著者

Yoshitaka Saito Shinya Tamaki Haruka Hasegawa Kenta Takahashi Akira Tokutome Yoh Takekuma Hiroko Yamashita Yoshito Komatsu Mitsuru Sugawara

出版者

The Pharmaceutical Society of Japan

雑誌

Biological and Pharmaceutical Bulletin (ISSN:09186158)

巻号頁・発行日

vol.44, no.4, pp.474-477, 2021-04-01 (Released:2021-04-01)

参考文献数

21

被引用文献数

3

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CT-P6 is a biosimilar of trastuzumab and is recommended to be administered for 30–90 min in subsequent maintenance infusions to prevent infusion-related reactions (IRRs). We administered CT-P6 for 30 min as the first injection and as an alternative to reference trastuzumab in the maintenance infusion and evaluated the safety of the administration. A total of 140 patients with breast or gastric cancer, who received a switch from tri-weekly reference trastuzumab to CT-P6 for 30 min in maintenance infusions, were retrospectively evaluated. Premedication was administered prior to an infusion of CT-P6 and a cytotoxic agent. However, premedication was not provided when CT-P6 was co-administered with pertuzumab or administered alone. The primary endpoint was the incidence of IRRs. The secondary endpoint was the incidence of diarrhea and skin toxicity. Ninety-five percent of the patients had breast cancer, and 44.3% had advance-stage cancer. The treatment included CT-P6 alone (17.9%) or with cytotoxic agents (23.6%), antihormonal drugs (25.7%), and pertuzumab (62.9%). Median administration time of trastuzumab at the switch was 13 administrations (range 2–140). Premedication was administered to 20.7% patients. One patient (0.7%) experienced grade 3 IRR. The frequency of diarrhea in the reference trastuzumab group and the CT-P6 group was 7.1 and 6.4%, respectively, and that of skin toxicity was 6.4 and 5.0%, respectively, without differences. In conclusion, we first demonstrated that an initial CT-P6 administration for 30 min during the switch from reference trastuzumab in maintenance infusion is an acceptable administration method.

著者

Nozomi SHIWA Hiroko YAMASHITA Koki TOMIOKA Kazunori KIMITSUKI Daria Llenaresas MANALO Satoshi INOUE Chun-Ho PARK

出版者

JAPANESE SOCIETY OF VETERINARY SCIENCE

雑誌

Journal of Veterinary Medical Science (ISSN:09167250)

巻号頁・発行日

pp.18-0591, (Released:2018-12-07)

被引用文献数

3

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In the present study, follicle-sinus complexes (FSCs) were harvested from the muzzle skin of 123 dogs with suspected canine rabies, and the sensitivity and specificity of FSC analysis were compared with those of brain tissue immunohistochemistry analysis. In the FSCs, viral antigen was detected from Merkel cells. Sensitivity was 97.3%, specificity was 100%, and the coefficient κ was 0.88. These results reconfirm that FSCs are very useful for the postmortem diagnosis of canine rabies, and suggest that 5 FSCs can yield results that are almost equivalent to those derived from brain tissue analysis in rabid dogs.