Table 1 Patient and tumor characteristics (per-protocol set, N = 386)

From: Axillary surgery in patients with sentinel node macrometastases: secondary results of the randomized INSEMA trial

Parameter

Category

cALND N (%)

N = 169

SLNB alone N (%)

N = 217

Overall N (%)

N = 386

Age

<35 years

1 (0.6)

0 (0.0)

1 (0.3)

35 to <50 years

29 (17.2)

34 (15.7)

63 (16.3)

50 to <60 years

60 (35.5)

75 (34.6)

135 (35.0)

60 to <70 years

47 (27.8)

57 (26.3)

104 (26.9)

≥70 years

32 (18.9)

51 (23.5)

83 (21.5)

BMI

<30 kg/m2

117 (69.2)

164 (75.6)

281 (72.8)

≥30 kg/m2

52 (30.8)

53 (24.4)

105 (27.2)

Preoperative tumor sizea

≤2 cm

139 (82.2)

174 (80.2)

313 (81.1)

>2 cm

30 (17.8)

43 (19.8)

73 (18.9)

Pathological tumor size

pTis

0 (0.0)

1 (0.5)

1 (0.3)

pT1

99 (58.6)

129 (59.4)

228 (59.1)

pT2

68 (40.2)

84 (38.7)

152 (39.4)

pT3

2 (1.2)

3 (1.4)

5 (1.3)

Number of involved SLNs (only macrometastases)

1

127 (75.2)

171 (78.8)

298 (77.2)

2

34 (20.1)

41 (18.9)

75 (19.4)

3

8 (4.7)

5 (2.3)

13 (3.4)

Number of all involved LNs (SLNB + cALND)

1–3

150 (88.8)

  

4–9

19 (11.2)

ER/PgR status

Negative

2 (1.2)

5 (2.3)

7 (1.8)

Positive

167 (98.8)

212 (97.7)

379 (98.2)

HER2 status

Negative

162 (95.9)

205 (94.9)

367 (95.3)

Positive

7 (4.1)

11 (5.1)

18 (4.7)

Missing

0

1

1

Intrinsic subtype

HR+/HER2−

160 (94.7)

201 (93.1)

361 (93.8)

TNBC

2 (1.2)

4 (1.9)

6 (1.6)

HER2+

7 (4.1)

11 (5.1)

18 (4.7)

Missing

0

1

1

Tumor grading

G1

45 (26.6)

63 (29.0)

108 (28.0)

G2

115 (68.0)

143 (65.9)

258 (66.8)

G3

9 (5.3)

11 (5.1)

20 (5.2)

Ki-67

≤20%

128 (76.6)

176 (84.6)

304 (81.1)

>20%

39 (23.4)

32 (15.4)

71 (18.9)

Missing

2

9

11

Histological subtype

Invasive carcinoma (NST)

125 (74.0)

155 (71.4)

280 (72.5)

Invasive or mixed lobular carcinoma

22 (13.0)

25 (11.5)

47 (12.2)

Other

22 (13.0)

37 (17.1)

59 (15.3)

  1. BMI body mass index, SLN sentinel lymph node, SLNB sentinel lymph node biopsy, LN lymph node, ER estrogen receptor, PgR progesterone receptor, NST no special type, cALND completion axillary lymph node dissection.
  2. aBased on the results of sonography. If those were missing, results from other assessments were used in the following order: mammography and magnetic resonance imaging.