Real-world clinical scenarios during introduction of trastuzumab biosimilar for HER2-positive breast cancer in the European Union

Figures & data

Figure 1. Study schema.

Adapted from [32].

Figure 2. Patient enrollment.

Adapted from [32].

Table 1. Patient baseline demographics/enrollment and disease history characteristics.

	Treatment setting at trastuzumab-anns initiation			Trastuzumab-anns initiation status
	Adjuvant (N = 167)	Neoadjuvant (N = 159)	Metastatic (N = 162)	Naive new starter (N = 344)	Switcher (N = 144)	All subjects (N = 488)
Median age, years (min/max)	55 (28, 85)	52 (30, 84)	59 (31, 87)	55 (28, 87)	57 (31, 86)	56 (28, 87)
Mean weight, kg (SD)	66.3 (12.2)	68.0 (13.5)	70.4 (14.4)	68.1 (13.2)	68.3 (14.1)	68.2 (13.4)
Female sex, n (%)	166 (99.4)	157 (98.7)	160 (98.8)	341 (99.1)	142 (98.6)	483 (99.0)
Mean time from trastuzumab-anns initiation to enrollment, months (SD)^†	7.55 (6.88)	5.93 (5.88)	10.50 (7.13)	6.70 (6.46)	11.12 (6.95)	8.00 (6.91)
Mean time from initial breast cancer diagnosis to trastuzumab-anns initiation, months (SD)^‡	7.21 (13.07)	3.58 (5.99)	50.04 (59.97)	7.36 (20.58)	50.00 (58.15)	19.37 (40.25)
ER/PR status at diagnosis, n (%)
Negative	41 (24.6)	50 (31.4)	59 (36.4)	99 (28.8)	51 (35.4)	150 (30.7)
Positive	123 (73.7)	106 (66.7)	98 (60.5)	239 (69.5)	88 (61.1)	327 (67.0)
Unknown	3 (1.8)	3 (1.9)	5 (3.1)	6 (1.7)	5 (3.5)	11 (2.3)
Breast cancer stage at trastuzumab-anns initiation, n (%)
0^§	3 (1.8)	1 (0.6)	0	4 (1.2)	0	4 (0.8)
I	54 (32.3)	22 (13.8)	0	71 (20.6)	5 (3.5)	76 (15.6)
II	54 (32.3)	86 (54.1)	1 (0.6)	125 (36.3)	16 (11.1)	141 (28.9)
III	34 (20.4)	35 (22.0)	5 (3.1)	60 (17.4)	14 (9.7)	74 (15.2)
IV	5 (3.0)	1 (0.6)	144 (88.9)	56 (16.3)	94 (65.3)	150 (30.7)
Unknown/missing	17 (10.2)	14 (8.8)	12 (7.4)	28 (8.1)	15 (10.4)	43 (8.8)

† Time between enrollment date and trastuzumab-anns initiation date = (date of enrollment – date of trastuzumab-anns initiation + 1) × (12 ÷ 365.25).

‡ Time between date of initial BC diagnosis and date of trastuzumab-anns initiation = (date of trastuzumab-anns Initiation – date of BC diagnosis + 1) × (12 ÷ 365.25).

§ Ductal carcinoma in situ HER2+.

BC: Breast cancer; ER: Estrogen receptor; N: Number of subjects in analysis set; n: Number of subjects with observed data; PR: Progesterone receptor; SD: Standard deviation.

Adapted from [32].

Figure 3. Treatment settings.

(A) Patient trastuzumab status at trastuzumab-anns initiation. (B) Switcher patient trastuzumab treatment history.

^aPercentages based on the numbers of switches.

iv.: Intravenous; SC: Subcutaneous.

Adapted from [32].

Table 2. Distribution of trastuzumab-anns use across treatment settings.

Pre-trastuzumab-anns treatment setting	Treatment setting at trastuzumab-anns initiation			Trastuzumab-anns initiation status
	Adjuvant (N = 167) n (%)	Neoadjuvant (N = 159) n (%)	Metastatic (N = 162) n (%)	Naïve new starter (N = 344) n (%)	Switcher (N = 144) n (%)	All subjects (N = 488) n (%)
Adjuvant	56 (33.5)	2 (1.3)	1 (0.6)	45 (13.1)	14 (9.7)	59 (12.1)
Neoadjuvant	4 (2.4)	93 (58.5)	3 (1.9)	89 (25.9)	11 (7.6)	100 (20.5)
Maintenance	1 (0.6)	0	0	0	1 (0.7)	1 (0.2)
Metastatic	1 (0.6)	0	19 (11.7)	2 (0.6)	18 (12.5)	20 (4.1)
Line of therapy for metastatic setting^†
First	1 (100)	0	10 (52.6)	2 (100)	9 (50.0)	11 (55.0)
Second	0	0	1 (5.3)	0	1 (5.6)	1 (5.0)
Third	0	0	3 (15.8)	0	3 (16.7)	3 (15.0)
Fifth or later^‡	0	0	4 (21.1)	0	4 (22.2)	4 (20.0)
Maintenance	0	0	1 (5.3)	0	1 (5.6)	1 (5.0)
Other	0	0	0	0	0	0

† Latest line of therapy for metastatic setting prior to trastuzumab-anns initiation. Percentages are of those who had metastatic setting pre-trastuzumab-anns treatment.

‡ No patients were in the fourth line of therapy for any treatment setting.

N: Number of subjects in the analysis set; n: Number of subjects with observed data.

Adapted from [32].

Table 3. Treatment status at trastuzumab-anns initiation.

	Adjuvant (N = 167) n (%)	Neoadjuvant (N = 159) n (%)	Metastatic (N = 162) n (%)	All subjects (N = 488) n (%)
Naive new starter	133 (79.6)	145 (91.2)	66 (40.7)	344 (70.5)
Switcher	34 (20.4)	14 (8.8)	96 (59.3)	144 (29.5)
From originator iv.^†	15 (44.1)	8 (57.1)	46 (47.9)	69 (47.9)
From originator SC^†	6 (17.6)	0	16 (16.7)	22 (15.3)
From trastuzumab-pkrb^†	1 (2.9)	0	2 (2.1)	3 (2.1)
From trastuzumab-dttb^†	0	0	0	0
From ado-trastuzumab emtansine^†	3 (8.8)	0	1 (1.0)	4 (2.8)
From trastuzumab other^†	3 (8.8)	1 (7.1)	1 (1.0)	5 (3.5)
From trastuzumab unknown brand^†	6 (17.6)	5 (35.7)	30 (31.3)	41 (28.5)

† Percentages based on numbers of switchers.

iv.: Intravenous; N: Number of subjects in analysis set; n: Number of subjects with observed data; SC: Subcutaneous.

Adapted from [32].

Figure 4. Treatment status at end of study.

(A) Patient trastuzumab-anns treatment status^a. (B) Reasons for trastuzumab-anns discontinuation^b.

^aPatients with missing trastuzmab-anns end date and reason are treated as ongoing patients.

^bDose administration error and pregnancy each reported as 0.

Adapted from [32].

Table 4. Safety summary and TEAEs of interest.

	Treatment setting at trastuzumab-anns initiation			Trastuzumab-anns initiation status
	Adjuvant (N = 167) n (%)	Neoadjuvant (N = 159) n (%)	Metastatic (N = 162) n (%)	Naïve new starter (N = 344) n (%)	Switcher (N = 144) n (%)	All subjects (N = 488) n (%)
Number of subjects reporting TEAE, n (%)	31 (18.6)	42 (26.4)	38 (23.5)	80 (23.3)	31 (21.5)	111 (22.7)
Grade ≥2	13 (7.8)	32 (20.1)	23 (14.2)	50 (14.5)	18 (12.5)	68 (13.9)
Grade ≥3	4 (2.4)	8 (5.0)	12 (7.4)	14 (4.1)	10 (6.9)	24 (4.9)
Grade ≥4	1 (0.6)	0	7 (4.3)	4 (1.2)	4 (2.8)	8 (1.6)
Serious	8 (4.8)	8 (5.0)	15 (9.3)	22 (6.4)	9 (6.3)	31 (6.4)
Leading to trastuzumab-anns discontinuation	0	1 (0.6)	1 (0.6)	1 (0.3)	1 (0.7)	2 (0.4)
Life-threatening AEs n (%)	1 (0.6)	1 (0.6)	3 (1.9)	5 (1.5)	0	5 (1.0)
Fatal AEs	1 (0.6)	0	6 (3.7)	3 (0.9)	4 (2.8)	7 (1.4)
Number of subjects reporting TEAE of interest (%)	18 (10.8)	28 (17.6)	23 (14.2)	53 (15.4)	16 (11.1)	69 (14.1)
Cardiac dysfunction	2 (1.2)	3 (1.9)	6 (3.7)	9 (2.6)	2 (1.4)	11 (2.3)
Administration/infusion-related reactions	0	0	1 (0.6)	1 (0.3)	0	1 (0.2)
Neutropenia	8 (4.8)	17 (10.7)	3 (1.9)	25 (7.3)	3 (2.1)	28 (5.7)
Pulmonary disorders	6 (3.6)	4 (2.5)	4 (2.5)	13 (3.8)	1 (0.7)	14 (2.9)
Infections	6 (3.6)	10 (6.3)	13 (8.0)	17 (4.9)	12 (8.3)	29 (5.9)

Grading categories determined using Common Terminology Criteria for Adverse Events version 4.0; a TEAE is any reportable adverse event (protocol-exempted events) starting on or after the first dose of trastuzumab-anns and up to the last dose of trastuzumab-anns + 30 days.

AE: Adverse event; N: Number of subjects in the analysis set; n: Number of subjects with observed data; TEAE: Treatment-emergent adverse event.

Adapted from [32].

Wyrwicz L , RodríguezSánchez CA , Sánchez-RoviraP , LewisS , SandschaferD , SanT. Real-World Clinical Scenarios During Introduction of Trastuzumab Biosimilar for HER2-Positive Breast Cancer. Poster presented at: European Society for Medical Oncology.Paris, France, 9–13 September 2022.

 Google Scholar