Minarik Jiri, Pavlicek Petr, Pour Ludek, Pika Tomas, Maisnar Vladimir, Spicka Ivan, Jarkovsky Jiri, Krejci Marta, Bacovsky Jaroslav, Radocha Jakub, Straub Jan, Kessler Petr, Wrobel Marek, Walterova Lenka, Sykora Michal, Obernauerova Jarmila, Brozova Lucie, Gregora Evzen, Adamova Dagmar, Gumulec Jaromir, Adam Zdenek, Scudla Vlastimil, Hajek Roman
Department of Hemato-oncology, University Hospital Olomouc and Medical Faculty of Palacky University Olomouc, Olomouc, Czech Republic.
Department of Clinical Hematology, University Hospital Kralovske Vinohrady, Praha, Czech Republic.
PLoS One. 2015 Apr 14;10(4):e0123866. doi: 10.1371/journal.pone.0123866. eCollection 2015.
Subcutaneous (SC) application of bortezomib has been recently introduced as a new application route in multiple myeloma (MM) patients. We performed an analysis to compare the outcomes of bortezomib-based therapy in multiple myeloma (MM) patients treated using either intravenous (IV) or subcutaneous (SC) route of administration.
During January 2012 through December 2013, we performed a retrospective analysis of 446 patients with MM treated with bortezomib-based regimens (either once weekly - 63% or twice weekly - 27%) in both, the first line setting, and in relapse, with separate analysis of patients undergoing autologous stem cell transplantation. We assessed the response rates and toxicity profiles in both, IV and SC route of bortezomib administration.
The response rates in both IV and SC arm were similar with overall response rate 71.7% vs 70.7%, complete remissions in 13.9% vs 8.6%, very good partial remissions in 30.8% vs 34.5% and partial remissions in 27% vs 27.6%. The most frequent grade ≥ 3 toxicities were anemia, thrombocytopenia and neutropenia, with no significant differences between IV and SC group. There were no significant differences in the rate of peripheral neuropathy (PN). PN of any grade was present in 48% in the IV arm and in 41% in the SC arm. PN grade ≥ 2 was present in 20% vs 18% and PN grade ≥ 3 was present in 6% vs 4%.
We conclude that subcutaneous application of bortezomib has similar therapeutic outcomes and toxicity profile as intravenous route of application. In our cohort there was no difference in the incidence of PN, suggesting that PN is dose dependent and might be reduced by lower intensity schemes rather than by the route of administration.
皮下注射硼替佐米最近被引入作为多发性骨髓瘤（MM）患者的一种新给药途径。我们进行了一项分析，以比较采用静脉注射（IV）或皮下注射（SC）给药途径治疗的多发性骨髓瘤（MM）患者中基于硼替佐米治疗的结果。
在2012年1月至2013年12月期间，我们对446例接受基于硼替佐米方案治疗的MM患者进行了回顾性分析（一线治疗及复发时，分别分析接受自体干细胞移植的患者），这些方案为每周一次（63%）或每周两次（27%）。我们评估了硼替佐米静脉注射和皮下注射给药途径的缓解率和毒性特征。
静脉注射组和皮下注射组的缓解率相似，总缓解率分别为71.7%和70.7%，完全缓解率分别为13.9%和8.6%，非常好的部分缓解率分别为30.8%和34.5%，部分缓解率分别为27%和27.6%。最常见的≥3级毒性为贫血、血小板减少和中性粒细胞减少，静脉注射组和皮下注射组之间无显著差异。周围神经病变（PN）发生率无显著差异。静脉注射组48%出现任何级别的PN，皮下注射组为41%。≥2级PN分别为20%和18%，≥3级PN分别为6%和4%。
我们得出结论，皮下注射硼替佐米与静脉注射给药途径具有相似的治疗结果和毒性特征。在我们的队列中，PN发生率无差异，提示PN是剂量依赖性的，可能通过较低强度方案而非给药途径来降低。
