Adis, Mairangi Bay, North Shore, Auckland, New Zealand.
Drugs. 2013 Jan;73(1):45-54. doi: 10.1007/s40265-013-0006-6.
A subcutaneous formulation of bortezomib is now indicated in the EU and the US for the treatment of patients with multiple myeloma. This article reviews pharmacological, therapeutic efficacy and tolerability data relevant to the utilization of subcutaneous bortezomib (Velcade(®)) in the treatment of patients with multiple myeloma. In a randomized, nonblind, phase III study, subcutaneous bortezomib was noninferior to intravenous bortezomib in the treatment of adults with relapsed multiple myeloma, as determined by the overall response rate after four cycles of therapy (primary endpoint). No significant differences between the subcutaneous and intravenous bortezomib formulations were observed in the median time to first response, median progression-free survival, median time to progression and 1-year overall survival. Compared with intravenous bortezomib, subcutaneous bortezomib confers a significant advantage with respect to the incidence of peripheral neuropathy (all grades, grade ≥2 and grade ≥3). As a consequence, it provides a new treatment option for patients with multiple myeloma, particularly those with pre-existing neuropathy or at a high risk of developing peripheral neuropathy.
硼替佐米皮下制剂现已在欧盟和美国获批用于多发性骨髓瘤患者的治疗。本文综述了皮下硼替佐米(万珂®)在多发性骨髓瘤患者治疗中的应用相关的药代动力学、疗效和耐受性数据。在一项随机、非盲、III 期研究中,皮下硼替佐米与静脉用硼替佐米在治疗复发多发性骨髓瘤的成年患者中的疗效相当,以四个疗程治疗后的总缓解率为主要终点(非劣效性)。两种硼替佐米制剂在首次缓解时间、无进展生存期、进展时间和 1 年总生存率方面均无显著差异。与静脉用硼替佐米相比,皮下硼替佐米在周围神经病变(所有级别、≥2 级和≥3 级)的发生率方面具有显著优势。因此,为多发性骨髓瘤患者,特别是那些存在周围神经病变或具有发生周围神经病变高风险的患者提供了一种新的治疗选择。