Table 1 Patient characteristics at baselinea

From: Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial

Characteristic

N = 15

Sex: n (%)

 Female

14 (93.3)

 Male

1 (6.7)

Age: median (range)

 Age at baseline (years)

69 (30–76)

ECOG performance status: n (%)

 ECOG 0

9 (60)

 ECOG 1

6 (40)

Presence of neurological symptoms at baseline: n (%)

 Yes

6 (40)

 No

9 (60)

Disease subtype: n (%)

 HER2-positive/luminal B

12(80)

 HER2-positive/nonluminal

3 (20)

Disease stage at primary diagnosis: n (%)

 Stage IV

10 (66.7)

 Stage I–III

5 (33.3)

Brain metastasis-free survival (BMFS): median (range)

 BMFS from diagnosis of metastatic disease (months)

17 (0-48)

Brain-only disease: n (%)

 Yes

2 (13.3)

 No

13 (86.7)

Visceral metastases: n (%)

 Yes

12 (80)

 No

3 (20)

GPA indexb at baseline: n (%)

 GPA 2.5

3 (20)

 GPA 3.0

11 (73.3)

 GPA 3.5

1 (6.7)

Previous HER2-directed therapy: n (%)

 Trastuzumab + pertuzumab

15 (100)

 T-DM1

9 (60)

 Lapatinib

4 (26.7)

 Other

1 (6.7)

Status of brain metastases; n (%)

 Untreated

6 (40)

 Primary brain metastases after previous local therapy

9 (60)

Type of previous local therapy for brain metastases: n (%)

 WBRT

3 (20)

 WBRT + SRT/SRS and/or neurosurgery

3 (20)

 SRT/SRS

3 (20)

Time from last previous local intervention to inclusion: median (range)

 Time from last local treatment (months)

13 (5–65)

Previous lines of treatment for metastatic breast cancer: median (range)

Number of previous lines of treatment before trastuzumab deruxtecan

2 (1–5)

  1. aN, Number of patients in the ITT population; n, number of patients.
  2. bGPA, Graded Prognostic Assessment, breast cancer specific. Sparduto P. W. et al. Beyond an updated Graded Prognostic Assessment (Breast GPA): a prognostic index and trends in treatment and survival in breast cancer brain metastases from 1985 to today. Int. J. Radiat. Oncol. Biol. Phys. 107, 334–343 (2020).