유방암 환자에서 수술 후 보조요법으로 투여한 Trastuzumab 정맥주사와 피하주사 제형의 안전성 비교
Comparison Adverse Events on Intravenous Versus Subcutaneous Trastuzumab as Part of Adjuvant Therapy for Breast Cancer
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Background : A subcutaneous trastuzumab formulation has been developed as an alternative to the intravenous formulation. Although the safety of the two formulations was similar, some adverse reactions such as surgical wound infection and infusion-related reaction were more common after subcutaneous injection in clinical studies. The purpose of this study was to evaluate the safety of the two formulations in breast cancer patients. Methods : From January 2014 to June 2018, electronic medical records of patients with stage I-III breast cancer who received trastuzumab as an adjuvant therapy were reviewed retrospectively. We evaluated the incidence rate and severity of adverse reactions between the intravenous injection group (group IV) and the subcutaneous injection group (group SC). We also analyzed patients switching from IV to SC, or vice versa. Results : A total of 180 patients (108 patients in the IV group, 72 patients in the SC group) were evaluated. Adverse reactions occurred in 94 patients (87.0%) in the IV group and 62 patients (86.1%) in the SC group (p=0.858). There were no significant differences in the incidence and severity of most adverse reactions, except for infusion-related or injection site reactions, which was 16 patients (14.8%) in group IV versus 0 in group SC (p<0.001). In the IV group, 19 patients switched to SC. The most common reasons for switch were preferences (six patients, 31.6%). On the other hand, there was no patient who switched from SC to IV. Conclusion : The two injection formulation did not show significant difference in the frequency of adverse reactions, but injection-related reactions or injection site reactions occurred significantly in the IV group, unlike the pre-marketing study results. Considering the advantages of the SC formulation, such as preference, the SC formulation is an advantageous treatment alternative to the IV formulation.
Abstract
Background : A subcutaneous trastuzumab formulation has been developed as an alternative to the intravenous formulation. Although the safety of the two formulations was similar, some adverse reactions such as surgical wound infection and infusion-related reaction were more common after subcutaneous injection in clinical studies. The purpose of this study was to evaluate the safety of the two formulations in breast cancer patients. Methods : From January 2014 to June 2018, electronic medical records of patients with stage I-III breast cancer who received trastuzumab as an adjuvant therapy were reviewed retrospectively. We evaluated the incidence rate and severity of adverse reactions between the intravenous injection group (group IV) and the subcutaneous injection group (group SC). We also analyzed patients switching from IV to SC, or vice versa. Results : A total of 180 patients (108 patients in the IV group, 72 patients in the SC group) were evaluated. Adverse reactions occurred in 94 patients (87.0%) in the IV group and 62 patients (86.1%) in the SC group (p=0.858). There were no significant differences in the incidence and severity of most adverse reactions, except for infusion-related or injection site reactions, which was 16 patients (14.8%) in group IV versus 0 in group SC (p<0.001). In the IV group, 19 patients switched to SC. The most common reasons for switch were preferences (six patients, 31.6%). On the other hand, there was no patient who switched from SC to IV. Conclusion : The two injection formulation did not show significant difference in the frequency of adverse reactions, but injection-related reactions or injection site reactions occurred significantly in the IV group, unlike the pre-marketing study results. Considering the advantages of the SC formulation, such as preference, the SC formulation is an advantageous treatment alternative to the IV formulation.
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