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Safety Evaluation of Initial CT-P6 Administration for 30 min during the Switch from Reference Trastuzumab in Maintenance Infusion: A Multicenter Observational Study
| Title: | Safety Evaluation of Initial CT-P6 Administration for 30 min during the Switch from Reference Trastuzumab in Maintenance Infusion: A Multicenter Observational Study |
| Authors: | Saito, Yoshitaka Browse this author →KAKEN DB | | Tamaki, Shinya Browse this author | | Hasegawa, Haruka Browse this author | | Takahashi, Kenta Browse this author | | Tokutome, Akira Browse this author | | Takekuma, Yoh Browse this author →KAKEN DB | | Yamashita, Hiroko Browse this author →KAKEN DB | | Komatsu, Yoshito Browse this author →KAKEN DB | | Sugawara, Mitsuru Browse this author →KAKEN DB |
| Keywords: | trastuzumab | | biosimilar | | CT-P6 | | infusion-related reaction (IRR) | | adverse effect | | safety |
| Issue Date: | 1-Apr-2021 |
| Publisher: | The Pharmaceutical Society of Japan |
| Journal Title: | Biological & pharmaceutical bulletin |
| Volume: | 44 |
| Issue: | 4 |
| Start Page: | 474 |
| End Page: | 477 |
| Publisher DOI: | 10.1248/bpb.b20-00984 |
| Abstract: | 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. |
| Type: | article |
| URI: | http://hdl.handle.net/2115/81809 |
| Appears in Collections: | 薬学研究院 (Faculty of Pharmaceutical Sciences) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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