Department of Head and Neck Surgery, Roswell Park Cancer Institute, Buffalo, New York, USA.
JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):706-11. doi: 10.1001/jamaoto.2013.3387.
There is an immediate need to develop local intraoperative adjuvant treatment strategies to improve outcomes in patients with cancer who undergo head and neck surgery.
To determine the safety of photodynamic therapy with 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) in combination with surgery in patients with head and neck squamous cell carcinoma.
DESIGN, SETTING, AND PARTICIPANTS: Nonrandomized, single-arm, single-site, phase 1 study at a comprehensive cancer center among 16 adult patients (median age, 65 years) with biopsy-proved primary or recurrent resectable head and neck squamous cell carcinoma.
Intravenous injection of HPPH (4.0 mg/m2), followed by activation with 665-nm laser light in the surgical bed immediately after tumor resection.
Adverse events and highest laser light dose.
Fifteen patients received the full course of treatment, and 1 patient received HPPH without intraoperative laser light because of an unrelated myocardial infarction. Disease sites included larynx (7 patients), oral cavity (6 patients), skin (1 patient), ear canal (1 patient), and oropharynx (1 patient, who received HPPH only). The most frequent adverse events related to photodynamic therapy were mild to moderate edema (9 patients) and pain (3 patients). One patient developed a grade 3 fistula after salvage laryngectomy, and another patient developed a grade 3 wound infection and mandibular fracture. Phototoxicity reactions included 1 moderate photophobia and 2 mild to moderate skin burns (2 due to operating room spotlights and 1 due to the pulse oximeter). The highest laser light dose was 75 J/cm2.
The adjuvant use of HPPH-photodynamic therapy and surgery for head and neck squamous cell carcinoma seems safe and deserves further study.
clinicaltrials.gov Identifier: NCT00470496.
目前迫切需要制定局部术中辅助治疗策略，以改善接受头颈部手术的癌症患者的治疗效果。
评估 2-(1-己氧基乙基)-2-去乙烯基焦脱镁叶绿酸-a（HPPH）联合手术治疗头颈部鳞状细胞癌患者的安全性。
设计、地点和参与者：这是一项在一家综合性癌症中心进行的非随机、单臂、单中心、1 期研究，纳入了 16 名经活检证实的原发性或复发性可切除头颈部鳞状细胞癌成年患者（中位年龄 65 岁）。
静脉注射 HPPH（4.0mg/m2），然后在肿瘤切除后立即用 665nm 激光照射手术床。
不良事件和最高激光剂量。
15 名患者接受了完整的治疗过程，1 名患者因非相关的心肌梗死而未接受术中激光治疗。疾病部位包括喉（7 例）、口腔（6 例）、皮肤（1 例）、耳道（1 例）和口咽（1 例，仅接受 HPPH 治疗）。与光动力疗法相关的最常见不良事件为轻至中度水肿（9 例）和疼痛（3 例）。1 例患者在挽救性喉切除术后发生 3 级瘘管，另 1 例患者发生 3 级伤口感染和下颌骨骨折。光毒性反应包括 1 例中度畏光和 2 例轻至中度皮肤灼伤（2 例归因于手术室聚光灯，1 例归因于脉搏血氧仪）。最高激光剂量为 75J/cm2。
辅助使用 HPPH-光动力疗法联合手术治疗头颈部鳞状细胞癌似乎是安全的，值得进一步研究。
clinicaltrials.gov 标识符：NCT00470496。
