Xu Yan, Deng Shuhui, Mao Xuehan, An Gang, Li Zengjun, Wang Yafei, Fulciniti Mariateresa, Ho Matthew, Lin Jianhong, Sui Weiwei, Liu Wei, Zou Dehui, Yi Shuhua, Huang Wenyang, Liu Hong, Lv Rui, Li Jian, Wang Tingyu, Du Chenxing, Munshi Nikhil C, Qiu Lugui
State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academic Medical Science and Peking Union Medical College, Tianjin, China; Department of Medical Oncology, Jerome Lipper Center for Multiple Myeloma Research, Lebow Institute for Myeloma Therapeutics, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA.
State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academic Medical Science and Peking Union Medical College, Tianjin, China.
Clin Lymphoma Myeloma Leuk. 2018 Jun;18(6):422-430. doi: 10.1016/j.clml.2018.03.006. Epub 2018 Mar 15.
Peripheral neuropathy (PN) is an important toxicity that limits the use of bortezomib (Btz). Attempts to reduce PN have included its subcutaneous (SC) administration.
We retrospectively analyzed 307 patients with newly diagnosed multiple myeloma from a single Chinese center, receiving Btz-based regimens administered either via SC injection (SC group, n = 167) or intravenous (IV) infusion (IV group, n = 140). The efficacy and safety of Btz administration via SC and IV were then compared.
Most baseline characteristics were similar between these 2 groups. A lower frequency of adverse events, especially grade ≥ 3 PN (P = .002), was observed in the SC group compared with the IV group. The estimated median Btz dosage when PN developed was higher (20.8 mg/m vs. 15.6 mg/m), and fewer patients reduced or discontinued Btz owing to adverse events in the SC group compared with the IV group. The overall response rate (≥ partial response [PR]) was comparable (94.8% vs. 96.2%). However, patients in the IV group required fewer cycles to achieve PR, whereas a larger proportion of patients in the IV group achieved ≥ very good PR. After a median follow-up of 23 months (range, 1-84 months), no significant difference in median progression-free survival (not arrived vs. 33.0 ± 2.735 months) and overall survival (not arrived vs. 56.0 months) was noted.
SC Btz is associated with better tolerance; however, IV administration achieves a faster and deeper response in Chinese patients with newly-diagnosed multiple myeloma.
周围神经病变（PN）是限制硼替佐米（Btz）使用的一种重要毒性反应。为减少PN所做的尝试包括皮下（SC）给药。
我们回顾性分析了来自中国单个中心的307例新诊断的多发性骨髓瘤患者，这些患者接受了基于Btz的治疗方案，给药方式为皮下注射（SC组，n = 167）或静脉（IV）输注（IV组，n = 140）。然后比较了SC和IV途径给予Btz的疗效和安全性。
这两组之间的大多数基线特征相似。与IV组相比，SC组不良事件的发生率较低，尤其是≥3级PN（P = .002）。发生PN时的Btz估计中位剂量更高（20.8 mg/m² 对 15.6 mg/m²），与IV组相比，SC组中因不良事件而减少或停用Btz的患者更少。总体缓解率（≥部分缓解[PR]）相当（94.8% 对 96.2%）。然而，IV组患者达到PR所需的周期更少，而IV组中达到≥非常好的PR的患者比例更高。中位随访23个月（范围1 - 84个月）后，未观察到中位无进展生存期（未达到对33.0 ± 2.735个月）和总生存期（未达到对56.0个月）有显著差异。
皮下注射Btz耐受性更好；然而，静脉给药在新诊断的中国多发性骨髓瘤患者中能实现更快、更深的缓解。
