Midostaurin plus intensive chemotherapy for younger and older Patients with AML and FLT3 internal tandem duplications
We conducted a single-arm phase-II trial (AMLSG 16-10) to evaluate midostaurin with intensive chemotherapy followed by allogeneic hematopoietic-cell transplantation (HCT) and a one-year midostaurin maintenance therapy in adult patients with acute myeloid leukemia (AML) and FLT3 internal tandem dupli...
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| Veröffentlicht in: | Blood advances 2022-09, Vol.6 (18), p.5345-5355 |
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| creator | Döhner, Hartmut Weber, Daniela Krzykalla, Julia Fiedler, Walter Wulf, Gerald Georg Salih, Helmut R Lübbert, Michael Kühn, Michael Schroeder, Thomas Salwender, Hans Götze, Katharina S Westermann, Jörg Fransecky, Lars Mayer, Karin Hertenstein, Bernd Ringhoffer, Mark Tischler, Hans-Joachim Machherndl-Spandl, Sigrid Schrade, Anika Paschka, Peter Gaidzik, Verena I Theis, Frauke Thol, Felicitas R Heuser, Michael Schlenk, Richard F Bullinger, Lars Saadati, Maral Benner, Axel Larson, Richard A Stone, Richard M Döhner, Konstanze Ganser, Arnold |
| description | We conducted a single-arm phase-II trial (AMLSG 16-10) to evaluate midostaurin with intensive chemotherapy followed by allogeneic hematopoietic-cell transplantation (HCT) and a one-year midostaurin maintenance therapy in adult patients with acute myeloid leukemia (AML) and FLT3 internal tandem duplication (ITD). Patients 18-70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free (EFS) and overall survival (OS). Results were compared to a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared to patients (18-59yrs) treated on the placebo arm of the CALGB 10603/RATIFY trial. The trial accrued 440 patients (18-60yrs, n=312; 61-70yrs, n=128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared to the AMLSG control (HR 0.55; P |
| doi_str_mv | 10.1182/bloodadvances.2022007223 |
| format | Article |
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Patients 18-70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free (EFS) and overall survival (OS). Results were compared to a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared to patients (18-59yrs) treated on the placebo arm of the CALGB 10603/RATIFY trial. The trial accrued 440 patients (18-60yrs, n=312; 61-70yrs, n=128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared to the AMLSG control (HR 0.55; P<0.001); both in younger (HR 0.59; P<0.001) and older patients (HR 0.42; P<0.001). Multivariate analysis also showed a significant beneficial effect on OS compared to the AMLSG control (HR 0.57; P<0.001) as well as to the CALGB 10603/RATIFY trial (HR 0.71; p=0.005). The treatment effect of midostaurin remained significant in sensitivity analysis including allogeneic HCT as a time-dependent covariate. Addition of midostaurin to chemotherapy was safe in younger and older patients. In comparison to historical controls, the addition of midostaurin to intensive therapy led to a significant improvement in outcome in younger and older patients with AML and FLT3-ITD.</description><identifier>ISSN: 2473-9529</identifier><identifier>EISSN: 2473-9537</identifier><identifier>DOI: 10.1182/bloodadvances.2022007223</identifier><identifier>PMID: 35486475</identifier><language>eng</language><publisher>United States</publisher><ispartof>Blood advances, 2022-09, Vol.6 (18), p.5345-5355</ispartof><rights>Copyright © 2022 American Society of Hematology.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c365t-98fde9dd72c0da210d48435794a49dcc00c71ca260dccc987c444d261c3b9d303</citedby><cites>FETCH-LOGICAL-c365t-98fde9dd72c0da210d48435794a49dcc00c71ca260dccc987c444d261c3b9d303</cites><orcidid>0000-0002-6719-1847 ; 0000-0002-3658-0284 ; 0000-0002-7238-6956 ; 0000-0003-3510-4304 ; 0000-0003-2116-5536 ; 0000-0003-2215-2059 ; 0000-0001-9168-3203 ; 0000-0002-6276-8002 ; 0000-0002-9378-526X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,860,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35486475$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Döhner, Hartmut</creatorcontrib><creatorcontrib>Weber, Daniela</creatorcontrib><creatorcontrib>Krzykalla, Julia</creatorcontrib><creatorcontrib>Fiedler, Walter</creatorcontrib><creatorcontrib>Wulf, Gerald Georg</creatorcontrib><creatorcontrib>Salih, Helmut R</creatorcontrib><creatorcontrib>Lübbert, Michael</creatorcontrib><creatorcontrib>Kühn, Michael</creatorcontrib><creatorcontrib>Schroeder, Thomas</creatorcontrib><creatorcontrib>Salwender, Hans</creatorcontrib><creatorcontrib>Götze, Katharina S</creatorcontrib><creatorcontrib>Westermann, Jörg</creatorcontrib><creatorcontrib>Fransecky, Lars</creatorcontrib><creatorcontrib>Mayer, Karin</creatorcontrib><creatorcontrib>Hertenstein, Bernd</creatorcontrib><creatorcontrib>Ringhoffer, Mark</creatorcontrib><creatorcontrib>Tischler, Hans-Joachim</creatorcontrib><creatorcontrib>Machherndl-Spandl, Sigrid</creatorcontrib><creatorcontrib>Schrade, Anika</creatorcontrib><creatorcontrib>Paschka, Peter</creatorcontrib><creatorcontrib>Gaidzik, Verena I</creatorcontrib><creatorcontrib>Theis, Frauke</creatorcontrib><creatorcontrib>Thol, Felicitas R</creatorcontrib><creatorcontrib>Heuser, Michael</creatorcontrib><creatorcontrib>Schlenk, Richard F</creatorcontrib><creatorcontrib>Bullinger, Lars</creatorcontrib><creatorcontrib>Saadati, Maral</creatorcontrib><creatorcontrib>Benner, Axel</creatorcontrib><creatorcontrib>Larson, Richard A</creatorcontrib><creatorcontrib>Stone, Richard M</creatorcontrib><creatorcontrib>Döhner, Konstanze</creatorcontrib><creatorcontrib>Ganser, Arnold</creatorcontrib><title>Midostaurin plus intensive chemotherapy for younger and older Patients with AML and FLT3 internal tandem duplications</title><title>Blood advances</title><addtitle>Blood Adv</addtitle><description>We conducted a single-arm phase-II trial (AMLSG 16-10) to evaluate midostaurin with intensive chemotherapy followed by allogeneic hematopoietic-cell transplantation (HCT) and a one-year midostaurin maintenance therapy in adult patients with acute myeloid leukemia (AML) and FLT3 internal tandem duplication (ITD). Patients 18-70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free (EFS) and overall survival (OS). Results were compared to a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared to patients (18-59yrs) treated on the placebo arm of the CALGB 10603/RATIFY trial. The trial accrued 440 patients (18-60yrs, n=312; 61-70yrs, n=128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared to the AMLSG control (HR 0.55; P<0.001); both in younger (HR 0.59; P<0.001) and older patients (HR 0.42; P<0.001). Multivariate analysis also showed a significant beneficial effect on OS compared to the AMLSG control (HR 0.57; P<0.001) as well as to the CALGB 10603/RATIFY trial (HR 0.71; p=0.005). The treatment effect of midostaurin remained significant in sensitivity analysis including allogeneic HCT as a time-dependent covariate. Addition of midostaurin to chemotherapy was safe in younger and older patients. 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Patients 18-70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free (EFS) and overall survival (OS). Results were compared to a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared to patients (18-59yrs) treated on the placebo arm of the CALGB 10603/RATIFY trial. The trial accrued 440 patients (18-60yrs, n=312; 61-70yrs, n=128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared to the AMLSG control (HR 0.55; P<0.001); both in younger (HR 0.59; P<0.001) and older patients (HR 0.42; P<0.001). Multivariate analysis also showed a significant beneficial effect on OS compared to the AMLSG control (HR 0.57; P<0.001) as well as to the CALGB 10603/RATIFY trial (HR 0.71; p=0.005). The treatment effect of midostaurin remained significant in sensitivity analysis including allogeneic HCT as a time-dependent covariate. Addition of midostaurin to chemotherapy was safe in younger and older patients. 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| title | Midostaurin plus intensive chemotherapy for younger and older Patients with AML and FLT3 internal tandem duplications |
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