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New 5 year Metvix-PDT data demonstrate long-term efficacy & reliability for NM skin cancer treatment

01.02.2006

Patient compliance and cosmetic benefits indicate positive role of this novel non-melanoma skin cancer therapy

New five year clinical trial results have demonstrated the high efficacy and long-term response rates of Metvix® photodynamic therapy (MAL-PDT) in NMSC compared to current standard treatments cryotherapy and surgery. As NMSC is the most common form of skin cancer in Caucasians and, like all skin cancers, has been increasing over recent decades, new methods to effectively treat are essential to prevent extensive damage and further skin cancer developing.

"This is an exciting step forward in the treatment of NMSC, including superficial and nodular basal cell carcinomas. MAL-PDT has shown consistent efficacy in previous trial results, however, the newly available five year data confirm that MAL-PDT is a reliable treatment option, with the added cosmetic benefits which are so important to patients." said Dr Peter Foley, Department of Medicine, University of Melbourne, Australia.

Long-term measurement of the response rates for any new cancer treatment is necessary to demonstrate high efficacy and reliability. Several ongoing Metvix®-PDT clinical trials in basal cell carcinoma have reached the 60 month follow up mark demonstrating reliable long term efficacy within the range of standard treatments.1 In addition Metvix®-PDT not only meets the efficacy standards of current treatments but also has significant benefits in relation to compliance, re-treatment, high selectivity, cosmetic aspects including healing.2, 3, 4, 5, 6, 7

The 60 month data in two of the main forms of NMSC showed:

In superficial basal cell carcinomas (sBCC) similar recurrence with Metvix®-PDT to cryotherapy of 22% vs 19% (with no additional recurrences from 36 months). This was despite using only one Metvix®-PDT treatment session for most patients instead of the recommended standard protocol of two sessions seven days apart. Superior cosmesis including healing were demonstrated compared to cryotherapy
In nodular basal cell carcinomas (nBCC) Metvix®-PDT was non-inferior to surgery in relation to initial response rates with recurrence rates at 60 months being only slightly higher at 14% vs 4% respectively, however, with overall cosmetic outcome for patients being significantly superior after MAL-PDT compared to surgery (84% vs 36% excellent or good cosmetic outcome)8

Commenting on the trial results, Dr Colin Morton, Department of Dermatology, Falkirk Royal Infirmary, Scotland said: "The potential for the use of MAL-PDT as a standard treatment for non-melanoma skin cancers has been closely monitored for some time by the medical community. The new five year data, combined with the original high clearance rates and good cosmesis, are welcomed as confirmation of its place in our therapeutic armamentarium. Recurrence rates are comparable to current non-surgical treatments, but given its safety and lesion selectivity, MAL-PDT can be safely repeated if necessary. As a non-invasive, easy to use therapy, that can be carefully delivered under physician control using standardised procedures, MAL-PDT appears set to become a much more widely used therapy."

An important consideration of treatment is the potential for scarring and the healing process which is integral to patient satisfaction. In a combined analysis of 404 patients treated with MAL-PDT, 68% of BCC subjects indicated a preference for MAL-PDT compared to previous treatment with surgery and 62% of subjects preferred MAL-PDT to previous treatments such as cryotherapy, 5-FU, surgery or other (pooled analysis from 6 phase III studies in AK & BCC).9

With increasing incidence of skin cancers it is important that all members of the medical community are aware of potential skin cancer cases and are kept informed of the range of treatment options available. Metvix®-PDT now has the supporting evidence that confirms the long term efficacy of the treatment and its place as a standard treatment for NMSC.

References

1. Foley, P (2005). Long-term outcomes (five-year data) with MAL-PDT (abstract). Presented at 14th Congress of the European Academy of Dermatology and Venereology, London, October 2005.
2. Szeimies, RM et al (2002). Photodynamic therapy using topical methyl 5-aminolevulinate compared with cryotherapy for actinic keratosis: a prospective randomized study. J Am Acad Dermatol 47:258-262
3. Horn M et al (2003). Topical methyl aminolevulinate therapy in patients with basal cell carcinoma prone to complications and poor cosmetic outcome with conventional treatment. Brit J Dermatol 149:1242-1249
4. Peng Q et al (1996). Build up of esterified aminolevulinic-acid-derivative-induced porphyrin fluorescence in normal mouse skin. J Photochem Photobiol B 34:95-96
5. Kloek J et al (1996). Prodrugs of 5-aminolevulinic acid for photodynamic therapy. Photochem Photobiol 64:994-1000
6. Fritsch C et al (1998). Preferential relative porphyrin enrichment in solar keratoses upon topical application of -aminolevulinic acid methylester. Photochem Photobiol 68:218-221
7. Parisier DM et al (2003). Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective multicenter trial. J Am Acad Dermatol 48:227-232
8. Rhodes LE et al (2005). A randomized European comparison of excision surgery and MAL-PDT in nodular basal cell carcinoma. Arch Dermatol 140:17-23
9. Vinciullo C et al (2005). Patient satisfaction after treatment of basal cell carcinoma and actinic keratoses with MAL-PDT compared to previous other therapies (poster). Presented at 14th Congress of the European Academy of Dermatology and Venereology, London, October 2005.