Organ
of the
GD — Society for Dermopharmacy
 |
Issue 2 (2004) |
Dermatotherapy
Imiquimod-Creme in use at non-melanocyte skin cancer
Refundable so far only therapy of the superficial basal cell carcinoma
The local immuno stimulator Imquimod is already available as five-percent cream (Aldara® 5 % cream) for some time now for the local treatment of condyloma (Condylomata acuminata) in the genital and perianal area. Moreover, the preparation attracts increasingly interest as therapy option for the non-melanocyte light skin cancer. Recently it has been released for use of small superficial basal cell carcinoma and is now also refunded by the public health funds for this indication. The costs for a therapy cycle are approximately 300 Euro.
In contrast to the superficial basal cell carcinoma, Imquimod cream has so far not yet been released for the therapy of the actinic keratosis appearing at a considerably higher frequency. Correspondingly, prescriptions to the debit of a public health fund are not yet possible for this indication. At a press conference organized by the company 3M Medica in Neuss on 30 September, expectations were expressed that the approval for this indication will be granted in the course of 2005.
High effectiveness
for the treatment of basal
cell carcinoma
Basis of the approval of Imquimod cream for the treatment of the superficial basal cell carcinoma were the results of two double-blind placebo-controlled clinical studies of altogether 724 patients (Geisse J. et al., J. Am. Acad. Dermatol. 50 [2004], 722-733).
Inclusion criteria in both studies were histologically confirmed single primary tumours with a size of 0.5 to 4.0 cm2 and a diameter of 0.5 to 2.0 centimetres. Excluded were tumours located within a distance of one centimetre from the eye, nose, mouth, ears and the hair line.
12 weeks after the termination of treatment, a histological and clinical assessment has been performed. Histologically healed were the tumours at 82 percent of the patients who have been treated once daily with Imquimod cream over the period of six weeks on five successive days. This result was significant in comparison to the placebo group and did not differ significantly compared with the placebo group for which the therapy duration - at otherwise equal therapy conditions - has been performed over seven instead of five days per week.
Clinical healing rates were with 79 respectiveley 73 percent in both Verum groups lower than the histological healing rates. This at first sight surprising finding is explained in such a way that the pharmacologically conditioned local skin reactions such as erythema, oedema, hardening, scab formation, erosions, scaling, vesicles and ulcerations frequently tend to last much longer than the termination of therapy and may misleadingly convey the impression of still present tumour rests.
Information
on application and tolerability
The mentioned local skin reactions appeared in both studies at a frequency of ten to over fifty percent respectively. If it should be necessary due to the medical condition of the patients or due to the severity of the local skin reaction, the treatment can be temporarily interrupted and after abating of the disturbance restarted. The same applies, if signs of infection arise at the treatment area.
It is recommended to apply the Imquimod cream before going-to-bed and to leave it for approximately eight hours on the skin. After the application of the cream and the eight-hour reaction time, the treatment area has to be washed with a mild soap and water. During the reaction time having showers or taking baths should be abstained from.
Imquimod cream is only available in the market in a packing unit with 12 pouch packs containing 250 milligrams cream each. As for each treatment a new pouch has to be used, three original packings for the price totalling 299.34 Euro are required for a therapy cycle. (jk)
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