Primary Therapy of Waldenstrom Macroglobulinemia With Bortezomib, Dexamethasone, and Rituximab: WMCTG Clinical Trial 05-180

Primary Therapy of Waldenstrom Macroglobulinemia With Bortezomib, Dexamethasone, and Rituximab: WMCTG Clinical Trial 05-180
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DOI:
10.1200/jco.2008.20.4677
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发表时间:
2009-08-10
影响因子:
45.3
通讯作者:
Ghobrial, Irene M.
Ghobrial, Irene M.
中科院分区:
医学1区
文献类型:
--
作者:
Treon, Steven P.;Ioakimidis, Leukothea;Ghobrial, Irene M.

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我们检测了初治的症状性Waldenstrom巨球蛋白血症(WM)患者波特佐米、地塞米松和利妥昔单抗(BDR)的活性。患者和方法用波特佐米1.3 mg/m(2)静脉滴注;地塞米松40 mg在第1、4、8、11天;利妥昔单抗375 mg/m(2)在第11天。结果中位骨髓受累从55%降至10%(P=.0004),血清免疫球蛋白M水平从4830降至1115 mg/dL(P=0.0001),红细胞压积从29.8%升至38.2%(P=.0002)。总有效率和主要有效率分别为96%和83%,其中3例完全缓解,2例接近完全缓解,3例部分缓解,11例部分缓解,3例轻微缓解。有效时间的中位数为1.4个月。中位随访时间为22.8个月,23例患者中有18例无疾病进展。周围神经病是最常见的毒性反应,它被分解为
PurposeWe examined the activity of bortezomib, dexamethasone, and rituximab (BDR) in patients with symptomatic, untreated Waldenstrom macroglobulinemia (WM).Patients and MethodsA cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy. Twenty-three patients received a median of seven cycles of treatment.ResultsMedian bone marrow disease involvement declined from 55% to 10% (P = .0004), serum immunoglobulin M levels declined from 4,830 to 1,115 mg/dL (P = .0001), and hematocrit increased from 29.8% to 38.2% (P = .0002) at best response. The overall response rates and major response rates were 96% and 83% with three complete responses, two near complete responses, three very good partial responses, 11 partial responses, and three minor responses. Responses occurred at a median of 1.4 months. With a median follow-up of 22.8 months, 18 of 23 patients remained free of disease progression. Peripheral neuropathy was the most common toxicity, and it resolved to grade