Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma: results of two randomized studies.
BACKGROUND
Data suggest that photodynamic therapy using topical methyl aminolevulinate (MAL PDT) may be a noninvasive alternative to excisional surgery for nodular basal cell carcinoma (BCC). In the studies described here, we investigated the histologic response, tolerability, and cosmetic outcome with MAL PDT for primary nodular BCC (<or= 5 mm in depth).


METHODS
Two multicenter, randomized, double-blind studies with similar design and procedures were conducted. After surface debridement and minor tumor debulking, MAL cream 160 mg/g (66 patients with 75 lesions) or placebo cream (65 patients with 75 lesions) was applied for 3 h, followed by illumination with broad-spectrum red light (75 J/cm(2), 570-670 nm). This was repeated 7 days later. Lesions with a partial response (>or= 50% reduction in greatest diameter) at 3 months were re-treated (21%). Treatment sites were excised at 3 months (clinical nonresponders) or 6 months (clinical responders) after the last treatment.


RESULTS
Histologically verified lesion complete response rates were higher with MAL PDT than with placebo [73% (55/75) vs. 27% (20/75)]. Treatment was most effective for facial lesions (89% complete response). Cosmetic outcome was good or excellent in 98% of evaluable, completely responding lesions treated with MAL PDT.


CONCLUSIONS
Although longer follow-up studies are required, these promising data indicate the potential of topical MAL PDT as a noninvasive treatment alternative for nodular BCC.
Foley
Peter
P
Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia. peter.foley@svhm.org.au
Freeman
Michael
M
Menter
Alan
A
Siller
Gregory
G
El-Azhary
Rokea A
RA
Gebauer
Kurt
K
Lowe
Nicholas J
NJ
Jarratt
Michael T
MT
Murrell
Dedee F
DF
Rich
Phoebe
P
Pariser
David M
DM
Oseroff
Allan R
AR
Barnetson
Ross
R
Anderson
Christopher
C
Kossard
Steven
S
Gibson
Lawrence E
LE
Tope
Whitney D
WD
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid