mTHPC-mediated photodynamic therapy in patients with advanced, incurable head and neck cancer: A multicenter study of 128 patients

Background. The aim of this multicenter study was to assess tumor response, clinical quality-of-life benefit, survival, and safety after treatment with mTHPC in patients with recurrent/refractory squamous cell carcinoma of the head and neck unsuccessfully treated or unsuitable for treatment with conventional modalities. Methods. One hundred twenty-eight patients were treated with mTHPC followed, 96 hours later, by illumination of the tumor surface with 652-nm laser light. Tumor response was assessed with WHO criteria and tumor mass reduction from baseline. Clinical quality-of-life benefit was based on the University of Washington Quality-of-Life questionnaire. Results. By use of WHO criteria, 38% of evaluable patients achieved an overall tumor response, and 16% achieved a complete tumor response. Forty-three percent of assessable lesions achieved 100% tumor mass reduction, and 58% achieved 50% or greater tumor mass reduction. Fifty-three percent of evaluable patients experienced significant clinical quality-of-life benefit. Subset analyses revealed two subgroups in which significantly better responses were seen in patients with tumors 10 mm or less in depth and patients with fully illuminated lesions. In patients fulfilling both categories, overall tumor response was 54%, complete tumor response was 30%, and 61% demonstrated significant clinical quality-of-life benefit. Median survival was significantly better in responders. No major toxicities were detected. Conclusions. Patients with advanced cancer of the head and neck who have exhausted other treatment options can achieve significant clinical benefit and improvement in quality of life with mTHPC. (C) 2004 Wiley Periodicals, Inc.