Abe Tomoya, Sagara Atsunobu, Suzuki Takayuki, Okada Daichi, Takei Daisuke, Matsuzaka Kazumasa, Kobayashi Honoka, Hiraide Makoto, Sano Motohiko, Nakayama Toshiaki
Department of Pharmacy, Saitama Cancer Center, Ina, Saitama 362-0806, Japan.
Division of Applied Pharmaceutical Education and Research, Hoshi University School of Pharmacy and Pharmaceutical Sciences, Tokyo 142-8501, Japan.
Mol Clin Oncol. 2025 Jan 9;22(3):24. doi: 10.3892/mco.2025.2819. eCollection 2025 Mar.
To the best of our knowledge, there have been no reports from clinical settings regarding safety information on a fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PHESGO) when switched from the intravenous formulation of pertuzumab and trastuzumab in Japan. The lack of information on switching from the intravenous formulation to PHESGO in clinical settings may contribute to hesitation in making the switch. The present study analyzed the safety of 51 patients with breast or colorectal cancer treated with PHESGO. The focus was on evaluating infusion reactions (IRs), and skin and subcutaneous tissue disorders. The study included patients who received PHESGO at the Saitama Cancer Center between January 1, 2024 and March 31, 2024. The group using it as initial induction therapy was compared with the group that switched from the intravenous formulation. IRs were assessed using the Common Terminology Criteria for Adverse Events version 5.0. Patients with grade 1 or higher symptoms on the day of administration or the following day were considered to have IRs. IRs occurred in 4 of 16 patients (25%) in the initial induction group and none in the switching group (P=0.0073). It was suggested that IRs with PHESGO were more likely to occur at the time of first administration, similar to existing intravenous formulations. The study also examined patients who switched to an intravenous formulation after receiving PHESGO; skin and subcutaneous tissue disorders occurred in five patients, three of whom continued on a slower dose rate, and two of whom discontinued PHESGO and switched to pertuzumab and trastuzumab for intravenous infusion. With PHESGO, IRs are also more likely to occur the first time, and when skin and subcutaneous tissue disorders occur, there is a tendency to switch formulations in groups with a history of intravenous formulation use.
据我们所知，在日本，当从帕妥珠单抗和曲妥珠单抗静脉制剂转换为皮下注射用固定剂量组合（PHESGO）时，临床环境中尚无关于其安全性信息的报告。临床环境中缺乏从静脉制剂转换为PHESGO的信息可能导致在进行转换时犹豫不决。本研究分析了51例接受PHESGO治疗的乳腺癌或结直肠癌患者的安全性。重点是评估输注反应（IRs）以及皮肤和皮下组织疾病。该研究纳入了2024年1月1日至2024年3月31日期间在埼玉癌症中心接受PHESGO治疗的患者。将将其用作初始诱导治疗的组与从静脉制剂转换而来的组进行了比较。使用不良事件通用术语标准第5.0版评估IRs。给药当天或第二天出现1级或更高症状的患者被视为发生了IRs。初始诱导组的16例患者中有4例（25%）发生了IRs，转换组无一例发生（P=0.0073）。结果表明，与现有的静脉制剂类似，PHESGO的IRs在首次给药时更有可能发生。该研究还检查了接受PHESGO后转换为静脉制剂的患者；5例患者出现了皮肤和皮下组织疾病，其中3例继续以较慢的剂量率用药，2例停止使用PHESGO并转换为静脉输注用帕妥珠单抗和曲妥珠单抗。使用PHESGO时，首次使用时也更有可能发生IRs，并且当出现皮肤和皮下组织疾病时，有静脉制剂使用史的组有转换制剂的倾向。
