Intracranial Efficacy of Pyrotinib and Capecitabine Combination Therapy in HER2-Positive Breast Cancer with Brain Metastases

Figures & data

Table 1 Baseline Demographics and Clinical Characteristics of Enrolled Breast Cancer Patients

Variable	Total
Total (n = 56)	56
Age
< 65	37
≥ 65	19
ECOG
0	18
1	35
2	3
Hormone receptor
Estrogen and/or progesterone receptor positive	33
Estrogen and progesterone receptor negative	23
Prior lines of treatment
0	16
1	28
2	11
≥3	1
Previous anti-HER2 antibody treatment
Trastuzumab	56
Pertuzumab	10
Inetetamab	3
T-DM1	2
BAT8001	0
No	0
Measurable metastatic sites
Only Intracranial metastasis	19
Intracranial and extracranial metastases	37
BM treatment status at baseline
Untreated (A)	22
Treated and stable (B)	20
Treated and progressing (C)	14
Prior therapy for BMs
Surgery	1
SRT	21
WBRT	12
No	22

Abbreviations: ECOG, Eastern Cooperative Oncology Group; HER2, Human Epidermal Growth Factor Receptor 2; BM, brain metastases; SRT, Stereotactic Radiation Therapy; WBRT, whole brain radiotherapy.

Table 2 Summary of the Pathologic Response

Variable	Total	A	B	C
Total (n = 56)	56	22	20	14
Best overall response
CR	4	3	1	0
PR	29	13	10	6
SD	16	5	6	5
PD	7	1	3	3
CNS-ORR (%)	58.93	72.73	55.00	42.86
CNS-DCR (%)	82.14	90.91	80.00	71.43

Abbreviations: CR, Complete response; PR, Partial response; SD, Stable disease; PD, Progressive disease; ORR, Objective response rate; DCR, Disease control rate.

Figure 1 (A–C) Swimmer-style clinical follow-up plot detailing the clinical course of all enrolled patients in Cohort A–C. (D) Kaplan–Meier curves for progression-free survival for patients in Cohort A–C.

Figure 2 Overall QoL score (A), physical function score (B), emotional function score (C), and cognitive function score (D) of patients in Cohort A–C during treatment period.

Table 3 Treatment- Related Adverse Events (TRAEs)

Adverse Event	Cohort A (n=22)		Cohort B (n=20)		Cohort C (n=14)		Total (n=56)
	Grade 3–4	All Grade	Grade 3–4	All Grade	Grade 3–4	All Grade	Grade 3–4	All Grade
Diarrhea	6	21	4	18	3	14	13	53
Hand-foot syndrome	2	14	2	10	1	8	5	32
Anaemia	1	13	2	12	1	8	4	33
Decreased WBC count	4	9	3	8	3	6	10	23
Decreased neutrophil count	4	8	3	8	3	5	10	21
Vomiting	0	10	0	9	1	8	1	27
Nausea	0	10	0	10	0	9	0	29
Decreased appetite	0	6	0	6	0	4	0	16
ALT/AST increased	0	8	0	6	0	4	0	18
TBIL increased	0	9	0	9	0	6	0	24
Asthenia	0	4	0	4	0	4	0	12
Rash	0	1	0	0	0	1	0	2
Weight loss	0	5	0	5	0	3	0	13
Hypokalemia	3	6	2	9	2	7	7	22

Data Sharing Statement

All data included in this study are available upon request by contact with the corresponding author.