Department of Haematology, Cardiff University School of Medicine, Cardiff, UK.
Leukemia. 2013 Jan;27(1):75-81. doi: 10.1038/leu.2012.229. Epub 2012 Aug 14.
The treatment of older patients with acute myeloid leukaemia, who are not considered suitable for conventional intensive therapy, is unsatisfactory. Low-dose Ara-C(LDAC) has been established as superior to best supportive care, but only benefits the few patients who enter complete remission. Alternative or additional treatments are required to improve the situation. This randomised trial compared the addition of the immunoconjugate, gemtuzumab ozogamicin (GO), at a dose of 5 mg on day 1 of each course of LDAC, with the intention of improving the remission rate and consequently survival. Between June 2004 and June 2010, 495 patients entered the randomisation. The addition of GO significantly improved the remission rate (30% vs 17%; odds ratio(OR) 0.48 (0.32-0.73); P=0.006), but not the 12 month overall survival (25% vs 27%). The reason for the induction benefit failing to improve OS was two-fold: survival of patients in the LDAC arm who did not enter remission and survival after relapse were both superior in the LDAC arm. Although the addition of GO to LDAC doubled the remission rate it did not improve overall survival. Maintaining remission in older patients remains elusive.
对于不适合常规强化治疗的老年急性髓系白血病患者的治疗效果并不令人满意。低剂量阿糖胞苷（LDAC）已被证实优于最佳支持治疗，但仅使少数进入完全缓解的患者受益。需要替代或额外的治疗方法来改善这种情况。这项随机试验比较了在每个 LDAC 疗程的第 1 天添加免疫偶联物吉妥珠单抗奥佐米星（GO）的效果，目的是提高缓解率，从而提高生存率。在 2004 年 6 月至 2010 年 6 月期间，共有 495 名患者进入随机分组。GO 的添加显著提高了缓解率（30%比 17%；优势比[OR]0.48（0.32-0.73）；P=0.006），但 12 个月的总生存率（25%比 27%）没有改善。诱导获益未能提高 OS 的原因有两个：未进入缓解的 LDAC 组患者的生存率和缓解后复发的患者的生存率均在 LDAC 组中更高。尽管添加 GO 可使 LDAC 的缓解率提高一倍，但并未改善总体生存率。对于老年患者，维持缓解仍然难以实现。
