Kübler A C, de Carpentier J, Hopper C, Leonard A G, Putnam G
Department of Oral and Maxillofacial Surgery, University of Cologne, Köln, Germany.
Int J Oral Maxillofac Surg. 2001 Dec;30(6):504-9. doi: 10.1054/ijom.2001.0160.
Carcinoma of the lip is a common cancer of the head and neck area; its incidence is approximately one-quarter that for oral cavity cancers. It occurs most frequently on the lower lip of elderly males. This non-randomized Phase II study aimed to estimate the complete response (CR) rate to Foscan-mediated photodynamic therapy (Foscan-PDT) in patients with primary cancer of the lip, duration of CR, and the tolerability and safety of Foscan-PDT. Twenty-five patients with squamous cell carcinoma (SCC) of the lip (Tis, T1, T2/N0/M0) and Karnofsky status > or = 70 received 0.15 mg/kg Foscan intravenously, followed 4 days later by a single non-thermal illumination of the tumour (light dose 20 J/cm2, irradiance 100 mW/cm2, lambda=652 nm). Response was determined after 12 weeks and mean follow up is 424 days so far. After 12 weeks, 96% of cases (24/25) showed CR, and all CRs were confirmed by biopsy. The most common adverse event was swelling and local pain at the treatment site. Tumour recurrence was observed in two patients 4 and 18 months after PDT. One patient developed a single lymph node metastasis 7 months after therapy. Photosensitivity reactions occurred in five patients. The functional results were excellent in all patients without any signs of limited mouth opening or impaired lip closure. The cosmetic outcome was better than after surgical therapy. Foscan-PDT is an effective treatment modality for small primary tumours of the lips. Foscan-PDT yields complete response rates comparable to those published for surgery or radiotherapy without causing major toxicity. It allows preservation of form and function and does not compromise future treatment options for recurrent, residual or second primary disease.
唇癌是头颈部常见的癌症；其发病率约为口腔癌的四分之一。它最常发生在老年男性的下唇。这项非随机的II期研究旨在评估福司可林介导的光动力疗法（Foscan-PDT）对原发性唇癌患者的完全缓解（CR）率、CR持续时间以及Foscan-PDT的耐受性和安全性。25例唇鳞状细胞癌（SCC，Tis、T1、T2/N0/M0）且卡氏评分≥70的患者静脉注射0.15mg/kg福司可林，4天后对肿瘤进行单次非热照射（光剂量20J/cm²，辐照度100mW/cm²，波长=652nm）。12周后确定反应情况，迄今为止平均随访424天。12周后，96%的病例（24/25）显示CR，所有CR均经活检证实。最常见的不良事件是治疗部位肿胀和局部疼痛。PDT治疗后4个月和18个月分别观察到2例患者肿瘤复发。1例患者在治疗后7个月出现单个淋巴结转移。5例患者发生光敏反应。所有患者的功能结果都非常好，没有任何张口受限或唇闭合受损的迹象。美容效果优于手术治疗。Foscan-PDT是治疗唇部小原发性肿瘤的有效治疗方式。Foscan-PDT产生的完全缓解率与手术或放疗报道的相当，且不会引起严重毒性。它能保留形态和功能，不影响复发性、残留性或第二原发性疾病的未来治疗选择。
