Medical Oncology Dept, San Raffaele Scientific Institute, Via Olgettina, 60, 20132 Milan, Italy.
Investigational and Clinical Oncology, Candiolo Cancer Institute, FPO-IRCCS, St. Prov. 142, 10060 Candiolo, Italy.
Eur J Cancer. 2018 Dec;105:61-70. doi: 10.1016/j.ejca.2018.09.034. Epub 2018 Nov 3.
Subcutaneous trastuzumab (H SC) is a valuable alternative to the intravenous formulation. This study assessed H SC safety and tolerability in human epidermal growth factor receptor 2 (HER2)+ early/locally advanced breast cancer (EBC/LABC).
SCHEARLY is a prospective, two-cohort, non-randomised, multicentre Italian trial included in the umbrella study UmbHER1, planning a 1-year treatment with H SC 600 mg in HER2+ EBC/LABC. Patients were sequentially assigned to cohort A (N = 121) and B (N = 119) to receive H SC via a handheld syringe and a single-use injection device, respectively. Adjuvant or neoadjuvant treatment included anthracycline-containing regimens followed by H SC plus taxanes and then alone for 18 cycles totally.
Two hundred forty patients were enrolled (adjuvant therapy: 81.7%; neoadjuvant therapy: 18.3%), and 201 completed the treatment (early discontinuation was mainly due to intercurrent adverse events [AEs], 7.5%). Overall, the two cohorts displayed similar safety profiles. From H SC start, the rate of treatment-related AEs in the safety population (N = 228) was 3.9% for grade ≥3 AEs; 0.9% for serious AEs (one pleuropericarditis and one anaphylactic shock, both resolved) and 14.5% for cardiac AEs, the most common being the decreased left ventricular ejection fraction (7.9%; mean reduction from the screening to the follow-up visit was 2.9%). No cases of congestive heart failure occurred. The rate of systemic administration-related reactions and local injection site reactions was 68.0% and 21.9%, respectively, mostly of grade 1-2.
H SC 600 mg confirmed to be a safe and tolerable option as adjuvant/neoadjuvant therapy in patients with HER2+ EBC and LABC. CLINICALTRIALS.
NCT01940497.
皮下注射曲妥珠单抗（H SC）是静脉制剂的一种有价值的替代选择。本研究评估了 H SC 在人表皮生长因子受体 2（HER2）+早期/局部晚期乳腺癌（EBC/LABC）中的安全性和耐受性。
SCHEARLY 是一项前瞻性、两队列、非随机、多中心意大利试验，纳入了伞式研究 UmbHER1，计划对 HER2+ EBC/LABC 患者进行为期 1 年的 H SC 600mg 治疗。患者按队列 A（N=121）和 B（N=119）顺序分配，分别接受手持注射器和一次性注射装置给药。辅助或新辅助治疗包括含蒽环类药物的方案，随后是 H SC 联合紫杉烷类药物，然后单独使用 18 个周期。
共纳入 240 例患者（辅助治疗：81.7%；新辅助治疗：18.3%），201 例完成治疗（早期停药主要是由于并发不良事件[AE]，占 7.5%）。总体而言，两个队列的安全性相似。从 H SC 开始，在安全性人群（N=228）中，治疗相关 AE 的发生率为≥3 级 AE 为 3.9%；严重 AE 为 0.9%（1 例胸膜炎和 1 例过敏性休克，均已解决）和 14.5%的心脏 AE，最常见的是左心室射血分数降低（7.9%；从筛查到随访的平均降低幅度为 2.9%）。无充血性心力衰竭发生。全身给药相关反应和局部注射部位反应的发生率分别为 68.0%和 21.9%，主要为 1-2 级。
H SC 600mg 作为辅助/新辅助治疗 HER2+ EBC 和 LABC 患者，是一种安全且耐受良好的选择。临床试验。
NCT01940497。
