Li Jian, Zhou Dao-Bin, Jiao Li, Duan Ming Hui, Zhang Wei, Zhao Yong Qiang, Shen Ti
Department of Hematology, Peking Union Medical College Hospital, Beijing, China.
Clin Lymphoma Myeloma. 2009 Oct;9(5):394-8. doi: 10.3816/CLM.2009.n.077.
Renal impairment is a common complication of multiple myeloma (MM) and is related to shorter overall survival and increased rates of early death. Bortezomib is a new agent for the treatment of patients with myeloma, with high response rates and controllable side effects. In this study, we will evaluate the efficacy and safety of bortezomib and dexamethasone in patients with newly diagnosed MM complicated by renal impairment.
This is a prospective study of the general characteristics, reversibility of renal impairment, response of myeloma, and side effects of 18 consecutive newly diagnosed patients with MM and renal impairment who received > or = 2 cycles of bortezomib and dexamethasone.
Of 18 patients newly diagnosed with MM, the median age was 60 years, and the median serum creatinine was 5.3 mg/dL. Patients received a median of 4 cycles of bortezomib and dexamethasone. Reversal of renal impairment was documented in 38.9% of the patients, and the median time to reversal was 16 days. Moreover, 33.3% of the patients achieved renal response (a 50% decrease in serum creatinine). The overall response rate of MM was 83.3%, including a 33.3% complete response (CR) rate, a 16.7% near-CR rate, a 16.7% very good partial response (PR) rate, and a 16.7% PR rate. Grade 3/4 adverse events consisted of infection (n = 3), peripheral neuropathy (n = 3), and ileus (n = 1). After a median follow-up of 15.7 months, the median progression-free survival for all patients was 12.6 months.
Bortezomib plus dexamethasone is a safe and effective regimen for newly diagnosed patients with MM complicated by renal impairment.
肾功能损害是多发性骨髓瘤（MM）的常见并发症，与总体生存期缩短和早期死亡率增加有关。硼替佐米是一种治疗骨髓瘤患者的新药，缓解率高且副作用可控。在本研究中，我们将评估硼替佐米和地塞米松对新诊断的合并肾功能损害的MM患者的疗效和安全性。
这是一项前瞻性研究，对18例连续新诊断的合并肾功能损害且接受≥2个周期硼替佐米和地塞米松治疗的MM患者的一般特征、肾功能损害的可逆性、骨髓瘤的反应及副作用进行研究。
18例新诊断的MM患者，中位年龄为60岁，中位血清肌酐为5.3mg/dL。患者接受硼替佐米和地塞米松治疗的中位周期数为4个。38.9%的患者肾功能损害得到逆转，中位逆转时间为16天。此外，33.3%的患者实现了肾脏反应（血清肌酐降低50%）。MM的总体缓解率为83.3%，包括33.3%的完全缓解（CR）率、16.7%的接近CR率、16.7%的非常好的部分缓解（PR）率和16.7%的PR率。3/4级不良事件包括感染（n=3）、周围神经病变（n=3）和肠梗阻（n=1）。中位随访15.7个月后，所有患者的中位无进展生存期为12.6个月。
硼替佐米联合地塞米松是新诊断的合并肾功能损害的MM患者的一种安全有效的治疗方案。
