Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial.

Autor: Stebbing J; Division of Cancer, Imperial Centre for Translational and Experimental Medicine, London, UK. j.stebbing@imperial.ac.uk.; Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK. j.stebbing@imperial.ac.uk., Baranau YV; Department of Oncology, Belarusian State Medical University, Minsk, Belarus., Baryash V; Department of Oncology, Belarusian State Medical University, Minsk, Belarus., Manikhas A; City Clinical Oncology Dispensary, Saint Petersburg, Russian Federation., Moiseyenko V; Clinical Research Center of Specialised Types of Care (Oncology), GBUZ Saint Petersburg, Saint Petersburg, Russian Federation., Dzagnidze G; S. Khechinashvili University Clinic, Ltd, Tbilisi, Georgia., Zhavrid E; N.N. Alexandrov National Cancer Centre of Belarus, Minsk Region, Belarus., Boliukh D; Vinnytsya Regional Clinical Oncology Dispensary, Vinnytsia, Ukraine., Pikiel J; Wojewodzkie Centrum Onkologii, Gdańsk, Poland., Eniu AE; Hôpital Riviera-Chablais, Vaud-Valais, Rennaz, Switzerland., Li RK; St Luke's Medical Center, Quezon City, Philippines., Tiangco B; The Medical City, Ortigas Avenue, Pasig City, Philippines., Lee SJ; Celltrion, Inc., Incheon, Republic of Korea., Kim S; Celltrion, Inc., Incheon, Republic of Korea.
Jazyk: angličtina
Zdroj: Breast cancer research and treatment [Breast Cancer Res Treat] 2021 Aug; Vol. 188 (3), pp. 631-640. Date of Electronic Publication: 2021 Jun 20.
DOI: 10.1007/s10549-021-06240-5
Abstrakt: Purpose: Equivalent efficacy was demonstrated for the biosimilar CT-P6 and trastuzumab following neoadjuvant therapy for patients with human epidermal growth factor receptor-2 (HER2)-positive early breast cancer. Following adjuvant treatment, efficacy and safety were comparable between treatments. We report updated safety and efficacy data after up to 3 years' follow-up.
Methods: Following neoadjuvant chemotherapy with CT-P6/trastuzumab, patients underwent surgery and continued receiving adjuvant CT-P6/trastuzumab. The primary endpoint (previously reported) was pathological complete response. Time-to-event analyses (disease-free survival [DFS], progression-free survival [PFS], and overall survival [OS]), study drug-related and cardiac adverse events, and immunogenicity were assessed during post-treatment follow-up.
Results: Most patients entered the follow-up period (CT-P6: 259 [95.6%]; trastuzumab: 269 [96.8%]). After a median follow-up of 38.7 (CT-P6) and 39.6 (trastuzumab) months, medians were not reached for time-to-event parameters; estimated hazard ratios (HRs) and 3-year survival rates were similar between groups. Estimated HRs (95% confidence intervals) for CT-P6 versus trastuzumab were 1.23 (0.78-1.93) for DFS, 1.31 (0.86-2.01) for PFS, and 1.10 (0.57-2.13) for OS (intention-to-treat population). Safety findings were comparable between groups for the overall study and follow-up period, including study drug-related cardiac disorders (CT-P6: 22 [8.1%] patients; trastuzumab: 24 [8.6%] patients [overall]) and decreases in left ventricular ejection fraction. Immunogenicity was similar between groups.
Conclusion: The similarity of the time-to-event analyses between CT-P6 and trastuzumab supports the equivalence in terms of efficacy established for the primary endpoint. CT-P6 was well tolerated, with comparable safety and immunogenicity to trastuzumab. ClinicalTrials.gov: NCT02162667 (registered June 13, 2014).
(© 2021. The Author(s).)
Databáze: MEDLINE
Externí odkaz: