A subgroup analysis of the HannaH trial suggested that patients with body weight >80 kg might experience reduced efficacy with the SC formulation compared with the IV formulation, but these results did not reach statistical significance. 20 Furthermore, preliminary data from a small observational trial in patients with HER2-positive non-MBC indicated that, in obese patients, a fixed-dose SC regimen of 600 mg was not equivalent to a dosage regimen adjusted to the patient’s body weight at a dose of 6 mg/kg IV. 21 Additional research, including larger controlled trials, is therefore required to understand the clinical implication(s) of these findings.
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Intravenous and subcutaneous formulations of trastuzumab, and trastuzumab biosimilars: implications for clinical practice.
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