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

Authors

  • Peter Foley MBBS, BMedSc, MD, FACD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Michael Freeman MBBS, FACD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Alan Menter MB, FAAD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Gregory Siller MBBS, FACD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Rokea A. El-Azhary MD, PhD, FAAD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Kurt Gebauer MBBS, FACD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Nicholas J. Lowe MD, FAAD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Michael T. Jarratt MD, FAAD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Dedee F. Murrell BMBCh, MD, FAAD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Phoebe Rich MD, FAAD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • David M. Pariser MD, FAAD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Allan R. Oseroff MD, PhD, FAAD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Ross Barnetson MD, FRACP, FACD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Christopher Anderson MBBS, FACD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Steven Kossard MBBS, FACD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Lawrence E. Gibson MD, FAAD,

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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  • Whitney D. Tope MPhIL, MD, FAAD

    1. From the Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Vic., Suite 5 ACH House, Benowa and Department of Dermatology, Princess Alexandra Hospital, Woolloongabba, Qld, Fremantle Dermatology, Fremantle, WA, and Department of Dermatology, St. George Hospital, University of New South Wales, Sydney, Department of Dermatology, Royal Prince Alfred Hospital, University of Sydney, Camperdown, Dermatology Center, Liverpool Hospital, Liverpool, and Skin and Cancer Foundation, Darlinghurst, New South Wales, Australia, and Baylor Dermatology Research Institute, Dallas, Texas, Mayo Clinic, Rochester, Minnesota, Clinical Research Specialists Inc., Santa Monica, California, DermResearch Inc., Austin, Texas, North-west Cutaneous Research Specialists, Portland, Oregon, Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc., Norfolk, Virginia, Department of Dermatology, Roswell Park Cancer Institute and University at Buffalo, Buffalo, New York, and Advancements in Dermatology, PA, Edina, Minnesota
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Peter Foley, mbbs, bmedsc, md, facd Department of Medicine (Dermatology) The University of Melbourne
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy 3065
Vic. Australia
E-mail: peter.foley@svhm.org.au

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.

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