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.