The France-PDT study: a national prospective observational cohort survey on the use of methyl-aminolevulinate photodynamic therapy in France, with up to 6-month follow-up.

BACKGROUND

The efficacy and safety of MAL-PDT have been shown in actinic keratoses (AK), basal cell carcinoma (BCC), and Bowen's disease (BD).

OBJECTIVES

To appraise the current use of MAL-PDT in France.

METHODS

National prospective cohort survey, including 583 patients treated for the first time with MAL-PDT. Clinical and treatment data were collected at baseline, month 3, and month 6 if applicable. The primary objective was to estimate the rate of misuse of MAL, defined as divergence from the French Summary of Product Characteristics.

RESULTS

Of 174 contacted physicians, 66 agreed to participate in the study, and 56 included at least one patient. Among the 456 patients included in the observational cohort, 203 had AK, 130 had BCC, and 63 had BD. Referring to the French SPC of Metvixia®, the MAL-PDT was misused in 48.7% of BCC, 25.6% of AK and 23.4% of BD. The main criteria for misuse in BCC were the performance of two rather than one lighting sessions at baseline cure. The main criteria for misuse in AK were the duration of lighting and the performance of 2 rather than 1 lighting sessions at baseline cure. The main criteria for misuse in BD were the performance of 1 rather than 2 lighting sessions at baseline cure and the duration of illumination.

CONCLUSION

Contrasting with the French label, nearly one third of French dermatologists treat BCC with two sessions, as recommended at European level and in Australia. International consensus guidelines are needed to homogenize and rationalize current use of MAL-PDT.