Survival advantage with decitabine versus intensive chemotherapy in patients with higher risk myelodysplastic syndrome - Comparison with historical experience
Survival advantage with decitabine versus intensive chemotherapy in patients with higher risk myelodysplastic syndrome - Comparison with historical experience
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DOI：
10.1002/cncr.22508
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发表时间：
2007-03-15
期刊：
影响因子：
6.2
通讯作者：
Issa, Jean-Pierre
中科院分区：
文献类型：
--
作者：
Kantarjian, Hagop M.;O'Brien, Susan;Issa, Jean-Pierre
背景地西他滨是一种低甲基化药物，具有活性，已被批准用于治疗骨髓增生异常综合征（MDS）和慢性粒单核细胞白血病。强化化疗是治疗高危MDS患者的一种可接受形式。这两种治疗形式在MDS中的疗效比较尚不清楚。本研究的目的是比较地西他滨和强化化疗治疗MDS的疗效和毒性。作者在高危MDS患者中比较了低强度地西他滨治疗（n = 115例患者）与强化化疗（用于急性髓性白血病[AML]）。对376名历史患者（1995年至2005年）的队列进行了两项比较：第一项比较包括一个由115名患者组成的子队列（A组），根据年龄、国际预后评分系统和细胞遗传学，这些患者与115名地西他滨研究患者相匹配;第二项比较包括整个队列的376名不匹配的患者（B组）。对结局进行多变量分析。根据AML标准，地西他滨组的完全缓解（CR）率为43%，A组强化化疗组为46%，B组强化化疗组为52%。与A组相比，地西他滨组6周死亡率为3%，强化化疗组为13%（P = 0.006），地西他滨组3个月死亡率为7%，强化化疗组为23%（P = 0.001）。A组地西他滨组的生存率优于强化化疗组（中位生存期：22个月vs 12个月; P
BACKGROUND. Decitabine, a hypornethylating agent, is active and has been approved for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia. Intensive chemotherapy is an accepted form of therapy for patients with higher risk MDS. The comparative efficacy of these 2 forms of treatment in MDS is unknown. The objective of the current study was to compare the efficacy and toxicity profiles of decitabine and intensive chemotherapy in MDS.METHODS. The authors compared lower intensity decitabine therapy (n = 115 patients) with intensive chemotherapy (as it is used in acute myeloid leukemia [AML]) in patients with higher risk MDS. Two comparisons were made with a cohort of 376 historic patients (from 1995 to 2005): The first comparison included a subcohort of 115 patients (Group A) who matched the 115 decitabine study patients according to age, International Prognostic Scoring System, and cytogenetics; and the second comparison included the whole cohort of 376 patients without matching (Group B). A multivariate analysis was performed for outcome.RESULTS. The complete remission (CR) rate according to AML criteria was 43% with decitabine, 46% with intensive chemotherapy in Group A, and 52% with intensive chemotherapy in Group B. Compared with Group A, mortality at 6 weeks was 3% with decitabine versus 13% with intensive chemotherapy (P =.006) and, at 3 months, 7% with decitabine versus 23% with intensive chemotherapy (P =.001). Survival was better with decitabine versus intensive chemotherapy in Group A (median survival: 22 months vs 12 months; P