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Study Title and Description

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



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial.
Author Bath-Hextall F., Ozolins M., Armstrong SJ., Colver GB., Perkins W., Miller PS., Williams HC.
Country Centre for Evidence Based Dermatology, University of Nottingham, Nottingham, UK; School of Nursing, Midwifery, and Physiotherapy, University of Nottingham, Nottingham, UK.
Year 2014
Numbers Pubmed ID: 24332516

Secondary Publication Information
UI Title Author Country Year
Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial. Williams HC., Bath-Hextall F., Ozolins M., Armstrong SJ., Colver GB., Perkins W., Miller PS. Centre for Evidence Based Dermatology, University of Nottingham, Nottingham, UK. Electronic address: Hywel.williams@nottingham.ac.uk. 2017
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Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Imiquimod
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2 excision
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design RCT
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Multicenter etc. Multicenter
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Country/Region UK
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Funding Industry supplied materials
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Inclusion criteria histologically confirmed, primary, previously untreated, nodular or superficial basal-cell carcinoma not arising at sites at high risk for subclinical tumour spread
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Exclusion criteria morphoeic or recurrent basal-cell carcinoma and those with Gorlin syndrome
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N Enrolled/Randomized/Analyzed 501
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501
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485
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... Histologically proven BCC (usually a punch or shave biopsy specimen of no more than 25% of the total lesion, though sometimes at surgery)
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent) o
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Secondary size assessment
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Baseline Characteristics
Question Imiquimod excision Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 69 67
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61, 76 59, 74
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12 mm 10 mm
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9, 16 mm 8, 15 mm
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Gender/Racial descent 102 87
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41 40
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Lesion location 91 72
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37 33
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40 36
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16 16
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110 106
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44 48
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Trunk 95 (38%) Neck 15 (6%) Arm 16 (6%) Leg 24 (10%) Other 7 (3%) Trunk 86 (39%) Neck 20 (9%) Arm 16 (7%) Leg 20 (9%) Other 6 (3%)
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Skin type (Fitzpatrick score) 34 29
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14 13
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92 101
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37 46
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104 78
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42 35
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15 12
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6 6
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not recorded: 2 (<1%) not recorded: 0
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Number of lesions per patient 247 220
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100 100
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Previous treatments No data entered.
Immunocompromized status 12 7
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5 3
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taking taking immunosuppressive drugs drugs taking taking immunosuppressive drugs drugs
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Number of patients/lesions 254 247
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254 247
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254 247
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254 247
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41 58
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31 58
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5 had lesions that were not basal-cell carcinomas; 10 unwilling or unable to attend 7 died 6 were non-contactable or had moved 5 had adverse events 2 had possibly treatment-related adverse events|| 1 had previously treated basal-cell carcinoma; 5 missing primary endpoint 7 did not accept treatment 2 for whom treatment was considered unsuitable by doctor 1 was too ill 1 was confused about dates; 20 unwilling to continue§ 9 had lesions that were not basal-cell carcinomas¶ 7 died 5 were non-contactable or had moved; 20 unwilling to continue§ 9 had lesions that were not basal-cell carcinomas¶ 7 died 5 were non-contactable or had moved
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213 188
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213 188
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Lesion extent number of people 119 100
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baseline numbers not given, these are from 1 year followup baseline numbers not given, these are from 1 year followup
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111 99
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baseline numbers not given, these are from 1 year followup baseline numbers not given, these are from 1 year followup
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Imiquimod excision


1 years

N Analyzed 212 188
Counts 29 2


2 years

N Analyzed 212 188
Counts 2 0


3 years

N Analyzed 212 188
Counts 3 1


5 years

N Analyzed 206 177
Counts 11 2
Outcome: Recurrence or relapse      Population: superficial
Time Point Measure Imiquimod excision


1 years

N Analyzed 114 98
Counts 13 1


2 years

N Analyzed 114 98
Counts 2 0


3 years

N Analyzed 114 98
Counts 2 1


5 years

N Analyzed 111 94
Counts 8 2
Outcome: Recurrence or relapse      Population: nodular
Time Point Measure Imiquimod excision


1 years

N Analyzed 98 90
Counts 16 1


2 years

N Analyzed 98 90
Counts 0 0


3 years

N Analyzed 98 90
Counts 1 0


5 years

N Analyzed 95 83
Counts 3 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure Imiquimod excision


6 months

N Analyzed 213 195
Counts 74 32


3 years

N Analyzed 170 174
Counts 103 62
Outcome: Cosmetic outcome (categorical)      Population: all sites: superficial
Time Point Measure Imiquimod excision


6 months

N Analyzed 112 99
Counts 33 10


3 years

N Analyzed 93 89
Counts 62 29
Outcome: Cosmetic outcome (categorical)      Population: all sites: nodular
Time Point Measure Imiquimod excision


6 months

N Analyzed 101 96
Counts 41 20


3 years

N Analyzed 77 85
Counts 41 33
Outcome: Cosmetic outcome (categorical)      Population: head and neck
Time Point Measure Imiquimod excision


6 months

N Analyzed 93 81
Counts 52 22


3 years

N Analyzed 74 72
Counts 46 29
Outcome: Cosmetic outcome (categorical)      Population: head and neck: superficial
Time Point Measure Imiquimod excision


6 months

N Analyzed 30 25
Counts 17 4


3 years

N Analyzed 26 24
Counts 16 9
Outcome: Cosmetic outcome (categorical)      Population: head and neck: nodular
Time Point Measure Imiquimod excision


6 months

N Analyzed 63 56
Counts 35 18


3 years

N Analyzed 48 48
Counts 30 20
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Imiquimod excision


during tx N/A

N Analyzed 242 201
Counts 169 139


16 (post treatment) weeks

N Analyzed 233 206
Counts 98 151
Outcome: Adverse events: pain      Population: superficial
Time Point Measure Imiquimod excision


during tx N/A

N Analyzed 122 101
Counts 78 66


16 (post treatment) weeks

N Analyzed 122 103
Counts 59 78
Outcome: Adverse events: pain      Population: nodular
Time Point Measure Imiquimod excision


during tx N/A

N Analyzed 120 100
Counts 91 73


16 (post treatment) weeks

N Analyzed 111 103
Counts 39 73
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure Imiquimod excision


up to 3 years

N Analyzed 254 229
Counts 242 208
Outcome: Adverse events: Any      Population: superficial
Time Point Measure Imiquimod excision


up to 3 years

N Analyzed 128 114
Counts 121 107
Outcome: Adverse events: Any      Population: nodular
Time Point Measure Imiquimod excision


up to 3 years

N Analyzed 126 115
Counts 121 101
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure Imiquimod excision


up to 3 years

N Analyzed 254 229
Counts 5 0
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure Imiquimod excision


up to 3 years

N Analyzed 254 229
Counts 99 97
Outcome: Adverse events: Any serious/severe      Population: superficial
Time Point Measure Imiquimod excision


up to 3 years

N Analyzed 128 114
Counts 52 60
Outcome: Adverse events: Any serious/severe      Population: nodular
Time Point Measure Imiquimod excision


up to 3 years

N Analyzed 126 115
Counts 47 37
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure Imiquimod excision


up to 3 years

N Analyzed 254 229
Counts 0 0
Outcome: Long-term Mortality      Population: All Participants
Time Point Measure Imiquimod excision


up to 5 years

N Analyzed 213 188
Counts 3 6


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes
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RCT:....Adequate allocation concealment reported Yes
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RCT:....Adequate blinding of PATIENTS reported No
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RCT:....Adequate blinding of PROVIDERS reported No
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Yes
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes
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ALL.....Selective Reporting (judgement - put directly into notes field). No
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RCT.....Is the treatment effect by Intention to treat? Yes Modified ITT: all randomized patients who received at least 1 application of imiquimod or surgery and for whom the outcome was available
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ALL....Group similarity at baseline. Yes
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) No
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
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Overall, by outcome (judgement - put directly into notes field) low
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
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Quality Rating
No quality rating data was found.