ALLOGENEIC BONE-MARROW TRANSPLANTATION FOR CHRONIC MYELOID-LEUKEMIA IN FIRST CHRONIC PHASE - A RANDOMIZED TRIAL OF BUSULFAN-CYTOXAN VERSUS CYTOXAN-TOTAL-BODY IRRADIATION AS PREPARATIVE REGIMEN - A REPORT FROM THE FRENCH-SOCIETY-OF-BONE-MARROW-GRAFT (SFGM)
ALLOGENEIC BONE-MARROW TRANSPLANTATION FOR CHRONIC MYELOID-LEUKEMIA IN FIRST CHRONIC PHASE - A RANDOMIZED TRIAL OF BUSULFAN-CYTOXAN VERSUS CYTOXAN-TOTAL-BODY IRRADIATION AS PREPARATIVE REGIMEN - A REPORT FROM THE FRENCH-SOCIETY-OF-BONE-MARROW-GRAFT (SFGM)
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DOI：
10.1182/blood.v85.8.2263.bloodjournal8582263
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发表时间：
1995-04-15
期刊：
影响因子：
20.3
通讯作者：
GLUCKMAN, E
中科院分区：
文献类型：
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作者：
DEVERGIE, A;BLAISE, D;GLUCKMAN, E
从1988年3月至1991年3月，19个法国骨髓移植（BMT）中心参加了一项前瞻性随机试验，比较两种预处理方案的慢性粒细胞白血病患者移植在第一慢性期与HLA相同的同胞供体。共有120名连续患者随机接受120 mg/kg环磷酰胺，随后全身照射（CY-TBI; n = 55）或16 mg/kg白消安，随后120 mg/kg CY（BU-CY; n = 65）。使用了两种不同的TBI方案。13例患者接受了10-戈伊单剂量TBI（SDTBI），42例接受了分次TBI（FTBI）。诊断和BMT之间的中位时间为315天。总体5年精算生存率为62.9%（CY-TBI为65.8% +/- 12.5%，BU-CY为60.6 +/- 11.7%; P = 0.5），总体无病生存率为55%（CY-TBI为51% +/- 14%，BU-CY为59.1% +/- 11.8%; P = 0.75）。所有以CY-TBI为条件的患者都经历了持续的植入;相比之下，65例以BU-CY为条件的患者中有4例排斥移植物（P = .18）。在移植相关死亡率方面，两组之间没有显著的统计学差异（CY-TBI组为29%，BU-CY组为38%; P = 0.44）。到目前为止，中位随访时间为42个月，11例患者复发; 9例复发发生在CY-TBI后，主要发生在FTBI后（9例中的8例），2例发生在BU-CY后（P = .02）。BU-CY后复发的精算风险为4.4% ± 6.7%，SDTBI后为11.1% ± 20.8%，FTBI后为31.3% ± 18.1%（P = 0.039）。此外，与预处理方案无关，在16例接受抗白细胞介素-2受体单克隆抗体（MoAb）加短期甲氨蝶呤和环孢素治疗的患者中，移植后免疫抑制的增加显示出复发的精算风险增加（MoAb组57% +/- 30%，无MoAb组9% +/- 7.3%; P = 0.001）。我们的结论是，BU是一个可以接受的替代TBI的慢性髓性白血病患者在第一个慢性期接受骨髓移植HLA相同的同胞供体。BU-CY方案与CY-TBI方案的移植相关死亡率相近，BU-CY方案的抗白血病疗效与CY-TBI方案相近或更高。(C)1995年，美国血液学会。
From March 1988 to March 1991, 19 French bone marrow transplant (BMT) centers participated in a prospective randomized trial comparing two conditioning regimens for patients with chronic myeloid leukemia transplanted in first chronic phase with an HLA identical sibling donor. A total of 120 consecutive patients were randomized to receive either 120 mg/kg of cyclophosphamide followed by total body irradiation (CY-TBI; n = 55) or 16 mg/kg of busulfan followed by 120 mg/kg of CY (BU-CY; n = 65). Two different TBI regimens were used. Thirteen patients received a 10-Gy single-dose TBI (SDTBI), and 42 received a fractionated TBI (FTBI). Median time between diagnosis and BMT was 315 days. Overall 5-year actuarial survival was 62.9% (65.8% +/- 12.5% for CY-TBI and 60.6 +/- 11.7% for BU-CY; P = .5), and overall disease-free survival was 55% (51% +/- 14% for CY-TBI and 59.1% +/- 11.8% for BU-CY; P = .75). All patients conditioned with CY-TBI experienced sustained engraftment; in contrast, 4 of 65 patients conditioned with BU-CY rejected the graft (P = .18). There was no significant statistical difference between the two groups regarding transplant-related mortality (29% for CY-TBI and 38% for BU-CY; P = .44). So far, with a median follow up of 42 months, 11 patients have relapsed; 9 relapses occurred after CY-TBI, mostly after FTBI (8 of 9) and 2 after BU-CY (P = .02). The actuarial risk of relapse was 4.4% +/- 6.7% after BU-CY, 11.1% +/- 20.8% after SDTBI, and 31.3% +/- 18.1% after FTBI (P = .039). In addition, independently of the conditioning regimen, the increase of posttransplant immunosuppression in 16 patients with an anti-interleukin-2 receptor monoclonal antibody (MoAb) in addition to a short course of methotrexate and cyclosporine was shown to increase the actuarial risk of relapse (57% +/- 30% with MoAb v 9% +/- 7.3% without MoAb; P = .001). We conclude that BU is an acceptable alternative to TBI for patients with chronic myeloid leukemia in first chronic phase receiving BMT from HLA identical sibling donors. Both BU-CY and CY-TBI regimens gave similar transplant-related mortality, and the antileukemic efficiency of BU-CY regimen was either similar or even higher than that of CY-TBI. (C) 1995 by The American Society of Hematology.