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Study Title and Description

Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial.
Author Arits AH., Mosterd K., Essers BA., Spoorenberg E., Sommer A., De Rooij MJ., van Pelt HP., Quaedvlieg PJ., Krekels GA., van Neer PA., Rijzewijk JJ., van Geest AJ., Steijlen PM., Nelemans PJ., Kelleners-Smeets NW.
Country Department of Dermatology, Maastricht University Medical Centre, Maastricht, Netherlands. a.arits@MUMC.nl
Year 2013
Numbers Pubmed ID: 23683751

Secondary Publication Information
UI Title Author Country Year
Photodynamic therapy vs. topical imiquimod for treatment of superficial basal cell carcinoma: a subgroup analysis within a noninferiority randomized controlled trial. Roozeboom MH., Nelemans PJ., Mosterd K., Steijlen PM., Arits AH., Kelleners-Smeets NW. Department of Dermatology, Maastricht University Medical Centre, P. Debyelaan 25, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands. 2015
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Three-Year Follow-Up Results of Photodynamic Therapy vs. Imiquimod vs. Fluorouracil for Treatment of Superficial Basal Cell Carcinoma: A Single-Blind, Noninferiority, Randomized Controlled Trial. Roozeboom MH., Arits AH., Mosterd K., Sommer A., Essers BA., de Rooij MJ., Quaedvlieg PJ., Steijlen PM., Nelemans PJ., Kelleners-Smeets NW. Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands. Electronic address: mh.roozeboom@mumc.nl. 2016
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Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 MAL-PDT
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2 Imiquimod
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3 Fluorouacil
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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 Netherlands
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Funding No industry support
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Inclusion criteria 1 primary, histologically proven superficial basal-cell carcinoma per patient
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Exclusion criteria using immunosuppressive drugs, had genetic skin cancer disorders, if the tumour was located in the H zone (high-risk area of face) or scalp, or were breastfeeding or pregnant
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N Enrolled/Randomized/Analyzed 601
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601
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583
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... 3 mm punch biopsy and was assessed by various dermatopathologists at the participating hospitals until a consensus on the defi nition of a superfi cial basal-cell carcinoma was reached. It was defi ned as an epidermal tumour existing of small, discrete islands of basaloid cells with peripheral palisading and stromal retraction, presenting intermittently along the basal layer of the epidermis
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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 MAL-PDT Imiquimod Fluorouacil Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 63 62 64
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26, 87 30, 91 35, 86
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Gender/Racial descent 106 97 95
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52 49 47
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Lesion location 24 23 31
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12 12 15
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head/neck excluding H-zone head/neck excluding H-zone head/neck excluding H-zone
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59 54 50
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29 27 24
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119 121 120
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59 61 60
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trunk only trunk only trunk only
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upper extremities 32 (16%) lower extremities 27 (13%) upper extremities 26 (13%) lower extremities 28 (14%) upper extremities 27 (13%) lower extremities 23 (11%)
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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 202 198 201
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202 198 201
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6 9 3
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6 9 3
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2 refused treatment, 2 died, 2 did not attend fiollowup appointment 3 died, 2 refused treatment, 1 refused followup, 3 unresponsive on call 2 unresponsive on call, 1 withdrew
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196 189 198
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196 189 198
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Lesion extent number of people 100 100 100
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100 100 100
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an epidermal tumour existing of small, discrete islands of basaloid cells with peripheral palisading and stromal retraction, presenting intermittently along the basal layer of the epidermis an epidermal tumour existing of small, discrete islands of basaloid cells with peripheral palisading and stromal retraction, presenting intermittently along the basal layer of the epidermis an epidermal tumour existing of small, discrete islands of basaloid cells with peripheral palisading and stromal retraction, presenting intermittently along the basal layer of the epidermis
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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 MAL-PDT Imiquimod Fluorouacil


3 months

N Analyzed 196 189 198
Counts 31 19 24


1 years

N Analyzed 156 165 169
Counts 21 12 15


3 years

N Analyzed 126 145 146
Counts 10 2 8
Outcome: Lack of histological clearance      Population: Male
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 93 97
Counts 23 22
Outcome: Lack of histological clearance      Population: Female
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 103 92
Counts 29 9
Outcome: Lack of histological clearance      Population: <= 60 years old
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 81 77
Counts 25 8
Outcome: Lack of histological clearance      Population: >60 years old
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 115 112
Counts 27 23
Outcome: Lack of histological clearance      Population: Tumor on head/neck
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 24 20
Counts 9 4
Outcome: Lack of histological clearance      Population: Tumor on upper extremities
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 31 25
Counts 5 3
Outcome: Lack of histological clearance      Population: Tumor on lower extremities
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 26 28
Counts 2 6
Outcome: Lack of histological clearance      Population: Tumor on trunk
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 115 116
Counts 36 12
Outcome: Lack of histological clearance      Population: Tumor size <= 60 mm2
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 106 90
Counts 23 18
Outcome: Lack of histological clearance      Population: Tumor size > 60 mm2
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 86 96
Counts 27 12
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 years

N Analyzed 186 184 193
Counts 116 113 111
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure MAL-PDT Imiquimod Fluorouacil


1 weeks

N Analyzed 191 189 192
Counts 23 6 3


2 weeks

N Analyzed 150 189 192
Counts 27 9 14


3 weeks

N Analyzed 186 192
Counts 16 17


4 weeks

N Analyzed 186 184
Counts 21 23
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure MAL-PDT Imiquimod Fluorouacil


4 weeks

N Analyzed 196 189 198
Counts 0 9 4
Outcome: Adverse event: infection      Population: All Participants
Time Point Measure MAL-PDT Imiquimod Fluorouacil


4 weeks

N Analyzed 196 189 198
Counts 0 1 2
Outcome: Long-term Mortality      Population: All Participants
Time Point Measure MAL-PDT Imiquimod Fluorouacil


3 years

N Analyzed 196 189 198
Counts 5 4 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 patients were not blinded
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RCT:....Adequate blinding of PROVIDERS reported No caregivers were not blinded
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Yes all outcome assessors (except for AEs, which were assessed by patients) were blinded
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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). No
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RCT.....Is the treatment effect by Intention to treat? Yes
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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) Overall low RoB, Seems like a fairly good 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.