Department of Hematology, Medical University of Lodz, Lodz, Poland.
Department of Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.
Leuk Lymphoma. 2020 Mar;61(3):588-603. doi: 10.1080/10428194.2019.1678151. Epub 2019 Oct 29.
We present the results of a prospective, non-randomized phase 2 trial in which 253 AML patients (pts) under 60 years old received DAC (Daunorubicin + AraC + Cladribine) as first induction followed by CLAM (Cladribine + AraC + Mitoxantrone) as early second induction on day 16 based on bone marrow (BM) blasts on day 14 (D14). The CR/CRi rate after a single course of DAC was 83% for pts with D14 BM blasts less than 10%. Forty-six pts had >10% BM blasts on D14, of whom 35 received CLAM with rates of CR/CRi 60% and early death (ED) 23%. The remaining 11 pts were not fit to receive CLAM, with rates of CR/CRi 28%, PR 18%, and ED 18%. Median OS was 7.2 versus 7.5 months, respectively. The overall CR/CRi rate was 77% after the first induction, with final CR/CRi rate 80% after DAC reinduction for pts who achieved PR with initial DAC course. CLAM used as early second induction might improve CR/CRi rates for younger AML pts with poor early response to DAC induction, but may be associated with higher mortality.
我们呈现了一项前瞻性、非随机的 2 期临床试验结果，该试验纳入了 253 名年龄在 60 岁以下的 AML 患者。这些患者在第 14 天（D14）时根据骨髓（BM）原始细胞计数接受 DAC（柔红霉素+阿糖胞苷+克拉屈滨）作为首次诱导治疗，如果 D14 时 BM 原始细胞计数小于 10%，则在第 16 天接受 CLAM（克拉屈滨+阿糖胞苷+米托蒽醌）作为早期的二次诱导治疗。对于 D14 时 BM 原始细胞计数小于 10%的患者，单次 DAC 治疗后 CR/CRi 率为 83%。46 名患者在 D14 时 BM 原始细胞计数大于 10%，其中 35 名患者接受 CLAM 治疗，CR/CRi 率为 60%，早期死亡（ED）率为 23%。其余 11 名患者不适合接受 CLAM 治疗，CR/CRi 率为 28%，部分缓解（PR）率为 18%，ED 率为 18%。中位 OS 分别为 7.2 个月和 7.5 个月。首次诱导后的总体 CR/CRi 率为 77%，对于首次 DAC 疗程后获得 PR 的患者，再次接受 DAC 诱导后的最终 CR/CRi 率为 80%。对于早期对 DAC 诱导反应较差的年轻 AML 患者，早期应用 CLAM 可能会提高 CR/CRi 率，但可能与更高的死亡率相关。
