2225 5-Aminolevulinic acid photodynamic therapy for superficial basal cell carcinoma

Proceedings of the 39th Annual ASTRO Meeting

353

2225 S-AMINOLEVULIMC

David

Want,

Kingston

ACID

PHOTODYNAMIC

MD; James C. Kennedy,

Regional

Cancer

Centre,

MD,

THERAPY

FRCPC;

Kingston

Michael

General

FOR SUPERFICIAL

Bmndage,

Hospital,

BASAL

MSc, MD, FRCPC;

Queen’s

University,

Treatment of superficial basal cell carcinoma with topical 5-aminolevulinic plastic surgery and radiotherapy with potential for good cosmetic outcome this technique.

CELL

Deanna

Kingston,

CARCINOMA

Rothwell.,

MSc

Canada

acid photodynamic and local control

therapy (ALA-PDT) of disease. We report

offers an alternative our clinical experience

to with

Patients were treated prospectively on a study prorocol enrolling a total of I I B patients (63 male, 55 female) with an average age of 65 years. Consecutive patients meeting eligibility criteria were invited to participate over a four year period. Median followup was 27 months (range 1 to 76 months). In the study group, 62 patients had single lesions and 56 had multiple lesions. Of the 56 patients with multiple lesions, 33 had 2-4 lesions, 1 I had 5-9, and 11 had IO or more. All patients were treated with 20% ALA dissolved in Glaxal Base applied to the tumors for three to four hours Following removal of the cream, fluorescence intensity and distribution were assessed using a UV-A lamp, and the lesions were exposed to photoactivating light of wavelength greater than 600 nm for a light dose ranging from 100-150 J/cmZ. Lesions were reassessed in followup, and scored as complete or partial responses. At subsequent patient assessments, lesions were scored as continued complete responses or recurrences. In the patients with single lesions, there was an initial complete response rate of 90.3% Ofthe 56 patients with multiple lesions, 44 had all of their lesions respond completely, and there was an overall average response rate of 95.5%. Sixty three percent of males and 44% of females had all of their lesions respond completely. (p= 0.0 33, Chi-squared test). There was no difference in response rate with respect to age, or site of lesion. The recurrence rates were 35% for patients with single lesions, and IO 5% for patients with multiple lesions. ALA-PDT would appear to be a promising alternative to conventional treatment for superficial basal cell carcinoma. Based on these results, we are currently studying treatment with prolonged ALA exposure time (18 hours) and an improved light delivery system, and are collecting data on cosmetic outcome.

2226 MULTICENTER

PHASE I/II

EQUIPMENT

Alexander Katalinic, MD; M. Heinrieh and Peter Vaupd. MD; Department Niimberg,

EVALUATION

Seegenschmiedt, of Radiation Universit&str

STUDY OF INFRARED-A-HYPERTHERML~ MD;

Eike Walther,

Oncology & Institute 27, 91054 Erlangen

MD; Horst Jiirgen Feldmaan,

of Medical (Germany)

FOR SUPERFICIAL MD: Martin

Statistics & Documentation, and IRA-HT Study Group

University

TUMORS

Stuschke, MD; of Erlangen-

BACKGROUND: A water-filtered infrared-A radiation (IR-A) hyperthermia (HT) applicator system has been developed, which can be used to heat superficial malignant tumors without body contact. A prospective multicenter phase I-II equipment evaluation study was conducted to test technical feasibility of the system under various geometrical conditions, and to assess toxicity and efficacy of IR-A/HT and radiotherapy (RT). PATIENTS

& METHODS: From December 1991 to June 1994, a total of 53 patients who presented with 58 malignant lesions were entered in a prospective multicenter equipment evaluation study. There were 14 primary tumors, 36 recurrent lesions and 8 metastatic tumor lesions elegible. The lesions were located either in the head and neck (14), chestwall (3 I), abdominal wall (2) or at the extremities (11). The mean tumor volume was 100 ( f 209 ) cm3, and the mean tumor maximum depth reached I7 ( * 14 ) mm. A total of 209 IR-A/HT sessions were applied at a frequency of 1 - 2 times per week. Depending upon the treatment site and tumor extension up to 3 IR-ARIT radiators were used per each lesion. The HT sessions were applied either directly before or after external RT for 1 hour at steady state temperatures of 40.5 - 44°C. During HT the temperatures were controlled at various locations both at the body surface and invasively at depth using implanted probes. RT was applied daily with the exception of melanomas which were treated once per week. The mean single and total RT dose was 2 Gy and 46 + 14 Gy, respectively, while for melanomas the single dose was 8 Gy and the total dose 24 - 32 Gy. RESULTS: Contactless IR-A/HT was simple to apply and well tolerated by most patients. During and after the HT course 3 1 of 58 (53%) lesions developed acute toxicity, i.e. pain in 18 (31%) and increased skin reactions in 26 (45%) lesions. In 25 (43%) lesions chronic side-effects were observed: increased skin atrophy in 16 (28%); increased skin fibrosis in 20 (34%), teleangiectasia in 5 (9%) and skin necrosis or soft tissue ulceration in 6 (10%) lesions. At 3 months FU, 32 (SS%) achieved a complete remission (CR) and 19 (33%) a partial remission (PR); at 12 months FU, 16 patients (18 lesions) were deceased and 3 patients (4 lesions) not yet in FU, while 25 (43%) patients had a persistent local tumor control. In univariate analaysis, the following prognostic factors were found for the endpoint ,,CR“ at 3 or 12 months FU: Kamofsky Score, metastatic status, tumor size, total RT-dose, thermal variables Tmin(av) and Tmean. For the endpoint ,,acute treatment toxicity“, only the maximum temperature Tmax(av) was prognostically important (p < 0.05). Significant differences in the heating efficacy were also found when considering the ,,quality of the HT-application”: Smaller lesions which had < 10 mm depth and < 25 cm’ tumor surface area heated much better and reached a higher CR rate than lesions beyond these dimensions. However, there was also a stronger influence of tumor size on outcome than of heating quality. A comparison between IRNHT and microwave HT in the same lesion revealed that the IR-m-technique was inferior with regard to the pen&ration depth ofthe energy deposition, especially beyond 10 mm depth.

CONCLUSIONS: be safely

Water-filtered infrared-A radiation and very effectively applied to heat localized

provides shallow

an elegant HT technique which does not require contact superficial-tumors (> I cm depth). Multiple IRA-radiators

to the human body. It can can be well combined.