Objective: To document the impact on patient-reported outcomes and health-related quality of life (HRQoL) of treatment with imiquimod cream in patients with actinic keratosis (AK) and superficial basal cell carcinoma (sBCC). Methods: This open-label, multicenter study included AK and sBCC patients eligible for treatment with imiquimod 5% cream. HRQoL was measured by the Skindex-17 and the Skin Cancer Index (SCI) and treatment satisfaction by the Treatment Satisfaction Questionnaire for Medication. Results: 118 AK patients and 84 patients with sBCC were included. Low baseline HRQoL impairment was found on both questionnaires, which remained low after treatment, except for a small dip at the end of the application period. Conclusion: Imiquimod 5% cream treatment has no clinically relevant HRQoL impact in AK and sBCC patients according to the Skindex-17 and SCI. The effect of imiquimod treatment on HRQoL may be limited or these questionnaires do not fully capture relevant issues, such as fear of recurrence.

1.
Salasche SJ: Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol 2000;42:4-7.
2.
Flohil SC, van der Leest RJ, Dowlatshahi EA, Hofman A, de Vries E, Nijsten T: Prevalence of actinic keratosis and its risk factors in the general population: the Rotterdam Study. J Invest Dermatol 2013;133:1971-1978.
3.
Traianou A, Ulrich M, Apalla Z, de Vries E, Bakirtzi K, Kalabalikis D, Ferrandiz L, Ruiz-de-Casas A, Moreno-Ramirez D, Sotiriadis D, Ioannides D, Aquilina S, Apap C, Micallef R, Scerri L, Pitkänen S, Saksela O, Altsitsiadis E, Hinrichs B, Magnoni C, Fiorentini C, Majewski S, Ranki A, Proby CM, Stockfleth E, Trakatelli M; EPIDERM Group: Risk factors for actinic keratosis in eight European centres: a case-control study. Br J Dermatol 2012;167(suppl 2):36-42.
4.
Flohil SC, de Vries E, Neumann HA, Coebergh JW, Nijsten T: Incidence, prevalence and future trends of primary basal cell carcinoma in the Netherlands. Acta Derm Venereol 2011;91:24-30.
5.
Flohil SC, Seubring I, van Rossum MM, Coebergh JW, de Vries E, Nijsten T: Trends in basal cell carcinoma incidence rates: a 37-year Dutch observational study. J Invest Dermatol 2013;133:913-918.
6.
van der Geer S, Reijers HA, van Tuijl HF, de Vries H, Krekels GA: Need for a new skin cancer management strategy. Arch Dermatol 2010;146:332-336.
7.
Weinstock MA, Lee KC, Chren MM, Marcolivio K; VATTC Trial Group: Quality of life in the actinic neoplasia syndrome: the VA Topical Tretinoin Chemoprevention (VATTC) Trial. J Am Acad Dermatol 2009;61:207-215.
8.
Stockfleth E, Terhorst D, Braathen L, Cribier B, Cerio R, Ferrandiz C, Giannetti A, Kemeny L, Lindelof B, Neumann M, Sterry W, Kerl H, on behalf of the European Dermatology Forum: Guidelines for the management of actinic keratoses. http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-miscellaneous (accessed December 2013).
9.
Trakatelli M, Morton CA, Nagore E, Ulrich C, del Marmol V, Peris K, Basset-Seguin N, on behalf of the European Dermatology Forum: Update of the guideline on basal cell carcinoma. http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-miscellaneous (accessed December 2013).
10.
Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B: Ingenol mebutate gel for actinic keratosis. N Engl J Med 2012;366:1010-1019.
11.
Schon MP, Schon M: Imiquimod: mode of action. Br J Dermatol 2007;157:8-13.
12.
Stockfleth E, Sterry W, Carey-Yard M, Bichel J: Multicentre, open-label study using imiquimod 5% cream in one or two 4-week courses of treatment for multiple actinic keratoses on the head. Br J Dermatol 2007;157:41-46.
13.
Arits AH, Mosterd K, Essers BA, Spoorenberg E, Sommer A, de Rooij MJ, van Pelt HP, Quaedvlieg PJ, Krekels GA, van Neer PA, Rijzewijk JJ, van Geest AJ, Steijlen PM, Nelemans PJ, Kelleners-Smeets NW: Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial. Lancet Oncol 2013;14:647-654.
14.
Atkinson MJ, Kumar R, Cappelleri JC, Hass SL: Hierarchical construct validity of the Treatment Satisfaction Questionnaire for Medication (TSQM version II) among outpatient pharmacy consumers. Value Health 2005;8(suppl 1):S9-S24.
15.
Nijsten TE, Sampogna F, Chren MM, Abeni DD: Testing and reducing Skindex-29 using Rasch analysis: Skindex-17. J Invest Dermatol 2006;126:1244-1250.
16.
Bullinger M, Alonso J, Apolone G, Leplège A, Sullivan M, Wood-Dauphinee S, Gandek B, Wagner A, Aaronson N, Bech P, Fukuhara S, Kaasa S, Ware JE Jr: Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International Quality of Life Assessment. J Clin Epidemiol 1998;51:913-923.
17.
Waalboer-Spuij R, Nijsten TE: A review on quality of life in keratinocyte carcinoma patients. G Ital Dermatol Venereol 2013;148:249-254.
18.
Rhee JS, Matthews BA, Neuburg M, Logan BR, Burzynski M, Nattinger AB: Validation of a quality-of-life instrument for patients with nonmelanoma skin cancer. Arch Facial Plast Surg 2006;8:314-318.
19.
Rhee JS, Loberiza FR, Matthews BA, Neuburg M, Smith TL, Burzynski M: Quality of life assessment in nonmelanoma cervicofacial skin cancer. Laryngoscope 2003;113:215-220.
20.
Rhee JS, Matthews BA, Neuburg M, Logan BR, Burzynski M, Nattinger AB: The Skin Cancer Index: clinical responsiveness and predictors of quality of life. Laryngoscope 2007;117:399-405.
21.
Norman GR, Sloan JA, Wyrwich KW: Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41:582-592.
22.
Dauden E; BASALE Study Group: Effectiveness and satisfaction with imiquimod for the treatment of superficial basal cell carcinoma in daily dermatological practice. J Eur Acad Dermatol Venereol 2011;25:1304-1310.
23.
Geisse J, Caro I, Lindholm J, Golitz L, Stampone P, Owens M: Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: results from two phase III, randomized, vehicle-controlled studies. J Am Acad Dermatol 2004;50:722-733.
24.
Gupta AK, Paquet M, Villanueva E, Brintnell W: Interventions for actinic keratoses. Cochrane Database Syst Rev 2012;12:CD004415.
25.
Serra-Guillen C, Nagore E, Hueso L, Llombart B, Requena C, Sanmartín O, Botella-Estrada R, Guillen C: A randomized comparative study of tolerance and satisfaction in the treatment of actinic keratosis of the face and scalp between 5% imiquimod cream and photodynamic therapy with methyl aminolaevulinate. Br J Dermatol 2011;164:429-433.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.