Therapy Center, Roswell Park Cancer Institute, Buffalo, New York.
Department of Cell Stress Biology, Roswell Park Cancer Institute, Buffalo, New York.
Head Neck. 2016 Apr;38 Suppl 1(Suppl 1):E377-83. doi: 10.1002/hed.24003. Epub 2015 Jun 29.
The purpose of this study was for us to report results regarding the safety of 3-(1'-hexyloxyethyl) pyropheophorbide-a (HPPH) mediated photodynamic therapy (PDT) in early laryngeal disease, and offer preliminary information on treatment responses.
A single-institution, phase Ib, open label, noncomparative study of HPPH-PDT in patients with high-risk dysplasia, carcinoma in situ, and T1 squamous cell carcinoma (SCC) of the larynx. The primary outcomes were safety and maximum tolerated dose (MTD), and the secondary outcome was response.
Twenty-nine patients and 30 lesions were treated. The most common adverse event (AE) was transient hoarseness of voice. Severe edema, requiring tracheostomy, was the most serious AE, which occurred in 2 patients within several hours of therapy. The MTD was 100 J/cm(2) . Patients with T1 SCC seemed to have good complete response rate (82%) to HPPH-PDT at MTD.
HPPH-PDT can be safely used to treat early-stage laryngeal cancer, with potential efficacy. © 2015 The Authors Head & Neck Published by Wiley Periodicals, Inc. Head Neck 38: E377-E383, 2016.
本研究旨在报告3-(1'-己氧基乙基)焦脱镁叶绿酸-a(HPPH)介导的光动力疗法(PDT)治疗早期喉疾病的安全性结果,并提供有关治疗反应的初步信息。
一项在单一机构开展的Ib期、开放标签、非对照研究,纳入患有高危发育异常、原位癌和喉T1期鳞状细胞癌(SCC)的患者,采用HPPH-PDT治疗。主要结局为安全性和最大耐受剂量(MTD),次要结局为反应。
共治疗29例患者和30个病变。最常见的不良事件(AE)是短暂性声音嘶哑。严重水肿(需要气管切开术)是最严重的AE,有2例患者在治疗后数小时内出现。MTD为100 J/cm²。T1期SCC患者在MTD时对HPPH-PDT似乎有良好的完全缓解率(82%)。
HPPH-PDT可安全用于治疗早期喉癌,具有潜在疗效。© 2015作者 头颈 由威利期刊公司出版。头颈38: E377-E383, 2016。