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Study Title and Description

Effect of imiquimod as compared with surgery on the cancerization field in basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Effect of imiquimod as compared with surgery on the cancerization field in basal cell carcinoma.
Author Graells J., Ojeda RM., García-Cruz A.
Country Servei de Dermatologia, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, España. Electronic address: jordi.graells@pssjd.org.
Year 2014
Numbers Pubmed ID: 24139468

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Imiquimod
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2 Surgery
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design Retrospective nRCS
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Multicenter etc. Single center
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Country/Region Spain
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Funding NR
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Inclusion criteria patients treated for their first BCC at the hospital between January 2003 and December 2011
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Exclusion criteria patients followed for less than 3 months were excluded
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N Enrolled/Randomized/Analyzed 623
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NA
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621
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... histologically confirmed BCCs
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent) none
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Secondary size assessment
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Baseline Characteristics
Question Imiquimod Surgery Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 67.61 67.95
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Gender/Racial descent 36 238
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50.70 43.27
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Lesion location 5 31
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7.14 5.64
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limbs limbs
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65 519
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92.86 94.37
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 95 37
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 623
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NR
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NA
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NA
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2
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treated with cryotherapy
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621
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NR
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Lesion extent number of people 34 95
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1 170
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22 278
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure Imiquimod Surgery


5 years

N Enrolled 71 550
Counts 10 NR
SD
Outcome: Lack of clinical clearance      Population: superficial BCCs
Time Point Measure Imiquimod Surgery


5 years

N Enrolled 34 95
Counts 3 NR
SD
Outcome: Lack of clinical clearance      Population: infiltrating BCCs
Time Point Measure Imiquimod Surgery


5 years

N Enrolled 22 278
Counts 6 NR
SD
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Imiquimod Surgery


5 years

N Enrolled 71 550
Counts 17 210
SD
95% CI low 95% CI high Hazard Ratio (HR) p-value
Outcome: Recurrence or relapse      Population: univariate analysis Between-Arm Comparisons
Time Point Measure Imiquimod Surgery Comparison Measure Surgery vs. Imiquimod


5 years

N Enrolled 71 550 1.31
Counts 17 210 3.59
SD 2.16
.0026
95% CI low 95% CI high Hazard Ratio (HR) p-value
Outcome: Recurrence or relapse      Population: multivariate analysis ( Between-Arm Comparisons
Time Point Measure Imiquimod Surgery Comparison Measure Surgery vs. Imiquimod


5 years

N Enrolled 71 550 1.28
Counts 17 210 3.53
SD 2.13
.0032


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Not Applicable
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RCT:....Adequate allocation concealment reported Not Applicable
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RCT:....Adequate blinding of PATIENTS reported Not Applicable
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RCT:....Adequate blinding of PROVIDERS reported Not Applicable
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Not Applicable
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Unsure For "subsequent BCC" outcome, 67 subjects were lost to follow-up (10.7% of whole group), but distribution of missing by arm is not reported.
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ALL.....Selective Reporting (judgement - put directly into notes field). No Lack of clinical clearance was not reported for surgery arm. Adverse Events were only defined for Imiquimod arm. No AEs reported for surgery arm.
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RCT.....Is the treatment effect by Intention to treat? Not Applicable
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ALL....Group similarity at baseline. No The imiquimod and surgery groups differed: higher frequency of superficial BCCs in patients treated with imiquimod vs. surgery, the proportion of patients with a history of multiple BCCs and current multiple BCCs was higher in the group of patients who received imiquimod.
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Yes Multivariate analysis did not include variables such as: size, histology, or location of BCC), all of which may explain the difference in risk between imiquimod and surgery.
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Unsure AE was only defined for Imiquimod. Imiquimod-induced inflammation was classified as mild (not requiring any change in treatment), moderate (requir- ing the addition of a corticosteroid-antibiotic cream but no change in imiquimod treatment), or intense (requiring the temporary or permanent withdrawal of treatment).
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Overall, by outcome (judgement - put directly into notes field) High Risk
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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.