{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T08:56:15Z","timestamp":1769849775349,"version":"3.49.0"},"reference-count":30,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2003,3,3]],"date-time":"2003-03-03T00:00:00Z","timestamp":1046649600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2003,3,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>Gemtuzumab is used to treat patients with previously untreated or recurrent acute myelogenous leukemia (AML). The fludarabine and cytarabine (ara\u2010C) regimen is active in these patients. Resistance to gemtuzumab is associated with blast multidrug resistance (MDR). The objectives of this study were to evaluate the efficacy and toxicity of a combination regimen of gemtuzumab, fludarabine, ara\u2010C, and the MDR modifier (cyclosporine [CyA]) in patients with previously untreated AML, refractory anemia with excess blasts (RAEB), or RAEB in transformation (RAEBT).<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>The MFAC regimen was comprised of gemtuzumab (Mylotarg\u2122) (6 mg\/m<jats:sup>2<\/jats:sup> intravenously [i.v.] on Day 1); fludarabine and ara\u2010C (15 mg\/m<jats:sup>2<\/jats:sup> and 0.5 g\/m<jats:sup>2<\/jats:sup>, respectively, twice daily on Days 2\u20136); and CSA (6 mg\/kg loading dose before gemtuzumab, followed by 16 mg\/kg continuous i.v. infusion on Days 1 and 2).<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Fifty\u2010nine evaluable patients were treated: 39 patients (66%) had AML and 20 patients (34%) had RAEB\/RAEBT. Their median age was 57 years (range, 27\u201376 years). The MFAC regimen induced complete remission (CR) in 27 patients (46%) and CR with incomplete platelet recovery (CRp) in 1 patient (2%). The median survival period is 8 months. At 12 months, the survival rate is 38% and the event\u2010free survival rate in patients with CR\/CRp is 27%. Infections complicated 38% of the courses of chemotherapy. Grade 3\/4 toxicity included hyperbilirubinemia in 31% and transaminitis in 7% of the patients. Four patients (7%) developed hepatic venoocclusive disease (VOD).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>The MFAC regimen may merit further study in patients with AML if measures to avoid and\/or treat VOD can be incorporated into the regimen. Cancer 2003;97:1481\u20137. \u00a9 2003 American Cancer Society.<\/jats:p><jats:p>DOI 10.1002\/cncr.11239<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.11239","type":"journal-article","created":{"date-parts":[[2003,3,18]],"date-time":"2003-03-18T17:44:31Z","timestamp":1048009471000},"page":"1481-1487","source":"Crossref","is-referenced-by-count":64,"title":["Gemtuzumab, fludarabine, cytarabine, and cyclosporine in patients with newly diagnosed acute myelogenous leukemia or high\u2010risk myelodysplastic syndromes"],"prefix":"10.1002","volume":"97","author":[{"given":"Apostolia","family":"Tsimberidou","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elihu","family":"Estey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge","family":"Cortes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah","family":"Thomas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Faderl","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Srdan","family":"Verstovsek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guillermo","family":"Garcia\u2010Manero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Keating","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maher","family":"Albitar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"O'Brien","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hagop","family":"Kantarjian","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francis","family":"Giles","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2003,3,3]]},"reference":[{"key":"e_1_2_5_2_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2001.19.13.3244"},{"key":"e_1_2_5_3_2","doi-asserted-by":"publisher","DOI":"10.3816\/CLM.2002.s.002"},{"key":"e_1_2_5_4_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V99.12.4343"},{"key":"e_1_2_5_5_2","first-page":"1490","article-title":"Approval 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