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Photodynamic Therapy Using Topical Methyl Aminolevulinate Vs Surgery for Nodular Basal Cell Carcinoma Results of a Multicenter Randomized Prospective Trial

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Photodynamic Therapy Using Topical Methyl Aminolevulinate Vs Surgery for Nodular Basal Cell Carcinoma Results of a Multicenter Randomized Prospective Trial STUDY Photodynamic Therapy Using Topical Methyl Aminolevulinate vs Surgery for Nodular Basal Cell Carcinoma Results of a Multicenter Randomized Prospective Trial Lesley E. Rhodes, MD, FRCP; Menno de Rie, MD; Ylva Enstro¨m, MD; Richard Groves, FRCP; Tore Morken, MD; Victoria Goulden, MRCP; Gavin A. E. Wong, MRCP; Jean-Jacques Grob, MD; Sandeep Varma, MRCP; Peter Wolf, MD Background: Photodynamic therapy (PDT) is increas- Cosmesis and lesion recurrence were further assessed at ingly used as a noninvasive treatment for nodular basal 24 months. cell carcinoma (BCC), without a sound evidence base. Results: Data from 97 patients (105 lesions) were in- Objective: To compare topical PDT, with the use of the cluded in the 3-month per-protocol analysis. Complete sensitizer methyl aminolevulinate, and standard exci- response rates did not differ significantly between groups sion surgery in nodular BCC. (51/52 [98%] lesions with surgery vs 48/53 [91%] le- sions with methyl aminolevulinate PDT; difference [95% Design: Prospective, randomized study. confidence interval], 4.8% (−3.4% to 13.0%]; P=.25). At 12 months, tumor-free rates were 50 (96%) of 52 le- Setting: University dermatology departments. sions with surgery vs 44 (83%) of 53 with methyl ami- nolevulinate PDT (P=.15). More patients treated with Patients: A total of 101 adults with previously un- methyl aminolevulinate PDT than surgery had an excel- treated nodular BCC. lent or good cosmetic outcome at all time points (sig- nificant at 12 and 24 months on patient assessment, Interventions: Patients received methyl aminolevuli- PϽ.05, and at 3, 12, and 24 months on investigator evalu- nate PDT (n=52) or surgery (n=49). The PDT was given ation, PϽ.001). At 24 months, 5 lesions that had ini- twice, 7 days apart, with methyl aminolevulinate cream tially cleared with methyl aminolevulinate PDT had re- (160 mg/g) and 75 J/cm2 red light (570-670 nm). Thir- curred, compared with 1 after surgery. teen patients with a noncomplete response to PDT at 3 months (24% lesions) were retreated. Conclusions: Methyl aminolevulinate PDT is an effec- tive treatment for nodular BCC, and while there is a trend Outcome Measures: Primary end point was clini- for higher recurrence with this modality, it conveys the cally assessed lesion clearance at 3 months after treat- advantage over surgery of better cosmesis. ment. Secondary end points were sustained response rate at 12 months and cosmetic outcome at 3 and 12 months. Arch Dermatol. 2004;140:17-23 KIN CANCER IS THE MOST sue invasion and destruction is signifi- common cancer in white cant. Simple surgical excision is regarded populations, with an esti- as the treatment of choice for BCCs of the mated incidence of 1100 per nodular type5,6; however, cosmetic out- 1 million population per year come may be less than optimal. in northwest Europe,1 and twice and 10 Photodynamic therapy (PDT) offers S 2 times this number in the United States and the advantages over surgery of being a non- invasive procedure causing minimal dam- See also pages 26, 33, age to surrounding tissue, because of rela- tively selective uptake of photosensitizer 41, and 116 by malignant cells. Activation by visible CME course available at light releases reactive oxygen species that www.archdermatol.com produce local tissue destruction.7 Topi- cal PDT has been increasingly practiced 3 Author affiliations are listed Australia, respectively. Moreover, the in- since the description of 5-aminolevulinic 4 at the end of this article. cidence continues to rise. Basal cell car- acid, a precursor in heme biosynthesis, as The authors have no relevant cinoma (BCC) is the most frequent form, prodrug.8 Application of excess 5-ami- financial interest in this article. and the morbidity associated with local tis- nolevulinic acid results in buildup of pho- (REPRINTED) ARCH DERMATOL / VOL 140, JAN 2004 WWW.ARCHDERMATOL.COM 17 ©2004 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/29/2021 toactive porphyrins including protoporphyrin IX. Any ficient to cause pain or bleeding. A 1-mm-thick layer of methyl protoporphyrin IX formed, or remaining, after light ex- aminolevulinate cream was applied to each lesion and 5 mm posure is metabolized within 48 hours. Ease of applica- of surrounding tissue and covered with an adhesive occlusive tion of 5-aminolevulinic acid PDT has resulted in its wide- dressing (eg, Tegaderm; 3M Corp, St Paul, Minn) for 3 hours. spread use in several countries, without license, and in Dressings were then removed and the cream was washed off with 0.9% saline solution, immediately before illumination with the absence of randomized prospective trials with stan- 9 noncoherent red light from a standard light source (Cure- dard surgical treatment. Large series of BCCs treated with light; PhotoCure ASA), with emission spectrum of 570 to 670 5-aminolevulinic acid PDT show complete response rates nm, total fluence of 75 J/cm2, and fluence rate of 50 to 200 mW/ of 34% to 100%, with inferior clearance in nodular com- cm2. Fluence rate depended on distance of the lamp from the pared with superficial BCC.10 Routine double PDT treat- lesion, which was adjusted to achieve field sizes 3.5 to 5.5 cm ment may improve procedure efficacy.11 in diameter, as appropriate. Simple elliptical excision surgery Methyl aminolevulinate, the methyl ester of 5-ami- with at least 5-mm margins was performed with the patient un- nolevulinic acid, may offer advantages over 5-aminolevu- der local anesthesia in accordance with the usual practice of linic acid in terms of improved skin penetration be- the center. cause of enhanced lipophilicity12,13 and specificity for neoplastic cells.14 Initial experience suggests that methyl END POINT ASSESSMENTS aminolevulinate PDT is a promising treatment for BCC.15 At 3 months after the initial treatment, lesions were evaluated The aim of this first multicenter, randomized, parallel- by clinical inspection by the same investigator and rated as either group, prospective study was to compare the efficacy and complete response, ie, complete disappearance of the lesion, or cosmetic outcome of topical methyl aminolevulinate PDT noncomplete response, ie, noncomplete disappearance of the le- with standard simple excision surgery in primary nodu- sion. Lesions with noncomplete response to PDT at 3 months lar BCC. received a second treatment cycle and were reevaluated 3 months later. Further treatment of patients who did not show complete response to surgery at 3 months depended on the standard prac- METHODS tice of the center concerned. Investigator-assessed cosmetic out- come was evaluated 3 months after surgery or the last PDT treat- PATIENTS ment (ie, at 3 months for patients who required 1 PDT cycle and 6 months for patients who required 2 PDT cycles), in all pa- Between October 29, 1999, and September 8, 2000, 103 pa- tients who had shown a complete response in all lesions, and tients were enrolled from the specialist dermatology clinics of on the basis of a 4-point scale: (1) excellent: no scarring, atro- participating centers. All subjects were 18 years or older and phy, or induration, slight or no redness or change in pigmenta- had previously untreated primary nodular BCC suitable for tion compared with adjacent skin; (2) good: no scarring, atro- simple excision surgery. Diagnosis of clinically apparent nodu- phy, or induration, moderate redness or increase in pigmentation lar BCC was confirmed histologically. Excluded from the study compared with adjacent skin; (3) fair: slight to moderate occur- were patients with more than 10 eligible lesions; lesions in the rence of scarring, atrophy, or induration; and (4) poor: exten- midface region, orbital areas, and ears; lesions with a longest sive occurrence of scarring, atrophy, or induration. Evaluation diameter of less than 6 mm or more than 15 mm (face or scalp), of cosmetic outcome was repeated at the 12-month and 24- more than 20 mm (extremities or neck), or more than 30 mm month follow-up visits. In addition, patients gave a global as- (trunk); and pigmented, or morpheaform BCCs. Patients with sessment of cosmetic outcome on a similar 4-point scale (rang- porphyria, Gorlin syndrome, or a history of arsenic exposure; ing from excellent to poor) at 3, 12, and 24 months. Clinical those who had participated in any other investigational study evaluation for detection of lesion disease involvement or recur- in the past 30 days; those likely to be poor compliers; those rence was performed at 12 and 24 months after treatment. taking immunosuppressive medication; and women who were pregnant or breastfeeding were excluded. The study was ap- ADVERSE EVENTS proved by the local ethics committee responsible for each cen- ter and conducted in accordance with the Declaration of Hel- Local skin reactions during and after cream application and il- sinki (South Africa, 1996). Patients gave written informed lumination were documented. Adverse events (ie, any unfa- consent before study entry. vorable and unintended sign, symptom, or disease) either re- ported spontaneously by the patient or elicited after nonleading STUDY DESIGN questioning were noted at each follow-up visit, together with their severity, duration, and need for additional therapy. The Within 4 weeks of the screening visit, eligible patients were ran- severity of the adverse event was rated as follows: mild, tran- domized consecutively to treatment with PDT with the use of sient and easily tolerated; moderate, caused the patient dis- methyl aminolevulinate cream, 160 mg/g (Metvix; PhotoCure comfort and interrupted usual activities; and severe, caused con- ASA, Oslo, Norway) or excision surgery. The randomization siderable interference with usual activities and may have been list was kept centrally, and investigators called or faxed to the incapacitating or life-threatening. Local phototoxicity reac- monitor when a new patient was included to find out the treat- tions were graded in accordance with the National Cancer In- ment allocated to that patient number.
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