Bortezomib therapy alone and in combination with dexamethasone for previously untreated symptomatic multiple myeloma
Bortezomib therapy alone and in combination with dexamethasone for previously untreated symptomatic multiple myeloma
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DOI：
10.1111/j.1365-2141.2005.05540.x
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发表时间：
2005-06-01
影响因子：
6.5
通讯作者：
Crowley, J
中科院分区：
文献类型：
--
作者：
Jagannath, S;Durie, BGM;Crowley, J
硼替佐米，作为一个单一的代理和联合地塞米松，作为一线治疗32例未经治疗的症状性多发性骨髓瘤患者进行了检查。患者接受硼替佐米1.3 mg/m2，最多6个3周周期;如果2个周期后达到小于部分缓解（PR）或4个周期后达到小于完全缓解（CR），则添加口服地塞米松40 mg。缓解率（CR + PR）为88%，6%的患者检测不到副蛋白（CR），仅19%的患者可通过免疫固定检测到[接近CR]。所有32例患者均完成了前两个周期的硼替佐米单药治疗，其中3%达到CR，9%达到nCR，28%达到PR。10例患者在研究中接受了单药硼替佐米治疗，22例患者加用了地塞米松，导致15例缓解改善。最常见的≥ 2级不良事件包括感觉神经病变（31%）、便秘（28%）、肌痛（28%）和疲劳（25%）。5/10例患者的2级或3级感觉神经病变在中位3个月内可逆。硼替佐米治疗不影响8例患者的干细胞动员或6例患者的移植。硼替佐米单用或与地塞米松联合是一种有效的诱导治疗，在既往未经治疗的骨髓瘤患者中具有较高的CR和nCR率以及可管理的毒性。
Bortezomib, as a single agent and in combination with dexamethasone, was examined as first-line treatment in 32 consecutive patients with untreated symptomatic multiple myeloma. Patients received bortezomib 1.3 mg/m(2) for a maximum of six 3-week cycles; oral dexamethasone 40 mg was added if a less than partial response (PR) was achieved after two cycles or a less than complete response (CR) was achieved after four cycles. The response rate (CR + PR) was 88%, with undetectable paraprotein (CR) in 6%, and detectable by immunofixation only in 19% [near (n)CR]. All 32 patients completed the first two cycles of bortezomib alone, of whom 3% achieved CR, 9% nCR, and 28% PR. Ten patients received single-agent bortezomib on study, and dexamethasone was added in 22, leading to 15 improved responses. The most common adverse events >= grade 2 included sensory neuropathy (31%), constipation (28%), myalgia (28%) and fatigue (25%). Sensory neuropathy grade 2 or 3 was reversible within a median of 3 months in five of 10 patients. Bortezomib treatment did not affect stem cell mobilization in eight or transplantation in six patients. Bortezomib alone or in combination with dexamethasone is an effective induction therapy with a high CR and nCR rate and manageable toxicities in previously untreated patients with myeloma.