Assessment of safety and tolerability of subcutaneous trastuzumab in patients with HER2-positive early breast cancer: Results of an open-label, randomized, multicenter, phase IIIB ESCAPE trial

Kaidarova D. Zhavrid E. Shatkovskaya O. Prokharau A. Akhmed N. Sembayev D. Rutzhanova Z. Ivankov A.
January 2024 Elsevier Ltd

Cancer Treatment and Research Communications
2024 #40

Aim: To assess the safety and tolerability of subcutaneous (SC) trastuzumab (Herceptin) administered either with a single-use injection device (SID) or manually from a vial using a hand-held syringe. Methods: The ESCAPE trial (NCT02194166) included 90 women aged 18 years or older with HER2-positive early breast cancer who underwent surgical treatment and completed (neo) adjuvant chemotherapy and radiotherapy (if indicated). Patients enrolled in the study were first subjected to 4 cycles of trastuzumab IV (8 mg/kg loading dose followed by 6 mg/kg maintenance dose, q3w) prior to being randomized into groups: [A] SC trastuzumab (fixed dose 600 mg, q3w) administered through a hand-held syringe followed by 7 cycles of SC trastuzumab administered with an SID or [B] the reverse sequence. Results: Patient-reported outcomes revealed that 78 (94.0 % [95 % CI: 90.4–99.0]) out of 83 patients preferred SC trastuzumab over IV trastuzumab, among whom 28 patients indicated a strong preference. Sixteen out of 17 HCPs (94.1 %) were very satisfied with the use of SC trastuzumab, while 1/17 (5.9 %) remained uncertain. The mean time spent for IV vs. SC trastuzumab administration, including pre- and postinjection procedures, was 93.8 and 22 min, respectively. A total of 49 (54.4 %) patients reported 164 AEs. Conclusions: In this trial, SC trastuzumab was preferred over IV trastuzumab. The duration of SC trastuzumab administration was significantly shorter than that of IV trastuzumab, saving patients and HCPs time. Safety and efficacy results were consistent with other published trials and were not associated with any new safety signal.

Breast cancer , Intravenous injection , Randomized control trial , Subcutaneous injection , Trastuzumab

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Kazakh Institute of Oncology and Radiology of the Ministry of Health of the Republic of Kazakhstan, Almaty, Kazakhstan
N.N.Alexandrov National Cancer Center of Belarus, Belarus
Minsk Clinical Cancer Center/Department of Oncology, Belarusian State Medical University, Minsk, Belarus
Department of Chemotherapy, Multidisciplinary Medical Center of Akimat of Astana, Astana, Kazakhstan
Independent Researcher, Almaty, Kazakhstan

Kazakh Institute of Oncology and Radiology of the Ministry of Health of the Republic of Kazakhstan
N.N.Alexandrov National Cancer Center of Belarus
Minsk Clinical Cancer Center/Department of Oncology
Department of Chemotherapy
Independent Researcher

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