单袋输注帕妥珠单抗和曲妥珠单抗治疗癌症的安全性

Q4 Pharmacology, Toxicology and Pharmaceutics European Journal of Oncology Pharmacy Pub Date : 2020-07-01 DOI:10.1097/OP9.0000000000000026
Antoine De Coucy, Julien Ollivier, L. Malifarge, M. Deppenweiler, C. Donamaria, B. Lortal
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引用次数: 1

摘要

目的:生物物理和分析测定已经证明了通过单个输注袋联合给药的帕妥珠单抗和曲妥珠单抗混合物的物理和化学稳定性。关于在现实生活中使用这种做法的数据很少。我们报告了通过单输液袋联合给予帕妥珠单抗和曲妥珠单抗一线治疗人表皮生长因子受体2(HER2)阳性乳腺癌症的安全性。方法:使用癌症数据登记来识别所有HER2阳性的癌症乳腺癌患者。在周期1中,患者接受静脉内负荷剂量的帕妥珠单抗和曲妥珠单抗,在周期2及以后,患者通过单个输注袋(队列1)或单独输注(队列2)接受维持剂量。队列3中的患者接受了两种方案:分别输注,然后使用一个输液袋。对记录进行了一般和心脏安全性审查结果:总共有72名患者符合分析条件:队列1中有25名,队列2中有23名,队列3中有24名。队列1中有1名患者(4%)和队列2中有1例患者(4.3%)出现左心室功能障碍,导致治疗中断,但在队列3中未观察到这种功能障碍。在第1组与第2组或第3组之间,在改用单一输液袋后,未观察到一般或心脏毒性的显著差异。结论:在非临床试验环境中,Pertuzumab和曲妥珠单抗在单一输液袋中联合给药,具有可接受的一般和心脏耐受性。这一策略可以提高患者的舒适度,同时节省积极的医疗保健专业人员的时间。实践意义:帕妥珠单抗、曲妥珠单抗和第三种化疗剂的联合治疗是一线HER2阳性局部晚期/转移性癌症乳腺癌的标准治疗,可作为癌症乳腺癌的(新)辅助治疗。在实践中,这两种抗体是单独给药的,但这项研究支持通过单个输注袋联合给药帕妥珠单抗和曲妥珠单抗。在非临床试验人群中,联合给药具有可接受的一般耐受性和心脏耐受性。这一策略可以提高患者的依从性和舒适性,同时节省积极的医疗保健专业人员的时间和医疗资源利用率。
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Safety of pertuzumab and trastuzumab administered in a single infusion bag in breast cancer
Purpose:Biophysical and analytical assays have demonstrated the physical and chemical stabilities of an admixture of pertuzumab and trastuzumab co-administered via a single infusion bag. Few data are available concerning the use of this practice in real life. We report the safety of pertuzumab and trastuzumab co-administered via a single infusion bag for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Methods: A cancer data registry was used to identify all patients with HER2-positive breast cancer. In cycle 1, patients received intravenous loading doses of pertuzumab and trastuzumab, and in cycle 2 and onward, patients received maintenance doses via a single infusion bag (cohort 1) or as separate infusions (cohort 2). Patients in cohort 3 received both regimens: separate infusions followed by a single infusion bag. Records were reviewed for general and cardiac safety Results: In total, 72 patients were eligible for analysis: 25 in cohort 1, 23 in cohort 2, and 24 in cohort 3. One patient (4%) in cohort 1 and 1 patient (4.3%) in cohort 2 had left ventricular dysfunction that led to treatment discontinuation, but this dysfunction was not observed in cohort 3. No significant differences in general or cardiac toxicities were observed between cohort 1 and cohort 2, or cohort 3 after switching to a single infusion bag. Conclusion: Pertuzumab and trastuzumab co-administered in a single infusion bag, in a non-clinical-trial setting, had acceptable general and cardiac tolerance profiles. This strategy could improve the comfort of patients while saving active healthcare professionals’ time. Implications for practice: Combined treatment of pertuzumab, trastuzumab, and a third chemotherapeutic agent is the standard of care for first-line HER2-positive locally advanced/metastatic breast cancer and can be used as (neo)adjuvant treatment for breast cancer. In practice, the 2 antibodies are administered separately, but this study supports co-administration of pertuzumab and trastuzumab via a single infusion bag. Co-administration has acceptable general and cardiac tolerances in a non-clinical-trial population. This strategy could improve the compliance and comfort of patients while saving active healthcare professionals’ time and medical resource utilization.
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