Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma

Results of two randomized studies

Peter Foley, Michael Freeman, Alan Menter, Gregory Siller, Rokea A. El-Azhary, Kurt Gebauer, Nicholas J. Lowe, Michael T. Jarratt, Dedee F. Murrell, Phoebe Rich, David M. Pariser, Allan R. Oseroff, Ross Barnetson, Christopher Anderson, Steven Kossard, Lawrence E. Gibson, Whitney D. Tope

Research output: Contribution to journalArticle

47 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1236-1245
Number of pages10
JournalInternational Journal of Dermatology
Volume48
Issue number11
DOIs
StatePublished - Nov 1 2009
Externally publishedYes

Fingerprint

Basal Cell Carcinoma
Photochemotherapy
Cosmetics
Placebos
Debridement
Therapeutics
Lighting
Double-Blind Method
1-phenyl-3,3-dimethyltriazene
Light
Neoplasms

ASJC Scopus subject areas

  • Dermatology

Cite this

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

In: International Journal of Dermatology, Vol. 48, No. 11, 01.11.2009, p. 1236-1245.

Research output: Contribution to journalArticle

Foley, P, Freeman, M, Menter, A, Siller, G, El-Azhary, RA, Gebauer, K, Lowe, NJ, Jarratt, MT, Murrell, DF, Rich, P, Pariser, DM, Oseroff, AR, Barnetson, R, Anderson, C, Kossard, S, Gibson, LE & Tope, WD 2009, 'Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma: Results of two randomized studies', International Journal of Dermatology, vol. 48, no. 11, pp. 1236-1245. https://doi.org/10.1111/j.1365-4632.2008.04022.x
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. / Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma : Results of two randomized studies. In: International Journal of Dermatology. 2009 ; Vol. 48, No. 11. pp. 1236-1245.
@article{e0b224a3cdb04be2991ea5d63806faf9,
title = "Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma: Results of two randomized studies",
abstract = "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.",
author = "Peter Foley and Michael Freeman and Alan Menter and Gregory Siller and El-Azhary, {Rokea A.} and Kurt Gebauer and Lowe, {Nicholas J.} and Jarratt, {Michael T.} and Murrell, {Dedee F.} and Phoebe Rich and Pariser, {David M.} and Oseroff, {Allan R.} and Ross Barnetson and Christopher Anderson and Steven Kossard and Gibson, {Lawrence E.} and Tope, {Whitney D.}",
year = "2009",
month = "11",
day = "1",
doi = "10.1111/j.1365-4632.2008.04022.x",
language = "English (US)",
volume = "48",
pages = "1236--1245",
journal = "International Journal of Dermatology",
issn = "0011-9059",
publisher = "Wiley-Blackwell",
number = "11",

}

TY - JOUR

T1 - Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma

T2 - Results of two randomized studies

AU - Foley, Peter

AU - Freeman, Michael

AU - Menter, Alan

AU - Siller, Gregory

AU - El-Azhary, Rokea A.

AU - Gebauer, Kurt

AU - Lowe, Nicholas J.

AU - Jarratt, Michael T.

AU - Murrell, Dedee F.

AU - Rich, Phoebe

AU - Pariser, David M.

AU - Oseroff, Allan R.

AU - Barnetson, Ross

AU - Anderson, Christopher

AU - Kossard, Steven

AU - Gibson, Lawrence E.

AU - Tope, Whitney D.

PY - 2009/11/1

Y1 - 2009/11/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=70449433090&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=70449433090&partnerID=8YFLogxK

U2 - 10.1111/j.1365-4632.2008.04022.x

DO - 10.1111/j.1365-4632.2008.04022.x

M3 - Article

VL - 48

SP - 1236

EP - 1245

JO - International Journal of Dermatology

JF - International Journal of Dermatology

SN - 0011-9059

IS - 11

ER -