Non-Melanoma Skin Cancer Treated with Electronic Brachytherapy: Results at Two Years Ajay Bhatnagar MD, MBA Cancer Treatment Services Arizona Casa Grande, AZ University of Pittsburgh, School of Medicine Pittsburgh, PA Disclosure • I have received research funding from Xoft — a subsidiary of iCAD, Inc., Sunnyvale, CA, as the Principal Investigator for this study. Background • • • • 1 Non-melanoma skin cancer (NMSC) is the most common malignancy in the US • Affects 2 to 3 million people each year1 High dose rate (HDR) brachytherapy using surface applicators has shown efficacy in the treatment of NMSC An electronic brachytherapy (EBT) system permits treatment of NMSC without the use of a radioactive isotope • Xoft Axxent® eBx® system A miniature, electronic, HDR, low energy X-ray tube produces X-rays of 50 keV maximum energy Rogers HW, Martin A. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol 2010;146:283-287. Ir-192 HDR Surface Applicator vs. Xoft eBx Surface Applicator Dose Profile of Xoft 35mm Surface Applicator vs. Ir-192 Liepzig Applicator For 10 sources over the 80% field width (per AAPM TG25) • Flatness (Mean and S.D.): 3.2 % +/- 1.2% • Symmetry (Mean and S.D.): 4.2 % +/- 2.1% Superior Dose Profile with Xoft Applicator • Potential to decrease margins compared to Ir-192 Study Purpose • The objective of this IRB approved study was to assess adverse effects, cosmesis, and recurrence rates up to two years following HDR electronic brachytherapy for the treatment of non-melanoma skin cancer. Methods • July 2009 – February 2012, 122 patients with 171 NMSC tumors were treated with eBx using surface applicators • All received same dose fractionation • 5.0 Gy x 8 fractions = 40.0 Gy, 2 fractions per week • Prescription depth – Empirically 3 mm for most lesions – Determined by CT only for thick lesions • Surface applicator size (10, 20, 35, and 50 mm) was selected to allow for complete coverage of target lesion with acceptable margin • Patient care included • Petrolatum ointment during treatment • Aloe vera gel through 1 month post-treatment • Adverse Events Assessment: NCI CTCAEv4 criteria • Cosmesis Assessment: RTOG scale Treatment setup for patient with facial lesion showing a) thermoplastic mask cut out around lesion; b) surface applicator in contact with skin; c) shielding and applicator setup; and d) electronic brachytherapy controller to the right of the patient. a b c d Results PATIENT CHARACTERISTICS N Subjects N Lesions 122 Subjects 171 Lesions Mean Age (Range) 73 Years (49-97) Gender 63% Male 37% Female Ethnicity 97% Caucasian non-Hispanic • Mean Follow up 11 months (range 1-38 months) • No Recurrences to Date Tumor Characteristics TYPE (N=171 LESIONS) n % Basal Cell Carcinoma (BCC) 91 53% Squamous Cell Carcinoma (SCC) 70 41% Merkle Cell Carcinoma (MCC) 2 1% Cutaneous T-cell Lymphoma (CTCL) 3 2% Basal-Squamous Cell Carcinoma 1 1% n % Tis 10 6% T1 138 81% T2 4 2% Recurrence 15 9% Not available 4 2% STAGE (N=171 LESIONS) Tumor Characteristics LESION LOCATION (N=171 LESIONS) n % Nose 49 29% Face (forehead, temple, eyelid, glabella, sideburn, cheek, lip, chin) 50 29% Ear 22 13% Extremity 24 14% Scalp 14 8% Torso 12 7% Tumor Characteristics TUMOR SIZE (N=171 LESIONS) n % ≤ 1CM 101 59% > 1 CM TO ≤ 2CM 61 36% > 2 CM TO ≤ 3CM 6 3% >3 CM TO ≤ 4CM 2 1% >4 CM TO ≤ 5 CM 1 1% Number of Lesions Treated by Applicator Size and Dose Depth Applicator Size 1 mm Prescription Dose Depth 5 * 3 mm 4 mm 7 mm TOTAL mm§ 10 mm 2 64 1 9 0 76 20 mm 0 39 2 20 1 62 35 mm 0 5 2 22 0 29 50 mm 0 1 1 1 1 4 52 2 171 2 depths of109 TOTAL Includes prescription dose 4.0 mm to 4.1 6 mm * § Includes prescription dose depths of 4.75 mm to 5.6 mm Treatment Time and Dose Depth by Histopathology Histopathology (N=171 Lesions) n Treatment Time: mean (range) Basal Cell Carcinoma 91 5.6 (4-8.2) min Squamous Cell Carcinoma 70 5.8 (3.9-12.5) min Merkle Cell Carcinoma 2 5.8 (4.6-6.9) min Cutaneous T-cell Lymphoma 3 8.4 (5.7-13.8) min Basal-Squamous Cell Carcinoma 1 5.2 (5.2-5.2) min Not available 4 7.3 (4.5-11.2) min Adverse Events: Late 6 MONTHS (N=52 LESIONS) n % Hypopigmentation 4 8% Alopecia 2 4% Hyperpigmentation 1 2% Atrophy 1 2% n % Hypopigmentation 5 9% Alopecia 2 3% n % 4 13% 1 3% 1 YEAR (N=58 LESIONS) 2 YEARS (N=30 LESIONS) Hypopigmentation Alopecia • All Hypopigmentation was Grade 1 (mild) • No Grade 3 or higher Adverse Events Cosmesis 100 –– Percent of Lesions with Good or Excellent Cosmesis 89% 92% 95% 93% N=122 N=81 N=52 N=55 N=29 80 –– 75% 60 –– 40 –– 20 –– 0– 1 3 6 12 24 Post-Treatment Visit Month • No Patients with Fair or Poor Cosmesis CASE EXAMPLES Squamous cell carcinoma on right cheek Treated with 40 Gy to a 5 mm depth Pre-treatment Fraction 7 1 Mo 3 Mo 6 Mo 2 Yr Basal cell carcinoma on chin Treated with 40 Gy to a 3 mm depth Pre-treatment 2 Yr Basal cell carcinoma on right nostril and nasal bridge Treated with 40 Gy to a 5 mm depth Pre-treatment 2 Yr Squamous cell carcinoma on left arm Treated with 40 Gy to a 5 mm depth Pre-treatment 2 Yr Basal cell carcinoma on left tip of nose Treated with 40 Gy to a 3 mm depth Pre-treatment 23 Mo Basal cell carcinoma on right tip of nose Treated with 40 Gy to a 5 mm depth Pre-treatment 22 Mo Squamous cell carcinoma below left eye Treated with 40 Gy to a 3 mm depth Pre-treatment 20 Mo Squamous cell carcinoma on left cheek Treated with 40 Gy to a 5 mm depth Pre-treatment 1 Yr Squamous cell carcinoma on right antihelix Treated with 40 Gy to a 3 mm depth Pre-treatment 1 Yr Basal cell carcinoma on right upper eyelid Treated with 40 Gy to a 3 mm depth Pre-treatment 6 Mo Squamous cell carcinoma on left postauricular scalp Treated with 40 Gy to a 5 mm depth Pre-treatment 3 Mo Conclusions • As of date, treatment of non-melanoma skin cancer with HDR electronic brachytherapy using surface applicators was effective and convenient comparable to Ir-192 HDR brachytherapy • Cosmesis was good to excellent up to 2 years post-treatment • Toxicities were acceptable • No recurrences to date, but longer follow up is being collected • Brachytherapy (electronic or traditional) is an ideal modality for patients (especially elderly patients) with NMSC given the excellent results and convenient schedule • We (Radiation Oncology) need to take a more prominent role in the treatment of NMSC