1. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial
- Author
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Justin Stebbing, V. Baryash, Alexandru Eniu, Joanna Pikiel, S. Young Lee, Francisco J. Esteva, S. Yu, Yauheni Valerievich Baranau, R. K. Li, Sang Joon Lee, Daniil Stroyakovskiy, Andriy Rusyn, Dmytro Boliukh, B. Tiangco, Vladimir Moiseyenko, Giorgi Dzagnidze, Edvard Zhavrid, and Alexey Manikhas
- Subjects
0301 basic medicine ,Oncology ,Cancer Research ,Receptor, ErbB-2 ,medicine.medical_treatment ,Toxicology ,NEOADJUVANT CHEMOTHERAPY ,0302 clinical medicine ,Antineoplastic Agents, Immunological ,Breast cancer ,Trastuzumab ,Pharmacology (medical) ,Pharmacology & Pharmacy ,PATHOLOGICAL COMPLETE RESPONSE ,Stage (cooking) ,skin and connective tissue diseases ,Complete response ,Adjuvant ,Early breast cancer ,ADJUVANT TRASTUZUMAB ,Biosimilar ,Middle Aged ,Treatment Outcome ,030220 oncology & carcinogenesis ,Female ,Original Article ,Drug Monitoring ,1115 Pharmacology and Pharmaceutical Sciences ,Life Sciences & Biomedicine ,medicine.drug ,HER2 positive ,medicine.medical_specialty ,Breast Neoplasms ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,Oncology & Carcinogenesis ,Adverse effect ,CT-P6 ,Biosimilar Pharmaceuticals ,neoplasms ,Neoplasm Staging ,Pharmacology ,Heart Failure ,Science & Technology ,business.industry ,medicine.disease ,CONTROLLED SUPERIORITY TRIAL ,030104 developmental biology ,Heart failure ,business ,FOLLOW-UP - 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. Electronic supplementary material The online version of this article (10.1007/s00280-019-03920-4) contains supplementary material, which is available to authorized users.
- Published
- 2019