Table 1 Demographics and baseline clinical characteristics for patients with and without baseline BMs

From: Trastuzumab deruxtecan in HER2-positive advanced breast cancer with or without brain metastases: a phase 3b/4 trial

 

Patients with baseline BMs (N = 263)

Patients with no baseline BMs (N = 241)

Age, median (range), years

52 (28–86)

54 (24–87)

Female, n (%)

263 (100)

241 (100)

Race, n (%)

 White

231 (87.8)

209 (86.7)

 Black

4 (1.5)

2 (0.8)

 Asian

19 (7.2)

15 (6.2)

 Other

6 (2.3)

13 (5.4)

 Not reported

1 (0.4)

1 (0.4)

 Missing

2 (0.8)

1 (0.4)

HER2 status, n (%)

 2+

2 (0.8)

5 (2.1)

 3+

187 (71.1)

141 (58.5)

 Positivea

74 (28.1)

95 (39.4)

HR status, n (%)b

 HR+

165 (62.7)

150 (62.2)

ECOG PS at baseline, n (%)

  

 0

163 (62.0)

194 (80.5)

 1

100 (38.0)

47 (19.5)

Metastatic sites at baseline, n (%)c

 Bone and locomotor

97 (36.9)

85 (35.3)

 Liver metastases

58 (22.1)

66 (27.4)

 Lung

67 (25.5)

67 (27.8)

Measurable disease at baselined

 Yes

198 (75.3)

215 (89.2)

Prior regimens of anti-cancer therapies for metastatic disease

 Median number of regimens (range)

1.0 (0–4)

1.0 (0–4)

 Number of regimens, n (%)

  

 0

20 (7.6)

18 (7.5)

 1

132 (50.2)

124 (51.5)

 2

109 (41.4)

96 (39.8)

 ≥3

2 (0.8)

3 (1.2)

Prior HER2 inhibitor agents, n (%)e

262 (99.6)

240 (99.6)

 Trastuzumab

258 (98.1)

233 (96.7)

 Pertuzumab

228 (86.7)

207 (85.9)

 T-DM1

106 (40.3)

94 (39.0)

 Lapatinib

11 (4.2)

13 (5.4)

 Neratinib

4 (1.5)

2 (0.8)

 Tucatinibf

2 (0.8)

0

 T-DXd

1 (0.4)

0

 Specific agent not reported

1 (0.4)

0

Prior CNS therapies, n (%)

168 (63.9)

–

 Brain surgery

48 (18.3)

–

 CNS radiotheraphyg

158 (60.1)

–

 WBRT

40 (15.2)

–

 SRS

15 (5.7)

–

 IMRT

16 (6.1)

–

 SBRT

11 (4.2)

–

 Stereotactic intracranial radiotherapy

38 (14.4)

–

 3D conformal

13 (4.9)

–

 Other

44 (16.7)

–

 Missing

10 (3.8)

–

  1. ER, estrogen receptor; HR, hormone receptor; IMRT, intensity-modulated radiation therapy; PR, progesterone receptor; SBRT, stereotactic body radiation therapy.
  2. aHER2 status is positive if the specific HER2 status is unknown.
  3. bHR status is positive if either or both of ER/PR status is positive or is ≥1%. HR status is negative if both ER and PR status are either negative or have a result <1%.
  4. cPatients with metastasis in more than one site are counted once in each of those sites.
  5. d109/157 patients in the stable BMs subgroup and 89/106 patients in the active BMs subgroup had measurable disease at baseline.
  6. eWhere two or more treatments had the same month and year for start date but day was missing, the treatments were assumed to be a combination regimen; treatments were not included if only the year was reported (day and month both missing); patients with multiple occurrences for the same HER2 inhibitor or anti-HER2 combination regimen are counted only once for that inhibitor or regimen; patients with occurrences for more than one HER2 inhibitor or anti-HER2 combination regimen are counted once for each of those inhibitors or regimens.
  7. fTwo patients with prior tucatinib use were recorded as protocol deviations.
  8. g151 patients received intracranial radiotherapy and seven were treated with radiotherapy to spinal cord locations only.
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