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Front Oncol: The efficacy of trastuzumab biosimilar CT-P6 in HER2-positive early stage (EBC) and metastatic breast cancer (MBC) patients in the real world

 Last Update: 2021-11-02
 Source: Internet
 Author: User

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Breast cancer is a heterogeneous disease with multiple subtypes
.
Human epidermal growth factor receptor 2 (HER2) is amplified in approximately 25% of breast cancers, resulting in a more aggressive phenotype and a poor prognosis

Breast cancer is a heterogeneous disease with multiple subtypes

The study retrospectively investigated the medical records of the South Korean Severance Breast Cancer Registry

254 patients with HER2-positive EBC were analyzed

103 patients with HER2-positive MBC were analyzed

For EBC patients, there was no difference in the percentage of pCR obtained between the two groups

pCR

The median follow-up time (range) of MBC patients treated with CT-P6 and RTZ was 23.

0 (3.

The median follow-up time (range) of MBC patients treated with CT-P6 and RTZ was 23.

Prognosis of MBC patients

The prognosis of MBC patients The prognosis of MBC patients The prognosis of MBC patients

There was no significant difference in ORR and DCR between the two groups (ORR: CT-P6 vs RTZ 78.

9% vs 83.

There was no significant difference in ORR and DCR between the two groups (ORR: CT-P6 vs RTZ 78.

Evaluation of the efficacy of MBC

In the EBC cohort, there was no difference in the LVEF rate before treatment between the two groups (mean [95% CI] LVEF: CT-P6: 68.

1 [60.
7-69.
1] vs RTZ: 68.
1% [67.
1-69.
1]; P = 0.
983) or neoadjuvant There was no difference after treatment (CT-P6: 65.
9% [65.
0-66.
8] vs RTZ: 66.
5% [65.
3-67.
7]; P=0.
424)
.
After neoadjuvant chemotherapy, 23/104 patients (22.
1%) in the CT-P6 group had a LVEF decrease of ≥10% from baseline, while it was 13/90 (14.
4%) in the RTZ group (P=0.
171)
.
The LVEF of the two groups of patients did not drop below 50% at any time
.

In the EBC cohort, there was no difference in the LVEF rate before treatment between the two groups (mean [95% CI] LVEF: CT-P6: 68.
1 [60.
7-69.
1] vs RTZ: 68.
1% [67.
1-69.
1]; P = 0.
983) or neoadjuvant There was no difference after treatment (CT-P6: 65.
9% [65.
0-66.
8] vs RTZ: 66.
5% [65.
3-67.
7]; P=0.
424)
.
After neoadjuvant chemotherapy, 23/104 patients (22.
1%) in the CT-P6 group had a LVEF decrease of ≥10% from baseline, while it was 13/90 (14.
4%) in the RTZ group (P=0.
171)
.
The LVEF of the two groups of patients did not drop below 50% at any time
.
In the EBC cohort, there was no difference in the LVEF rate before treatment between the two groups (mean [95% CI] LVEF: CT-P6: 68.
1 [60.
7-69.
1] vs RTZ: 68.
1% [67.
1-69.
1]; P = 0.
983) or neoadjuvant There was no difference after treatment (CT-P6: 65.
9% [65.
0-66.
8] vs RTZ: 66.
5% [65.
3-67.
7]; P=0.
424)
.
After neoadjuvant chemotherapy, 23/104 patients (22.
1%) in the CT-P6 group had a LVEF decrease of ≥10% from baseline, while it was 13/90 (14.
4%) in the RTZ group (P=0.
171)
.
The LVEF of the two groups of patients did not drop below 50% at any time
.

In the MBC cohort, both CT-P6 and RTZ showed manageable cardiac safety, which was assessed by LVEF
.
Of the 38 patients in the CT-P6 group, 19 (50.
0%) had a LVEF decrease of ≥10% from baseline, while the RTZ group was 27/63 (42.
9%) (P=0.
695)
.
Among patients treated with CT-P6, 3/38 (7.
9%) of patients had LVEF dropped to less than 50% at any time
.
One of the patients stopped CT-P6 for 1 month and then restarted; the rest of the patients continued the treatment, and the treatment was stopped after 3 months due to the progress of the disease
.
Among patients treated with RTZ, 4/65 (6.
2%) had LVEF dropped to less than 50% at any time
.
Two of the patients discontinued RTZ treatment, one patient resumed treatment after one month of discontinuation, and the other continued to use RTZ treatment
.

In the MBC cohort, both CT-P6 and RTZ showed manageable cardiac safety, which was assessed by LVEF
.
Of the 38 patients in the CT-P6 group, 19 (50.
0%) had a LVEF decrease of ≥10% from baseline, while the RTZ group was 27/63 (42.
9%) (P=0.
695)
.
Among patients treated with CT-P6, 3/38 (7.
9%) of patients had LVEF dropped to less than 50% at any time
.
One of the patients stopped CT-P6 for 1 month and then restarted; the rest of the patients continued the treatment, and the treatment was stopped after 3 months due to the progress of the disease
.
Among patients treated with RTZ, 4/65 (6.
2%) had LVEF dropped to less than 50% at any time
.
Two of the patients discontinued RTZ treatment, one patient restarted treatment after one month of discontinuation, and the other continued to use RTZ treatment
.
In the MBC cohort, both CT-P6 and RTZ showed manageable cardiac safety, which was assessed by LVEF
.
Of the 38 patients in the CT-P6 group, 19 (50.
0%) had a LVEF decrease of ≥10% from the baseline, while the RTZ group was 27/63 (42.
9%) (P=0.
695)
.

In summary, real-world data show that trastuzumab biosimilar CT-P6 has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients
.

In summary, real-world data show that trastuzumab biosimilar CT-P6 has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients
.
Real-world data indicate that the trastuzumab biosimilar CT-P6 has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients
.
Real-world data indicate that the trastuzumab biosimilar CT-P6 has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients
.

Original source:

Bae SJ, Kim JH, Ahn SG, Jeung HC, Sohn J, Kim GM, Kim MH, Kim SI, Park S, Park HS, Kim JY and Jeong J (2021) Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6 ) in HER2-Positive Early-Stage and Metastatic Breast Cancer.
Front.
Oncol.
11:689587.
doi: 10.
3389/fonc.
2021.
689587

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