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A newly published study shows that PDT treatment with MAL (Metvix ®) is effective in preventing new AK lesions in organ transplant patients
Organ transplant recipients on long-term immunosuppressive therapy are at increased risk of non-melanoma skin cancer (NMSC), including actinic keratoses (AK). AK is the most common premalignant skin lesion and can develop into the aggressive cancer squamous cell carcinoma (SCC). This increased risk of developing skin cancer - up to 100-fold in SCC and 10-fold in basal cell carcinoma (BCC) - increases with graft survival time and the duration of immunosuppressive therapy. Together, these factors contribute to substantially increased mortality in transplant recipients compared with the general population.
The open randomized, intrapatient, comparative, multicenter study was designed to evaluate the efficacy and tolerability of regularly repeated field topical Methyl AminoLevulinate (MAL) photodynamic treatment (PDT) as a preventive treatment for pre-malignant skin lesions in organ transplant recipients receiving long-term immunosuppressive therapy.
46% reduction in new AK lesions At 3 months, MAL-PDT significantly reduced the occurrence of new AK lesions, with 46% reduction (P=0.006) versus routine treatment (mainly cryotherapy). Patients who had undergone organ transplantation within 10 years showed an even greater reduction (61%). AK lesion complete response at 3 months and accumulated recurrence rates at 27 months were similar in both treatments. Adverse events with MAL-PDT were consistent with the tolerability profile of this treatment modality.
The cosmetic outcome was also favourable. At 27 months, hypo pigmentation (loss of skin colour) was reported for 16% in areas treated with MAL-PDT versus 51% on routine treatment (P<0.001) and scars for 13% versus 24%, respectively (P=0.73).
"Transplant patients require continuous care of skin lesions. The results of this study suggest that repeated field photodynamic therapy using topical MAL may prevent new actinic keratoses in transplant recipients, providing this patient population with the possibility of effective long-term treatment without significant scarring or tissue damage," said study investigator Ann-Marie Wennberg MD PhD, Associate Professor, Department of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden.
11 European centres, 81 patients, 2 treatment areas The study, which is published in the latest issue of "Transplantation", was conducted at 11 hospital dermatology outpatient centres in Europe between July 2003 and July 2006. Eighty-one transplant recipients with 889 lesions (90% actinic keratoses) participated in the study. Each patient was treated in two contra lateral areas on the face, scalp, neck, trunk or extremities; one area was treated with MAL-PDT (treatment area), while the control area was treated at the investigator's discretion, mainly cryotheraphy or surgery.
Photocure ASA is a Norwegian pharmaceutical listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the diagnosis of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
Photocure®, Metvix®, Aktilite® and Hexvix® are registered trademarks of Photocure ASA
For further information, contact: Photocure ASA Attn. Kjetil Hestdal (President and CEO) or Christian Fekete (CFO) Kjetil Hestdal (kh@photocure.no), Mobile: +47 913 19 535 Christian Fekete (cf@photocure.no), Mobile: +47 916 42 938
