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Study Title and Description

Photodynamic therapy using topical methyl aminolevulinate vs surgery for nodular basal cell carcinoma: results of a multicenter randomized prospective trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Photodynamic therapy using topical methyl aminolevulinate vs surgery for nodular basal cell carcinoma: results of a multicenter randomized prospective trial.
Author Rhodes LE., de Rie M., Enström Y., Groves R., Morken T., Goulden V., Wong GA., Grob JJ., Varma S., Wolf P.
Country Department of Dermatology, Royal Liverpool University Hospital, Liverpool, England.
Year 2004
Numbers Pubmed ID: 14732655

Secondary Publication Information
UI Title Author Country Year
Five-year follow-up of a randomized, prospective trial of topical methyl aminolevulinate photodynamic therapy vs surgery for nodular basal cell carcinoma. Rhodes LE., de Rie MA., Leifsdottir R., Yu RC., Bachmann I., Goulden V., Wong GA., Richard MA., Anstey A., Wolf P. Photobiology Unit, Department of Dermatology, University of Manchester, Salford Royal Foundation Hospital, Manchester M6 8HD, England. lesley.e.rhodes@manchester.ac.uk 2007
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Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 MAL PDT
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2 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. Multicenter
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Country/Region Europe
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Funding Industry funded
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Inclusion criteria >= 18 years with perviously untreated primary nodular BCC suitable for simple excision surgery
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Exclusion criteria > 10 eligible lesions; lesions in midface region, orbital areas, or ears; <6mm or >15mm in diameter (face and scalp), > 20mm (extremities or neck), >30mm (trunk); pigmented or morpheaform BCCs; polyphyria; Gorlin syndrome; history of arsenic exposure; in another study in past 30 days; likely to be poor compliers; taking immunosuppresive medication; pregnant or breasfeeding
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N Enrolled/Randomized/Analyzed 103
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103
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101
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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 ... visual ...
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question MAL PDT excision Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 69 67
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40, 95 38, 82
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longest lesion diameter 5-14mm 42/52; 15-19 11/52; 20-30mm 2/52 longest lesion diameter 5-14mm 44/49; 15-19 6/49; 20-30mm 3/49
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Gender/Racial descent 20 20
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38 41
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Lesion location 22 32
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40 58
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face/scalp face/scalp
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6 5
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11 9
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27 16
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49 29
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Skin type (Fitzpatrick score) 4 4
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8 8
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26 21
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50 43
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21 21
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40 43
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1 3
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2 6
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Number of lesions per patient 49 43
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94 88
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3 6
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6 12
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 53 50
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60 58
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52 49
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55 55
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2 2
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2 3
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1 protocol deviation; 1 adverse event 1 consent withdrawn; 1 death
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50 47
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53 52
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Lesion extent number of people 52 (100%) 49 (100%)
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 53 (50) 52 (47)
Counts 5 (5) 1 (1)
Outcome: Lack of clinical clearance      Population: face/scalp
Time Point Measure MAL PDT excision


3 months

N Analyzed 21 32
Counts 1 1
Outcome: Lack of clinical clearance      Population: trunk/neck
Time Point Measure MAL PDT excision


3 months

N Analyzed 27 15
Counts 4 0
Outcome: Lack of clinical clearance      Population: extremity
Time Point Measure MAL PDT excision


3 months

N Analyzed 5 5
Counts 0 0
Outcome: Lack of clinical clearance      Population: diameter 6-14mm
Time Point Measure MAL PDT excision


3 months

N Analyzed 40 43
Counts 4 1
Outcome: Lack of clinical clearance      Population: diameter 15-19mm
Time Point Measure MAL PDT excision


3 months

N Analyzed 11 6
Counts 1 0
Outcome: Lack of clinical clearance      Population: diameter 20-30mm
Time Point Measure MAL PDT excision


3 months

N Analyzed 2 3
Counts 0 0
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure MAL PDT excision


1 years

N Analyzed 46 (43) 50 (45)
Counts 2 0


2 years

N Analyzed 35 (34) 45 (41)
Counts 3 1


3 years

N Analyzed 35 (34) 45 (41)
Counts 2 0


4 years

N Analyzed 35 (34) 45 (41)
Counts 0 1


5 years

N Analyzed (31) (35)
Counts 0 0
Outcome: Recurrence or relapse      Population: diameter <= 10mm
Time Point Measure MAL PDT excision


1 years

N Analyzed (29) (34)
Counts 1 0


2 years

N Analyzed (29) (29)
Counts 3 0


3 years

N Analyzed (29) (29)
Counts 1 0


4 years

N Analyzed (29) (29)
Counts 0 0


5 years

N Analyzed (29) (29)
Counts 0 0
Outcome: Recurrence or relapse      Population: diameter 10-20mm
Time Point Measure MAL PDT excision


1 years

N Analyzed (19) (14)
Counts 1 0


2 years

N Analyzed (19) (14)
Counts 0 0


3 years

N Analyzed (19) (14)
Counts 1 1


4 years

N Analyzed (19) (14)
Counts 0 1


5 years

N Analyzed (19) (14)
Counts 0 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 44 45
Counts 36 15


1 years

N Analyzed 42 45
Counts 33 17


2 years

N Analyzed 29 39
Counts 24 16


5 years

N Analyzed 31 35
Counts 27 19
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 41 44
Counts 39 37


1 years

N Analyzed 42 43
Counts 41 36


2 years

N Analyzed 29 36
Counts 28 27
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 52 49
Counts 52 29
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 52 49
Counts 7 3
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 52 49
Counts 31 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 52 49
Counts 7 1
Outcome: Adverse event: infection      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 52 49
Counts 0 3
Outcome: Adverse events: other      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 52 49
Counts 2 0
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 52 49
Counts 2 0
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure MAL PDT excision


3 months

N Analyzed 60 58
Counts 1 0
Outcome: Long-term Mortality      Population: All Participants
Time Point Measure MAL PDT excision


2 years

N Analyzed 50 46
Counts 2 2


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
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RCT:....Adequate blinding of PROVIDERS reported No
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No could lead to bias as lack of cure was established clinically and both investigators and patients assessed cosmetic outcomes
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes No for the early followup; yes for followup beyond 1 year
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ALL.....Selective Reporting (judgement - put directly into notes field). hard to tell
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RCT.....Is the treatment effect by Intention to treat? No per protocol analysis was done. The authors state that an ITT analysis was nearly identical
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ALL....Group similarity at baseline. No location of lesions differed significantly; this matters because a subgroup analysis by location of lesion was done
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) The 5 year paper did not match the reporting of the original paper, either in numbers or subgroup definitions
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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 high RoB, especially given that the funding came from a PDT source
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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.