Different treatment strategies versus a common standard arm (CSA) in patients with newly diagnosed AML over the age of 60 years: a randomized German inter-group study

被引：7

作者：

Niederwieser, Dietger ^{[1
,2
,3
]}

Lang, Thomas ^{[4
]}

Krahl, Rainer ^{[1
]}

Heinicke, Thomas ^{[5
]}

Maschmeyer, Georg ^{[6
]}

Al-Ali, Haifa Kathrin ^{[7
]}

Schwind, Sebastian ^{[1
]}

Jentzsch, Madlen ^{[1
]}

Cross, Michael ^{[1
]}

Kahl, Christoph ^{[8
,9
]}

Wolf, Hans-Heinrich ^{[10
]}

Sayer, Herbert ^{[11
]}

Schulze, Antje ^{[1
]}

Dreger, Peter ^{[12
]}

Hegenbart, Ute ^{[12
]}

Kraemer, Alwin ^{[13
,14
]}

Junghanss, Christian ^{[15
]}

Muegge, Lars-Olof ^{[16
]}

Haehling, Detlev ^{[17
]}

Hirt, Carsten ^{[18
]}

Spaeth, Christian ^{[18
]}

Peter, Norma ^{[19
]}

Opitz, Bernhard ^{[20
]}

Florschuetz, Axel ^{[21
]}

Reifenrath, Kolja ^{[22
]}

Zojer, Niklas ^{[23
]}

Scholl, Sebastian ^{[24
]}

Poenisch, Wolfram ^{[1
]}

Heyn, Simone ^{[1
]}

Vucinic, Vladan ^{[1
]}

Hochhaus, Andreas ^{[24
]}

Aul, Carlo ^{[25
,26
]}

Giagounidis, Aristoteles ^{[25
,26
,27
]}

Balleisen, Leopold ^{[28
]}

Oldenkott, Bernd ^{[29
]}

Staib, Peter ^{[30
]}

Kiehl, Michael ^{[31
]}

Schuette, Wolfgang ^{[32
]}

Naumann, Ralph ^{[33
]}

Eimermacher, Hartmut ^{[34
]}

Doerken, Bernd ^{[35
]}

Sauerland, Cristina ^{[36
]}

Lengfelder, Eva ^{[37
]}

Hiddemann, Wolfgang ^{[38
]}

Woermann, Bernhard ^{[39
,40
]}

Mueller-Tidow, Carsten ^{[41
,42
]}

Serve, Hubert ^{[41
,43
]}

Schliemann, Christoph ^{[41
]}

Hehlmann, Ruediger ^{[44
]}

Berdel, Wolfgang E. ^{[41
]}

机构：

[1] Univ Leipzig, D-04106 Leipzig, Germany

[2] Lithuanian Univ Hlth Sci, Kaunas, Lithuania

[3] Aichi Med Univ, Nagakute, Japan

[4] Ludwig Maximilian Univ Munchen, Inst Med Informat Verarbeitung Biometrie & Epidemi, Munich, Germany

[5] Otto Von Guericke Univ, Dept Hematol & Oncol, Magdeburg, Germany

[6] Klinikum Ernst Von Bergmann, Dept Hematol Oncol & Palliat Care, Potsdam, Germany

[7] Univ Hosp Halle Saale, Krukenberg Canc Ctr, Dept Internal Med Oncol Hematol 4, Halle, Germany

[8] Rostock Univ Med Ctr, Dept Internal Med, Clin Hematol Oncol & Palliat Care 3, Rostock, Germany

[9] Klinikum Magdeburg gGmbH, Dept Hematol Oncol & Palliat Care, Magdeburg, Germany

[10] Univ Hosp, Dept Hematol & Oncol, Halle, Germany

[11] Helios Klinikum Erfurt, Med Klin Hamatol Stammzelltransplantat Onkol, Erfurt, Germany

[12] Univ Hosp, Med Dept 5, Heidelberg, Germany

[13] Heidelberg Univ, German Canc Res Ctr DKFZ, Clin Cooperat Unit Mol Hematol Oncol, Heidelberg, Germany

[14] Heidelberg Univ, Dept Internal Med 5, Heidelberg, Germany

[15] Hosp Zwickau, Innere Med Hamatol Onkol & Palliat Med 3, Zwickau, Germany

[16] Klinikum Schwerin, Dept Hematol & Oncol, Schwerin, Germany

[17] Univ Med Greifswald, Innere Med C, Sauerbruchstr, D-17475 Greifswald, Germany

[18] Carl Thieme Klinikum GmbH, Med Klin, Cottbus, Germany

[19] St Elisabeth & St Barbara Hosp Halle Saale, Halle, Germany

[20] Klinikum Dessau, Dessau, Germany

[21] Klinikum Zittau, Zittau, Germany

[22] Klin Ottakring, Ctr Oncol & Hematol & Palliat Care, Med Dept 1, Vienna, Austria

[23] Univ Klinikum Jena, Hematol Oncol, Jena, Germany

[24] St Johannes Hosp, Klin Hamatol & Onkol, Duisburg, Germany

[25] Marienhosp Dusseldorf, Dept Oncol Hematol & Palliat Care, Dusseldorf, Germany

[26] Evangel Krankenhaus Hamm, Dept Med 2, Hamm, Germany

[27] St Hedwig Krankenhaus Berlin, Dept Hematol & Oncol, Berlin, Germany

[28] St Antonius Krankenhaus Eschweiler, Dept Hematol Oncol, Eschweiler, Germany

[29] Klinikum Frankfurt Oder, Dept Med, Frankfurt, Germany

[30] Krankenhaus Martha Maria, Dept Internal Med 2, Halle, Germany

[31] St Marien Krankenhaus Siegen, Dept Hematol Oncol & Palliat Care, Siegen, Germany

[32] Kathol Krankenhaus Hagen, Dept Hematol & Oncol, Hagen, Germany

[33] Charite Campus Virchow, Dept Hematol & Oncol, Berlin, Germany

[34] Univ Hosp Munster, Inst Biometry & Clin Res, Munster, Germany

[35] Univ Hosp Mannheim, Med Dept 3, Mannheim, Germany

[36] Univ Hosp Grosshadern, Med Dept 3, Munich, Germany

[37] Charite Univ Med Berlin, Dept Med, Div Hematol Oncol & Tumour Immunol, Berlin, Germany

[38] Deutsch Gesell Hamatol & Med Onkol, Berlin, Germany

[39] Univ Hosp Munster, Dept Med A, Munster, Germany

[40] Univ Hosp Heidelberg, Dept Med 5, Heidelberg, Germany

[41] Goethe Univ, Dept Med, Hematol Oncol, Frankfurt, Germany

[42] Heidelberg Univ, Mannheim, Germany

[43] European LeukemiaNet, Weinheim, Germany

[44] Klinikum Leverkusen, Dept Med 3, Leverkusen, Germany

来源：

ANNALS OF HEMATOLOGY | 2023年 / 102卷 / 03期

关键词：

Acute myeloid leukemia; Prognostic factors; Induction therapy; Complete remission; Consolidation therapy; Allogeneic stem cell transplantation; ACUTE MYELOID-LEUKEMIA; HEMATOPOIETIC-CELL TRANSPLANTATION; ELDERLY-PATIENTS; CYTOSINE-ARABINOSIDE; REMISSION-INDUCTION; CHEMOTHERAPY; AZACITIDINE; ADULTS; DAUNORUBICIN; VENETOCLAX;

D O I：

10.1007/s00277-023-05087-8

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

A randomized inter-group trial comparing more intensive treatment strategies to a common standard arm 3 + 7 (CSA) was conducted in patients with non-M3 AML. Untreated patients >= 60 years were allocated to the CSA (n = 132) or to the study group arms (n = 1154) of the AMLCG (TAD/HAM versus HAM/HAM +/- G-CSF followed by TAD and maintenance) and the OSHO (intermediate-dose ara-C/mitoxantrone followed by ara-C/mitoxantrone). Median age of the 1147 eligible patients was 69 (range 60-87) years. CR/CRi status at 90 days was not significantly different between the CSA (54% (95%CI: 45-64)) and the study group arms (53% (95%CI: 47-60) and 59% (95%CI: 58-63)). The five-year event-free survival (EFS) probability (primary endpoint) was 6.2% (95%CI: 2.7-14.0) in the CSA, 7.6% (95%CI: 4.5-12.8) in study group A and 11.1% (95%CI: 9.0-13.7) in B. The 5-year OS was 17.2% (95%CI: 11.0-26.9), 17.0% (95%CI: 2.0-23.9), and 19.5% (95%CI: 16.7-22.8) in CSA, study group A and B, respectively. Neither study group differed significantly from the CSA regarding EFS, OS, or relapse-free survival. In multivariate analyses, allocation to the treatment strategy was not significantly associated with the time-to-event endpoints. The evaluation of more intensive treatment strategies did not show clinically relevant outcome differences when compared to CSA.

引用

页码：547 / 561

页数：15

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