Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma: results of two randomized studies

• Published in: International journal of dermatology 2009-11, Vol.48 (11), p.1236-1245
• Main Authors: Foley, Peter, Freeman, Michael, Menter, Alan, Siller, Gregory, El-Azhary, Rokea A., Gebauer, Kurt, Lowe, Nicholas J., Jarratt, Michael T., Murrell, Dedee F., Rich, Phoebe, Pariser, David M., Oseroff, Allan R., Barnetson, Ross, Anderson, Christopher, Kossard, Steven, Gibson, Lawrence E., Tope, Whitney D.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Aminolevulinic Acid - adverse effects; Aminolevulinic Acid - analogs & derivatives; Aminolevulinic Acid - therapeutic use; Biological and medical sciences; Carcinoma, Basal Cell - drug therapy; Carcinoma, Basal Cell - pathology; Dermatology; Diseases of the skin. Cosmetics; Female; Follow-Up Studies; Humans; Male; Medical sciences; Middle Aged; Photochemotherapy - adverse effects; Photochemotherapy - methods; Photosensitizing Agents - adverse effects; Photosensitizing Agents - therapeutic use; Prospective Studies; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Skin Neoplasms - drug therapy; Skin Neoplasms - pathology; Treatment Outcome; Tumors of the skin and soft tissue. Premalignant lesions
• ISSN: 0011-9059; 1365-4632
• DOI: 10.1111/j.1365-4632.2008.04022.x

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 (≤ 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/cm2, 570–670 nm). This was repeated 7 days later. Lesions with a partial response (≥ 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. Conclusion  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.