Double-blind, randomized phase III study to compare the efficacy and safety of CT-P6, trastuzumab biosimilar candidate versus trastuzumab as neoadjuvant treatment in HER2 positive early breast cancer (EBC)
| Autor: | Zakaria Zautashvili, V. Baryash, Rubi Khaw Li, Gabriela Morar-Bolba, Daniil Stroyakovskiy, Francisco J. Esteva, Dmitry Komov, Joanna Pikiel, Andriy Rusyn, Dmytro Boliukh, Igor Lifirenko, Alexey Manikhas, Vladimir Moiseyenko, Sang Joon Lee, Justin Stebbing, Sung Young Lee, Alexandru Eniu, Giorgi Dzagnidze, Edvard Javrid, Yauheni Valerievich Baranau |
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| Rok vydání: | 2017 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty 030219 obstetrics & reproductive medicine Cyclophosphamide business.industry medicine.medical_treatment Biosimilar Pharmacology 03 medical and health sciences 0302 clinical medicine Docetaxel Trastuzumab 030220 oncology & carcinogenesis Internal medicine Relative risk medicine Clinical endpoint skin and connective tissue diseases business neoplasms Adjuvant medicine.drug Epirubicin |
| Zdroj: | Journal of Clinical Oncology. 35:510-510 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 510 Background: CT-P6 (C) is a proposed biosimilar to trastuzumab. This trial (NCT02162667) evaluated the similarity of C and trastuzumab in efficacy and safety for HER2+ EBC. Methods: 549 patients with HER2+ EBC were randomized to receive C (n=271) or trastuzumab (n=278) in combination with docetaxel (Cycles 1-4) and 5-fluorouracil, epirubicin, and cyclophosphamide (Cycles 5-8). C or trastuzumab was administered at 8 mg/kg (Cycle 1 only) followed by 6 mg/kg every 3 weeks. The primary endpoint was pathological complete response (pCR) rate at surgery. Secondary endpoints were overall response rate (ORR), PK, PD and safety. After surgery, patients received adjuvant C or trastuzumab to complete a total of 1-year treatment. Results: The pCR rate was 46.8% for C and 50.4% for trastuzumab. The 95% CIs for the risk ratio estimate were within the equivalence margin (0.74, 1.35) in PPS and ITT analyses. Other efficacy endpoints were similar between C and trastuzumab. The proportion of patients with at least 1 treatment-emergent SAE was 6.6% for C and 7.6% for trastuzumab. Only 1 patient in each group withdrew treatment due to significant LVEF decrease. Infusion-related reaction was reported for 8.5% of patients in C and 9.0% of patients in trastuzumab. Conclusions: This study demonstrated the similarity of efficacy in terms of pCR between CT-P6 and trastuzumab in EBC patients. Secondary efficacy endpoints also supported the similarity between CT-P6 and trastuzumab. CT-P6 was well tolerated with a similar safety profile to that of trastuzumab during the neoadjuvant period. Clinical trial information: NCT02162667. [Table: see text] |
| Databáze: | OpenAIRE |
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