Key result
Biosimilar trastuzumab shows no difference in infusion reactions or cardiac dysfunction versus reference trastuzumab.
Why the study?
The safety regarding infusion reactions and cardiac dysfunction when switching from reference trastuzumab to biosimilar trastuzumab during breast cancer treatment required evaluation.
Does switching from reference trastuzumab to biosimilar trastuzumab affect the frequency of infusion reactions or cardiac dysfunction in patients with HER2-positive breast cancer?
Observational (n=37)
No
Does switching from reference trastuzumab to biosimilar trastuzumab affect the frequency of infusion reactions or cardiac dysfunction in patients with HER2-positive breast cancer?
Switching from reference to biosimilar trastuzumab does not appear to significantly increase the frequency of infusion reactions or the occurrence of cardiac dysfunction in patients with HER2-positive breast cancer.
Switching appears safe in this cohort; leaves open randomized confirmation before changing practice in HER2-positive breast cancer.
The present study is a safety survey of patients with human epidermal growth factor receptor type 2‑positive, chemotherapy‑naive breast cancer treated with trastuzumab plus paclitaxel at the Saitama Cancer Center (Saitama, Japan) between April 2018 and March 2022. The expression of infusion reaction (IR) and the effect on cardiac function were investigated in patients who switched from reference trastuzumab (HERCEPTIN®) to biosimilar trastuzumab (Trastuzumab‑NK) and continued treatment (switching group). The two groups (reference vs. biosimilar trastuzumab) had no significant difference in the expression of IR (P>0.999). In the switching group, IR associated with switching did not occur in all nine eligible patients. Left ventricular ejection fraction (LVEF) was used to assess cardiac function, and no patient in either group experienced a significant decrease in LVEF with treatment, meaning that there was no effect of switching on the decrease in LVEF. These results suggested that switching from reference to biosimilar trastuzumab may not have a significant effect on the frequency of IR expression or the occurrence of cardiac dysfunction.
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Abe et al. (2023) conducted an observational in HER2-positive breast cancer (n=37). Biosimilar trastuzumab (Trastuzumab-NK) vs. Reference trastuzumab (HERCEPTIN) was evaluated on Incidence of infusion reaction (Grade 1 or higher) (p=>0.999). Biosimilar trastuzumab showed no significant difference in the incidence of infusion reactions compared to reference trastuzumab (29% vs 24%, P>0.999), and switching between the two did not induce infusion reactions or cardiac dysfunction.
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