Patient/Tumor Characteristics | EBT | IBT |
---|---|---|
Number of Patients Enrolled | 65 | 75 |
Number of Patients Treated | 44 (67.7%) | 43 (57.3%) |
Age: mean (range) | 64 years (45-84) | 69 years (50-90) |
Menopausal Status: n (%) | Â | Â |
   Pre-Menopausal | 1 (2.3%) | 0 |
   Peri-Menopausal | 2 (4.6%) | 2 (5%) |
   Post-Menopausal | 41 (93.2%) | 41 (95%) |
Tumor Size: mean (range) | 1.2 cm (0.2-2.8 cm) | 1.0 cm |
AJCC Class: n (%) | Â | Â |
   Tis | 12 (27.3%) | 0 |
   T1a | 1 (2.3%) | 9 (21%) |
   T1b | 8 (18.2%) | 16 (37%) |
   T1c | 21 (47.7%) | 18 (42%) |
   T2 | 2 (4.6%) | 0 |
Histopathologic Grade | Â | Â |
   G1 Well Differentiated | 12 (27.3%) | 17 (40%) |
   G2 Moderately Differentiated | 18 (40.9%) | 16 (37%) |
   G3 Poorly Differentiated | 10 (22.7%) | 6 (14%) |
   Grade Not Available | 4 (9.1%) | 4 (9%) |
Minimum Distance from Balloon to Skin Surface | 6 mm | 5 mm |
Breast Cup Size | Â | Â |
   A | 0 | 1 (2%) |
   B | 12 (27.3%) | 9 (21%) |
   C | 16 (36.4%) | 15 (35%) |
   D+ | 11 (25.0%) | 11 (26%) |
   Not reported | 5 (11.4%) | 7 (16%) |
Cosmesis | EBT | IBT |
   Good - Excellent cosmesis at 1 month | 35/44 (80%) | 38/43 (88%) |
   Good - Excellent cosmesis at 1 year | 24/32 (75%) | -- |
   Good - Excellent cosmesis at 5 years | -- | 35/43 (81%) |
Adverse Events in > 2 patients | EBT a | IBT b |
Blistering | 3 (6.8%) | 2 (3.7%) |
Bruising / hematoma | 1 (2.3%) | 3 (5.6%) |
Catheter Site Drainage | 0 | 28 (51.9%) |
Desquamation, Dry | 2 (4.5%) | 7 (13.0%) |
Desquamation, Moist | 3 (6.8%) | 3 (5.6%) |
Dry Skin (Breast) | 2 (4.5%) | 6 (11.1%) |
Ecchymosis | 1 (2.3%) | 17 (31.5%) |
Edema (breast) | 0 | 8 (14.8%) |
Erythema, redness/rash | 27 (61.4%) | 31 (57.4%) |
Fibrosis | 2 (4.5%) | 3 (5.6%) |
Hyperpigmentation / Hypopigmentation | 9 (20.5%) | 5 (9.3%) |
Induration | 3 (6.8%) | 1 (1.9%) |
Infection | 2 (4.5%) | 2 (3.7%) |
Itching / Pruritis | 4 (9.1%) | 5 (9.3%) |
Pain, tenderness, discomfort | 13 (29.5%) | 23 (42.6%) |
Rash | 0 | 4 (7.4%) |
Seroma | 2 (4.5%) | 6 (11.1%) |
Skin Irritation | 0 | 3 (5.6%) |