Background: The aim of this multicenter study was to confirm the antitumor efficacy of
Foscan®-mediated photodynamic therapy (PDT) in patients with advanced, end-stage
head and neck squamous cell carcinoma (HNSCC).
Methods: Thirty-nine patients with HNSCC lesions ≤ 10 mm in depth, recurring
following standard treatment, were intravenously injected with Foscan®, followed
96 hours later by illumination of the tumor surface with 652 nm laser light. Tumor
response was assessed on an intent-to-treat basis using World Health Organization (WHO) criteria.
Results: Of 39 treated patients 19 obtained a complete response (CR), 2 a partial response (PR), 5 a stable disease (SD) for at least 8 weeks, 5 patients had progressive disease (PD) and 8 patients were non-evaluable (NE). Thus, in the per-protocol analysis 68% of the patients obtained an objective tumor response (CR: 61%, PR: 6.5%). Of the treated patients 54%
[95% CI: 37%; 70%] showed an objective tumor response (CR 49%). Median survival was significantly longer for responders (160 weeks) than for non-responders (32 weeks). No
major toxicities were observed.
Conclusions: Patients with advanced head and neck cancer with lesions ≤ 10 mm in depth, who have exhausted other treatment options, can achieve significant local control and survival
benefit from Foscan®-mediated PDT. As opposed to conventional treatment modalities,
this treatment is tolerated well