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Table 1 Patient demographic characteristics according to regimen after T-DM1

From: Real-world effectiveness of post-trastuzumab emtansine treatment in patients with HER2-positive, unresectable and/or metastatic breast cancer: a retrospective observational study (KBCSG-TR 1917)

 

All

(N = 128)

Regimen after T-DM1

Anti-HER2 therapy

(n = 105)

Without anti-HER2 therapy

(n = 23)

Age (years)

 Median (range)

59.0 (27–84)

60.0 (36–84)

57.0 (27–78)

  ≥ 60 years

62 (48.4)

54 (51.4)

8 (34.8)

ECOG PS

 0

67 (52.3)

57 (54.3)

10 (43.5)

 1

25 (19.5)

20 (19.0)

5 (21.7)

  ≥ 2

9 (7.0)

6 (5.7)

3 (13.0)

 Unknown

27 (21.1)

22 (21.0)

5 (21.7)

Hormone receptor status

 Positive

83 (64.8)

66 (62.9)

17 (73.9)

 Negative

43 (33.6)

38 (36.2)

5 (21.7)

 Unknown

2 (1.6)

1 (1.0)

1 (4.3)

HER2 status

 IHC3+

104 (81.3)

83 (79.0)

21 (91.3)

 IHC2+ and ISH+

21 (16.4)

19 (18.1)

2 (8.7)

 IHC not performed and ISH + a

3 (2.3)

3 (2.9)

0 (0.0)

Type of metastatic breast cancer

 De novob

46 (35.9)

39 (37.1)

7 (30.4)

 Recurrent

82 (64.1)

66 (62.9)

16 (69.6)

 Disease-free interval (months), median (range)c

39.59 (7.9–198.3)

39.59 (7.9–198.3)

42.00 (9.9–193.8)

Metastatic stie at initial metastatic diagnosis

 Liver

42 (32.8)

34 (32.4)

8 (34.8)

 Lung

36 (28.1)

33 (31.4)

3 (13.0)

 Bone

44 (34.4)

37 (35.2)

7 (30.4)

 Peritoneal dissemination

7 (5.5)

6 (5.7)

1 (4.3)

 Ascites

0 (0.0)

0 (0.0)

0 (0.0)

 CNS

5 (3.9)

5 (4.8)

0 (0.0)

 Skin/subcutaneous soft tissues

17 (13.3)

14 (13.3)

3 (13.0)

 Lymph nodes

60 (46.9)

50 (47.6)

10 (43.5)

 Others

6 (4.7)

5 (4.8)

1 (4.3)

Drug therapy prior to T-DM1 treatment

Anti-HER2 therapy

  Trastuzumab

120 (93.8)

99 (94.3)

21 (91.3)

  Pertuzumab

72 (56.3)

58 (55.2)

14 (60.9)

  Lapatinib

36 (28.1)

28 (26.7)

8 (34.8)

  None

6 (4.7)

5 (4.8)

1 (4.3)

Chemotherapy

  Anthracycline-based

64 (50.0)

50 (47.6)

14 (60.9)

  Taxane-based

108 (84.4)

88 (83.8)

20 (87.0)

  Paclitaxel

56 (43.8)

42 (40.0)

14 (60.9)

  Docetaxel

80 (62.5)

67 (63.8)

13 (56.5)

  Neither anthracycline nor taxane

19 (14.8)

16 (15.2)

3 (13.0)

  Capecitabine/S-1

47 (36.7)

34 (32.4)

13 (56.5)

No. of chemotherapy treatments before T-DM1 in any setting

 0

13 (10.2)

11 (10.5)

2 (8.7)

 1

36 (28.1)

32 (30.5)

4 (17.4)

 2

25 (19.5)

21 (20.0)

4 (17.4)

  ≥ 3

54 (42.2)

41 (39.0)

13 (56.5)

Duration from initial metastatic diagnosis to the start of T-DM1 treatment (months)

 Median (range)

22.00 (0.03–174.9)

Best response with T-DM1

 CR, PR

46 (35.9)

42 (40.0)

4 (17.4)

 SD, non-CR/non-PD, PD

80 (62.5)

62 (59.0)

18 (78.3)

 Unknown

2 (1.6)

1 (1.0)

1 (4.3)

Duration of T-DM1 treatment (months)

 Median (range)

5.09 (0.03–41.4)

5.78 (0.7–41.4)

2.33 (0.03–26.5)

  < 6 months

74 (57.8)

54 (51.4)

20 (87.0)

  ≥ 6 to < 12 months

30 (23.4)

29 (27.6)

1 (4.3)

  ≥ 12 months

24 (18.8)

22 (21.0)

2 (8.7)

Reason for T-DM1 treatment discontinuation

 Disease progression

102 (79.7)

82 (78.1)

20 (87.0)

 Toxicity

21 (16.4)

19 (18.1)

2 (8.7)

 Other

5 (3.9)

4 (3.8)

1 (4.3)

Metastatic site at start of drug therapy after T-DM1 treatment discontinuation

 Viscera

89 (69.5)

72 (68.6)

17 (73.9)

 Skin/subcutaneous soft tissues/lymph nodes

76 (59.4)

64 (61.0)

12 (52.2)

 Bone

53 (41.4)

42 (40.0)

11 (47.8)

 CNS

17 (13.3)

15 (14.3)

2 (8.7)

 Other

9 (7.0)

8 (7.6)

1 (4.3)

  1. Data are n (%) unless otherwise indicated
  2. aThe study protocol states that “IHC3+ or IHC2+/ISH+ tumors are defined as HER2-positive”. However, at the case review meeting, it was determined that study patients with “IHC not performed and ISH+” who underwent anti-HER2 therapy were to be regarded as HER2-positive
  3. bDefined as Stage IV (Any T + Any N + M1) or recurrence within 6 months after the start of initial treatment
  4. cA single missing case was excluded from recurrent cases
  5. CNS central nervous system, CR complete response, ECOG PS Eastern Cooperative Oncology Group Performance Status, HER2 human epidermal growth factor receptor 2, IHC immunohistochemistry, ISH in situ hybridization, PD progressive disease, PR partial response, SD stable disease, T-DMI trastuzumab emtansine