PMID- 15514380 OWN - NLM STAT- MEDLINE DCOM- 20041202 LR - 20220408 IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 22 IP - 21 DP - 2004 Nov 1 TI - Early deaths and treatment-related mortality in children undergoing therapy for acute myeloid leukemia: analysis of the multicenter clinical trials AML-BFM 93 and AML-BFM 98. PG - 4384-93 AB - PURPOSE: The rates of early death (ED) and treatment-related mortality (TRM) are unacceptably high in children undergoing intensive chemotherapy for acute myeloid leukemia (AML). Better strategies of supportive care might help to improve overall survival in these children. PATIENTS AND METHODS: In a retrospective study, we analyzed incidence, clinical features, and risk factors for lethal complications of 901 children enrolled onto the multicenter trials Acute Myeloid Leukemia-Berlin-Frankfurt-Muenster (AML-BFM) 93 and AML-BFM 98. RESULTS: One hundred four patients (11.5%) enrolled onto the clinical trials AML-BFM 93 and AML-BFM 98 died shortly after diagnosis or as a result of treatment-related complications. Thirty-two patients (3.5%) died before (six patients) or during (26 patients) the first 14 days of treatment, mainly as a result of bleeding or leukostasis. Low performance status, hyperleukocytosis, and French-American-British type M5 were the main risk factors for a lethal event before day 15. After day 15, the predominant causes of death were complications caused by infections, particularly bacterial and fungal infections. The incidence of lethal infections was highest during induction therapy and decreased thereafter. When comparing both clinical trials, significantly fewer patients died within the first 6 weeks in AML-BFM 98 than in AML-BFM 93 (14 [3.5%] of 430 patients v 35 [7.4%] of 471 patients; P = .01). CONCLUSION: To reduce the high incidence of ED and TRM in children with AML, early diagnosis and adequate treatment of complications are needed. Children with AML should be treated in specialized pediatric cancer centers only. Prophylactic and therapeutic regimens for better treatment management of bleeding disorders and infectious complications have to be assessed in future trials to ultimately improve overall survival in children with AML. FAU - Creutzig, Ursula AU - Creutzig U AD - Department of Pediatric Hematology and Oncology, University Children's Hospital Muenster, Albert-Schweitzer-Str 33, D-48129 Muenster, Germany. ursula@creutzig.de FAU - Zimmermann, Martin AU - Zimmermann M FAU - Reinhardt, Dirk AU - Reinhardt D FAU - Dworzak, Michael AU - Dworzak M FAU - Stary, Jan AU - Stary J FAU - Lehrnbecher, Thomas AU - Lehrnbecher T LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 04079A1RDZ (Cytarabine) RN - 143011-72-7 (Granulocyte Colony-Stimulating Factor) RN - 6PLQ3CP4P3 (Etoposide) RN - BZ114NVM5P (Mitoxantrone) RN - ZRP63D75JW (Idarubicin) SB - IM MH - Adolescent MH - Antineoplastic Combined Chemotherapy Protocols/*toxicity MH - Cause of Death MH - Chi-Square Distribution MH - Child MH - Child, Preschool MH - Cytarabine/administration & dosage/toxicity MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Etoposide/administration & dosage/toxicity MH - Female MH - Granulocyte Colony-Stimulating Factor/administration & dosage/toxicity MH - Humans MH - Idarubicin/administration & dosage/toxicity MH - Incidence MH - Infant MH - Infant, Newborn MH - Leukemia, Myeloid, Acute/*drug therapy/*mortality MH - Logistic Models MH - Male MH - Mitoxantrone/administration & dosage/toxicity MH - Randomized Controlled Trials as Topic MH - Retrospective Studies MH - Risk Factors MH - Survival Rate EDAT- 2004/10/30 09:00 MHDA- 2004/12/16 09:00 CRDT- 2004/10/30 09:00 PHST- 2004/10/30 09:00 [pubmed] PHST- 2004/12/16 09:00 [medline] PHST- 2004/10/30 09:00 [entrez] AID - 22/21/4384 [pii] AID - 10.1200/JCO.2004.01.191 [doi] PST - ppublish SO - J Clin Oncol. 2004 Nov 1;22(21):4384-93. doi: 10.1200/JCO.2004.01.191.