Details

Autor(en) / Beteiligte

• Mao, Yue-ying
• Cai, Hua-cong
• Shen, Kai-ni
• Chang, Long
• Zhang, Lu
• Zhang, Yan
• Feng, Jun
• Wang, Wei
• Yang, Chen
• Zhu, Tie-nan
• Duan, Ming-hui
• Zhou, Dao-bin
• Cao, Xin-xin
• Li, Jian

Titel

Benefit of high-dose idarubicin as induction therapy in acute myeloid leukemia: a prospective phase 2 study

Ist Teil von

• Annals of hematology, 2022-04, Vol.101 (4), p.831-836

Ort / Verlag

Berlin/Heidelberg: Springer Berlin Heidelberg

Erscheinungsjahr

2022

Quelle

MEDLINE

Beschreibungen/Notizen

• Idarubicin 12 mg/m 2 has been recommended as a standard induction therapy for acute myeloid leukemia (AML). It is unknown whether a higher dose of idarubicin can improve the remission rate. This phase 2 prospective single-arm study enrolled 45 adults with newly diagnosed AML between September 2019 and May 2021 (NCT 04,069,208). Induction therapy included administration of idarubicin 14 mg/m 2 for 3 days and cytarabine 100 mg/m 2 every 12 h subcutaneously for 7 days. The primary endpoint was the composite complete response rate (complete response (CR) plus complete response with incomplete blood count recovery (CRi)). The median age was 45 years (range 14–60 years). Forty (88.9%) patients had CR or CRi, including 39 patients with CR and 1 patient with CRi after one course of induction therapy. The median times to recovery of absolute neutrophil and platelet counts were 21 days. Only 1 patient died of intracranial hemorrhage during induction therapy. After a median follow-up of 14 months (range 3.5–24 months), the estimated 18-month overall survival and disease-free survival (DFS) were 66.9% and 57.5%, respectively. In conclusion, idarubicin 14 mg/m 2  plus cytarabine was a safe and efficient intensive regimen for younger and fit patients with newly diagnosed AML.