{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T06:18:53Z","timestamp":1790403533822,"version":"4.1.0"},"reference-count":17,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2014,9,15]],"date-time":"2014-09-15T00:00:00Z","timestamp":1410739200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["CA016672"],"award-info":[{"award-number":["CA016672"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2015,1,15]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>CPX\u2010351 is a liposome\u2010encapsulated fixed\u2010molar\u2010ratio formulation of cytarabine and daunorubicin that exploits molar ratio\u2013dependent drug\u2010drug synergy to enhance antileukemic efficacy.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>This phase II study randomized 125 patients 2:1 to CPX\u2010351 or investigators' choice of first salvage chemotherapy. Patients with acute myeloid leukemia (AML) in first relapse after initial Complete Remission (CR) lasting \u22651 month were stratified per the European Prognostic Index (EPI) into favorable, intermediate, and poor\u2010risk groups based on duration of first CR, cytogenetics, age, and transplant history. Control salvage treatment was usually based on cytarabine and anthracycline, often with 1 or more additional agents. Survival at 1 year was the primary efficacy end point.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Patient characteristics were well balanced between the 2 study arms. Improvements in efficacy outcomes were observed following CPX\u2010351, but did not meet prospectively defined statistical criteria for 1\u2010year survival improvement in the overall population. Subset analyses of the EPI\u2010defined poor\u2010risk strata demonstrated higher response rates (39.3% vs 27.6%) and improvements in event\u2010free survival (HR, 0.63; <jats:italic>P<\/jats:italic>\u2009=\u2009.08) and overall survival (HR, 0.55; <jats:italic>P<\/jats:italic>\u2009=\u2009.02). Also, 60\u2010day mortality was lower in the CPX\u2010351 study arm for poor\u2010risk patients (16.1% vs 24.1%).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>Taken together, the data suggest possible improved outcomes in CPX\u2010351\u2010treated first relapse AML patients with EPI\u2010defined poor\u2010risk disease. <jats:bold><jats:italic>Cancer<\/jats:italic> 2015;121:234\u201342<\/jats:bold>. \u00a9 <jats:italic>2014 American Cancer Society<\/jats:italic>.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.28974","type":"journal-article","created":{"date-parts":[[2014,9,15]],"date-time":"2014-09-15T15:44:59Z","timestamp":1410795899000},"page":"234-242","source":"Crossref","is-referenced-by-count":158,"title":["Phase II, multicenter, randomized trial of CPX\u2010351 (cytarabine:daunorubicin) liposome injection versus intensive salvage therapy in adults with first relapse AML"],"prefix":"10.1002","volume":"121","author":[{"given":"Jorge E.","family":"Cortes","sequence":"first","affiliation":[{"name":"The MD Anderson Cancer Center Houston Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart L.","family":"Goldberg","sequence":"additional","affiliation":[{"name":"John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric J.","family":"Feldman","sequence":"additional","affiliation":[{"name":"Weill Medical College of Cornell University and New York Presbyterian Hospital New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Rizzeri","sequence":"additional","affiliation":[{"name":"Duke University Medical Center, Durham  North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna E.","family":"Hogge","sequence":"additional","affiliation":[{"name":"British Columbia Cancer Agency, Vancouver  British Columbia Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Larson","sequence":"additional","affiliation":[{"name":"Rush University Cancer Center Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnaud","family":"Pigneux","sequence":"additional","affiliation":[{"name":"Haut\u2010L\u00e9v\u00eaque, Bordeaux  France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Recher","sequence":"additional","affiliation":[{"name":"Hopital Purpan, Toulouse  France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Schiller","sequence":"additional","affiliation":[{"name":"University of California Los Angeles Los Angeles California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krzysztof","family":"Warzocha","sequence":"additional","affiliation":[{"name":"Institute of Hematology and Transfusion Medicine Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hagop","family":"Kantarjian","sequence":"additional","affiliation":[{"name":"The MD Anderson Cancer Center Houston Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur C.","family":"Louie","sequence":"additional","affiliation":[{"name":"Celator Pharmaceuticals, Inc Princeton New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan E.","family":"Kolitz","sequence":"additional","affiliation":[{"name":"Hofstra North Shore\u2010Long Island Jewish School of Medicine Lake Success New York"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,9,15]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"National Comprehensive Cancer Network. 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