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

Dilyara Kaidarova; Edvard Zhavrid; Oxana Shatkovskaya; Aliaksandr Prokharau; Nina Akhmed; Dauren Sembayev; Zhanna Rutzhanova; Alexandr Ivankov

doi:10.1016/j.ctarc.2024.100817

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

Cancer Treat Res Commun. 2024 May 1:40:100817. doi: 10.1016/j.ctarc.2024.100817. Online ahead of print.

Authors

Dilyara Kaidarova¹, Edvard Zhavrid², Oxana Shatkovskaya¹, Aliaksandr Prokharau³, Nina Akhmed², Dauren Sembayev⁴, Zhanna Rutzhanova⁴, Alexandr Ivankov⁵

Affiliations

¹ Kazakh Institute of Oncology and Radiology of the Ministry of Health of the Republic of Kazakhstan, Almaty, Kazakhstan.
² N.N.Alexandrov National Cancer Center of Belarus, Belarus.
³ Minsk Clinical Cancer Center/Department of Oncology, Belarusian State Medical University, Minsk, Belarus.
⁴ Department of Chemotherapy, Multidisciplinary Medical Center of Akimat of Astana, Astana, Kazakhstan.
⁵ Independent Researcher, Almaty, Kazakhstan. Electronic address: sash.ivankov@gmail.com.

PMID: 38735220
DOI: 10.1016/j.ctarc.2024.100817

Abstract

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.

Keywords: Breast cancer; Intravenous injection; Randomized control trial; Subcutaneous injection; Trastuzumab.