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Study Title and Description

Comparison of topical methyl aminolevulinate photodynamic therapy with cryotherapy or Fluorouracil for treatment of squamous cell carcinoma in situ: Results of a multicenter randomized trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Comparison of topical methyl aminolevulinate photodynamic therapy with cryotherapy or Fluorouracil for treatment of squamous cell carcinoma in situ: Results of a multicenter randomized trial.
Author Morton C., Horn M., Leman J., Tack B., Bedane C., Tjioe M., Ibbotson S., Khemis A., Wolf P.
Country Forth Valley Dermatology Centre, Stirling Royal Infirmary, Stirling, Scotland.
Year 2006
Numbers Pubmed ID: 16785375

Secondary Publication Information
UI Title Author Country Year
A 24-month update of a placebo controlled European study comparing MAL-PDT with cryotherapy and 5-fluoracil in patients with Bowen’s disease (Abstract P08.73) Morton et al. 2005
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Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 MAL PDT
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2 PDT placebo
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3 Cryotherapy or Fluorouracil
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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 Europe
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Funding Industry funded
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Inclusion criteria >= 18 years old, histologically confirmed diagnosis of SCC in situ
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Exclusion criteria Lesions that had been treated within the previous 3 months or that were strongly pigmented, less than 6 mm or more than 40 mm in diameter, or located on the genitalia
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N Enrolled/Randomized/Analyzed 229
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229
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209
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Notes/Comments No randomization between the cryotherapy and fluorouracil arms
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... biopsy specimen taken within 5 months, and with no evidence of any change in appearance suggestive of lesion progression
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Preoperative assessment of clinical size of the tumor ... visual ...
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Percent non-primary (recurrent) ND
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Secondary size assessment photographs before and after treatment
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Baseline Characteristics
Question MAL PDT PDT placebo Cryotherapy or Fluorouracil Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 71.9 73.4 73.6
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43, 89 53, 88 39, 99
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18.9mm 19.3mm 19.8mm
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5, 40mm 8, 40mm 6, 45mm
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largest lesion diameter largest lesion diameter largest lesion diameter
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Gender/Racial descent 60 11 67
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62 65 60
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68 14 76
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71 82 65.5
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Lesion location 29 6 33
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23 25 26
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face/scalp face/scalp face/scalp
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80 16 77
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65 67 61
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15 2 17
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12 8 13
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Skin type (Fitzpatrick score) 10 4 9
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10 24 8
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45 9 51
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47 53 46
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36 3 44
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38 18 39
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5 1 8
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5 6 7
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Number of lesions per patient 81 13 103
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84 76 92
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8 2 4
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8 12 4
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7 2 5
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7 12 4
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 96 17 112
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124 24 127
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96 17 112
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7 2 9
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3 not treated, 1 consent withdrawn, 3 AEs 1 lost to followup, 1 AE 2 lost to followup, 1 AE, 1 dx not confirmed, 1 other; 1 AE, 3 with Fluorouracil Applied for <50% Planned
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91 15 103
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24 127
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Lesion extent number of people No data entered.
Lesion extent number of people 96 17 112
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Results & Comparisons


Results Data
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 111 19 114
Counts 30 15 36
Outcome: Lack of clinical clearance      Population: lesion size: 5-14mm
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 42 7 30
Counts 5 6 4
Outcome: Lack of clinical clearance      Population: lesion size: 15-29mm
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 48 10 65
Counts 11 7 21
Outcome: Lack of clinical clearance      Population: lesion size: >=30mm
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 21 2 18
Counts 7 2 10
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 111 19 114
Counts 8 15 17
Outcome: Lack of clinical clearance      Population: lesion size: 5-14mm
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 42 7 30
Counts 2 6 3
Outcome: Lack of clinical clearance      Population: lesion size: 15-29mm
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 48 10 65
Counts 5 7 10
Outcome: Lack of clinical clearance      Population: lesion size: >=30mm
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 21 2 18
Counts 1 2 4
Outcome: Lack of clinical clearance      Population: lesion location: face/scalp
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 28 5 27
Counts 1 3 5
Outcome: Lack of clinical clearance      Population: lesion location: neck/trunk
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 14 2 15
Counts 1 1 0
Outcome: Lack of clinical clearance      Population: lesion location: extremities
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 69 12 72
Counts 6 11 12
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


12 months

N Analyzed 103 4 97
Counts 15 2 19


24 months

N Analyzed
Counts
Percentage 32 40
Outcome: Recurrence or relapse      Population: lesion size: 5-14mm
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


12 months

N Analyzed 40 1 27
Counts 4 1 0
Outcome: Recurrence or relapse      Population: lesion size: 15-29mm
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


12 months

N Analyzed 43 3 55
Counts 5 1 15
Outcome: Recurrence or relapse      Population: lesion size: >=30mm
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


12 months

N Analyzed 20 0 12
Counts 6 0 3
Outcome: Recurrence or relapse      Population: lesion location: face/scalp
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


12 months

N Analyzed 27 2 22
Counts 2 1 6
Outcome: Recurrence or relapse      Population: lesion location: neck/trunk
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


12 months

N Analyzed 13 1 15
Counts 2 1 2
Outcome: Recurrence or relapse      Population: lesion location: extremities
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


12 months

N Analyzed 63 1 60
Counts 11 0 11
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 82 86
Counts 49 29
Percentage 60 34


12 months

N Analyzed 82 86
Counts 66 31
Percentage 81 36
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 82 86
Counts 77 69
Percentage 94 80


12 months

N Analyzed 82 86
Counts 80 62
Percentage 97 72
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 82 86
Counts 40 19
Percentage 49 22
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 82 86
Counts 73 47
Percentage 89 55
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 96 17 112
Counts 60 10 63
Percentage
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 96 17 112
Counts 0 0 1
Percentage
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 96 17 112
Counts 3 1 2
Percentage
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 96 17 112
Counts 19 4 30
Percentage
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure MAL PDT PDT placebo Cryotherapy or Fluorouracil


3 months

N Analyzed 96 17 112
Counts 4 2 3
Percentage


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unsure not fully randomized
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RCT:....Adequate allocation concealment reported Unsure
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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 No only one outcome assessor was reported to be blinded and that outcome was given at the fewest timepoints
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes possibly for long-term
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ALL.....Selective Reporting (judgement - put directly into notes field). It feels like there may be some selective reporting in the aesthetic outcomes
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RCT.....Is the treatment effect by Intention to treat? No per protocol, not too many dropouts for 1 year, unclear for 2 years
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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)
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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 to moderate RoB for the randomized arms due to lack of blinding and long term dropouts
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes possibly for long-term
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Quality Rating
No quality rating data was found.