Five-year follow-up of a randomized, prospective trial of topical methyl aminolevulinate photodynamic therapy vs surgery for nodular basal cell carcinoma.
OBJECTIVE
To compare 5-year lesion recurrence rates in primary nodular basal cell carcinoma treated with topical methyl aminolevulinate photodynamic therapy (PDT) or simple excision surgery.


METHODS
Prospective, randomized, multicenter study.


METHODS
University hospital dermatology departments.


METHODS
A total of 97 patients, 50 with 53 lesions treated with methyl aminolevulinate PDT and 47 with 52 lesions treated by excision surgery, were included in the per protocol analysis. Of the lesions treated with methyl aminolevulinate PDT and surgery, 49 and 52, respectively, showed complete clinical response at 3 months after treatment and were observed for long-term outcome evaluation.


METHODS
Topical methyl aminolevulinate cream, 160 mg/g, applied for 3 hours before illumination (75 J/cm(2) of red light at 570 to 670 nm) on 2 or 4 occasions (12 [23%] of 53 lesions); or excision surgery.


METHODS
Histologically confirmed lesion recurrence, sustained lesion complete response rate (time-to-event analysis), and investigator assessment of cosmetic outcome, 5 years after the last treatment.


RESULTS
At 5 years, recurrence was documented in 7 (14%) of 49 lesions (95% confidence interval [CI], 6%-27%) treated with methyl aminolevulinate PDT vs 2 (4%) of 52 lesions (95% CI, 1%-13%) treated with excision surgery (P = .09). Estimated sustained lesion complete response rates were 76% (95% CI, 59%-87%) and 96% (95% CI, 84%-99%), respectively (P = .01). More patients treated with methyl aminolevulinate PDT than surgery had an excellent or good cosmetic outcome: 27 (87%) of 31 patients (95% CI, 70%-96%) vs 19 (54%) of 35 patients (95% CI, 37%-71%) (P = .007).


CONCLUSIONS
Long-term follow-up indicates superior efficacy of surgery to methyl aminolevulinate PDT in nodular basal cell carcinoma. However, methyl aminolevulinate PDT is also an effective treatment for this indication and exhibits a more favorable cosmetic outcome.
Rhodes
Lesley E
LE
Photobiology Unit, Department of Dermatology, University of Manchester, Salford Royal Foundation Hospital, Manchester M6 8HD, England. lesley.e.rhodes@manchester.ac.uk
de Rie
Menno A
MA
Leifsdottir
Ragna
R
Yu
Raymond C
RC
Bachmann
Ingeborg
I
Goulden
Victoria
V
Wong
Gavin A E
GA
Richard
Marie-Aleth
MA
Anstey
Alex
A
Wolf
Peter
P
D000287:Administration, Topical; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local; D009824:Ointments; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000601:surgery*
D009824:Ointments; D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid