Burns after photodynamic therapyBMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7251.1731 (Published 24 June 2000) Cite this as: BMJ 2000;320:1731
Drug point gives misleading impression of incidence of burns with temoporfin (Foscan)
- Richard Bryce, medical director
- Scotia Pharmaceuticals, Stirling FK9 4TZ
- West Midlands Regional Burns Unit, Selly Oak University Hospital, Birmingham B29 6JD
- Regional Burns Unit, Chelsea and Westminster Hospital, London SW10 9NH
- Charterhouse Clinical Research Unit, Stamford Hospital, London W6 0TN
EDITOR—Hettiaratchy et al report partial thickness skin burns in six out of 14 healthy volunteers injected with temoporfin (Foscan) as part of a phase I pharmacokinetic study carried out on behalf of Scotia Pharmaceuticals at a contract clinical research unit.1 However, their report creates a misleading impression of the true incidence, severity, and overall risk of burns and other photosensitivity reactions with this drug and has led to inaccurate media comment and speculation.
The total number of subjects exposed to Foscan is 957 healthy volunteers and patients, many of whom have been treated with Foscan photodynamic therapy on two or more occasions in clinical studies for a range of different indications. In total, 22 serious adverse drug reactions attributable to photosensitivity including burns have been reported (2.3% of all subjects); this includes the six burns described in the drug point. In clinical studies 15 serious adverse drug reactions involving burns or photosensitivity reactions have been reported in 931 patients injected with Foscan (1.6%). This rate is about half the commonly reported rate of drug related mortality (3-7%) in patients treated with chemotherapy for advanced head and neck cancers.2–6
The table shows the much greater incidence of severe photosensitivity reactions in the volunteers participating in the study referred to by Hettiaratchy et al than in patients with cancer. Furthermore, all 14 of these volunteers reported localised photosensitivity reactions in their infusion arm. The separate pharmacokinetic study in the 23 patients with head and neck cancer, which had an identical study design, reported no serious adverse drug reactions, no burns or localised photosensitivity reactions, and only three generalised photosensitivity reactions of mild or moderate severity (13%); this is similar to the overall rate observed in clinical trials. The pharmacokinetic profile of Foscan in healthy subjects and cancer patients …
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