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Efficacy and safety of CT-P6 versus reference Trastuzumab in HER2-positive early breast cancer: Updated results of a randomised phase 3 trial.

Author

FJ Esteva,
Y V  Baranau,
V  Baryash,
A  Manikhas,
V  Moiseyenko,
G Dzagnidze,
E  Zhavrid ,
D  Boliukh,
D  Stroyakovskiy ,
J  Pikiel,
A E  Eniu,
R K  Li,
A V  Rusyn,
B  Tiangco,
S J  Lee,
S Young  Lee,
S Y  Yu ,
J  Stebbing

Related Institution

Perlmutter Cancer Center - NYU Langone Health

New York University Langone Medical Center

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Publication Information

Publication Type
Journal
Publication Sub Type
Journal Article, Original
Title
Cancer Chemotherapy and Pharmacology
Frequency
Others
Publication Date
October 2019
Volume
84
Issue
4
Page(s)
839-847

Abstract

Purpose: Neoadjuvant CT-P6, a trastuzumab biosimilar, demonstrated equivalent efficacy to reference trastuzumab in a phase 3 trial of HER2-positive early-stage breast cancer (EBC) (NCT02162667). We report post hoc analyses evaluating pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures.


Methods: Following neoadjuvant treatment and surgery, patients received adjuvant CT-P6 or trastuzumab (6 mg/kg) every 3 weeks for ≤ 1 year.


Results: In total, 271 and 278 patients received CT-P6 and trastuzumab, respectively. pCR and breast pCR rates were comparable between treatment groups regardless of age, region, or clinical stage. Overall, 47.6% (CT-P6) and 52.2% (trastuzumab) of patients experienced study drug-related treatment-emergent adverse events (TEAEs), including 17 patients reporting heart failure (CT-P6: 10; trastuzumab: 7). Two CT-P6 and three trastuzumab patients discontinued adjuvant treatment due to TEAEs.


Conclusion: Adjuvant CT-P6 demonstrated comparable efficacy and safety to trastuzumab at 1 year in patients with HER2-positive EBC, supporting CT-P6 and trastuzumab comparability.

Physical Location

LocationLocation CodeAvailable FormatAvailability
Philippine Council for Health Research and Development Fulltext pdf (Download)
SpringerLink Website Fulltext External Link (View)

 
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