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Photodynamic therapy vs. cryosurgery of basal cell carcinomas: results of a phase III clinical trial

Wang, I.; Bendsöe, Niels LU ; Klinteberg, C.A.F.; Enejder, A.M.K.; Andersson-Engels, Stefan LU ; Svanberg, Sune LU and Svanberg, Katarina LU (2001) In British Journal of Dermatology 144(4). p.832-840
Abstract
Background A previously reported randomized clinical trial showed treatment of Bowen's disease using photodynamic therapy (PDT) with topically applied delta -aminolaevulinic acid (ALA) to be at least as effective as cryosurgery and to be associated with fewer adverse effects. Objectives To compare ALA-PDT and cryotherapy in the treatment of histopathologically verified basal cell carcinomas (BCCs) in a non-blinded, prospective phase III clinical trial. Methods One lesion from each of 88 patients was included. The BCCs were divided into superficial and nodular lesions. The follow-up period was restricted to 1 year with close follow-up for the first 3 months. Efficacy was assessed as the recurrence rate 12 months after the first treatment... (More)
Background A previously reported randomized clinical trial showed treatment of Bowen's disease using photodynamic therapy (PDT) with topically applied delta -aminolaevulinic acid (ALA) to be at least as effective as cryosurgery and to be associated with fewer adverse effects. Objectives To compare ALA-PDT and cryotherapy in the treatment of histopathologically verified basal cell carcinomas (BCCs) in a non-blinded, prospective phase III clinical trial. Methods One lesion from each of 88 patients was included. The BCCs were divided into superficial and nodular lesions. The follow-up period was restricted to 1 year with close follow-up for the first 3 months. Efficacy was assessed as the recurrence rate 12 months after the first treatment session, verified by histopathology. Tolerability was evaluated as the time of healing, pain and discomfort during and after the treatment, and final cosmetic outcome. Results Histopathologically verified recurrence rates in the two groups were statistically comparable and were 25% (11 of 44) for ALA-PDT and 15% (six of 39) for cryosurgery. However, clinical recurrence rates were only 5% (two of 44) for PDT and 13% (five of 39) for cryosurgery. Additional treatments, usually one, had to be performed in 30% of the lesions in the PDT group, The healing time was considerably shorter and the cosmetic outcome significantly better with PDT. Pain and discomfort during the treatment session and in the following week were low, and were equivalent with the two treatment modalities. Conclusions In terms of efficacy, ISLA-PDT is comparable with cryosurgery as a treatment modality for BCCs. Retreatments are more often required with PDT than with cryosurgery, This can easily be performed due to the shorter healing time, less scarring and better cosmetic outcome that follows ALA-PDT. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
basal cell carcinoma, cryosurgery, δ-aminolaevulinic acid, photodynamic therapy, protoporphyrin IX, randomized controlled trial
in
British Journal of Dermatology
volume
144
issue
4
pages
832 - 840
publisher
Wiley-Blackwell
external identifiers
  • wos:000168274900022
  • scopus:0035029453
ISSN
1365-2133
DOI
10.1046/j.1365-2133.2001.04141.x
language
English
LU publication?
yes
id
b21e3e2c-aae6-4ecb-b345-92e081bc2e02 (old id 1119286)
date added to LUP
2008-07-17 11:01:38
date last changed
2018-03-18 03:46:22
@article{b21e3e2c-aae6-4ecb-b345-92e081bc2e02,
  abstract     = {Background A previously reported randomized clinical trial showed treatment of Bowen's disease using photodynamic therapy (PDT) with topically applied delta -aminolaevulinic acid (ALA) to be at least as effective as cryosurgery and to be associated with fewer adverse effects. Objectives To compare ALA-PDT and cryotherapy in the treatment of histopathologically verified basal cell carcinomas (BCCs) in a non-blinded, prospective phase III clinical trial. Methods One lesion from each of 88 patients was included. The BCCs were divided into superficial and nodular lesions. The follow-up period was restricted to 1 year with close follow-up for the first 3 months. Efficacy was assessed as the recurrence rate 12 months after the first treatment session, verified by histopathology. Tolerability was evaluated as the time of healing, pain and discomfort during and after the treatment, and final cosmetic outcome. Results Histopathologically verified recurrence rates in the two groups were statistically comparable and were 25% (11 of 44) for ALA-PDT and 15% (six of 39) for cryosurgery. However, clinical recurrence rates were only 5% (two of 44) for PDT and 13% (five of 39) for cryosurgery. Additional treatments, usually one, had to be performed in 30% of the lesions in the PDT group, The healing time was considerably shorter and the cosmetic outcome significantly better with PDT. Pain and discomfort during the treatment session and in the following week were low, and were equivalent with the two treatment modalities. Conclusions In terms of efficacy, ISLA-PDT is comparable with cryosurgery as a treatment modality for BCCs. Retreatments are more often required with PDT than with cryosurgery, This can easily be performed due to the shorter healing time, less scarring and better cosmetic outcome that follows ALA-PDT.},
  author       = {Wang, I. and Bendsöe, Niels and Klinteberg, C.A.F. and Enejder, A.M.K. and Andersson-Engels, Stefan and Svanberg, Sune and Svanberg, Katarina},
  issn         = {1365-2133},
  keyword      = {basal cell carcinoma,cryosurgery,δ-aminolaevulinic acid,photodynamic therapy,protoporphyrin IX,randomized controlled trial},
  language     = {eng},
  number       = {4},
  pages        = {832--840},
  publisher    = {Wiley-Blackwell},
  series       = {British Journal of Dermatology},
  title        = {Photodynamic therapy vs. cryosurgery of basal cell carcinomas: results of a phase III clinical trial},
  url          = {http://dx.doi.org/10.1046/j.1365-2133.2001.04141.x},
  volume       = {144},
  year         = {2001},
}