Neoadjuvant chemotherapy and HER2 dual blockade including biosimilar trastuzumab (SB3) for HER2-positive early breast cancer: Population based real world data from the Danish Breast Cancer Group (DBCG).
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
Biosimilar Pharmaceuticals
/ administration & dosage
Breast Neoplasms
/ drug therapy
Chemotherapy, Adjuvant
/ methods
Databases, Factual
Denmark
/ epidemiology
Female
Humans
Middle Aged
Neoadjuvant Therapy
/ methods
Receptor, ErbB-2
/ metabolism
Survival Rate
Trastuzumab
/ administration & dosage
Treatment Outcome
Young Adult
Breast cancer
NACT
Neoadjuvant
Ontruzant
Pertuzumab
Real-world
SB3
Trastuzumab
Journal
Breast (Edinburgh, Scotland)
ISSN: 1532-3080
Titre abrégé: Breast
Pays: Netherlands
ID NLM: 9213011
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
28
09
2020
revised:
28
10
2020
accepted:
29
10
2020
pubmed:
14
11
2020
medline:
12
8
2021
entrez:
13
11
2020
Statut:
ppublish
Résumé
Dual blockade with trastuzumab and pertuzumab combined with neoadjuvant chemotherapy (NACT) has been increasingly used for HER2-positive tumours >2 cm and/or with positive axillary lymph nodes in order to evaluate pathologic response and obtain better surgical management. SB3 is a registered biosimilar trastuzumab approved following a phase III trial demonstrating similar efficacy in the neoadjuvant setting as trastuzumab. However, the study was done without pertuzumab. The database of the Danish Breast Cancer Group was used to extract data on all patients who started NACT with SB3 and pertuzumab between September 1, 2018 and August 31, 2019. The primary endpoint was pathological complete response (pCR) rate. In total 215 patients received NACT and dual blockade. The median age was 55 (24-81). NACT used was cyclophosphamide and epirubicin followed by weekly paclitaxel (62% on six cycles, 35% on eight cycles) or other chemotherapy followed by weekly paclitaxel (3%). Overall, 56% of patients achieved pCR. 60 of 88 node-positive patients pre-NACT achieved ypN0(i-) after neoadjuvant treatment. pCR rate was significantly associated with estrogen receptor status and malignancy grade. An association with CEP17/HER2-ratio was assessed. Real world data on dual blockade with SB3 and pertuzumab in combination with NACT in a nationwide population-based study show a pCR rate comparable to that seen in previous clinical studies.
Sections du résumé
BACKGROUND
BACKGROUND
Dual blockade with trastuzumab and pertuzumab combined with neoadjuvant chemotherapy (NACT) has been increasingly used for HER2-positive tumours >2 cm and/or with positive axillary lymph nodes in order to evaluate pathologic response and obtain better surgical management. SB3 is a registered biosimilar trastuzumab approved following a phase III trial demonstrating similar efficacy in the neoadjuvant setting as trastuzumab. However, the study was done without pertuzumab.
METHOD
METHODS
The database of the Danish Breast Cancer Group was used to extract data on all patients who started NACT with SB3 and pertuzumab between September 1, 2018 and August 31, 2019. The primary endpoint was pathological complete response (pCR) rate.
RESULTS
RESULTS
In total 215 patients received NACT and dual blockade. The median age was 55 (24-81). NACT used was cyclophosphamide and epirubicin followed by weekly paclitaxel (62% on six cycles, 35% on eight cycles) or other chemotherapy followed by weekly paclitaxel (3%). Overall, 56% of patients achieved pCR. 60 of 88 node-positive patients pre-NACT achieved ypN0(i-) after neoadjuvant treatment. pCR rate was significantly associated with estrogen receptor status and malignancy grade. An association with CEP17/HER2-ratio was assessed.
CONCLUSION
CONCLUSIONS
Real world data on dual blockade with SB3 and pertuzumab in combination with NACT in a nationwide population-based study show a pCR rate comparable to that seen in previous clinical studies.
Identifiants
pubmed: 33186804
pii: S0960-9776(20)30205-8
doi: 10.1016/j.breast.2020.10.014
pmc: PMC7670201
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Biosimilar Pharmaceuticals
0
Ontruzant
0
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
pertuzumab
K16AIQ8CTM
Trastuzumab
P188ANX8CK
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
242-247Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest MBJ: Institutional grants from Nanostring Technologies and Oncology Venture, EHJ: Advisory board for Pfizer, Roche, Astra Zeneca and Novartis.
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