Hematology Department, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris (AP-HP), University Paris 7, 1 avenue Claude Vellefaux, Paris, France.
Am J Hematol. 2013 Sep;88(9):758-64. doi: 10.1002/ajh.23498. Epub 2013 Aug 7.
To provide data for future drug evaluation, we analyzed the outcome of 393 patients aged 50 years or older (median, 64 years) with AML in first relapse after treatment in recent ALFA trials. Salvage options were retrospectively classified as follows: best supportive care (BSC), low-dose cytarabine (LDAC), gemtuzumab ozogamicin (GO), intensive chemotherapy (ICT), or ICT combined with GO. Second complete remission (CR2) rate was 31% and median post-relapse survival was 6.8 months (0, 17, 42.5, 53, and 80% and 3.2, 5.6, 8.9, 9, and 19.8 months in BSC, LDAC, GO, ICT, and ICT + GO subsets, respectively). Age, performance status, WBC, CR1 duration, and favorable AML karyotype, but not other cytogenetic or molecular features, influenced post-relapse outcome. Multivariate adjustment and propensity score matching showed that intensive salvage (ICT/ICT+GO/GO versus LDAC/BSC) was associated with longer post-relapse survival, at least in patients with CR1 duration ≥12 months (P = 0.001 and 0.0005, respectively). Of interest, GO appeared to be as effective as standard ICT, and ICT + GO combination more effective than standard ICT. In conclusion, older patients with CR1 duration ≥12 months appeared to benefit from intensive salvage and results observed with GO-containing salvage suggest that GO combination studies should be actively pursued in this setting.
为了为未来的药物评估提供数据，我们分析了最近 ALFA 试验中 393 名年龄在 50 岁或以上（中位数为 64 岁）的 AML 患者在首次复发后的治疗结果。回顾性地将挽救治疗方案分类如下：最佳支持治疗（BSC）、低剂量阿糖胞苷（LDAC）、吉妥珠单抗奥佐米星（GO）、强化化疗（ICT）或 ICT 联合 GO。第二次完全缓解（CR2）率为 31%，中位复发后生存时间为 6.8 个月（0、17、42.5、53 和 80%，以及 3.2、5.6、8.9、9 和 19.8 个月，分别在 BSC、LDAC、GO、ICT 和 ICT+GO 亚组中）。年龄、体能状态、白细胞计数、CR1 持续时间和有利的 AML 核型，但不是其他细胞遗传学或分子特征，影响复发后结局。多变量调整和倾向评分匹配表明，强化挽救治疗（ICT/ICT+GO/GO 与 LDAC/BSC 相比）与更长的复发后生存时间相关，至少在 CR1 持续时间≥12 个月的患者中是如此（P=0.001 和 0.0005）。有趣的是，GO 似乎与标准 ICT 同样有效，而 ICT+GO 联合治疗比标准 ICT 更有效。总之，CR1 持续时间≥12 个月的老年患者似乎受益于强化挽救治疗，GO 治疗的观察结果表明，在这种情况下应积极开展 GO 联合治疗研究。
