Safety Evaluation of Initial CT-P6 Administration for 30 min during the Switch from Reference Trastuzumab in Maintenance Infusion: A Multicenter Observational Study

Author:

Saito Yoshitaka1,Tamaki Shinya2,Hasegawa Haruka3,Takahashi Kenta4,Tokutome Akira5,Takekuma Yoh1,Yamashita Hiroko6,Komatsu Yoshito7,Sugawara Mitsuru18

Affiliation:

1. Department of Pharmacy, Hokkaido University Hospital

2. KKR Sapporo Medical Center

3. Department of Pharmacy, National Hospital Organization Hokkaido Cancer Center

4. Department of Pharmacy, NTT Medical Center Sapporo

5. Department of Pharmacy, Sapporo Higashi Tokushukai General Hospital

6. Department of Breast Surgery, Hokkaido University Hospital

7. Cancer Center, Hokkaido University Hospital

8. Laboratory of Pharmacokinetics, Faculty of Pharmaceutical Sciences, Hokkaido University

Publisher

Pharmaceutical Society of Japan

Subject

Pharmaceutical Science,Pharmacology,General Medicine

Reference21 articles.

1. 1) Hudis CA. Trastuzumab–mechanism of action and use in clinical practice. N. Engl. J. Med., 357, 39–51 (2007).

2. 2) Lee J, Kang HA, Bae JS, Kim KD, Lee KH, Lim KJ, Choo MJ, Chang SJ. Evaluation of analytical similarity between trastuzumab biosimilar CT-P6 and reference product using statistical analyses. MAbs, 10, 547–571 (2018).

3. 3) Slamon DJ, Godolphin W, Jones LA, Holt J, Wong S, Keith D, Levin W, Stuart S, Udove J, Ullrich A, et. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science, 244, 707–712 (1989).

4. 4) Gravalos C, Jimeno A. HER2 in gastric cancer: a new prognostic factor and a novel therapeutic target. Ann. Oncol., 19, 1523–1529 (2008).

5. 5) Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortobagyi GN. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist, 14, 320–368 (2009).

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