Non‐invasive management of non‐melanoma skin cancer in patients with cancer predisposition genodermatosis: a role for confocal microscopy and photodynamic therapy

Background Patients with genodermatosis such as Gorlin syndrome (GS) and Xeroderma pigmentosum (XP) require a close follow‐up for early diagnosis and treatment of skin cancer. We aimed to evaluate the efficacy of methyl‐aminolevulinate (MAL) photodynamic therapy (PDT) in basal cell carcinomas (BCCs) from patients with GS and XP, and to determine the utility of reflectance confocal microscopy (RCM) in the diagnosis and the evaluation of therapeutic response. Patients and methods We included four patients with GS and two siblings with XP. Single or multiple lesions in localized areas were treated with 1–3 cycles of MAL PDT. RCM was performed before and 3 months after the treatment in target lesions in all the patients. Patients were followed up for 3 years. Results In XP patients, we treated 13 pigmented BCCs on the face. All the lesions responded to the treatment and six lesions showed a complete clinical clearing. In GS patients, facial or trunk areas with multiple BCCs were treated (up to 200). Complete clinical remission was obtained in 25–67% of the lesions. Some nodular and pigmented lesions failed to achieve a complete remission. RCM could identify already described confocal features for BCC. Tumour remissions could be assessed by this technique. Conclusions Methyl‐aminolevulinate PDT may be useful for the treatment of superficial BCC in GS and XP. In some nodular lesions, PDT may complement surgery reducing tumour size. RCM may be regarded in the future as a complementary technique in BCC for the diagnosis and post‐treatment assessment to non‐invasive therapeutic modalities.     

Topical methyl aminolaevulinate photodynamic therapy in patients with basal cell carcinoma prone to complications and poor cosmetic outcome with conventional treatment

Background Conventional treatment of basal cell carcinoma (BCC) causes morbidity and/or disfigurement in some patients because of the location (e.g. mid‐face) and size of the lesion. Objectives Following reports that such difficult‐to‐treat BCC lesions have been treated successfully with topical methyl aminolaevulinate (MAL) photodynamic therapy (PDT), a multicentre study was performed to determine the response of such BCC to MAL‐PDT. Methods An open, uncontrolled, prospective, multicentre study was conducted comprising patients with superficial and/or nodular BCC who were at risk of complications, poor cosmetic outcome, disfigurement and/or recurrence using conventional therapy. Patients were given one or two cycles within 3 months of topical MAL‐PDT, each consisting of two treatments 1 week apart. Tumour response was assessed clinically at 3 months after the last PDT, with histological confirmation of all lesions in clinical remission. The cosmetic outcome was rated. Patients with a BCC in remission will be followed up for 5 years for recurrence, of which the 24‐month follow‐up is reported here. Ninety‐four patients with 123 lesions were enrolled and treated with MAL‐PDT at nine European primary care and referral university hospitals. An independent blinded study review board (SRB) retrospectively excluded nine patients and a total of 15 lesions from the efficacy analysis, for not having a difficult‐to‐treat BCC according to the protocol. Results The lesion remission rate at 3 months was 92% (45 of 49) for superficial BCC, 87% (45 of 52) for nodular BCC, and 57% (four of seven) for mixed BCC, as assessed by clinical examination, and 85% (40 of 47), 75% (38 of 51), and 43% (three of seven), respectively, as assessed by histological examination and verified by the SRB. At 24 months after treatment, the overall lesion recurrence rate was 18% (12 of 66). The cosmetic outcome was graded as excellent or good by the investigators in 76% of the cases after 3 months follow‐up, rising to 85% at 12 months follow‐up, and 94% at 24 months follow‐up. Conclusions Topical MAL‐PDT is effective in treating BCC at risk of complications and poor cosmetic outcome using conventional therapy. MAL‐PDT preserves the skin and shows favourable cosmetic results.     

Topical methyl aminolaevulinate photodynamic therapy versus cryotherapy for superficial basal cell carcinoma: a 5 year randomized trial

This multicentre, randomized study compared photodynamic therapy using topical methyl aminolaevulinate (MAL PDT), a non-invasive modality, with cryotherapy for treatment of superficial basal cell carcinoma. Sixty patients with 114 lesions were treated with MAL cream (160 mg/g) applied for 3 hours before illumination (570-670 nm, light dose 75 J/cm) (1 session), and 58 with 105 lesions received cryotherapy (2 freeze-thaw cycles). Patients with an incomplete response at 3 months received 2 further MAL PDT sessions (n = 20) or repeat cryotherapy (n = 16). 100 lesions treated with MAL PDT and 93 lesions treated with cryotherapy were in complete response at 3 months after the last treatment and evaluable for recurrence over 5 years. There was no difference in 5-year recurrence rates with either treatment (20% with cryotherapy vs. 22% with MAL PDT, p = 0.86). However, more patients had an excellent cosmetic outcome with MAL PDT (60% vs. 16% with cryotherapy, p = 0.00078). These results provide support for the use of MAL PDT as a non-invasive, selective treatment alternative for primary superficial basal cell carcinoma.     

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

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.     

Multicentre intraindividual randomized trial of topical methyl aminolaevulinate-photodynamic therapy vs. cryotherapy for multiple actinic keratoses on the extremities

Background  Methyl aminolaevulinate–photodynamic therapy (MAL‐PDT) is an effective treatment in facial/scalp actinic keratosis (AK). Objectives The aims of this study were to compare efficacy, safety, cosmetic outcome and patient preference of MAL‐PDT vs. cryotherapy in patients with AK at other locations. Methods A multicentre, controlled, randomized, open, intraindividual, right–left comparison was performed. Patients with nonhyperkeratotic AK were treated once with MAL‐PDT and cryotherapy on either side of the body. At week 12, lesions showing noncomplete response were retreated. The primary efficacy variable was the lesion response at week 24. Investigator’s assessment of cosmetic outcome, patient’s preference in terms of cosmetic outcome and a patient preference questionnaire were also analysed at week 24. Results In total, of 121 patients with 1343 lesions (98% located on the extremities and the remainder on the trunk and neck) were included. Both treatments provided a high mean percentage reduction in lesion count at week 24 with significantly higher efficacy for cryotherapy: 78% for MAL‐PDT and 88% for cryotherapy (P = 0·002, per protocol population). Investigator’s assessment of cosmetic outcome was significantly better for MAL‐PDT than cryotherapy (P < 0·001), 79% of lesions having an excellent cosmetic outcome with MAL‐PDT vs. 56% with cryotherapy at week 24. The cosmetic outcome achieved by MAL‐PDT compared with cryotherapy was also preferred by patients (50% vs. 22%, respectively, P < 0·001), and 59% of patients would prefer to have any new lesions treated with MAL‐PDT compared with 25% with cryotherapy (P < 0·001). Both treatment regimens were safe and well tolerated. Conclusions MAL‐PDT showed inferior efficacy for treatment of non‐face/scalp AK compared with cryotherapy. However, both treatments showed high efficacy, and MAL‐PDT conveyed the advantages of better cosmesis and higher patient preference.     

Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial

BACKGROUND: Photodynamic therapy (PDT) is a promising new treatment modality for actinic keratoses. Methyl aminolevulinate (MAL) (Metvix, PhotoCure, Oslo, Norway) leads to selective accumulation of photoactive porphyrins in premalignant skin lesions and makes the lesions susceptible to phototoxic effects on illumination with red light. OBJECTIVE: This multicenter, randomized, double-blind study compared complete response rates, cosmetic outcome, and patient satisfaction for PDT with cream containing 160 mg/g MAL or placebo cream in the treatment of actinic keratoses. METHODS: After application of the cream under occlusion for 3 hours, the lesions were illuminated by noncoherent red light (570-670 nm, light dose 75 J/cm(2)). Treatment was repeated after 1 week and response was assessed 3 months later. A total of 80 patients were randomized into the study, 42 in the active and 38 in the placebo group. RESULTS: Complete lesion response rate was higher after MAL PDT than placebo, 89% versus 38% per protocol analysis (P =.001). An excellent or good cosmetic outcome was reported in more than 90% of patients treated with MAL. CONCLUSION: In this small study, PDT using topical MAL was a safe and effective treatment for actinic keratoses with excellent cosmetic outcome. It is a promising treatment that could benefit from further study.     

Photodynamic therapy using topical 5‐aminolaevulinic acid vs. surgery for basal cell carcinoma

Background Photodynamic therapy (PDT) is an attractive modality for the treatment of BCC, based on its generally favorable efficacy, adverse effect profile and its excellent cosmetic outcome. Objectives The purpose of the study is to compare the efficacy and cosmetic outcome of photodynamic therapy with topical 5‐aminolaevulinic acid (ALA‐PDT) vs. simple excision surgery for superficial and nodular basal cell carcinoma (BCC). Methods A total of 72 patients, 32 with 48 lesions, were treated with ALA‐ PDT, and 40 with 46 lesions treated by excision were included in this prospective, comparative, controlled, clinical study. The patients have been followed for 16–37 months (mean 25 months). The PDT was performed in combination with 5‐aminolaevulinic acid twice, one month apart. Surgical excision was performed under local anesthesia with a 3‐mm margin, followed by histological examination. The cosmetic outcome was evaluated by the physician according to a 4‐point scale. Results Overall 94 BCC were treated. Complete healing rates did not differ significantly between groups, P = 0.64 (46/48 [95.83%] lesions treated with PDT vs. 44/46 [95.65%] lesions with surgery). In the first 12 months of follow‐up, 4 lesions had recurred, 2 of which were in the PDT group while 2 lesions after surgery. The mean follow‐up was 25 months. The recurrence rate in the ALA‐PDT group was 4.16% vs. 4.34% in the surgery group, p = 0.64. The cosmetic outcome was superior for ALA‐PDT at all time points. At 12 months, 100% lesions treated with ALA‐PDT had an excellent or good cosmetic outcome, according to the investigator, compared with 88.86% with surgery, P = 0.01. Conclusion ALA‐PDT offers a similarly high efficacy, and a better cosmetic outcome than simple excision surgery in the treatment of BCC.     

A cost analysis of photodynamic therapy with methyl aminolevulinate and imiquimod compared with conventional surgery for the treatment of superficial basal cell carcinoma and Bowen’s disease of the lower extremities

Background Superficial basal cell carcinoma (sBCC) and Bowen’s disease (BD) are usually slow‐growing, low‐grade malignancies that mainly affect older persons. Surgery is often the first choice of treatment and the modality with the lowest failure rate. However, non‐invasive procedures, such as topical methyl aminolevulinate photodynamic therapy (MAL‐PDT) and imiquimod, are increasingly demanded by dermatologists and patients, because of their generally favourable efficacy and adverse effects profile and their excellent cosmetic outcome. Objective To assess the cost of MAL‐PDT and of treatment with imiquimod for primary non‐melanoma superficial cutaneous carcinomas compared with conventional surgery, thereby calculating the total medical cost, and the direct and indirect costs. Setting We collected data on 67 patients with 86 tumours (32 sBCC, 54 BD). Patients were treated between May 2006 and April 2007 at the Dermatology Department of the Costa del Sol Hospital in Marbella, Spain. The mean cost and mean cost per complete clinical response were calculated for each therapeutic option. Results After 2 years of follow‐up, a complete response was observed in 89.5% of the MAL‐PDT group, 87.5% of the imiquimod group and 97.5% of the surgery group. The difference in costs when compared with the surgery group was a mean saving per lesion treated of 307 euros for the imiquimod group, and 322 euros for the MAL‐PDT group. Conclusions Although surgery proved to be more effective treatment, our results suggest that its average cost is greater than that of non‐invasive therapy for the treatment of non‐melanoma superficial cutaneous carcinomas on the lower limbs, at least after the first 2 years of follow‐up.     

A clinical study comparing methyl aminolevulinate photodynamic therapy and surgery in small superficial basal cell carcinoma (8–20 mm), with a 12‐month follow‐up.

Objective To compare the efficacy and cosmetic outcome (CO) of photodynamic therapy with topical methyl aminolevulinate (MAL‐PDT) with simple excision surgery for superficial basal cell carcinoma (sBCC) over a 1‐year period. Methods In this multicentre, randomised, controlled, open study, patients were treated at baseline either with MAL‐PDT (two sessions, 7 days apart, repeated 3 months later if incomplete clinical response) or surgery (at baseline). Primary endpoints were clinical lesion response (CR) 3 months after last treatment and CO assessed by the investigator 12 months after last treatment. Secondary endpoints were CR at 12 months (i.e. recurrence) and CO assessed by the investigator at 3 and 6 months and by the patient at 3, 6 and 12 months. Results Overall, 196 patients were enrolled with 1.4 sBCC lesions on average per patient. Mean lesion count reduction at 3 months was 92.2% with MAL‐PDT vs. 99.2% with surgery [per protocol (PP) population] confirming the non‐inferiority hypothesis (95% confidence interval, –12.1, –1.9). A total of 92.2% lesions showed CR at 3 months with MAL‐PDT vs. 99.2% with surgery (PP population). At 12 months, 9.3% lesions recurred with MAL‐PDT and none with surgery. CO was statistically superior for MAL‐PDT at all time points. At 12 months, 94.1% lesions treated with MAL‐PDT had an excellent or good CO according to the investigator compared with 59.8% with surgery. This difference was confirmed with the patients’ assessment. The proportion of excellent CO markedly improved with time with MAL‐PDT unlike surgery. Conclusions MAL‐PDT offers a similarly high efficacy and a much better CO than simple excision surgery in the treatment of sBCC.     

European guidelines for topical photodynamic therapy part 1: treatment delivery and current indications – actinic keratoses,Bowen’s disease,basal cell carcinoma

Topical photodynamic therapy (PDT) is a widely used non‐invasive treatment for certain non‐melanoma skin cancers, permitting treatment of large and multiple lesions with excellent cosmesis. High efficacy is demonstrated for PDT using standardized protocols in non‐hyperkeratotic actinic keratoses, Bowen’s disease, superficial basal cell carcinomas (BCC) and in certain thin nodular BCC, with superiority of cosmetic outcome over conventional therapies. Recurrence rates following PDT are typically equivalent to existing therapies, although higher than surgery for nodular BCC. PDT is not recommended for invasive squamous cell carcinoma. Treatment is generally well tolerated, but tingling discomfort or pain is common during PDT. New studies identify patients most likely to experience discomfort and permit earlier adoption of pain‐minimization strategies. Reduced discomfort has been observed with novel protocols including shorter photosensitizer application times and in daylight PDT for actinic keratoses.     

Efficacy of topical photodynamic therapy for keratoacanthomas: a case-series of four patients

Topical photodynamic therapy (PDT) is an excellent treatment option for various non-melanoma skin cancers and precancerous lesions, including actinic keratosis, Bowen's disease, and basal cell carcinoma. The clinical use of PDT includes a broad range of neoplastic, inflammatory, and infectious skin diseases. There is also anecdotal evidence suggesting the efficacy of PDT for the treatment of keratoacanthomas (KA). We report a case-series of four patients with solitary KA confirmed by histology, treated with topical PDT with methylaminolevulinic acid (MAL) cream. After three sessions of PDT, the lesions completely disappeared. There was no evidence of recurrence and excellent cosmetic outcome was achieved after three years of follow-up. Topical photodynamic therapy with MAL can be a therapeutic alternative for KA with good clinical and cosmetic outcomes.     

Photodynamic therapy for basal cell carcinoma: clinical and pathological determinants of response

Background Photodynamic therapy (PDT) is increasingly used in the treatment of basal cell carcinoma (BCC). However, scant information is available about the impact of both patient‐ and lesion‐related characteristics on the effectiveness of therapy. Therefore, on the basis of the current data, it is difficult to draw clear‐cut indications to use PDT for treatment of BCC in clinical practice. Objective To investigate the clinical and pathological determinants of response of BCC to PDT with methylaminolevulinate (MAL) and red light. Methods The clinical and pathological characteristics of 194 BCCs in 135 patients, treated with MAL‐PDT, were evaluated. Lesions were treated with MAL‐PDT according to established methods and the response was assessed by clinical follow‐up of the patients. Results Complete response to PDT was 62%, with a better response for superficial BCC (95/116, 82%) than nodular BCC (26/78, 33%). When determinants of response were analysed, the nodular type and the location on the limbs emerged as significant clinical predictors of failure. Among the pathological characteristics, the nodular and infiltrative histotypes, as well as ulceration and tumour thickness were associated with a lower response to therapy. Patients’ age and gender, as well as the size of the lesions, were not found to be significant predictors. Conclusions Optimization of PDT procedure for BCC requires a careful selection of the lesions. In particular, superficial BCCs, preferentially located on the trunk, show the best therapeutic response.     

Treatment of superficial basal cell carcinoma by topical photodynamic therapy with fractionated 5‐aminolaevulinic acid 20% vs. two‐stage topical methyl aminolaevulinate: results of a randomized controlled trial

Photodynamic therapy (PDT) is a frequently used treatment for a type of skin cancer called superficial basal cell carcinoma (sBCC). It works by using a cream called a porphyrin precursor, which is applied to the affected skin area and covered with a dressing. After several hours and after removing the occlusive dressing, the area is irradiated with intense visible light which causes the death of cancer cells. There are two porphyrin precursors available in the Netherlands, 5‐aminolevulinic acid 20% (ALA) and methylaminolevulinic acid (MAL). In conventional MAL PDT, skin receives one illumination (treatment with light) which is repeated one week later. In the case of ALA, skin receives two different illuminations, two hours apart. This is called fractionated ALA‐PDT. In this study, from the Netherlands, we investigated whether this fractionated ALA‐PDT is superior to conventional MAL‐PDT. 162 patients were randomly assigned to one of two groups. 82 patients were treated with fractionated ALA‐PDT and 80 patients with conventional MAL‐PDT. After 12 months a total of 6 treatment failures (recurrence of the sBCC) occurred after ALA‐PDT and 13 after MAL‐PDT. Although there were twice as many treatment failures in the MAL‐PDT group, this difference was not statistically significant. Secondly, we investigated pain scores in both treatment groups because PDT is known to cause a severe burning sensation. We found that ALA‐PDT resulted in more pain and side effects, such as erythema (skin redness, like sunburn), wounds/erosions and vesicles (small blisters) compared to MAL‐PDT. In conclusion, there is a trend toward better efficacy of ALA‐PDT compared to MAL‐PDT for the treatment of sBCC, although the difference was not significant.     

Photodynamic therapy: treatment of choice for actinic cheilitis?

ABSTRACT: The major therapeutic approaches (5‐fluorouracil, imiquimod, vermilionectomy, and CO₂ Laser ablation) for actinic cheilitis are aimed at avoiding and preventing a malignant transformation into invasive squamous cell carcinoma via destruction/removal of the damaged epithelium. Recently, photodynamic therapy (PDT) has been introduced as a therapeutic modality for epithelial skin tumors, with good efficacy/safety profile and good cosmetic results. Regarding actinic cheilitis, PDT could be considered a new therapeutic option? The target of our study was to evaluate the efficacy and tolerability of PDT in actinic cheilitis, using a methyl‐ester of aminolevulinic acid (MAL) as topical photosensitizing agent and controlled the effects of the therapy for a 30‐month follow‐up period. MAL‐PDT seems to be the ideal treatment for actinic cheilitis and other actinic keratosis, especially on exposed parts such as the face, joining tolerability and clinical efficacy with an excellent cosmetic outcome.     

Photodynamic Therapy in Dermatology – an Update 2008

Photodynamic therapy (PDT) is used for the prevention and treatment of non‐melanoma skin cancer. Until recently, clinically approved indications have been restricted to actinic keratoses, nodular and superficial basal cell carcinoma, and – since 2006 – Bowen disease. However, the range of indications has been expanding continuously. PDT is also used for the treatment of non‐malignant conditions such as acne vulgaris and leishmaniasis, as well as for treating premature skin aging due to sun exposure. Here, PDT is used for the stimulation of immunomodulatory effects in contrast to the induction of necrosis and apoptosis as produced in the treatment of skin tumors. The porphyrin precursor 5‐aminolevulinic acid (ALA) or its methyl ester (MAL, so far the only approved formulation in Europe) is applied topically as photosensitizer to exclude systemic reactions. Possible light sources include lasers as well as incoherent light sources; irradiation with incoherent light sources is cheaper and more appropriate for large treatment areas. The main advantages of PDT in comparison to other treatment modalities are its excellent cosmetic results and its high remission rates despite low invasiveness.This article provides up‐to‐date information about PDT with focus on recently published studies.     

Is the step‐up therapy of topical 5‐aminolevulinic acid photodynamic therapy effective and safe for the patients with recalcitrant facial flat wart?

Facial flat wart, caused by human papilloma virus type 3 and less often, type 10, 27, and 41, often brings many cosmetic problems to children and young adults. Considering the disturbing cosmetic problem, the treatment of facial flat wart is always frustrating and often unsuccessful, although there are many treatment modalities. Considering the possible serious side effects of 5‐aminolevulinic acid photodynamic therapy (ALA‐PDT), we designed step‐up therapy of ALA‐PDT on different clinical phases of facial flat wart. As a new protocol of ALA‐PDT, we found the step‐up therapy of ALA‐PDT could also receive excellent effects with the lower side effects. Meanwhile, the tolerance of patients to ALA‐PDT could improve with subsequent treatment sessions and escalating doses of ALA‐PDT.     

Methylaminolaevulinate-based photodynamic therapy of Bowen's disease and squamous cell carcinoma

Background  Photodynamic therapy (PDT) with methylaminolaevulinate (MAL) is an approved noninvasive treatment option for actinic keratosis and Bowen's disease (BD), two precursors of invasive squamous cell carcinoma (SCC).
Objectives  To assess efficacy, prognostic features, tolerability and cosmetic outcome of MAL-PDT for the treatment of BD and SCC.
Methods  In total, 112 biopsy-proven lesions of BD and SCC in 55 subjects were treated in an outpatient setting. MAL cream (160 mg g⁻¹) was applied for 3 h prior to illumination with a light-emitting diode source (wavelength range 635 ± 18 nm; light dose 37 J cm⁻²). A second MAL-PDT session was given 7 days later. Complete response rate at 3 months after the last treatment, recurrence rate at the 24-month follow-up, and cosmetic outcome were recorded.
Results  The overall complete response rates were 73·2% at 3 months and 53·6% at 2 years. Clinical thickness, atypia and lesion depth were significant predictors of the response at 3 months when using a univariate analysis ( P  <   0·001). A multivariate logistic regression model, with robust variance estimation, showed that cell atypia was the only statistically significant independent predictor of the treatment outcome at 3 months.
Conclusions  MAL-PDT may represent a valuable, effective and well tolerated treatment option with good cosmetic outcome for superficial, well-differentiated (Broders' scores I and II) BD and microinvasive SCC. In contrast, its use for superficial SCCs with a microinvasive histological pattern and for nodular, invasive lesions, particularly if poorly differentiated keratinocytes are present (Broders' scores III and IV), should be avoided.     

Field treatment of facial and scalp actinic keratoses with photodynamic therapy: survey of patient perceptions of treatment satisfaction and outcomes

Background: Diffuse field change with actinic keratoses (AK) is a ubiquitous skin disease in Australia, with potential for malignant transformation. We report on 35 consecutive patients who had field therapy with single session photodynamic therapy (PDT) using 1 h incubation time for 5‐aminolevulinic acid (5‐ALA) or 3 h for methyl‐aminolevulinate (MAL). Methods: We retrospectively telephone surveyed our patient cohort regarding their satisfaction and perceptions of the effectiveness, side‐effect profile and benefits of PDT. We also reviewed all patients' notes for significant side‐effects. Results: Sixty‐nine per cent (n = 24/35) of patients responded to the telephone survey; 66% (n = 16/24) of the respondents reported good clearance of AK and claimed a good cosmetic outcome. All respondents reported moderate or severe pain (42% and 58%, respectively) during the illumination phase. Twenty per cent of all patients treated had suffered from one or more of the following side‐effects: pustulation; severe erythema; and skin erosions. Conclusions: Overall, our results compared favourably with previously published studies using 5‐ALA or MAL PDT. However, our patient cohort experienced a greater side‐effect profile. This may have been due to our patients having greater disease burden compared to other studies and possibly due to our use of topical retinoids prior to PDT in selected patients.     

A follow-up study of recurrence and cosmesis in completely responding superficial and nodular basal cell carcinomas treated with methyl 5-aminolaevulinate-based photodynamic therapy alone and with prior curettage

BACKGROUND: Methyl 5-aminolaevulinate (mALA) is an ester derivative of 5-aminolaevulinic acid (ALA) with increased lipophilicity compared with ALA. OBJECTIVES: To assess long-term cure rate, cosmesis, recurrence rate and extent of fibrosis after mALA-based photodynamic therapy (PDT) of superficial and nodular basal cell carcinomas (BCCs) showing early complete response to treatment. METHODS: Of 350 BCCs treated, 310 responded completely. These were in 59 patients who were followed for 2-4 years (mean 35 months) after mALA-PDT. Nodular tumours were curetted before PDT, and mALA 160 mg g(-1) was applied to all tumours for 24 h or 3 h before illumination from a broad-band halogen light source with light doses from 50 to 200 J cm(-2). Fibrosis was assessed histologically in 23 biopsies. RESULTS: The overall cure rate for 350 BCCs, including non-responders and recurrences was 79%. Of 310 lesions, 277 (89%) remained in complete response, and the cosmetic outcome was excellent or good in 272 of the completely responding lesions (98%). Histological examination showed dermal fibrosis in one of 23 biopsies. CONCLUSIONS: We conclude that mALA-based PDT with prior curettage of nodular lesions is a promising new method for the treatment of BCC.     

Efficacy of photodynamic therapy with methyl aminolevulinate in the treatment of superficial and nodular basal cell carcinoma: an open-label trial

Photodynamic therapy with methyl aminolevulinate (MAL-PDT) is a non-invasive therapy for superficial and nodular basal cell carcinoma (BCC). We performed an open-label trial to evaluate efficacy, safety, tolerability and cosmetic outcome of MAL-PDT in selected patients with superficial and nodular BCCs. Ninety-four superficial and 24 nodular BCCs in 69 patients were treated with 2 to 8 MAL-PDT sessions. Efficacy, safety, tolerability and cosmetic outcome were evaluated at months 1, 3, 6 and 12 after the last MAL-PDT treatment and then every 3 months. One patient discontinued the study for reasons unrelated to study procedures. Complete clinical regression was detected in 84/94 (89.4%) superficial BCCs, and 12/23 (52.2%) nodular BCCs one month after 2 MAL-PDT sessions. No further clinical improvement was observed in either superficial or nodular BCCs with treatment continuation up to a maximum of 8 MAL-PDT sessions. Adverse effects were limited to mild local skin reactions, and cosmetic outcome was rated as excellent or good. Recurrence was observed in 2/84 (2.4%) successfully treated superficial BCCs at 6 and 12 months after treatment discontinuation. Based on the efficacy, tolerability, cosmetic outcome and recurrence rate, our results support the use of MAL-PDT for treatment of superficial BCC and for selected cases of nodular BCC.