Pivot X, Spano J P, Espie M, Cottu P, Jouannaud C, Pottier V, Moreau L, Extra J M, Lortholary A, Rivera P, Spaeth D, Attar-Rabia H, Benkanoun C, Dima-Martinez L, Esposito N, Gligorov J
University Hospital Jean Minjoz, INSERM 1098, Besancon, France.
AP-HP Pitié-Salpêtrière-Charles Foix, UPMC Université Paris 06, Paris, France.
Eur J Cancer. 2017 Sep;82:230-236. doi: 10.1016/j.ejca.2017.05.009. Epub 2017 Jun 23.
HannaH (NCT00950300) and PrefHer (NCT01401166) studies validated the subcutaneous (H-s.c.) formulation of trastuzumab as effective and safe as intravenous (H-i.v.) and highly preferred by patients in early breast cancer. The present randomised MetaspHer trial (NCT01810393) is the first study assessing patient's preference in metastatic setting.
Patients with HER2-positive metastatic breast cancer who completed a first line chemotherapy with trastuzumab and achieved a long-term response lasting more than 3 years were randomised to receive 3 cycles of 600-mg fixed-dose adjuvant H-s.c., followed by 3 cycles of standard H-i.v., or the reverse sequence. Primary end-point was overall preference for H-s.c. or H-i.v. at cycle six, assessed by Patient Preference Questionnaire (PPQ). Secondary end-points included healthcare professional (HCP) satisfaction; safety and tolerability; quality of life.
Hundred and thirteen patients were randomised and treated. H-s.c. was preferred by 79/92 evaluable intent-to-treat patients (85.9%, 95% confidence interval [CI; 78.8-93.0]; p < 0.001), 13/92 preferred H-i.v. (14.1%, 95% CI [7.0-21.3]). HCPs were most satisfied with H-s.c. (56/88 available data, 63.6%, [53.6-73.7]). On the safety population, adverse events occurred in 73 (67.6%) and 49 (44.1%) patients during the H-s.c. and H-i.v. periods, respectively; 7 (6.5%) and 4 (3.6%) were grade ≥ III, 3 (2.8%) and 2 (1.8%) were serious.
The safety was consistent with the known H-i.v. and H-s.c. profiles without safety concern raised. Definitively, patients preferred H-s.c. as reported in early stage by PrefHer study.
HannaH（NCT00950300）和PrefHer（NCT01401166）研究证实，曲妥珠单抗皮下注射（H-s.c.）制剂与静脉注射（H-i.v.）制剂一样有效且安全，并且在早期乳腺癌患者中更受青睐。目前的MetaspHer随机试验（NCT01810393）是第一项评估转移性乳腺癌患者偏好的研究。
完成一线曲妥珠单抗化疗并获得持续超过3年的长期缓解的HER2阳性转移性乳腺癌患者被随机分组，接受3个周期的600mg固定剂量辅助性H-s.c.治疗，随后接受3个周期的标准H-i.v.治疗，或相反顺序。主要终点是在第6周期时对H-s.c.或H-i.v.的总体偏好，通过患者偏好问卷（PPQ）进行评估。次要终点包括医疗保健专业人员（HCP）满意度、安全性和耐受性、生活质量。
113例患者被随机分组并接受治疗。在92例可评估的意向性治疗患者中，79例（85.9%，95%置信区间[CI；78.8-93.0]；p<0.001）偏好H-s.c.，13例（14.1%，95%CI[7.0-21.3]）偏好H-i.v.。HCP对H-s.c.最满意（88份可用数据中有56份，63.6%，[53.6-73.7]）。在安全性人群中，H-s.c.和H-i.v.治疗期间分别有73例（67.6%）和49例（44.1%）患者发生不良事件；7例（6.5%）和4例（3.6%）为≥III级，3例（2.8%）和2例（1.8%）为严重不良事件。
安全性与已知的H-i.v.和H-s.c.特征一致，未引发安全性担忧。确切地说，正如PrefHer研究在早期所报告的，患者更偏好H-s.c.。
