摘要
背景及目的:硼替佐米(bortezomib)是一种有效、可逆性的蛋白酶体抑制剂,通过诱导骨髓瘤细胞的凋亡,在骨髓瘤患者的治疗中发挥持久的疗效。本研究旨在观察硼替佐米联合地塞米松治疗初治、难治/复发多发性骨髓瘤(multiple myeloma,MM)患者的疗效和毒副作用,及该方案在肾功能不全患者中应用的安全性。方法:24例MM患者接受硼替佐米联合地塞米松方案治疗,每3周为一个疗程。所有患者共接受中位3个疗程(1～8个疗程)的化疗。采用EBMT疗效评价标准评价疗效,按国立癌症研究所的常规毒性判定标准评价不良反应。结果:全组中位随访4个月,总有效率79.2%(19/24)。轻链型患者CR率57.1%(4/7),明显高于非轻链型患者5.9%(1/17),差异有统计学意义(P=0.014)。7例合并肾功能不全的患者与肾功能正常患者的疗效相近,差异无统计学意义(P=0.272)。Ⅲ～Ⅳ级不良反应包括白细胞减少(2/24,8.3%)、血小板减少(8/24,33.3%)、腹泻(2/24,8.3%)和乏力(1/24,4.2%),经对症治疗或推迟化疗后均可恢复。结论:硼替佐米联合地塞米松方案治疗MM患者有明显疗效,在轻链型患者疗效更加显著。副作用可以耐受,在合并肾功能不全的患者可安全应用。
BACKGROUND ＆ OBJECTIVE： Bortezomib, a potent and reversible proteasome inhibitor, induces apoptosis of myeloma cells, resulting in durable responses in patients with multiple myeloma （MM）. This study was to explore the medical effects and side effects of bortezomib combined dexamethasone in treating newly diagnosed and relapsed or refractory MM, and evaluate the safety of this regimen in the patients with renal impairment. METHODS： Twenty-four MM patients were treated with bortezomib and dexamethasone in a 21-day cycle. The patients received a median of 3 cycles （range, 1-8 cycles） of the treatment. Response to bortezomib was evaluated according to the criteria of the European Group for Blood and Marrow Transplantation （EBMT）; adverse events were graded according to the National Cancer Institute Common Toxicity Criteria. RESULTS： During the follow-up with a median of 4 months, 19 （79.2%） patients responded to the treatment, The complete remission （CR） rate was significantly higher in the patients of light-chain type than in those of non-light-chain type （57.1% vs. 5.9%, P=0.014）. The response rates of the patients with and without renal impairment were similar （100% vs. 70.6%, P=0.272）, and the renal functions were ameliorated in the patients with renal impairment during chemotherapy. Grade III - IV adverse events, including leucocytopenia （8.3%）, thrombocytopenia （33.3%）, diarrhea （8.3%） and debility （4.2%）, could be relieved by symptomatic treatment or delayed chemotherapy. CONCLUSIONS, The combination of bortezomib and dexamethasone shows obvious effects on MM, especially in the patients with light-chain type. The adverse events can be tolerant in most patients, and this regimen is also safe in the patients with renal impairment.
出处
《癌症》
SCIE
CAS
CSCD
北大核心
2008年第4期429-434,共6页
Chinese Journal of Cancer
