Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): A multicentre, non-inferiority, randomised controlled trial

The Lancet Oncology

Volumn 15, Issue 1, 2014, Pages 96-105

  Bath Hextall, Fiona ^a   Ozolins, Mara ^a   Armstrong, Sarah J ^a   Colver, Graham B ^c   Perkins, William ^d   Miller, Paul S J ^b   Williams, Hywel C ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^b UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^c CHESTERFIELD ROYAL HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^d NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

IMIQUIMOD;

ADULT; AGED; APPLICATION SITE ERYTHEMA; APPLICATION SITE PRURITUS; ARTICLE; BASAL CELL CARCINOMA; BLEEDING; COMMON COLD; CONTROLLED STUDY; CREAM; DRUG EFFICACY; DRUG WITHDRAWAL; FEMALE; FLU LIKE SYNDROME; HEADACHE; HEART INFARCTION; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; INFLAMMATION; INTENTION TO TREAT ANALYSIS; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NODULAR BASAL CELL CARCINOMA; OUTCOME ASSESSMENT; PAIN; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SKIN BIOPSY; SKIN CANCER; SKIN DISEASE; SKIN REDNESS; SKIN SWELLING; SUPERFICIAL BASAL CELL CARCINOMA; TREATMENT DURATION; TREATMENT RESPONSE; VERY ELDERLY;

EID: 84891372701     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(13)70530-8     Document Type: Article

References (31)

1. Wong C, Strange R, Lear J Basal cell carcinoma. BMJ 2003, 327:794-798.
2. Lomas A A systematic review of worldwide incidence of non-melanoma skin cancer. Br J Dermatol 2012, 166:1069-1080.
3. Bath-Hextall F, Leonardi-Bee J, Smith C, Meal A, Hubbard R Trends in incidence of basal cell carcinoma; additional evidence from a UK-primary care database study. Int J Cancer 2007, 121:2105-2108.
4. Skellett A, Hafiji J, Greenberg D, Wright K, Levell N The incidence of basal cell carcinoma in the under-30s in the UK. Clin Exp Dermatol 2012, 37:227-229.
5. Morris S, Cox B, Bosanquet N Cost of skin cancer in England. Eur J Health Econ 2009, 10:267-273.
6. Chen S, Bravata D, Weil E, Olkin I A comparison of dermatologists' and primary care physicians' accuracy in diagnosing melanoma. Arch Dermatol 2001, 137:1627-1634.
7. Bath-Hextall F, Perkins W, Bong J, Williams H Interventions for basal cell carcinoma of the skin. Cochrane Database Syst Rev 2007, 1. CD003412.
8. Improving outcomes for people with skin tumours including melanoma (update): the management of low-risk basal-cell carcinomas in the community National Collaborating Centre for Cancer, (accessed Oct 22, 2013). http://www.nice.org.uk/nicemedia/live/10901/48878/48878.pdf.
9. Roozeboom M, Artis A, Nelemans P, Kelleners-Smeets N Overall treatment success after treatment of primary superficial basal cell carcinoma: a systematic review and meta-analysis of randomized and nonrandomized trials. Br J Dermatol 2012, 167:733-756.
10. Aldara 5% cream Electronic Medicines Compendium (eMC), (accessed Dec 23, 2013). http://www.medicines.org.uk/emc/medicine/8/spc#INDICATIONS.
11. Schön M, Schön MP The antitumoral mode of action of imiquimod and other imidazoquinolines. Curr Med Chem 2007, 14:681-687.
12. Micali G, Lacarrubba F, Dinotta F, Massimino D, Nasca MR Treating skin cancer with topical cream. Expert Opin Pharmacother 2010, 11:1515-1527.
13. Ozolins M, Williams HC, Armstrong SJ, Bath-Hextall FJ The SINS trial: a randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma. Trials 2010, 11:42.
14. Baxter JM, Patel AN, Varma S Facial basal cell carcinoma. BMJ 2012, 21:345.
15. Marks R, Gebauer K, Shumack S, et al. Imiquimod 5% cream in the treatment of superficial basal cell carcinoma: results of a multicentre 6-week dose-response trial. J Am Acad Dermatol 2001, 44:807-813.
16. Rowe DE, Carroll RJ, Day CL Long-term recurrence rates in previously untreated (primary) basal cell carcinoma: implications for patient follow-up. J Dermatol Surg Oncol 1989, 15:315-328.
17. Assman S, Pocock S, Enos L, Kasten L Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000, 355:1064-1069.
18. Zou G A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol 2004, 159:702-706.
19. Arits AH, Mosterd K, Essers BA, et al. 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.
20. McKay KM, Sambrano BL, Fox PS, Bassett RL, Chon S, Prieto VG Thickness of superficial basal cell carcinoma predicts imiquimod efficacy, a proposal for thickness-based definition of superficial basal cell carcinoma. Br J Dermatol 2013, 169:549-554.
21. Eigentler T, Kamin A, Weide B, et al. A phase III, randomized, open label study to evaluate the safety and efficacy of imiquimod 5% cream applied thrice weekly for 8 and 12 weeks in the treatment of low-risk nodular basal cell carcinoma. J Am Acad Dermatol 2007, 57:616-621.
22. Quirk C, Gebauer K, De'Ambrosis B, Slade H, Meng T Sustained clearance of superficial basal cell carcinoma treated with imiquimod cream 5%: results of a prospective 5-year study. Cutis 2010, 85:318-324.
23. Gollnick H, Barona C, Frank R Recurrence rate of superficial basal cell carcinoma following treatment with imiquimod 5% cream: conclusion of a 5-year long-term follow-up study in Europe. Eur J Dermatol 2008, 18:677-682.
24. Vanaclocha F, Dauden E, Badia X Cost-effectiveness of treatment of superficial basal cell carcinoma: surgical excision vs. imiquimod 5% cream. Br J Dermatol 2007, 156:769-771.
25. De Cock M, Nuijten J, Hollestein A, Hamel-Gariepy L Cost-effectiveness model of Aldara (imiquimod) cream 5% in superficial basal cell carcinoma in the Netherlands. Value Health 2005, 8:A144.
26. Sverre J, Kristensen F, Hamel-Gariepy L, Albrektsen T Cost-effectiveness analysis: Aldara (imiquimod) cream 5% in the treatment of superficial basal cell carcinoma in Norway. Value Health 2005, 8:A143.
27. Rhodes L, de Rie M, Leifsdottir R, et al. Five-year follow-up of a randomized, prospective trial of topical methyl aminolevulinate photodynamic therapy vs surgery for nodular basal cell carcinoma. Arch Dermatol 2007, 143:1131-1136.
28. Incomplete excision rates of basal cell carcinomas in primary care and dermatology: a multicentre audit 2008, British Society for Dermatological Surgery, British Association of Dermatologists, Liverpool, UK.
29. Dermatological surgery: a comparison of activity and outcomes in primary and secondary care 2008, British Society for Dermatological Surgery, British Association of Dermatologists, Liverpool, UK.
30. Dabrera G Is the adequacy of excision of basal cell carcinoma related to operator experience?. Clin Exp Dermatol 2007, 32:103-104.
31. Murchie P, Delaney E, Thompson W, Lee A Excising basal cell carcinomas: comparing the performance of general practitioners, hospital skin specialists and other hospital specialists. Clin Exp Dermatol 2008, 33:565-571.