Surgery and radiotherapy are standard treatments for early oral squamous cell carcinoma, both resulting in good tumour control. However, neither of these modalities is without consequent functional or cosmetic impairment, and there are patients in whom both are contraindicated. Furthermore, there is a significant risk of metachronous tumours developing in the oral cavity, and salvage or retreatment with either surgery or radiotherapy poses difficulties. Photodynamic therapy (PDT) offers the potential for improved functional and cosmetic outcomes, while achieving comparable tumour control. We conducted an open-label, multicentre study to assess the efficacy and safety of metatetrahydroxyphenylchlorin (mTHPC) in patients with early oral cancer. One hundred twenty-one patients received intravenously administered mTHPC, followed 96 hr later by illumination of the tumour surface with 652 nm laser light. Of these patients, 114 were protocol compliant. A complete tumour response was achieved in 85% of protocol-compliant patients (97 of 114 patients). A complete response was maintained in 85% of responders at 1 year and in 77% at 2 years. One-and 2-year actuarial survival rates were 89% and 75%, respectively. In the opinion of the investigators, tumour clearance was accompanied by excellent cosmetic and functional results, without impact on the patients' performance status. Mild-to-moderate pain at the treatment site, a recognised side effect of PDT in the oral cavity, was reported by 82% of patients but was manageable with appropriate analgesia. Mild-to-moderate skin photosensitivity reactions were reported for 13% of patients. mTHPC offers an effective alternative treatment for early oral squamous cell carcinoma. It is associated with excellent functional and cosmetic results and can be used in conjunction with other standard therapies. © 2004 Wiley-Liss, Inc.
Key words: oral cancer; photodynamic therapy; mTHPCEach year, there are about 50,000 1 new cases of oral cavity cancer throughout Europe with an average incidence of 13 per 100,000. 2 Globally, the total number of new cases of oral cancer per year is approximately 212,000, and the death rate is 137,000. 3 The greatest incidence is in India where, in 1990, there were more than 80,000 cases with 50,000 deaths. 4 The main predisposing factors are tobacco use and alcohol, which seem to have a synergistic effect. 5 The mainstays of treatment for early disease are surgery and radiotherapy, either alone or in combination. The results of treatment vary considerably with the site and stage of the primary lesion. Initial local control is achieved in 67-95% of T 1 tumours, dropping to 50 -81% with T 2 disease. 6,7 The probability of maintaining local control at 2 years for patients with T 1 or T 2 squamous cell carcinoma of the oral cavity is 75-85%, although this again varies with the tumour site. 6,7 Although some early cancers are cured effectively, the overall outcome remains unsatisfactory with 5-year survival rates ranging from 50% (hard palate) to 95% (lip). Since 1...