Photodynamic therapy using topical methyl aminolevulinate vs surgery for nodular basal cell carcinoma: results of a multicenter randomized prospective trial.
BACKGROUND
Photodynamic therapy (PDT) is increasingly used as a noninvasive treatment for nodular basal cell carcinoma (BCC), without a sound evidence base.


OBJECTIVE
To compare topical PDT, with the use of the sensitizer methyl aminolevulinate, and standard excision surgery in nodular BCC.


METHODS
Prospective, randomized study.


METHODS
University dermatology departments.


METHODS
A total of 101 adults with previously untreated nodular BCC.


METHODS
Patients received methyl aminolevulinate PDT (n = 52) or surgery (n = 49). The PDT was given twice, 7 days apart, with methyl aminolevulinate cream (160 mg/g) and 75 J/cm(2) red light (570-670 nm). Thirteen patients with a noncomplete response to PDT at 3 months (24% lesions) were retreated.


METHODS
Primary end point was clinically assessed lesion clearance at 3 months after treatment. Secondary end points were sustained response rate at 12 months and cosmetic outcome at 3 and 12 months. Cosmesis and lesion recurrence were further assessed at 24 months.


RESULTS
Data from 97 patients (105 lesions) were included in the 3-month per-protocol analysis. Complete response rates did not differ significantly between groups (51/52 [98%] lesions with surgery vs 48/53 [91%] lesions with methyl aminolevulinate PDT; difference [95% confidence interval], 4.8% (-3.4% to 13.0%]; P =.25). At 12 months, tumor-free rates were 50 (96%) of 52 lesions with surgery vs 44 (83%) of 53 with methyl aminolevulinate PDT (P =.15). More patients treated with methyl aminolevulinate PDT than surgery had an excellent or good cosmetic outcome at all time points (significant at 12 and 24 months on patient assessment, P<.05, and at 3, 12, and 24 months on investigator evaluation, P<.001). At 24 months, 5 lesions that had initially cleared with methyl aminolevulinate PDT had recurred, compared with 1 after surgery.


CONCLUSIONS
Methyl aminolevulinate PDT is an effective treatment for nodular BCC, and while there is a trend for higher recurrence with this modality, it conveys the advantage over surgery of better cosmesis.
Rhodes
Lesley E
LE
Department of Dermatology, Royal Liverpool University Hospital, Liverpool, England.
de Rie
Menno
M
Enström
Ylva
Y
Groves
Richard
R
Morken
Tore
T
Goulden
Victoria
V
Wong
Gavin A E
GA
Grob
Jean-Jacques
JJ
Varma
Sandeep
S
Wolf
Peter
P
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010778:Photochemotherapy / Q000009:adverse effects; D017319:Photosensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000601:surgery*
D009824:Ointments; D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid