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Study Title and Description

Fractionated 5-aminolaevulinic acid-photodynamic therapy vs. surgical excision in the treatment of nodular basal cell carcinoma: results of a randomized controlled trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Fractionated 5-aminolaevulinic acid-photodynamic therapy vs. surgical excision in the treatment of nodular basal cell carcinoma: results of a randomized controlled trial.
Author Mosterd K., Thissen MR., Nelemans P., Kelleners-Smeets NW., Janssen RL., Broekhof KG., Neumann HA., Steijlen PM., Kuijpers DI.
Country Department of Dermatology, University Hospital Maastricht, PO BOX 5800, 6202 AZ Masstricht, The Netherlands. k.mosterd@mumc.nl
Year 2008
Numbers Pubmed ID: 18717680

Secondary Publication Information
UI Title Author Country Year
Fractionated 5-aminolevulinic acid photodynamic therapy after partial debulking versus surgical excision for nodular basal cell carcinoma: A randomized controlled trial with at least 5-year follow-up Marieke H. Roozeboom, MD,a,c Martine A. Aardoom,a Patty J. Nelemans, MD, PhD,b Monique R. T. M. Thissen, MD, PhD,a,c Nicole W. J. Kelleners-Smeets, MD, PhD,a,c Danielle I. M. Kuijpers, MD, PhD,d and Klara Mosterd, MD, PhDa, 2013
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Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 ALA-PDT
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2 Surgical excision
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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. Single center
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Country/Region Netherlands
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Funding NR
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Inclusion criteria Older than 18 years, with previously untreated nBCC with a largest diameter of 20 mm
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Exclusion criteria Patient-related exclusion criteria comprised pregnancy, a life expectancy of less than 5 years, any known skin cancer syndromes, the use of phototoxic ‚ĀĄphotosensitive drugs and hypersensitivity to light or ALA cream. Tumour-related exclusion criteria comprised recurrent or pigmented BCC, histological subtypes other than nodular and a localization on concave areas or hairy skin
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N Enrolled/Randomized/Analyzed 151
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149
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149
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... 3mm punch biopsy
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Preoperative assessment of clinical size of the tumor ... visual ...
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Percent non-primary (recurrent) 0
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Secondary size assessment In the PDT group, tumor thickness was retrospectively measured by an independent investigator on the initial diagnostic punch biopsy specimen, by using a microscope and a 0.1-mm precise liner. A total of 30 biopsy specimens (35%) was randomly reexamined by a pathologist whose measurements were compared with those of the investigator to confirm the accuracy.
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Baseline Characteristics
Question ALA-PDT Surgical excision Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 8.9 mm 9.3 mm 64.7
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4.0 mm 4.3 mm 13
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max diameter max diameter 9.1 mm
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64.0 65.1 4.1 mm
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24, 83 21, 91 max diameter
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21, 91
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Gender/Racial descent 40 44 74
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48.2 50 43.3
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lesions lesions lesions
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Lesion location 44 45 89
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53 51 52
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lesions lesions lesions
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rest of body n=39 (47%) lesions rest of body n=43 (49%) lesions 14.6
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lesions
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rest of body n=82 (48%) lesions
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 132
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lesions
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13
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lesions
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4
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lesions
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77.2
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7.6
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2.3
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 85 88 149
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83 88 173
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12
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22
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nine persons with 16 tumours died due to causes unrelated to the tumour or the treatment
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Lesion extent number of people 83 88 171
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lesions lesions lesions
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure ALA-PDT Surgical excision


3 months

N Analyzed 85 88
Counts 4 0


6 months

N Analyzed 83 88
Counts 11 0


12 months

N Analyzed 83 88
Counts 12 0


18 months

N Analyzed 83 88
Counts 16 0


24 months

N Analyzed 83 88
Counts 20 0


60 months

N Analyzed 83 88
Counts 23 0


96 months

N Analyzed 83 88
Counts 25 0
Outcome: Incomplete excision      Population: All Participants
Time Point Measure ALA-PDT Surgical excision


3 months

N Analyzed 83 88
Counts 0 2
Outcome: Long-term Mortality      Population: All Participants
Time Point Measure ALA-PDT Surgical excision


12 months

N Analyzed 85 88
Counts 6 9


24 months

N Analyzed 85 88
Counts 8 13


36 months

N Analyzed 85 88
Counts 13 18


60 months

N Analyzed 85 88
Counts 14 19
Outcome: Adverse events: other      Population: All Participants
Time Point Measure ALA-PDT Surgical excision


60 months

N Analyzed 85 88
Counts 1 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure ALA-PDT Surgical excision


60 months

N Analyzed 85 88
Counts 0 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure ALA-PDT Surgical excision


60 months

N Analyzed 85 88
Counts 0 0
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure ALA-PDT Surgical excision


60 months

N Analyzed 85 88
Counts 0 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes
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RCT:....Adequate allocation concealment reported Yes
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RCT:....Adequate blinding of PATIENTS reported No No blinding
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RCT:....Adequate blinding of PROVIDERS reported No No blinding
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No No blinding
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes 48 months >30% missingness
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ALL.....Selective Reporting (judgement - put directly into notes field). The lack of specificity in AE and baseline data reporting may suggest selective reporting
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RCT.....Is the treatment effect by Intention to treat? Yes
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ALL....Group similarity at baseline. Unsure Very few baseline details were given. Those that are given are similar.
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Population was not well described, so it is difficult to establish if there was any confounding
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No AEs were not defined
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Overall, by outcome (judgement - put directly into notes field) Overall moderate for early followup and high for later followup
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes 48 months differential
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Quality Rating
No quality rating data was found.