Clinical Experience and Prognostic Factors with Bortezomib-Combined Regimen in 40 Patients with Multiple Myeloma

Juan Li, Ying Zhao
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Abstract

To explore the medical effects, prognostic factors relating to the effects and side effects of bortezomib-combined regimen in treatment of multiple myeloma (MM), and evaluate the safety of this regimen in patients with special conditions. Methods: Forty newly diagnosed and relapsed or refractory MM treated with the regimen of combination of bortezomib and dexamethasone in a cycle of 3 weeks. All of the patients received a median of 3 (1–9) cycles of the treatment. Response to bortezomib was evaluated according to the criteria of the European Group for Blood and Marrow Transplantation (EBMT) and adverse events were graded according to the National Cancer Institute Common Toxicity Criteria. Results: Total response rate was 75.0% (30/40), and the rate of CR+nCR was 42.5% (17/40). Eighty percent patients (24/30) showed effects after the first cycle, although the median time of best effect was 2 cycles. Compare to the other types, light-chain type had higher total response rate (100.0% vs. 65.5%, P=0.038)and CR rate (36.4% vs. 6.9%, P=0.039), and also responded earlier with 81.8% (9/11) patients reached the best effect after the first cycle. The factors which showed no relationship to the effects were age ( 65 years, P=0.081), sex (P=0.696), DS staging (P=1.0), ISS staging(P=0.969), newly or retreated (P=0.731), using thalidomide or not(P=0.338), renal function damage or not(P=0.401), PLT level(P=1.0), hypercalcemia or not(P=0.306), Hb level(P=0.70)and the ratio of tumor cells in bone marrow(P=0.693). Grade III~IV adverse effects in this VD regimen was low, including leucocytopenia, thrombocytopenia, diarrh ea and debility, could be relieved by symptomatic treatment or delay the chemotherapy. The rate of infection was high and which was one of the important cause of death. Renal function improvement could be showed in all of the 10 patients who had renal inadequacy, and compared with normal patients, the incidences of side and adverse effects had no statistical differences. Conclusion: The Bortezomib combination regimen has significant effect in MM treatment. It shows more significant in light-chain type patients, and show earlier effect onset. This regimen can be tolerant in most patients, and is also safe in patients with renal inadequacy.
硼替佐米联合治疗多发性骨髓瘤40例的临床经验及预后因素分析
探讨硼替佐米联合方案治疗多发性骨髓瘤(MM)的疗效、影响疗效和副作用的预后因素,并评价该方案在特殊情况患者中的安全性。方法:采用硼替佐米联合地塞米松方案,以3周为周期治疗40例新诊断复发或难治性MM。所有患者接受治疗的中位数为3(1-9)个周期。根据欧洲血液和骨髓移植组织(EBMT)的标准评估对硼替佐米的反应,并根据国家癌症研究所共同毒性标准对不良事件进行分级。结果:总有效率为75.0% (30/40),CR+nCR率为42.5%(17/40)。80%的患者(24/30)在第一个周期后出现效果,但最佳效果的中位时间为2个周期。轻链型总有效率(100.0% vs. 65.5%, P=0.038)和CR率(36.4% vs. 6.9%, P=0.039)高于其他类型,且反应较早,81.8%(9/11)患者在第一个周期后达到最佳效果。年龄(65岁)、性别(P=0.696)、DS分期(P=1.0)、ISS分期(P=0.969)、新退(P=0.731)、是否使用沙利度胺(P=0.338)、是否肾功能损害(P=0.401)、PLT水平(P=1.0)、是否高钙血症(P=0.306)、Hb水平(P=0.70)、骨髓肿瘤细胞比例(P=0.693)与疗效无关。该方案III~IV级不良反应低,包括白细胞减少、血小板减少、腹泻和虚弱,可通过对症治疗或延迟化疗缓解。感染率高,是造成死亡的重要原因之一。10例肾功能不全患者肾功能均有改善,与正常患者比较,副反应发生率无统计学差异。结论:硼替佐米联合治疗MM疗效显著。轻链型患者更明显,且起效早。该方案对大多数患者具有耐受性,对肾功能不全患者也是安全的。
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