Imiquimod 5% cream for the treatment of superficial and nodular basal cell carcinoma

randomized studies comparing low-frequency dosing with and without occlusion

STERRY, W.
RUZICKA, T.
HERRERA, E.
TAKWALE, A.
BICHEL, J.
ANDRES, K.
DING, L.
THISSEN, M. R.T.M.

Department of Dermatology, University Hospital Charité, Humboldt University, 10117 Berlin, Germany (STERRY)
^*University Clinic of Dermatology, Moorenstr. 5, 40225 Düsseldorf, Germany
†Servicio Dermatología, Hospital Clínico de Malaga, Campus Teatinos s/n, 29010 – Malaga, Spain
‡Walsgrave Hospital, Coventry CV2 2DX, U.K.
§3M Medica, 46325 Borken, Germany
¶3M Pharmaceuticals, St. Paul, MN 55144, U.S.A.
^**Department of Dermatology, University Hospital Maastricht, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands

Correspondence: Professor Wolfram Sterry, MD, Universitätsklinikum Charité, Med. Fakultät der Humboldt-Universität, Fachabteilung Haut und Geschlechtskrankheiten, Schumannstr. 20–21, D-10117 Berlin, Germany. E-mail: [email protected]

These studies were sponsored by 3M Pharmaceuticals, St. Paul, MN, U.S.A. Drs Sterry, Ruzicka, Herrera, and Takwale have received financial support from 3M Pharmaceuticals for performing clinical trials. Dr Bichel, and Ms Andres and Ms Ding are employees of 3M Pharmaceuticals. Abstracts and posters for these two studies were presented at the 8th World Congress on Cancers of the Skin, Zurich, Switzerland, 18–21 July 2001.

All enrolling investigators are listed in the Acknowledgments.

Accepted for publication 1 July 2002

British Journal of Dermatology 147(6):p 1227-1236, December 2002.

Summary

Background

Imiquimod 5% cream has been investigated for non-surgical treatment of superficial and nodular basal cell carcinoma (BCC) tumours.

Objectives

Two studies were conducted to examine the effect of occlusion at low dosing frequencies on the safety and efficacy of topical imiquimod 5% cream for the treatment of superficial and nodular BCC.

Patients and methods

Both open-label studies were conducted in Europe. Patients diagnosed with BCC were enrolled into either the superficial (93 patients) or nodular (90 patients) study, depending on the histological confirmation of the patient's tumour subtype. Patients were randomized to one of four groups to apply imiquimod 5% cream 2 or 3 days per week either with or without occlusion. Six weeks following a 6-week treatment period, the entire target tumour area was excised and histologically examined for evidence of residual tumour.

Results

In both studies, the highest histologically complete response rate was seen in the 3 days per week with occlusion groups, with complete response rates of 87% and 65% for the superficial and nodular studies, respectively. Occlusion did not have a statistically significant effect on response rate at either dosing frequency. Response rates for superficial and nodular BCC tumours treated 3 days per week without occlusion were 76% and 50%, respectively.

Conclusions

In the superficial study, the complete response rate of 87% in the 3 days per week with occlusion group was similar to that of daily and 5 days per week dosing without occlusion in a previous 12-week study and one study of daily dosing without occlusion for 6 weeks. All treatment groups had acceptable safety profiles in both studies. Occlusion did not have a statistically significant effect on efficacy for either superficial or nodular BCC tumours.