Intraindividual, right–left comparison of topical 5-aminolevulinic acid photodynamic therapy vs. 5% imiquimod cream for actinic keratoses on the upper extremities

Backround  Actinic keratoses (AKs) are considered as in situ squamous cell carcinoma. Early and effective treatment is important.
Objective  To compare the efficacy, cosmetic outcome and patient preference of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) with that of 5% imiquimod (IMIQ) cream in patients with AKs on the dorsa of hands and forearms.
Methods  Subjects received two ALA-PDT treatment sessions and one or two courses of imiquimod (three times per week for 4 weeks each). Treatments were randomly allocated to alternate upper extremities. Assessments included lesion response one and six months after treatment, cosmetic outcome evaluated by the investigators and patients' preference 6 months after treatment. Efficacy end point included the individual AK lesion clearance rate.
Results  Thirty patients with 256 lesions were included in the study. At the first follow-up, treatment with ALA-PDT resulted in significantly larger rate of cured lesions relative to 5% IMIQ cream (70.16% vs. 18.26%). At the second follow-up both treatments showed a high rate of cured lesions (65.32% for PDT vs. 55.65% for IMIQ cream). Response rates obtained in grade I lesions were higher for both treatments (71.64% for PDT vs. 72.13% for IMIQ), while treatment with PDT resulted in a significant larger rate of cured grade II lesions (57.89% for PDT vs. 37.03 for IMIQ).
Difference in cosmetic outcome was not statistically significant. Results for subject preference favoured ALA-PDT.
Conclusions  Our study shows that ALA-PDT and 5% IMIQ cream are both attractive treatment options for upper extremities AKs with comparable efficacy and cosmetic outcomes.

Conflicts of interest

None declared.     

Treatment of Gorlin syndrome (nevoid basal cell carcinoma syndrome) with methylaminolevulinate photodynamic therapy in seven patients,including two children: interest of tumescent anesthesia for pain control in children

Objective To report our experience of methylaminolevulinate photodynamic therapy (MAL‐PDT) in the treatment of multiple basal cell carcinoma (BCC) in adults and children with Gorlin syndrome (GS). Design Report of cases. Setting University of Montpellier, Department of Dermatology. Patients Seven Gorlin patients (41 superficial or nodular carcinomas), including two children. Interventions Prior superficial curettage for superficial BBCs or debulking for nodular BCCs was systematically performed. Methylaminolevulinic acid was applied topically to lesions 3 h before illumination with 635 nm red light for 10 min (37 J/cm²). To prevent treatment discomfort, analgesics and/or cooling by sprayed water were most often provided, and occasionally 1% lidocaine local anesthesia. A ropivacaine‐lidocaine tumescent anesthesia was performed on the youngest patient. Main outcome measures The initial response rate; tolerance, particularly in children; cosmetic outcome. Results Overall clearance in patients was 60% after one session of MAL‐PDT and 78% after three sessions. Resolution of the lesions was accompanied by an excellent cosmetic outcome in all patients. Treatments were well tolerated in adults with moderate pain sensation during illumination. In a child, tumescent anesthesia assured excellent tolerance in all treatment stages. Conclusion We add our experience to previous articles that consider PDT as an interesting option in the treatment of GS. To our knowledge, this study is the first report of MAL‐PDT in GS children using tumescent anesthesia. Specific guidelines for adult and pediatric patients remain to be established.     

Photodynamic therapy with 5-aminolaevulinic acid, dimethylsulfoxide and curettage in basal cell carcinoma: a 6-year clinical and histological follow-up

Background   Long-term follow-up data are needed to evaluate treatment effect after photodynamic therapy (PDT).
Objective   To investigate long-term clinical, histological and cosmetic follow-up results in basal cell carcinoma (BCC) after PDT, including treatment response related to patients and lesion characteristics.
Materials and methods   A longitudinal study of 44 patients with 60 histologically verified BCC tumours, treated with one or two sessions of dimethylsulfoxide (DMSO)-supported 5-aminolaevulinic acid – PDT following curettage, was performed. Lesions in complete remission after 3 months were followed with clinical inspection, histological investigation and evaluation of cosmetic outcome at regular intervals; long-term efficacy assessed as verified recurrence within 72 months after PDT.
Results   Complete remission at 3 months was achieved in 55 lesions from 39 patients. Two patients with one lesion each died. At 72 months, 43 of 53 lesions remained disease-free (81%); 68% remained after one treatment session, and 91% remained after two treatment sessions. Recurrence of tumour occurred at 6, 12, 24 and 36 months in 2, 4, 2 and 2 lesions, respectively; clinical investigation identified 97% of them. Male sex and H-mid-face zone were significantly associated with recurrence.
The cosmetic outcome at 72 months was rated as good or excellent by patients and investigators in more than 90% of evaluated cases.
Conclusion   DMSO-PDT following curettage is an effective treatment for BCC, with favourable long-term clinical, histopathological and cosmetic results. Clinical examination of treated lesions appears to be sufficient for long term follow up.     

Photodynamic therapy for the treatment of extramammary Paget's disease

BACKGROUND: Surgical and ablative treatment modalities for extramammary Paget's disease (EMPD) have high recurrence rates and can be associated with significant morbidity. OBJECTIVES: To evaluate photodynamic therapy (PDT) for the treatment of EMPD. METHODS: We conducted a retrospective review of notes and histology of five men with anogenital, groin and axillary EMPD treated with PDT at Roswell Park Cancer Institute between 20 April 1995 and 1 February 2001. RESULTS: Sixteen EMPD lesions were treated with topical aminolaevulinic acid (ALA)-PDT. Eleven of these lesions had failed previous Mohs micrographic surgery, excision or laser ablation. When evaluated 6 months after one treatment with ALA-PDT, eight of 16 (50%) sites achieved a complete clinical response (CR); six of eight CRs were in lesions that had failed prior conventional therapies. Three of the eight CRs (37.5%) recurred at 9, 10 and 10 months. One patient who was partially responsive to topical ALA-PDT subsequently received systemic Photofrin(R)-PDT, with a complete clinical and histological response at 1 year. Functional and cosmetic outcome was excellent in all patients. CONCLUSIONS: PDT is an effective treatment for EMPD. Recurrence rates are high with topical ALA-PDT, but comparable with standard therapies. Topical ALA-PDT causes little scarring and is preferred for superficial disease and mucosal surfaces. Systemic Photofrin(R)-PDT may be better suited for bulky disease. While further studies are indicated, PDT is well tolerated and appears to be a useful therapy for EMPD.     

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.     

High and sustained efficacy after two sessions of topical 5-aminolaevulinic acid photodynamic therapy for basal cell carcinoma: a prospective, clinical and histological 10-year follow-up study

Background Prolonged follow‐up data on topical photodynamic therapy (PDT) in basal cell carcinoma (BCC) are necessary for a full evaluation of its effect and for comparison with conventional treatment methods. Objectives To assess 10‐year long‐term PDT efficacy in primary and recurrent BCC and to evaluate clinical and histopathological factors which may be associated with treatment failure. Methods We performed a longitudinal study on 60 histologically verified BCCs in 44 patients treated with curettage and one or two sessions of dimethylsulphoxide (DMSO)‐supported topical 5‐aminolaevulinic acid (ALA)‐based PDT. Treated lesions were investigated by clinical and histopathological examination at regular intervals. The main outcomes were 10‐year lesion complete response rate using a time‐to‐event analysis, histological treatment failure and cosmesis. Results Overall complete response rate for all lesions was 75% (95% confidence interval 64–87%); 60% after one and 87% after two treatment sessions. The response rate was 78% for primary lesions; 63% after one and 90% after two sessions. The cosmetic outcome was rated as good or excellent in 91–100% of evaluated cases. Treatment failure was documented in 15 (25%) of 60 lesions; clinical investigation identified 14 of them. All failures were noted within 3 years of treatment. Male gender, recurrent tumour and one treatment session were factors significantly associated with treatment failure. The only lesion larger than 2·0 cm relapsed. Conclusions Two sessions of DMSO‐supported topical ALA‐PDT and curettage can provide long‐term effective treatment results with favourable cosmetic outcome in primary, small BCC.     

Comparative Study of Photodynamic Therapy with Topical Methyl Aminolevulinate versus 5-Aminolevulinic Acid for Facial Actinic Keratosis with Long-Term Follow-Up

Background

Few studies have compared the efficacy, cosmetic outcomes, and adverse events between 5-aminolevulinic acid photodynamic therapy (ALA-PDT) and methyl aminolevulinate-PDT (MAL-PDT) for actinic keratoses (AKs) in Asian ethnic populations with dark-skin.

Objective

We retrospectively compared the long-term efficacy, recurrence rates, cosmetic outcomes, and safety of ALA-PDT versus MAL-PDT for facial AKs in Koreans.

Methods

A total of 222 facial AKs in 58 patients were included in this study. A total of 153 lesions (29 patients) were treated with 5-ALA, and 69 lesions (29 patients) with MAL. ALA and MAL creams were applied for 6 hours and 3 hours, respectively; the lesions were then illuminated with a halogen lamp at 150 J/cm² for ALA-PDT and a diode lamp at 37 J/cm² for MAL-PDT.

Results

The complete response rates of ALA-PDT and MAL-PDT were 56.9% and 50.7%, respectively, with no significant difference at 12 months after treatment. No significant difference in recurrence rates was observed between the 2 PDT modalities at either 6 or 12 months after treatment. There was no significant difference in the cosmetic outcomes between the 2 treatment modalities at 12 months after PDT. However, ALA-PDT caused significantly more painful than MAL-PDT (p=0.005). The adverse events were mild to moderate, transient, and self-limiting for both modalities.

Conclusion

MAL-PDT was similar to ALA-PDT in terms of long-term efficacy, recurrence rates, cosmetic outcomes, and adverse events; however, it was a significantly less painful procedure than ALA-PDT in our study.     

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.     

Photodynamic therapy with delta-aminolaevulinic acid for nodular basal cell carcinomas using a prior debulking technique

The incidence of basal cell carcinomas (BCCs) is still increasing, and there is a demand for an easy, effective and selective non-invasive treatment such as topical photodynamic therapy (PDT). Twenty-three patients with 24 nodular BCCs were treated once with delta-aminolaevulinic acid (delta-ALA) PDT (100 mW cm(-2), 120 J/cm2) 3 weeks after prior debulking of the BCCs. Three months after PDT, all lesions were surgically excised and histopathologically evaluated for residual tumour. Twenty-two (92%) of the 24 nodular BCCs showed a complete response on clinical and histopathological examination. PDT for superficially abraded nodular BCCs with topically applied delta-ALA and the VersaLight as light source is an easy, effective and safe therapy, with excellent cosmetic results and no serious side-effects, in cases where non-surgical treatment of BCCs is indicated.     

Long‐term follow‐up of photodynamic therapy with a self‐adhesive 5‐aminolaevulinic acid patch: 12 months data

Background Photodynamic therapy with a self‐adhesive 5‐aminolaevulinic acid (5‐ALA) patch shows high efficacy rates in the treatment of mild to moderate actinic keratosis (AK) in short term trials. Objectives The purpose of the trial was to follow up patients after successful 5‐ALA patch‐PDT at 3 month intervals over a total period of 12 months. Patients who had received placebo‐PDT or cryosurgery served for comparison. Patients/methods Three months after therapy, 360 patients from two separate randomized parallel group phase III studies (one superiority trial vs. placebo‐PDT, one noninferiority trial vs. cryosurgery) were suitable for the follow‐up study. Patients had to show at least one successfully treated AK lesion after initial therapy. A total of 316 patients completed the follow‐up. Results Twelve months after a single treatment, 5‐ALA patch‐PDT still proved superior to placebo‐PDT and cryosurgery (P < 0·001 for all tests). On a lesion basis, efficacy rates were 63% and 79% for PDT, 63% for cryosurgery and 9% and 25% for placebo‐PDT. Recurrence rates of patch‐PDT proved superior to those of cryosurgery (per protocol set: P = 0·011, full analysis set: P = 0·049). While 31% of cryosurgery lesions were still hypopigmented after 1 year, the 5‐ALA patch‐PDT groups showed hypopigmentation in 0% (superiority trial) and 3% (noninferiority trial) of the treated lesions. Conclusion Twelve months after a single 5‐ALA patch‐PDT the majority of lesions were still cleared with an excellent cosmetic outcome. 5‐ALA patch‐PDT proved to be superior to cryosurgery in the noninferiority study setting.     

Five–year results of curettage–cryosurgery of selected large primary basal cell carcinomas on the nose: an alternative treatment in a geographical area underserved by Mohs' surgery

Mohs' micrographic surgery (MMS) is the recommended treatment for large basal cell carcinomas (BCCs) of the nose. This 5–year follow–up study attempts to evaluate whether curettage–cryosurgery (CC) could be an alternative therapy in a country where optimal resources for MMS are lacking. All patients with a primary nasal or perinasal BCC, 10 mm or larger in diameter, were assessed at a skin tumour clinic. Sixty–one BCCs of non–morphoeiform type were treated with CC. Most of the tumour was removed by careful curettage with different sized curettes. The tumour area was then frozen with liquid nitrogen in a double freeze–thaw cycle. Fifty patients were followed for at least 5 years with only one recurrence. The cosmetic result was good or acceptable in all patients. A thorough curettage followed by cryosurgery could be a safe and inexpensive alternative therapy even for large primary non–morphoeiform BCCs of the nose.     

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.     

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.     

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.     

ALA光动力治疗鲍温样丘疹病临床研究

目的观察5氨基酮戊酸(5aminolevulinicacid,ALA)光动力疗法(photodynamictherapy,PDT)治疗鲍温样丘疹病的临床疗效。方法治疗组38例采用ALAPDT治疗,每周治疗1次,共治疗4次;对照组15例予以二氧化碳激光治疗。结果治疗组痊愈12例,显效12例,有效率为61.2%,复发2例,复发率16.7%,无明显疼痛、创面等副作用;对照组痊愈9例,显效3例,有效率为80.0%,复发5例,复发率55.5%,15例均有术后明显创面疼痛,8例合并创面感染,9例出现表浅瘢痕。两组之间有效率和复发率无显著性差异(P>0.05)。结论ALAPDT是治疗鲍温样丘疹病的一种安全、有效、无明显痛苦和不良反应的新疗法。     

Long-term follow-up of metil aminolevulinate (MAL)-PDT in difficult-to-treat cutaneous Bowen's disease

Bowen's disease (BD) is a form of intraepidermal squamous cell carcinoma, which is clinically characterized by gradually enlarging, well-demarcated erythematous plaques with irregular borders and surface crusting or scaling, affecting primarily the elderly. BD often presents with lesions difficult to treat with standard therapy as surgery, cryosurgery, or 5-fluorouracil (5-FU) for the risk of significantly poor cosmetic outcome, failure rate, and adverse events, related mainly to the age of the patients. Topical PDT with methyl aminolevulinate (MAL) represents a valid and approved therapy for BD lesions in many cases, especially for lesions located at poor healing sites or for large patches of disease, due to its high efficacy coupled with good tolerability and tissue-sparing attitude. In this study, we sought to investigate the efficacy, safety, and cosmetic outcome of MAL-PDT in a series of patients with BD lesions which were challenging to treat for clinical, surgical, and patient-related reasons, such as size of the lesion, difficult surgical approach for anatomical sites, or age of patients and request of the best cosmetic result. We also performed a long-term follow-up to assess recurrence rates and eventual late-onset adverse events.     

Topical 5-aminolaevulinic acid-photodynamic therapy for the treatment of urethral condylomata acuminata

BACKGROUND: Electrocoagulation and laser evaporation for urethral condylomata acuminata have high recurrence rates and can be associated with urethral malformations. OBJECTIVES: To investigate the effect of photodynamic therapy (PDT) with topical 5-aminolaevulinic acid (ALA) on urethral condylomata acuminata and to examine the histological changes in lesions of condylomata acuminata after ALA-PDT. METHODS: Patients with urethral condylomata (n = 164) were given topical ALA followed by intraurethral PDT through a cylindrical fibre. Patients included 11 individuals with 16 penile or vulval condylomatous lesions which were biopsied before or after treatment; the histological changes were then evaluated by light microscopy and electron microscopy. RESULTS: The complete response rate was 95% and the recurrence rate was 5% after 6-24 months of follow-up. Light microscopy revealed keratinocytes in the middle and upper layers of the epidermis showing marked vacuolation and some necrocytosis 1 and 3 h after PDT. Necrosis in all layers of the epidermis was noted 5 h after PDT. Electron microscopy of keratinocytes revealed distinct ultrastructural abnormalities of mitochondria and the endoplasmic reticulum, and membrane damage. Apoptotic bodies were detected 3 h after PDT and a large number of keratinocytes exhibited necrosis 5 h after PDT. CONCLUSIONS: Results suggest that, compared with conventional therapies, topical ALA-PDT is a simple, effective, safe and well-tolerated treatment for urethral condylomata acuminata that is associated with a low recurrence rate. The mechanism might be the triggering of both apoptosis and necrosis by ALA-PDT in human papillomavirus-infected keratinocytes.     

Five-year follow-up of a randomized, prospective trial of topical methyl aminolevulinate photodynamic therapy vs surgery for nodular basal cell carcinoma

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.     

Photodynamic therapy with meta-tetrahydroxyphenylchlorin for basal cell carcinoma: a phase I/II study

BACKGROUND: Photodynamic therapy (PDT) is a convenient and effective method of treating small superficial tumours. New second-generation photosensitizers offer some advantages over first-generation sensitizers such as haematoporphyrin derivatives. OBJECTIVES: To define the optimal treatment parameters (drug dose, light dose and time interval) using meta-tetrahydroxyphenylchlorin (mTHPC) as a photosensitizer in patients with multiple basal cell carcinomas (BCCs). METHODS: Light of 652 nm (100 mW cm(-2)) was used for illuminating different tumours (n = 187) with light doses of 5--15 J cm(-2). Following an intravenous injection of 0.1 mg kg(-1) mTHPC each patient (n = 5) was illuminated on 4 consecutive days. Each day at least three BCCs per patient were treated with PDT. RESULTS: Response evaluation at 6, 12 and 18 months showed maximum responses for illumination with 10 or 15 J cm(-2) on days 1 or 2 after injection (86% complete responses). Normal tissue reactions (oedema and erythema) around the treatment site were more severe on day 1 than after longer intervals. CONCLUSIONS: mTHPC is a very effective photosensitizer; short illumination times can result in long-term cures with good cosmetic healing and with skin phototoxicity of short duration.     

Photodynamic therapy for superficial basal cell carcinoma and Bowen's disease

Photodynamic therapy (PDT) is an effective treatment for superficial basal cell carcinoma (BCCs) and Bowen's disease. Several studies have reported complete response rates of 80-95% and an excellent cosmetic outcome. Bowen's disease and superficial basal cell carcinomas characteristically affect older patients who may also have associated difficulties with mobility. Using a portable PDT light source we were able to deliver PDT in a community setting with the aim of providing a more convenient service for patients. This randomised study confirmed that community delivered PDT is a viable treatment option and can be administered safely in the community by a trained dermatology nurse. The results from patient questionnaires suggest that community delivered PDT is more convenient to the patient, and also cost effective.