Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations
To evaluate efficacy and safety of venetoclax + azacitidine among treatment-naïve patients with IDH1/2-mutant (mut) acute myeloid leukemia (AML). Data were pooled from patients enrolled in a phase III study (NCT02993523) that compared patients treated with venetoclax + azacitidine or placebo + azaci...
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| Veröffentlicht in: | Clinical cancer research 2022-07, Vol.28 (13), p.2753-2761 |
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| creator | Pollyea, Daniel A DiNardo, Courtney D Arellano, Martha L Pigneux, Arnaud Fiedler, Walter Konopleva, Marina Rizzieri, David A Smith, B Douglas Shinagawa, Atsushi Lemoli, Roberto M Dail, Monique Duan, Yinghui Chyla, Brenda Potluri, Jalaja Miller, Catherine L Kantarjian, Hagop M |
| description | To evaluate efficacy and safety of venetoclax + azacitidine among treatment-naïve patients with IDH1/2-mutant (mut) acute myeloid leukemia (AML).
Data were pooled from patients enrolled in a phase III study (NCT02993523) that compared patients treated with venetoclax + azacitidine or placebo + azacitidine and a prior phase Ib study (NCT02203773) where patients were treated with venetoclax + azacitidine. Enrolled patients were ineligible for intensive therapy due to age ≥75 years and/or comorbidities. Patients on venetoclax + azacitidine received venetoclax 400 mg orally (days 1-28) and azacitidine (75 mg/m2; days 1-7/28-day cycle).
In the biomarker-evaluable population, IDH1/2mut was detected in 81 (26%) and 28 (22%) patients in the venetoclax + azacitidine and azacitidine groups. Composite complete remission [CRc, complete remission (CR)+CR with incomplete hematologic recovery (CRi)] rates (venetoclax + azacitidine/azacitidine) among patients with IDH1/2mut were 79%/11%, median duration of remission (mDoR) was 29.5/9.5 months, and median overall survival (mOS) was 24.5/6.2 months. CRc rates among patients with IDH1/2 wild-type (WT) were 63%/31%, mDoR 17.5/10.3 months, and mOS 12.3/10.1 months. In patients with IDH1mut, CRc rates (venetoclax + azacitidine/azacitidine) were 66.7%/9.1% and mOS 15.2/2.2 months. In patients with IDH2mut, CRc rates were 86.0%/11.1% and mOS not reached (NR)/13.0 months. Patients with IDH1/2 WT AML treated with venetoclax + azacitidine with poor-risk cytogenetics had inferior outcomes compared with patients with IDH1/2mut, who had superior outcomes regardless of cytogenetic risk (mOS, IDH1/2mut: intermediate-risk, 24.5 months; poor-risk, NR; IDH1/2 WT: intermediate, 19.2 and poor, 7.4 months). There were no unexpected toxicities in the venetoclax + azacitidine group.
Patients with IDH1/2mut who received venetoclax + azacitidine had high response rates, durable remissions, and significant OS; cytogenetic risk did not mitigate the favorable outcomes seen from this regimen for IDH1/2mut. See related commentary by Perl and Vyas, p. 2719. |
| doi_str_mv | 10.1158/1078-0432.CCR-21-3467 |
| format | Article |
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Data were pooled from patients enrolled in a phase III study (NCT02993523) that compared patients treated with venetoclax + azacitidine or placebo + azacitidine and a prior phase Ib study (NCT02203773) where patients were treated with venetoclax + azacitidine. Enrolled patients were ineligible for intensive therapy due to age ≥75 years and/or comorbidities. Patients on venetoclax + azacitidine received venetoclax 400 mg orally (days 1-28) and azacitidine (75 mg/m2; days 1-7/28-day cycle).
In the biomarker-evaluable population, IDH1/2mut was detected in 81 (26%) and 28 (22%) patients in the venetoclax + azacitidine and azacitidine groups. Composite complete remission [CRc, complete remission (CR)+CR with incomplete hematologic recovery (CRi)] rates (venetoclax + azacitidine/azacitidine) among patients with IDH1/2mut were 79%/11%, median duration of remission (mDoR) was 29.5/9.5 months, and median overall survival (mOS) was 24.5/6.2 months. CRc rates among patients with IDH1/2 wild-type (WT) were 63%/31%, mDoR 17.5/10.3 months, and mOS 12.3/10.1 months. In patients with IDH1mut, CRc rates (venetoclax + azacitidine/azacitidine) were 66.7%/9.1% and mOS 15.2/2.2 months. In patients with IDH2mut, CRc rates were 86.0%/11.1% and mOS not reached (NR)/13.0 months. Patients with IDH1/2 WT AML treated with venetoclax + azacitidine with poor-risk cytogenetics had inferior outcomes compared with patients with IDH1/2mut, who had superior outcomes regardless of cytogenetic risk (mOS, IDH1/2mut: intermediate-risk, 24.5 months; poor-risk, NR; IDH1/2 WT: intermediate, 19.2 and poor, 7.4 months). There were no unexpected toxicities in the venetoclax + azacitidine group.
Patients with IDH1/2mut who received venetoclax + azacitidine had high response rates, durable remissions, and significant OS; cytogenetic risk did not mitigate the favorable outcomes seen from this regimen for IDH1/2mut. See related commentary by Perl and Vyas, p. 2719.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>DOI: 10.1158/1078-0432.CCR-21-3467</identifier><identifier>PMID: 35046058</identifier><language>eng</language><publisher>United States: American Association for Cancer Research</publisher><subject>Aged ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Azacitidine - administration & dosage ; Bridged Bicyclo Compounds, Heterocyclic - therapeutic use ; Clinical Trials: Targeted Therapy ; Dancing ; Humans ; Isocitrate Dehydrogenase - genetics ; Leukemia, Myeloid, Acute - drug therapy ; Leukemia, Myeloid, Acute - genetics ; Leukemia, Myeloid, Acute - mortality ; Mutation ; Sulfonamides</subject><ispartof>Clinical cancer research, 2022-07, Vol.28 (13), p.2753-2761</ispartof><rights>2022 The Authors; Published by the American Association for Cancer Research.</rights><rights>2022 The Authors; Published by the American Association for Cancer Research 2022 American Association for Cancer Research</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c411t-bc9e4399391a3f2df152382f4e0608fe52c2db2151b4a70ab752b1c004ba61413</citedby><cites>FETCH-LOGICAL-c411t-bc9e4399391a3f2df152382f4e0608fe52c2db2151b4a70ab752b1c004ba61413</cites><orcidid>0000-0001-9000-562X ; 0000-0002-1908-3307 ; 0000-0001-8680-877X ; 0000-0003-2594-9696 ; 0000-0001-6519-4860 ; 0000-0002-0903-7390 ; 0000-0001-9003-0390 ; 0000-0002-2488-4758</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,3343,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35046058$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pollyea, Daniel A</creatorcontrib><creatorcontrib>DiNardo, Courtney D</creatorcontrib><creatorcontrib>Arellano, Martha L</creatorcontrib><creatorcontrib>Pigneux, Arnaud</creatorcontrib><creatorcontrib>Fiedler, Walter</creatorcontrib><creatorcontrib>Konopleva, Marina</creatorcontrib><creatorcontrib>Rizzieri, David A</creatorcontrib><creatorcontrib>Smith, B Douglas</creatorcontrib><creatorcontrib>Shinagawa, Atsushi</creatorcontrib><creatorcontrib>Lemoli, Roberto M</creatorcontrib><creatorcontrib>Dail, Monique</creatorcontrib><creatorcontrib>Duan, Yinghui</creatorcontrib><creatorcontrib>Chyla, Brenda</creatorcontrib><creatorcontrib>Potluri, Jalaja</creatorcontrib><creatorcontrib>Miller, Catherine L</creatorcontrib><creatorcontrib>Kantarjian, Hagop M</creatorcontrib><title>Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>To evaluate efficacy and safety of venetoclax + azacitidine among treatment-naïve patients with IDH1/2-mutant (mut) acute myeloid leukemia (AML).
Data were pooled from patients enrolled in a phase III study (NCT02993523) that compared patients treated with venetoclax + azacitidine or placebo + azacitidine and a prior phase Ib study (NCT02203773) where patients were treated with venetoclax + azacitidine. Enrolled patients were ineligible for intensive therapy due to age ≥75 years and/or comorbidities. Patients on venetoclax + azacitidine received venetoclax 400 mg orally (days 1-28) and azacitidine (75 mg/m2; days 1-7/28-day cycle).
In the biomarker-evaluable population, IDH1/2mut was detected in 81 (26%) and 28 (22%) patients in the venetoclax + azacitidine and azacitidine groups. Composite complete remission [CRc, complete remission (CR)+CR with incomplete hematologic recovery (CRi)] rates (venetoclax + azacitidine/azacitidine) among patients with IDH1/2mut were 79%/11%, median duration of remission (mDoR) was 29.5/9.5 months, and median overall survival (mOS) was 24.5/6.2 months. CRc rates among patients with IDH1/2 wild-type (WT) were 63%/31%, mDoR 17.5/10.3 months, and mOS 12.3/10.1 months. In patients with IDH1mut, CRc rates (venetoclax + azacitidine/azacitidine) were 66.7%/9.1% and mOS 15.2/2.2 months. In patients with IDH2mut, CRc rates were 86.0%/11.1% and mOS not reached (NR)/13.0 months. Patients with IDH1/2 WT AML treated with venetoclax + azacitidine with poor-risk cytogenetics had inferior outcomes compared with patients with IDH1/2mut, who had superior outcomes regardless of cytogenetic risk (mOS, IDH1/2mut: intermediate-risk, 24.5 months; poor-risk, NR; IDH1/2 WT: intermediate, 19.2 and poor, 7.4 months). There were no unexpected toxicities in the venetoclax + azacitidine group.
Patients with IDH1/2mut who received venetoclax + azacitidine had high response rates, durable remissions, and significant OS; cytogenetic risk did not mitigate the favorable outcomes seen from this regimen for IDH1/2mut. See related commentary by Perl and Vyas, p. 2719.</description><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Azacitidine - administration & dosage</subject><subject>Bridged Bicyclo Compounds, Heterocyclic - therapeutic use</subject><subject>Clinical Trials: Targeted Therapy</subject><subject>Dancing</subject><subject>Humans</subject><subject>Isocitrate Dehydrogenase - genetics</subject><subject>Leukemia, Myeloid, Acute - drug therapy</subject><subject>Leukemia, Myeloid, Acute - genetics</subject><subject>Leukemia, Myeloid, Acute - mortality</subject><subject>Mutation</subject><subject>Sulfonamides</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUVlOwzAQtRCIQuEIIF8grcdLlh-kKiyt1AJChV_LcRxqyFIlbqFcikNwMVJKK_iaGc28NzPvIXQGpAcgwj6QIPQIZ7QXxw8eBY9xP9hDRyBE4DHqi_0238500HHTvBACHAg_RB0mCPeJCI9QPSrmSjtcZfjJlMZVOlfvWJUpHnwobZ1NbWmwLfG0NsoVpnTerfr6XBp8r5xtywa_WTfDA71wBk9WJq9sisdm8WoKq36IRpdD6FM8WbgWUZXNCTrIVN6Y09_YRY_XV9N46I3vbkbxYOxpDuC8REeGsyhiESiW0TQDQVlIM26IT8LMCKppmlAQkHAVEJUEgiagCeGJ8ttHWRddbHjni6QwqW6PrVUu57UtVL2SlbLyf6e0M_lcLWXEfMEEbwnEhkDXVdPUJtthgci1CXItsFwLLFsTJAW5NqHFnf9dvENtVWffstuE1A</recordid><startdate>20220701</startdate><enddate>20220701</enddate><creator>Pollyea, Daniel A</creator><creator>DiNardo, Courtney D</creator><creator>Arellano, Martha L</creator><creator>Pigneux, Arnaud</creator><creator>Fiedler, Walter</creator><creator>Konopleva, Marina</creator><creator>Rizzieri, David A</creator><creator>Smith, B Douglas</creator><creator>Shinagawa, Atsushi</creator><creator>Lemoli, Roberto M</creator><creator>Dail, Monique</creator><creator>Duan, Yinghui</creator><creator>Chyla, Brenda</creator><creator>Potluri, Jalaja</creator><creator>Miller, Catherine L</creator><creator>Kantarjian, Hagop M</creator><general>American Association for Cancer Research</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-9000-562X</orcidid><orcidid>https://orcid.org/0000-0002-1908-3307</orcidid><orcidid>https://orcid.org/0000-0001-8680-877X</orcidid><orcidid>https://orcid.org/0000-0003-2594-9696</orcidid><orcidid>https://orcid.org/0000-0001-6519-4860</orcidid><orcidid>https://orcid.org/0000-0002-0903-7390</orcidid><orcidid>https://orcid.org/0000-0001-9003-0390</orcidid><orcidid>https://orcid.org/0000-0002-2488-4758</orcidid></search><sort><creationdate>20220701</creationdate><title>Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations</title><author>Pollyea, Daniel A ; DiNardo, Courtney D ; Arellano, Martha L ; Pigneux, Arnaud ; Fiedler, Walter ; Konopleva, Marina ; Rizzieri, David A ; Smith, B Douglas ; Shinagawa, Atsushi ; Lemoli, Roberto M ; Dail, Monique ; Duan, Yinghui ; Chyla, Brenda ; Potluri, Jalaja ; Miller, Catherine L ; Kantarjian, Hagop M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c411t-bc9e4399391a3f2df152382f4e0608fe52c2db2151b4a70ab752b1c004ba61413</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Azacitidine - administration & dosage</topic><topic>Bridged Bicyclo Compounds, Heterocyclic - therapeutic use</topic><topic>Clinical Trials: Targeted Therapy</topic><topic>Dancing</topic><topic>Humans</topic><topic>Isocitrate Dehydrogenase - genetics</topic><topic>Leukemia, Myeloid, Acute - drug therapy</topic><topic>Leukemia, Myeloid, Acute - genetics</topic><topic>Leukemia, Myeloid, Acute - mortality</topic><topic>Mutation</topic><topic>Sulfonamides</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pollyea, Daniel A</creatorcontrib><creatorcontrib>DiNardo, Courtney D</creatorcontrib><creatorcontrib>Arellano, Martha L</creatorcontrib><creatorcontrib>Pigneux, Arnaud</creatorcontrib><creatorcontrib>Fiedler, Walter</creatorcontrib><creatorcontrib>Konopleva, Marina</creatorcontrib><creatorcontrib>Rizzieri, David A</creatorcontrib><creatorcontrib>Smith, B Douglas</creatorcontrib><creatorcontrib>Shinagawa, Atsushi</creatorcontrib><creatorcontrib>Lemoli, Roberto M</creatorcontrib><creatorcontrib>Dail, Monique</creatorcontrib><creatorcontrib>Duan, Yinghui</creatorcontrib><creatorcontrib>Chyla, Brenda</creatorcontrib><creatorcontrib>Potluri, Jalaja</creatorcontrib><creatorcontrib>Miller, Catherine L</creatorcontrib><creatorcontrib>Kantarjian, Hagop M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pollyea, Daniel A</au><au>DiNardo, Courtney D</au><au>Arellano, Martha L</au><au>Pigneux, Arnaud</au><au>Fiedler, Walter</au><au>Konopleva, Marina</au><au>Rizzieri, David A</au><au>Smith, B Douglas</au><au>Shinagawa, Atsushi</au><au>Lemoli, Roberto M</au><au>Dail, Monique</au><au>Duan, Yinghui</au><au>Chyla, Brenda</au><au>Potluri, Jalaja</au><au>Miller, Catherine L</au><au>Kantarjian, Hagop M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2022-07-01</date><risdate>2022</risdate><volume>28</volume><issue>13</issue><spage>2753</spage><epage>2761</epage><pages>2753-2761</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>To evaluate efficacy and safety of venetoclax + azacitidine among treatment-naïve patients with IDH1/2-mutant (mut) acute myeloid leukemia (AML).
Data were pooled from patients enrolled in a phase III study (NCT02993523) that compared patients treated with venetoclax + azacitidine or placebo + azacitidine and a prior phase Ib study (NCT02203773) where patients were treated with venetoclax + azacitidine. Enrolled patients were ineligible for intensive therapy due to age ≥75 years and/or comorbidities. Patients on venetoclax + azacitidine received venetoclax 400 mg orally (days 1-28) and azacitidine (75 mg/m2; days 1-7/28-day cycle).
In the biomarker-evaluable population, IDH1/2mut was detected in 81 (26%) and 28 (22%) patients in the venetoclax + azacitidine and azacitidine groups. Composite complete remission [CRc, complete remission (CR)+CR with incomplete hematologic recovery (CRi)] rates (venetoclax + azacitidine/azacitidine) among patients with IDH1/2mut were 79%/11%, median duration of remission (mDoR) was 29.5/9.5 months, and median overall survival (mOS) was 24.5/6.2 months. CRc rates among patients with IDH1/2 wild-type (WT) were 63%/31%, mDoR 17.5/10.3 months, and mOS 12.3/10.1 months. In patients with IDH1mut, CRc rates (venetoclax + azacitidine/azacitidine) were 66.7%/9.1% and mOS 15.2/2.2 months. In patients with IDH2mut, CRc rates were 86.0%/11.1% and mOS not reached (NR)/13.0 months. Patients with IDH1/2 WT AML treated with venetoclax + azacitidine with poor-risk cytogenetics had inferior outcomes compared with patients with IDH1/2mut, who had superior outcomes regardless of cytogenetic risk (mOS, IDH1/2mut: intermediate-risk, 24.5 months; poor-risk, NR; IDH1/2 WT: intermediate, 19.2 and poor, 7.4 months). There were no unexpected toxicities in the venetoclax + azacitidine group.
Patients with IDH1/2mut who received venetoclax + azacitidine had high response rates, durable remissions, and significant OS; cytogenetic risk did not mitigate the favorable outcomes seen from this regimen for IDH1/2mut. See related commentary by Perl and Vyas, p. 2719.</abstract><cop>United States</cop><pub>American Association for Cancer Research</pub><pmid>35046058</pmid><doi>10.1158/1078-0432.CCR-21-3467</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-9000-562X</orcidid><orcidid>https://orcid.org/0000-0002-1908-3307</orcidid><orcidid>https://orcid.org/0000-0001-8680-877X</orcidid><orcidid>https://orcid.org/0000-0003-2594-9696</orcidid><orcidid>https://orcid.org/0000-0001-6519-4860</orcidid><orcidid>https://orcid.org/0000-0002-0903-7390</orcidid><orcidid>https://orcid.org/0000-0001-9003-0390</orcidid><orcidid>https://orcid.org/0000-0002-2488-4758</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; American Association for Cancer Research; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Aged Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Azacitidine - administration & dosage Bridged Bicyclo Compounds, Heterocyclic - therapeutic use Clinical Trials: Targeted Therapy Dancing Humans Isocitrate Dehydrogenase - genetics Leukemia, Myeloid, Acute - drug therapy Leukemia, Myeloid, Acute - genetics Leukemia, Myeloid, Acute - mortality Mutation Sulfonamides |
| title | Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations |
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