Abstract
Trastuzumab is the standard treatment in Canada for patients with breast cancer positive for her2 (human epidermal growth factor receptor 2), dramatically improving outcomes in that patient group. However, its current intravenous (IV) administration is associated with long infusion times that place a significant burden on health care resources and patient quality of life. In an effort to provide a faster and easier administration method, a subcutaneous (sc) formulation of trastuzumab has been developed. Data from comparative trials demonstrate that the two formulations are comparable with respect to pharmacokinetics and efficacy. They also have similar safety profiles, with the exception of mild local and administration reactions with the sc formulation. Furthermore, the sc formulation is preferred by patients and health care professionals, and greatly reduces administration and chair time. Additional advantages include easier preparation and dosing, reduced drug wastage, and reduced discomfort at the injection site. By using well-thought-out administration procedures, the sc formulation can be given safely and effectively, potentially reducing the burden on health care resources and improving quality of life for patients.
Highlights
Breast cancer is the 3rd most prevalent malignancy in Canada, accounting for 13% of all cancers[1]
The 600 mg fixed sc dose was identified based on the results of a phase i/ib dose-finding study showing that an 8 mg/kg sc dose of trastuzumab resulted in an exposure comparable to that with an iv dose of 6 mg/kg[29]
After a median follow-up of 12.2–12.4 months, the analysis showed that the pharmacokinetics profile of the 600 mg sc dose was noninferior to that of the standard iv dose [geometric mean ratio for Ctrough: 1.33; 90% confidence interval: 1.24 to 1.44; noninferiority margin: 0.80], with no loading dose required
Summary
Breast cancer (bca) is the 3rd most prevalent malignancy in Canada, accounting for 13% of all cancers[1]. In 2017, approximately 26,300 Canadian women were newly diagnosed with bca. Within the 15 years, the number of new bca cases is expected to rise by 25% because of the country’s growing and aging population. In approximately 15% –25% of these malignancies, overexpression of the her[2] (human epidermal growth factor receptor 2) protein or amplification of the HER2 gene—or both—arises and is associated with an aggressive disease course and poor prognosis[2,3]. The development of treatments that target her[2] have revolutionized the outcome of patients with her2-positive bca
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