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Study Title and Description

Intralesional interferon therapy for basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Intralesional interferon therapy for basal cell carcinoma.
Author Cornell RC., Greenway HT., Tucker SB., Edwards L., Ashworth S., Vance JC., Tanner DJ., Taylor EL., Smiles KA., Peets EA.
Country Division of Dermatology and Cutaneous Surgery, Scripps Clinic and Research Foundation, La Jolla, CA 92037.
Year 1990
Numbers Pubmed ID: 2229497

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 interferon
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2 placebo
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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 US
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Funding No industry support
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Inclusion criteria superficial or noduloulcerative Becconfirmed by biopsy and was 32 to 70 years of age, not pregnant,and in good general health.
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Exclusion criteria previously received therapy to the test lesion, immunosuppressive or cytotoxic therapy (within the prior 4 weeks), or exogenous interferon/interferon-inducer except interferonalfa-2b (Intron A), BCC located in the perioral or central area of the face or penetrating to deep tissue
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N Enrolled/Randomized/Analyzed 172
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172
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165
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... punch or shave biopsy
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Preoperative assessment of clinical size of the tumor ... visual ... photographed and its size and anatomic location were precisely defined.
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Percent non-primary (recurrent)
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Secondary size assessment
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Baseline Characteristics
Question interferon placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 56 57
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83 (mm^2) 75 (mm^2)
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Gender/Racial descent 23 6
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19 14
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Lesion location 31 7
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25 17
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head and face head and face
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15 6
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12 14
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77 25
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63 59
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient nd
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 130 42
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nd nd
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130 42
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nd nd
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7 0
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nd nd
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Seven patients were excluded from week 16 histologic and from clinical data analyses because of missed injections, adverse experiences, and/or failure to satisfy the entry criteria. 42
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123 nd
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nd
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Lesion extent number of people 57 19
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66 23
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noduloulcerative noduloulcerative
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
P-Value P-Value P-Value
Outcome: Lack of clinical clearance      Population: All Participants Between-Arm Comparisons
Time Point Measure interferon placebo Comparison Measure interferon vs. placebo


16 weeks

N Analyzed 120 42 <0.0001
Counts 18 30
Percentage 15 71


20 weeks

N Analyzed 120 42 <0.0001
Counts 17 30
Percentage 14 71


52 weeks

N Analyzed 118 41 <0.0001
Counts 22 33
Percentage 19 80
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure interferon placebo


52 weeks

N Analyzed 130 42
Counts 97 21
Percentage 75 50


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes
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RCT:....Adequate allocation concealment reported No Data
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RCT:....Adequate blinding of PATIENTS reported Yes
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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? No
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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
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ALL....Group similarity at baseline. Yes Location might be slightly different, disadvantages the treatment group
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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) Overall low RoB
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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
Guideline Used Overall Rating