Baylor University Medical Center, Texas Oncology, US Oncology, 3410 Worth Street, Suite 400, Dallas, TX 75246, USA.
Department of Medical Oncology, Portuguese Oncology Institute of Porto, Porto, Portugal.
Eur J Cancer. 2021 Jul;152:223-232. doi: 10.1016/j.ejca.2021.03.047. Epub 2021 Jun 16.
The aim of the study was to assess patient preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112).
Patients who completed neoadjuvant P + H + chemotherapy + surgery were randomised 1:1 to three intravenous (IV) P + H cycles followed by three cycles of PH FDC SC or vice versa (crossover) and then chose subcutaneous (SC) injection or IV infusion to continue up to 18 cycles (continuation). Assessments were via patient and healthcare professional (HCP) questionnaires.
One hundred and sixty patients were randomised (cut-off: 24 February 2020); 136 (85.0%, 95% confidence interval: 78.5-90.2%) preferred SC; 22 (13.8%) preferred IV; 2 (1.3%) had no preference. The main reasons for SC preference were reduced clinic time (n = 119) and comfort during administration (n = 73). One hundred and forty-one patients (88.1%) were very satisfied/satisfied with SC injection versus 108 (67.5%) with IV infusion; 86.9% chose PH FDC SC continuation. HCP perceptions of median patient treatment room time ranged from 33.0-50.0 min with SC and 130.0-300.0 min with IV. Most adverse events (AEs) were grade 1/2 (no 4/5s); serious AE rates were low. AE rates before and after switching were similar (cycles 1-3 IV → cycles 4-6 SC: 77.5% → 72.5%; cycles 1-3 SC → cycles 4-6 IV: 77.5% → 63.8%).
Most patients strongly preferred PH FDC SC over P + H IV. PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.
该研究的目的是评估在法国 PHranceSCa 中，曲妥珠单抗和帕妥珠单抗皮下固定剂量组合（PH FDC SC）治疗人表皮生长因子受体 2（HER2）阳性早期乳腺癌患者的偏好（NCT03674112）。
完成新辅助 P+H+化疗+手术的患者以 1:1 随机分为三组，分别接受 3 个周期的静脉注射（IV）P+H 治疗，随后接受 3 个周期的 PH FDC SC 治疗，或者反之（交叉），然后选择皮下（SC）注射或 IV 输注继续治疗 18 个周期（延续）。评估通过患者和医疗保健专业人员（HCP）的问卷进行。
160 名患者被随机分配（截止日期：2020 年 2 月 24 日）；136 名（85.0%，95%置信区间：78.5-90.2%）患者偏好 SC；22 名（13.8%）偏好 IV；2 名（1.3%）无偏好。SC 偏好的主要原因是就诊时间缩短（n=119）和给药期间舒适度增加（n=73）。141 名患者（88.1%）对 SC 注射非常满意/满意，108 名患者（67.5%）对 IV 输注非常满意/满意；86.9%选择继续使用 PH FDC SC。HCP 对患者治疗室中位时间的感知范围为 33.0-50.0 分钟，IV 输注为 130.0-300.0 分钟。大多数不良事件（AE）为 1/2 级（无 4/5 级）；严重 AE 发生率较低。转换前后的 AE 发生率相似（IV 第 1-3 周期→SC 第 4-6 周期：77.5%→72.5%；SC 第 1-3 周期→IV 第 4-6 周期：77.5%→63.8%）。
大多数患者强烈偏好 PH FDC SC 而非 P+H IV。PH FDC SC 通常具有良好的耐受性，没有新的安全性信号（即使在转换时），并且提供了一种比 IV 输注更快的替代方案。
