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Study Title and Description

The effect of intralesional 5-Fluorouracil Therapeutic Implant (MPI 5003) for treatment of basal cell carcinoma



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title The effect of intralesional 5-Fluorouracil Therapeutic Implant (MPI 5003) for treatment of basal cell carcinoma
Author Orenberg EK et al
Country -- Not Found --
Year 1992
Numbers Pubmed ID: 1430394

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 7.5 mg 5-FU 0.25 ml of MPI 5003 (7.5 mg 5-FU) intralesionally
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2 15 mg 5-FU 0.5 ml of MPI 5003 (15 mg 5-FU) intralesionally
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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. Unclear
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Country/Region USA
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Funding NR
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Inclusion criteria Biopsy-proven nodular BCC, 06-1.5 cm diameter
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Exclusion criteria Previous local treatment or systemic cancer therapy within 6 months; Gorlin's syndrome, morpheaform, pigmented or deeply invasive lesions; Patients with any serious or debilitating illness, chronic respiratory disease, depressed bone marrow, autoimmunedisease, or with hypersensitivity to 5-FU, epinephrine, or bovine coUagen; Pregnant or lactating women and subjects requiring the use of nonsteroidal antiinflammatory drugs, nonselective beta-blocking drugs, aspirin, and topical or systemic steroids
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N Enrolled/Randomized/Analyzed 20
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20
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20
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question 7.5 mg 5-FU 15 mg 5-FU Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 123.9 mm2 76.4 mm2 60
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75 mm2 80.5 mm2 22-78
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54-468 mm2 24-144 mm2 99.7 mm2
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Calculated myself Calculated myself 80.5 mm2
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1 1 24-468 mm2
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1 1 Calculated myself
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1 1 1
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1 1
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1
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1
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Gender/Racial descent 2
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5
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Lesion location 3 1 4
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3 1 1
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4 1 1
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3 3
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1 4
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3 7
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 10 10 20
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100 100 100
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 10 10 20
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10 10 20
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N/A N/A N/A
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10 10 20
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10 10 20
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N/A N/A N/A
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0 0 0
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0 0 0
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10 10 20
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10 10 20
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N/A N/A N/A
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Lesion extent number of people 10 10 20
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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 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 4 2
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 5 8
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 5 6
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 9
Counts 2 2
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 3 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 2 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 0 2
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 0 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 3 4
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 2 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 0 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


18 weeks

N Analyzed 10 10
Counts 0 0
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure 7.5 mg 5-FU 15 mg 5-FU


not given N/A

N Analyzed 10 10
Counts 9 10


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unclear RoB
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RCT:....Adequate allocation concealment reported Unclear RoB
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RCT:....Adequate blinding of PATIENTS reported Low RoB
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RCT:....Adequate blinding of PROVIDERS reported Low RoB
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Low RoB
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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). Yes
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RCT.....Is the treatment effect by Intention to treat? Unsure No dropouts/protocol breaks reports
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ALL....Group similarity at baseline. No
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field)
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined High RoB
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Overall, by outcome (judgement - put directly into notes field) Unsure High RoB, Lots of uncertainty, very small study
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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.