Gemtuzumab ozogamicin with or without interleukin 11 in patients 65 years of age or older with untreated acute myeloid leukemia and high-risk myelodysplastic syndrome: comparison with idarubicin plus continuous-infusion, high-dose cytosine arabinoside
Gemtuzumab ozogamicin with or without interleukin 11 in patients 65 years of age or older with untreated acute myeloid leukemia and high-risk myelodysplastic syndrome: comparison with idarubicin plus continuous-infusion, high-dose cytosine arabinoside
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DOI：
10.1182/blood.v99.12.4343
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发表时间：
2002-06-15
期刊：
影响因子：
20.3
通讯作者：
Kantarjian, HM
中科院分区：
文献类型：
--
作者：
Estey, EH;Thall, PF;Kantarjian, HM
我们研究了51例65岁或以上的新诊断急性髓性白血病（AML）、转化中原细胞过多的难治性贫血（RA）或原细胞过多的RA患者使用吉妥珠单抗ozogamicin （GO）的治疗。在第1天和第8天，以9 mg/m(2)的体表面积剂量给予氧化石墨烯，或者在治疗上等效于第1天和第15天，加或不加白细胞介素11 （IL-11；第3天至第28天每天15马克杯/公斤），随机分配IL-11治疗。无IL-11的氧化石墨烯完全缓解率为26例中2例（8%），有IL-11的氧化石墨烯完全缓解率为25例中9例（36%）。回归分析表明，IL-11可独立预测CR，但不能预测生存率。我们比较了氧化石墨烯加或不加IL-11与伊达柔比星加阿糖胞嘧啶（IA），如以前给药，在类似的患者。[A]的CR率为15 / 31(48%)，与IL-11或不含IL-11的GO相比，IA的生存率更高（P = .03）。除了考虑可能对结果的协变量影响外，我们还考虑了可能的试验效应（TEs），因为[A]和GO是否含有IL-11不是随机试验的组。考虑到协变量和TEs后，含有或不含有IL-11的GO的生存期长于1A的贝叶斯后验概率在细胞遗传学发现异常（AC）的患者中小于0.01，在细胞遗传学发现正常（NC）的患者中小于0.15。在CR方面，不含IL-11的氧化石墨烯（所有细胞遗传学组）的相似概率小于0.02，含IL-11的氧化石墨烯（AC组）的相似概率小于0.25，含IL-11的氧化石墨烯（NC组）的相似概率约为0.50。如果TEs是先前观察到的2 - 5倍，则需要得出结论，无论是否存在IL-11， GO患者的生存时间可能比IA患者更长。因此，几乎没有证据表明，在新诊断的AML或骨髓增生异常综合征的老年患者中，应使用含有或不含IL-11的氧化石墨烯而不是[A]。（Blood. 2002;99:4343-4349） (C) 2002年由美国血液学会出版。
We investigated treatment with gemtuzumab ozogamicin (GO) in 51 patients aged 65 years or older with newly diagnosed acute myeloid leukemia (AML), refectory anemia (RA) with excess of blasts in transformation, or RA with excess blasts. GO was given in doses of 9 mg/m(2) of body-surface area on days 1 and 8 or, therapeutically equivalently, on days 1 and 15, with or without Interleukin 11 (IL-11; 15 mug/kg per day on days 3 to 28), with assignment to IL-11 treatment made randomly. Complete remission (CR) rates were 2 of 26 (8%) for GO without IL-11 and 9 of 25 (36%) for GO with IL-11. Regression analyses indicated that IL-11 was independently predictive of CR but not survival. We compared GO with or without IL-11 with idarubicin plus cytosine arabinoside (IA), as previously administered, in similar patients. The CR rate with [A was 15 of 31 (48%), and survival was superior with IA compared with GO with or without IL-11 (P = .03). Besides accounting for possible covariate effects on outcome, we also accounted for possible trial effects (TEs) arising because [A and GO with or without IL-11 were not arms of a randomized trial. Bayesian posterior probabilities that GO with or without IL-11 produced longer survival than 1A, after accounting for covariates and TEs, were less than 0.01 in patients with abnormal cytogenetic findings (AC) and less than 0.15 In patients with normal cytogenetic findings (NC). Regarding CR, the analogous probabilities were less than 0.02 for GO without IL-11 (all cytogenetic groups), and for GO with IL-11, less than 0.25 for AC groups and about 0.50 for NC groups. TEs 2 to 5 times the magnitude of those previously observed would be needed to conclude that survival with GO with or without IL-11 is likely longer than with IA. Thus, there is little evidence to suggest that GO with or without IL-11 should be used instead of [A in older patients with newly diagnosed AML or myelodysplastic syndrome. (Blood. 2002;99:4343-4349) (C) 2002 by The American Society of Hematology.