All-trans-retinoic acid in acute promyelocytic leukemia
All-trans-retinoic acid in acute promyelocytic leukemia
复制标题
DOI：
10.1056/nejm199710093371501
复制
发表时间：
1997-10-09
影响因子：
158.5
通讯作者：
Wiernik, PH
中科院分区：
文献类型：
--
作者：
Tallman, MS;Andersen, JW;Wiernik, PH
背景全反式维甲酸诱导急性早幼粒细胞白血病完全缓解。然而，目前尚不清楚是否诱导治疗与全反式维甲酸是上级单独化疗或是否维持治疗与全反式维甲酸改善outcome.Methods 346例未经治疗的急性早幼粒细胞白血病患者被随机分配到接受全反式维甲酸或柔红霉素加阿糖胞苷作为诱导治疗。完全缓解的患者接受巩固治疗，包括一个与诱导化疗相同的治疗周期，然后是大剂量阿糖胞苷加柔红霉素。两个周期的巩固治疗后仍在完全缓解的患者，然后随机分配到维持治疗与全反式维甲酸或observation.Results的174例接受化疗，120（69%）有一个完全缓解，因为124的172（72%）给予全反式维甲酸（P=0.56）。当同时考虑诱导和维持治疗时，在1年、2年和3年的无病生存率估计值分别为77%、61%和55%，化疗组和全反式维甲酸组分别为86%、75%和75%，全反式维甲酸组和全反式维甲酸组分别为86%、75%和75%。75%，60%和60%的全反式维甲酸然后观察; 29%，18%和18%的化疗然后观察。通过意向性治疗分析，接受化疗的患者在进入研究后1年、2年和3年的总生存率分别为75%、57%和50%，而67%的人被分配到全反式维甲酸结论全反式维甲酸诱导或维持治疗急性早幼粒细胞白血病较单纯化疗可提高患者的无病生存率和总生存率，应作为急性早幼粒细胞白血病的治疗方案。(C)1997年，马萨诸塞州医学会。
Background All-trans-retinoic acid induces complete remission in acute promyelocytic leukemia. However, it is not clear whether induction therapy with all-trans-retinoic acid is superior to chemotherapy alone or whether maintenance treatment with all-trans-retinoic acid improves outcome.Methods Three hundred forty-six patients with previously untreated acute promyelocytic leukemia were randomly assigned to receive all-trans-retinoic acid or daunorubicin plus cytarabine as induction treatment. Patients who had a complete remission received consolidation therapy consisting of one cycle of treatment identical to the induction chemotherapy, then high-dose cytarabine plus daunorubicin. Patients still in complete remission after two cycles of consolidation therapy were then randomly assigned to maintenance treatment with all-trans-retinoic acid or to observation.Results Of the 174 patients treated with chemotherapy, 120 (69 percent) had a complete remission, as did 124 of the 172 (72 percent) given all-trans-retinoic acid (P=0.56). When both induction and maintenance treatments were taken into account, the estimated rates of disease-free survival at one, two, and three years were 77, 61, and 55 percent, respectively, for patients assigned to chemotherapy then all-trans-retinoic acid; 86, 75, and 75 percent for all-trans-retinoic acid then all-trans-retinoic acid; 75, 60, and 60 percent for all-trans-retinoic acid then observation; and 29, 18, and 18 percent for chemotherapy then observation. By intention-to-treat analysis, the rates of overall survival at one, two, and three years after entry into the study were 75, 57, and 50 percent, respectively, among patients assigned to chemotherapy, and 82, 72, and 67 percent among those assigned to all-trans-retinoic acid (P=0.003).Conclusions All-trans-retinoic acid as induction or maintenance treatment improves disease-free and overall survival as compared with chemotherapy alone and should be included in the treatment of acute promyelocytic leukemia. (C) 1997, Massachusetts Medical Society.