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

Autor: Esteva, F. J., Baranau, Y. V., Baryash, V., Manikhas, A., Moiseyenko, V., Dzagnidze, G., Zhavrid, E., Boliukh, D., Stroyakovskiy, D., Pikiel, J., Eniu, A. E., Li, R. K., Rusyn, A. V., Tiangco, B., Lee, S. J., Lee, S. Young, Yu, S. Y., Stebbing, J.
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Zdroj: Cancer Chemotherapy & Pharmacology; Oct2019, Vol. 84 Issue 4, p839-847, 9p
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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