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Study Title and Description

Nonsurgical treatment of basal cell carcinomas with intralesional 5-fluorouracil/epinephrine injectable gel.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Nonsurgical treatment of basal cell carcinomas with intralesional 5-fluorouracil/epinephrine injectable gel.
Author Miller BH., Shavin JS., Cognetta A., Taylor RJ., Salasche S., Korey A., Orenberg EK.
Country Dermatology Service, University of Arizona Health Sciences Center, USA.
Year 1997
Numbers Pubmed ID: 8996264

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 1.0 mL 5-FU weekly/6 weeks
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2 0.5 mL 5-FU weekly/6 weeks
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3 1.0 mL 5-FU 2x weekly/3 weeks
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4 1.0 mL 5-FU twi 2x weekly/3 weeks
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5 0.5 mL 5-FU 2x weekly/4 weeks
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6 0.5 mL 5-FU 3x weekly/2 weeks
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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 USA
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Funding No industry support
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Inclusion criteria 6-15 mm in largest diameter, well-defined margins, at least 50 mm from any other malignancy that would otherwise be treated with surgery or curettage/electrodesiccation
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Exclusion criteria lesions already received treatment, high-risk sites, tumors considered to be more appropriately treated with Mohs micrographic surgery, deep tissue involved lesions, morpheaform lesions, lesions associated with basal cell nevus syndrome. Patients with known hypersensitivities or allergies to 5-FU, sulfites, epinephrine, or bovine collagen; patients with history of autoimmune disease or immunosuppression; women who were pregnant or lactating
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N Enrolled/Randomized/Analyzed 122
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122
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116
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... punch or shave biopsy of no more than 25% of total legion
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Preoperative assessment of clinical size of the tumor ... visual ... 6-15mm in largest diameter, well-defined margins
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Percent non-primary (recurrent)
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Secondary size assessment
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Baseline Characteristics
Question 1.0 mL 5-FU weekly/6 weeks 0.5 mL 5-FU weekly/6 weeks 1.0 mL 5-FU 2x weekly/3 weeks 1.0 mL 5-FU twi 2x weekly/3 weeks 0.5 mL 5-FU 2x weekly/4 weeks 0.5 mL 5-FU 3x weekly/2 weeks Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 61
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29-86
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80
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18-225
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mm^2
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Gender/Racial descent 25
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20
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Lesion location 49
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40%
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64
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52%
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head (n=9) (%=7)
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 20 21 18 19 21 17 122
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20 21 18 19 21 17 122
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122
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122
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6
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6
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116
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116
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Lesion extent number of people 38
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84
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure 1.0 mL 5-FU weekly/6 weeks 0.5 mL 5-FU weekly/6 weeks 1.0 mL 5-FU 2x weekly/3 weeks 1.0 mL 5-FU twi 2x weekly/3 weeks 0.5 mL 5-FU 2x weekly/4 weeks 0.5 mL 5-FU 3x weekly/2 weeks




N Analyzed
Counts
Percentage




N Analyzed
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Percentage




N Analyzed
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Percentage


12 weeks post last injection weeks

N Analyzed 20 21 18 19 21 17
Counts 2 1 1 4 2 0
Percentage 10 5 6 21 10 0
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure 1.0 mL 5-FU weekly/6 weeks 0.5 mL 5-FU weekly/6 weeks 1.0 mL 5-FU 2x weekly/3 weeks 1.0 mL 5-FU twi 2x weekly/3 weeks 0.5 mL 5-FU 2x weekly/4 weeks 0.5 mL 5-FU 3x weekly/2 weeks


12 weeks post last injection weeks

N Analyzed 18
Counts 6
Percentage 33
Incidence (per 1000) 10
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure 1.0 mL 5-FU weekly/6 weeks 0.5 mL 5-FU weekly/6 weeks 1.0 mL 5-FU 2x weekly/3 weeks 1.0 mL 5-FU twi 2x weekly/3 weeks 0.5 mL 5-FU 2x weekly/4 weeks 0.5 mL 5-FU 3x weekly/2 weeks


time of injection weeks

N Analyzed 20 21 18 19 21 17
Counts 20 21 18 19 21 17
Percentage 100 100 100 100 100 100
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure 1.0 mL 5-FU weekly/6 weeks 0.5 mL 5-FU weekly/6 weeks 1.0 mL 5-FU 2x weekly/3 weeks 1.0 mL 5-FU twi 2x weekly/3 weeks 0.5 mL 5-FU 2x weekly/4 weeks 0.5 mL 5-FU 3x weekly/2 weeks


12 weeks post last injection weeks

N Analyzed 20 21 18 19 21 17
Counts 0 0 0 0 0 0
Percentage 0 0 0 0 0 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unclear RoB randomization procedure undefined
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RCT:....Adequate allocation concealment reported Unclear RoB randomization procedure undefined
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RCT:....Adequate blinding of PATIENTS reported Low RoB open label but outcomes aren't likely influenced
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RCT:....Adequate blinding of PROVIDERS reported Low RoB open label but outcomes aren't likely influenced
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Low RoB open label but outcomes aren't likely influenced
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes drops outs occurred either prior to completion or were unrelated to treatment
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ALL.....Selective Reporting (judgement - put directly into notes field). No adverse events selectively reported or not stratified, cosmetic outcome not fully reported, histologic clearance is reported fully
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RCT.....Is the treatment effect by Intention to treat? Unsure FLAG some drop outs related to treatment
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ALL....Group similarity at baseline. No Data
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Yes
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Low RoB
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Overall, by outcome (judgement - put directly into notes field) No moderate rob for clearance, high rob for other outcomes
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes
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Quality Rating
No quality rating data was found.