Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial
| Autor: | 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, Alexey Manikhas |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
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 |
| Zdroj: | Cancer Chemotherapy and Pharmacology BASE-Bielefeld Academic Search Engine |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|