Post-surgical treatment of early-stage breast cancer with electronic brachytherapy: an intersociety, multicenter brachytherapy trial

Figures & data

Figure 1 Electronic source.

Table 1 Patient characteristics at baseline

Number of patients	69
Mean age in years (range)	67.5 (43.4–85.3)
Female	69 (100%)
Menopausal status
Post-menopausal	64 (92.7%)
Peri-menopausal	2 (2.9%)
Pre-menopausal	3 (4.4%)
Race
Caucasian	54 (78.3%)
African-American	13 (18.8%)
Hispanic	1 (1.5%)
Asian	1 (1.5%)

Table 2 Tumor characteristics at baseline

Tumor size (mean and range) N = 65a	1.2 (0.1–3.0) cm
Initial volume of excised tissue (mean and range)	161.6 (7.20–690.00) mL
Tumor characteristics in all patients	69 (100%)
AJCC class
Tis	20 (29.0%)
T1a	8 (11.6%)
T1b	18 (26.1%)
T1c	20 (29.0%)
T2	3 (4.4%)
Histopathologic grade
Grade 1 well differentiated	19 (27.5%)
Grade 2 moderately differentiated	21 (30.4%)
Grade 3 poorly differentiated	12 (17.4%)
Grade not available	17 (24.6%)
Lesion location (side)
Left side	42 (60.9%)
Right side	27 (39.1%)
Lesion location (vertical)
Upper	44 (63.8%)
Lower	8 (11.6%)
Midline	17 (24.6%)
Lesion location (horizontal)
Outer	38 (55.1%)
Inner	15 (21.7%)
Midline	16 (23.2%)

a Note: Tumor size not recorded in the medical chart of four DCIS patients.

Abbreviation: AJCC, American Joint Committee on Cancer.

Table 3 Applicator sizes used and respective saline volumes

Applicator sizes used and saline instilled (0.9NS) in mL
Final applicator model
Balloon applicator diameters	3–4 cm spherical	4–5 cm spherical	5–6 cm spherical	5 × 7 cm ellipsoidal
N	17	39	12	1
Mean (mL)	36.47	53.41	89.58	140.00
Std Dev (mL)	6.06	9.38	21.37	–
Min (mL)	30.00	30.00	60.00	140.00
Max (mL)	45.00	75.00	130.00	140.00

Abbreviations: NS, normal saline; Std Dev, standard deviation; Min, minimum; Max, maximum.

Table 4 Grade 1 adverse events. Adverse events that were possibly, probably, or definitely related to applicator placement or radiation therapy as reported at each follow-up visit unless otherwise noted

Grade 1 events	1 month	6 months	1 year
Number of patients	68a	59	37
Induration/firmness-slight	25 (36.8%)b	14 (23.7%)	5 (13.5%)
Erythema	27 (39.7%)c	1 (1.7%)	1 (2.7%)
Breast tenderness	14 (20.6%)d	11 (18.6%)	4 (10.8%)
Hyperpigmentation	14 (20.6%)	6 (10.2%)	2 (5.4%)
Pruritis	14 (20.6%)	2 (3.4%)	1 (2.7%)
Field contracture-slight indent in skin	7 (10.3%)	6 (10.2%)e	2 (5.4%)
Seroma	8 (11.8%)	4 (6.8%)	4 (10.8%)
Rash/desquamation-dry	9 (13.2%)	0	0
Palpable mass	3 (4.4%)e	2 (3.4%)	4 (10.8%)
Rash/desquamation-moist	6 (8.8%)	0	0
Breast edema	3 (4.4%)	1 (1.7%)	1 (2.7%)
Infection	0	1 (1.7%)	0
Loss of subcutaneous tissue on palpation	1 (1.5%)	1 (1.7%)	1 (2.7%)
Atrophy-slight	2 (2.9%)	0	1 (2.7%)
Hypopigmentation	1 (1.5%)	2 (3.4%)	1 (2.7%)
Telangiectasia	2 (2.9%)	1 (1.7%)	0
Lymphedema	0	2 (3.4%)	0
Pigmentation change	(1.5%)	0	0
Bleeding at treated site	1 (1.5%)	0	0
Blistering	1 (1.5%)	0	0
Skin thickening	0	1 (1.7%)	0
Wound dehiscence (wound complication – noninfection)	1 (1.4%)	0	0

a Notes: One of the 69 treated patients did not complete the 1-month follow-up visit due to an acute myocardial infarction and subsequent death; no treatment-related adverse events occurred in this patient;

b Includes one unscheduled visit around 1 month post-treatment;

c Includes three treatment visits and one unscheduled visit around 1 month;

d Includes two unscheduled visits around 1 month post-treatment and one Balloon Applicator Insertion visit;

e Includes one occurrence in the nontreated breast;

f Includes one with an indurated scar.

Table 5 Grade 2 and 3 adverse events. Adverse events that were possibly, probably, or definitely related to applicator placement or radiation therapy as reported at each follow-up visit

	1 month	6 months	1 year
Grade 2 events
Number of patients	68a	59	37
Induration/firmness	4 (5.9%)	3 (5.1%)	1 (2.7%)
Erythema	4 (5.9%)	0	1 (2.7)d
Seroma	1 (1.5%)	2 (3.4%)c	1 (2.7%)
Rash/desquamation – moist	3 (4.4%)b	0	0
Breast tenderness	1 (1.5%)	1 (1.7%)	0
Hypopigmentation	2 (2.9%)	0	0
Palpable mass	2 (2.9%)	0	0
Field contracture – slight indent in skin	0	0	1 (2.7%)
Field contracture – significant	0	1 (1.7%)	0
Infection	1 (1.5%)	0	0
Grade 3 eventse
Field contracture – significant	1 (1.5%)	0	0
Fibrosis connective tissue	0	0	1 (2.7%)c

a Notes: One of the 69 treated patients did not complete the 1-month follow-up visit due to an acute myocardial infarction and subsequent death; no treatment-related adverse events occurred in this patient;

b Includes three unscheduled visits around 1 month post-treatment;

c Includes one unscheduled visit around 6 months post-treatment;

d Includes one unscheduled visit around 1 year post-treatment;

e One patient had Grade 3 diarrhea that was related to a Clostridium difficile infection due to a prophylactic antibiotic.