Five-Year Follow-up of a Randomized, Prospective Trial of Topical Methyl Aminolevulinate Photodynamic Therapy vs Surgery for Nodular Basal Cell Carcinoma
Abstract
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. DESIGN: Prospective, randomized, multicenter study. SETTING: University hospital dermatology departments. PATIENTS: 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. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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.
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Several studies have shown that PDT results in superior cosmetic outcomes compared to surgical treatment.
“Several studies have shown that PDT results in superior cosmetic outcomes compared to surgical treatment.”
From Photodynamic Therapy for Non-Melanoma Skin Cancers (2016) · cites this paper as [51]
MAL PDT is a more effective treatment option than ALA PDT for nodular BCC.
“Methylaminolevulinate (MAL) PDT is a more effective treatment option than 5-aminolevulinic acid (ALA) PDT for nodular BCC.”
From Photodynamic Therapy for Non-Melanoma Skin Cancers (2016) · cites this paper as [51]
MAL/PDT showed a 14% recurrence rate for treatment of nodular BCC in another study.
“MAL/PDT showed a 14% recurrence rate for treatment of nodular BCC in another study [51].”
From Photodynamic Therapy for Non-Melanoma Skin Cancers (2016) · cites this paper as [51]
Compared to surgical excision, PDT appears to result in higher BCC recurrence rates.
“Compared to surgical excision, PDT appears to result in higher BCC recurrence rates [42,47,51,52,54].”
From Photodynamic Therapy for Non-Melanoma Skin Cancers (2016) · cites this paper as [51]
Rhodes et al. found the recurrence rate for primary nodular BCC to be 14% with PDT and 4% with surgical excision at the 5-year follow-up point.
“Rhodes et al. found the recurrence rate for primary nodular BCC to be 14% with PDT and 4% with surgical excision at the 5-year follow-up point [51].”
From Photodynamic Therapy for Non-Melanoma Skin Cancers (2016) · cites this paper as [51]
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- Authors
- Rhodes, L. E., de Rie, M. A., Leifsdottir, R., Yu, R. C., Bachmann, I., Goulden, V., Wong, G. A. E., Richard, M.-A., Anstey, A., & Wolf, P.
- Affiliations
- University of Manchester (GB)
- Venue
- Archives of Dermatology
- Publisher
- American Medical Association (AMA)
- Published
- 2007-09-01
- Volume
- 143
- Issue
- 9
- Pages
- 1131-6
- ISSN
- 0003-987X (ISSN-L)
- OpenAlex
- W2026103783
- Cited by
- 275
- References
- 13
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 10 · 2023: 9 · 2022: 13 · 2021: 8 · 2020: 17 · 2019: 16 · 2018: 19 · 2017: 9 · 2016: 17 · 2015: 18 · 2014: 13 · 2013: 18 · 2012: 18
- FWCI
- 11.47
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Dermatology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Research Explorer (The University of Manchester) (submittedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Nonmelanoma Skin Cancer Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Photodynamic Therapy Research Studies
- Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
- Keywords
- surgical excision, lesion recurrence, complete response rate, cosmetic outcome, long-term follow-up, skin cancer treatment, red light illumination, per-protocol analysis, histological recurrence, treatment efficacy comparison, patient satisfaction with treatment outcomes
- MeSH terms
- Administration, Topical, Aged, Aged, 80 and over, Aminolevulinic Acid, Basal Cell Carcinoma, Female, Follow-Up Studies, Humans, Male, Neoplasm Recurrence, Local, Ointments, Photochemotherapy, Skin Neoplasms, Photosensitizing Agents
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