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Six-year survival outcomes for patients with HER2-positive early breast cancer treated with CT-P6 or reference trastuzumab: observational follow-up study of a phase 3 randomised controlled trial

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posted on 2024-03-19, 09:55 authored by Justin Stebbing, Yauheni Baranau, Valery Baryash, Vladimir Moiseyenko, Dmytro Boliukh, Nicoleta Antone, Alexey Manikhas, Anatolii Chornobai, Taehong Park, Eric Hyungseok Baek, Jaeyong Lee, Jiin Choi, Nahyun Kim, Keumyoung Ahn, Sang Joon Lee, Sunghyun Kim

Background: The Phase 3 CT-P6 3.2 study demonstrated equivalent efficacy and comparable safety between CT-P6 and reference trastuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive early breast cancer after up to 3 years’ follow-up. 

Objective: To investigate long-term survival with CT-P6 and reference trastuzumab. 

Methods: In the CT-P6 3.2 study, patients with HER2-positive early breast cancer were randomised to neoadjuvant chemotherapy with CT-P6 or reference trastuzumab, surgery, and adjuvant CT-P6 or reference trastuzumab before a 3-year post-treatment follow-up. Patients who completed the study could enter a 3-year extension (CT-P6 4.2 study). Data were collected every 6 months to assess overall survival (OS), disease-free survival (DFS), and progression-free survival (PFS). 

Results: Of 549 patients enrolled in the CT-P6 3.2 study, 216 (39.3%) patients continued in the CT-P6 4.2 study (CT-P6, 107; reference trastuzumab, 109) (intention-to-treat extension set). Median follow-up was 76.4 months for both groups. Medians were not reached for time-to-event parameters; estimated hazard ratios (95% confidence intervals) for CT-P6 versus reference trastuzumab were 0.59 (0.17–2.02) for OS, 1.07 (0.50–2.32) for DFS, and 1.08 (0.50–2.34) for PFS. Corresponding 6-year survival rates in the CT-P6 and reference trastuzumab groups, respectively, were 0.96 (0.90–0.99) and 0.94 (0.87–0.97), 0.87 (0.78–0.92) and 0.89 (0.81–0.94), and 0.87 (0.78–0.92) and 0.89 (0.82–0.94). 

Conclusions: Data from this extended follow-up of the CT-P6 3.2 study demonstrate the comparable long-term efficacy of CT-P6 and reference trastuzumab up to 6 years. 

EudraCT number: 2019-003518-15 (retrospectively registered 10 March 2020).



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Springer Science and Business Media LLC


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