Christoph Röllig, Björn Steffen, Christoph Schliemann, Jan-Henrik Mikesch, Nael Alakel, Regina Herbst, Mathias Hänel, Richard Noppeney, Maher Hanoun, Martin Kaufmann, Barbora Weinbergerova, Kerstin Schäfer-Eckart, Tim Sauer, Andreas Neubauer, Andreas Burchert, Claudia D Baldus, Jolana Mertová, Edgar Jost, Dirk Niemann, Jan Novák, Stefan W Krause, Sebastian Scholl, Andreas Hochhaus, Gerhard Held, Tomas Szotkowski, Andreas Rank, Christoph Schmid, Lars Fransecky, Sabine Kayser, Markus Schaich, Michael Kramer, Frank Fiebig, Annett Haake, Johannes Schetelig, Jan Moritz Middeke, Friedrich Stölzel, Uwe Platzbecker, Christian Thiede, Carsten Müller-Tidow, Wolfgang E Berdel, Gerhard Ehninger, Jiri Mayer, Hubert Serve, Martin Bornhäuser
{"title":"对新诊断的急性髓细胞白血病采用含标准剂量或高剂量多柔比星的 7+3 单药或双药诱导：白血病研究联盟的随机 DaunoDouble 试验。","authors":"Christoph Röllig, Björn Steffen, Christoph Schliemann, Jan-Henrik Mikesch, Nael Alakel, Regina Herbst, Mathias Hänel, Richard Noppeney, Maher Hanoun, Martin Kaufmann, Barbora Weinbergerova, Kerstin Schäfer-Eckart, Tim Sauer, Andreas Neubauer, Andreas Burchert, Claudia D Baldus, Jolana Mertová, Edgar Jost, Dirk Niemann, Jan Novák, Stefan W Krause, Sebastian Scholl, Andreas Hochhaus, Gerhard Held, Tomas Szotkowski, Andreas Rank, Christoph Schmid, Lars Fransecky, Sabine Kayser, Markus Schaich, Michael Kramer, Frank Fiebig, Annett Haake, Johannes Schetelig, Jan Moritz Middeke, Friedrich Stölzel, Uwe Platzbecker, Christian Thiede, Carsten Müller-Tidow, Wolfgang E Berdel, Gerhard Ehninger, Jiri Mayer, Hubert Serve, Martin Bornhäuser","doi":"10.1200/JCO.24.00235","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To determine the optimal daunorubicin dose and number of 7 + 3 induction cycles in newly diagnosed AML, this randomized controlled trial compared a once daily dose of 60 mg/m<sup>2</sup> with 90 mg/m<sup>2</sup> daunorubicin in the first 7 + 3 induction and one versus two cycles of 7 + 3 induction.</p><p><strong>Patients and methods: </strong>Patients age 18-65 years with newly diagnosed AML were randomly assigned to 60 versus 90 mg/m<sup>2</sup> daunorubicin once daily plus cytarabine. Patients with marrow blasts below 5% on day 15 after first induction were randomly assigned to receive a second induction cycle or no second induction cycle.</p><p><strong>Results: </strong>Eight hundred and sixty-four patients with a median age of 52 years were randomly assigned. After a preplanned interim analysis showing no significant difference in response between 60 and 90 mg/m<sup>2</sup>, all consecutive patients received 60 mg/m<sup>2</sup> daunorubicin once daily. The proportion of good early responders was 44% versus 48% (<i>P</i> = .983) with a composite complete remission (CRc) rate of 90% versus 89% after induction (<i>P</i> = .691); the 3-year relapse-free survival (RFS) after 60 versus 90 mg/m<sup>2</sup> once daily was 54% versus 50% (<i>P</i> = .561), and the 3-year overall survival (OS) was 65% versus 58% (<i>P</i> = .242). Among 389 good responders, CRc rates at the end of induction were 87% after single induction and 85% after double induction. The 3-year RFS was 51% versus 60% (hazard ratio [HR], 1.3; <i>P</i> = .091), and the 3-year OS was 76% versus 75% after single versus double induction (HR, 1.0; <i>P</i> = .937).</p><p><strong>Conclusion: </strong>The use of 90 mg/m<sup>2</sup> daunorubicin once daily in the context of classical 7 + 3 induction does not significantly improve early response and does not lead to higher remission rates or longer survival than 60 mg/m<sup>2</sup> once daily. In patients with a good early response after first induction, a second induction has only a limited impact on RFS and does not result in an OS benefit.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"65-74"},"PeriodicalIF":42.1000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Single or Double Induction With 7 + 3 Containing Standard or High-Dose Daunorubicin for Newly Diagnosed AML: The Randomized DaunoDouble Trial by the Study Alliance Leukemia.\",\"authors\":\"Christoph Röllig, Björn Steffen, Christoph Schliemann, Jan-Henrik Mikesch, Nael Alakel, Regina Herbst, Mathias Hänel, Richard Noppeney, Maher Hanoun, Martin Kaufmann, Barbora Weinbergerova, Kerstin Schäfer-Eckart, Tim Sauer, Andreas Neubauer, Andreas Burchert, Claudia D Baldus, Jolana Mertová, Edgar Jost, Dirk Niemann, Jan Novák, Stefan W Krause, Sebastian Scholl, Andreas Hochhaus, Gerhard Held, Tomas Szotkowski, Andreas Rank, Christoph Schmid, Lars Fransecky, Sabine Kayser, Markus Schaich, Michael Kramer, Frank Fiebig, Annett Haake, Johannes Schetelig, Jan Moritz Middeke, Friedrich Stölzel, Uwe Platzbecker, Christian Thiede, Carsten Müller-Tidow, Wolfgang E Berdel, Gerhard Ehninger, Jiri Mayer, Hubert Serve, Martin Bornhäuser\",\"doi\":\"10.1200/JCO.24.00235\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To determine the optimal daunorubicin dose and number of 7 + 3 induction cycles in newly diagnosed AML, this randomized controlled trial compared a once daily dose of 60 mg/m<sup>2</sup> with 90 mg/m<sup>2</sup> daunorubicin in the first 7 + 3 induction and one versus two cycles of 7 + 3 induction.</p><p><strong>Patients and methods: </strong>Patients age 18-65 years with newly diagnosed AML were randomly assigned to 60 versus 90 mg/m<sup>2</sup> daunorubicin once daily plus cytarabine. Patients with marrow blasts below 5% on day 15 after first induction were randomly assigned to receive a second induction cycle or no second induction cycle.</p><p><strong>Results: </strong>Eight hundred and sixty-four patients with a median age of 52 years were randomly assigned. After a preplanned interim analysis showing no significant difference in response between 60 and 90 mg/m<sup>2</sup>, all consecutive patients received 60 mg/m<sup>2</sup> daunorubicin once daily. The proportion of good early responders was 44% versus 48% (<i>P</i> = .983) with a composite complete remission (CRc) rate of 90% versus 89% after induction (<i>P</i> = .691); the 3-year relapse-free survival (RFS) after 60 versus 90 mg/m<sup>2</sup> once daily was 54% versus 50% (<i>P</i> = .561), and the 3-year overall survival (OS) was 65% versus 58% (<i>P</i> = .242). Among 389 good responders, CRc rates at the end of induction were 87% after single induction and 85% after double induction. The 3-year RFS was 51% versus 60% (hazard ratio [HR], 1.3; <i>P</i> = .091), and the 3-year OS was 76% versus 75% after single versus double induction (HR, 1.0; <i>P</i> = .937).</p><p><strong>Conclusion: </strong>The use of 90 mg/m<sup>2</sup> daunorubicin once daily in the context of classical 7 + 3 induction does not significantly improve early response and does not lead to higher remission rates or longer survival than 60 mg/m<sup>2</sup> once daily. In patients with a good early response after first induction, a second induction has only a limited impact on RFS and does not result in an OS benefit.</p>\",\"PeriodicalId\":15384,\"journal\":{\"name\":\"Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"65-74\"},\"PeriodicalIF\":42.1000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1200/JCO.24.00235\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/16 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1200/JCO.24.00235","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/16 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Single or Double Induction With 7 + 3 Containing Standard or High-Dose Daunorubicin for Newly Diagnosed AML: The Randomized DaunoDouble Trial by the Study Alliance Leukemia.
Purpose: To determine the optimal daunorubicin dose and number of 7 + 3 induction cycles in newly diagnosed AML, this randomized controlled trial compared a once daily dose of 60 mg/m2 with 90 mg/m2 daunorubicin in the first 7 + 3 induction and one versus two cycles of 7 + 3 induction.
Patients and methods: Patients age 18-65 years with newly diagnosed AML were randomly assigned to 60 versus 90 mg/m2 daunorubicin once daily plus cytarabine. Patients with marrow blasts below 5% on day 15 after first induction were randomly assigned to receive a second induction cycle or no second induction cycle.
Results: Eight hundred and sixty-four patients with a median age of 52 years were randomly assigned. After a preplanned interim analysis showing no significant difference in response between 60 and 90 mg/m2, all consecutive patients received 60 mg/m2 daunorubicin once daily. The proportion of good early responders was 44% versus 48% (P = .983) with a composite complete remission (CRc) rate of 90% versus 89% after induction (P = .691); the 3-year relapse-free survival (RFS) after 60 versus 90 mg/m2 once daily was 54% versus 50% (P = .561), and the 3-year overall survival (OS) was 65% versus 58% (P = .242). Among 389 good responders, CRc rates at the end of induction were 87% after single induction and 85% after double induction. The 3-year RFS was 51% versus 60% (hazard ratio [HR], 1.3; P = .091), and the 3-year OS was 76% versus 75% after single versus double induction (HR, 1.0; P = .937).
Conclusion: The use of 90 mg/m2 daunorubicin once daily in the context of classical 7 + 3 induction does not significantly improve early response and does not lead to higher remission rates or longer survival than 60 mg/m2 once daily. In patients with a good early response after first induction, a second induction has only a limited impact on RFS and does not result in an OS benefit.
期刊介绍：
The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
