Department of Medicine, Roswell Park Comprehensive Cancer Centre, Buffalo, NY, United States (USA).
Department of Medicine, Roswell Park Comprehensive Cancer Centre, Buffalo, NY, United States (USA).
Clin Lymphoma Myeloma Leuk. 2021 Sep;21(9):613-620. doi: 10.1016/j.clml.2021.04.007. Epub 2021 Apr 12.
The optimal approach to combine gemtuzumab-ozogamicin (GO) with various chemotherapy backbones and other newer agents safely remains to be determined.
We performed a retrospective analysis of the safety and outcomes of adult patients with newly diagnosed acute myeloid leukemia (AML) treated with GO with intensified versus standard anthracycline doses (daunorubicin dose 90 mg/m vs 60 mg/m) ± FLT3 inhibitors. The χ test and Mann-Whitney U test were used to compare categorical and continuous data. Survival estimates were calculated by Kaplan-Meier method and survival comparisons made using log-rank test.
We report a 97% overall response rate in 34 patients with newly diagnosed AML with a median age of 54 years (19-75 years) treated with GO and standard induction. The 11 patients (100%) receiving GO plus daunorubicin dose 90 mg/m as part of 7 + 3 induction achieved complete response versus 91% (20/22) complete response in the standard daunorubicin dose group (P = NS). No increased toxicity was noted with the higher daunorubicin dose or when GO and 7 + 3 were combined with FLT3 inhibitors in 3 younger patients (<60 years). Two older patients treated with GO+7 + 3 and FLT3i experienced grade 3 or higher cardiotoxicity. We observed a longer estimated event-free survival for patients with newly diagnosed AML in our cohort (median, 24 months; 95% confidence interval, 17.2 to not reached) compared with historical data.
We demonstrate that anthracycline dose intensification with GO may offer higher response rates without increased toxicity in younger patients presenting with de novo AML across European Leukemia Net risk categories.
联合吉妥珠单抗奥佐米星（GO）与各种化疗方案和其他新型药物的最佳方法仍有待确定。
我们对接受 GO 联合强化与标准蒽环类剂量（柔红霉素剂量 90mg/m2 与 60mg/m2）±FLT3 抑制剂治疗的初诊急性髓系白血病（AML）成年患者的安全性和结局进行了回顾性分析。采用卡方检验和 Mann-Whitney U 检验比较分类和连续数据。采用 Kaplan-Meier 法计算生存率，并用对数秩检验进行生存比较。
我们报告了 34 例初诊 AML 患者的总体缓解率为 97%，中位年龄为 54 岁（19-75 岁），接受 GO 联合标准诱导治疗。11 例（100%）接受 GO 联合柔红霉素 90mg/m2 作为 7+3 诱导方案的患者达到完全缓解，而标准柔红霉素剂量组的完全缓解率为 91%（20/22）（P=NS）。在 3 例年龄较小（<60 岁）的患者中，高剂量柔红霉素或 GO 联合 7+3 与 FLT3 抑制剂联合使用时，未观察到毒性增加。2 例接受 GO+7+3 和 FLT3i 治疗的老年患者发生 3 级或更高级别的心脏毒性。与历史数据相比，我们队列中的初诊 AML 患者观察到更长的无事件生存时间（中位数 24 个月；95%置信区间 17.2-未达到）。
我们证明，GO 联合蒽环类药物剂量强化治疗可在不增加毒性的情况下，为不同欧洲白血病网危险分层的初诊 AML 年轻患者带来更高的缓解率。
