{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T13:46:33Z","timestamp":1792676793547,"version":"4.5.0"},"reference-count":32,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"13","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2001,7,1]]},"abstract":"<jats:p> PURPOSE: Three open-label, multicenter trials were conducted to evaluate the efficacy and safety of single-agent Mylotarg (gemtuzumab ozogamicin; CMA-676; Wyeth Laboratories, Philadelphia, PA), an antibody-targeted chemotherapy agent, in patients with CD33-positive acute myeloid leukemia (AML) in untreated first relapse. <\/jats:p><jats:p> PATIENTS AND METHODS: The study population comprised 142 patients with AML in first relapse with no history of an antecedent hematologic disorder and a median age of 61 years. All patients received Mylotarg as a 2-hour intravenous infusion, at a dose of 9 mg\/m<jats:sup>2<\/jats:sup>, at 2-week intervals for two doses. Patients were evaluated for remission, survival, and treatment-emergent adverse events. <\/jats:p><jats:p> RESULTS: Thirty percent of patients treated with Mylotarg obtained remission as characterized by 5% or less blasts in the marrow, recovery of neutrophils to at least 1,500\/\u03bcL, and RBC and platelet transfusion independence. Although patients treated with Mylotarg had relatively high incidences of myelosuppression, grade 3 or 4 hyperbilirubinemia (23%), and elevated hepatic transaminase levels (17%), the incidences of grade 3 or 4 mucositis (4%) and infections (28%) were relatively low. There was a low incidence of severe nausea and vomiting (11%) and no treatment-related cardiotoxicity, cerebellar toxicity, or alopecia. Many patients received Mylotarg on an outpatient basis (38% and 41% of patients for the first and second doses, respectively). Among the 142 patients, the median total duration of hospitalization was 24 days; 16% of patients required 7 days of hospitalization or less. <\/jats:p><jats:p> CONCLUSION: Administration of the antibody-targeted chemotherapy agent Mylotarg to patients with CD33-positive AML in first relapse induces complete remissions with what appears to be a favorable safety profile. <\/jats:p>","DOI":"10.1200\/jco.2001.19.13.3244","type":"journal-article","created":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T02:26:22Z","timestamp":1487903182000},"page":"3244-3254","source":"Crossref","is-referenced-by-count":756,"title":["Efficacy and Safety of Gemtuzumab Ozogamicin in Patients With CD33-Positive Acute Myeloid Leukemia in First Relapse"],"prefix":"10.1200","volume":"19","author":[{"given":"Eric L.","family":"Sievers","sequence":"first","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard A.","family":"Larson","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward A.","family":"Stadtmauer","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elihu","family":"Estey","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bob","family":"L\u00f6wenberg","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herv\u00e9","family":"Dombret","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chatchada","family":"Karanes","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Theobald","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John M.","family":"Bennett","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew L.","family":"Sherman","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark S.","family":"Berger","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catharine B.","family":"Eten","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael R.","family":"Loken","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques J.M.","family":"van Dongen","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irwin D.","family":"Bernstein","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederick R.","family":"Appelbaum","sequence":"additional","affiliation":[{"name":"From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands;..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the Mylotarg Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"R1-091095","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199909303411407"},{"key":"R2-091095","unstructured":"Brincker  H:   Estimate of overall treatment results in acute nonlymphocytic leukemia based on age-specific rates of incidence and of complete remission.  Cancer Treat Rep 69:  5,1985-11,"},{"key":"R3-091095","unstructured":"Rowe  JM:   What is the best induction regime for acute myelogenous leukemia?  Leukemia 12:  S16,1998-S19,     (suppl 1)"},{"key":"R4-091095","unstructured":"Bishop  JF:   The treatment of adult acute myeloid leukemia.  Semin Oncol 24:  57,1997-69,"},{"key":"R5-091095","unstructured":"Kantarjian  HM,   Estey  EH,   Keating  MA:   New chemotherapeutic agents in acute myeloid leukemia.  Leukemia 10:  S4,1996-S6,     (suppl 1)"},{"key":"R6-091095","unstructured":"Welborn  JL,   Kopecky  KJ,   Meyers  FJ,  et al:   Carboplatin infusion in relapsed and refractory acute myeloid leukemia:  A Southwest Oncology Group trial.   Leukemia 9:  1126,1995-1129,"},{"key":"R7-091095","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(86)92674-7"},{"key":"R8-091095","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1989.7.8.1071"},{"key":"R9-091095","doi-asserted-by":"publisher","DOI":"10.1007\/s002770050163"},{"key":"R10-091095","unstructured":"Hiddemann  W,   Martin  WR,   Sauerland  C,  et al:   Definition of refractoriness against conventional chemotherapy in acute myeloid leukemia:  A proposal based on the results of retreatment by thioguanine, cytosine arabinoside, and daunorubicin (TAD9) in 150 patients with relapse after standardized first line therapy.   Leukemia 4:  184,1990-188,"},{"key":"R11-091095","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2141.1993.tb04664.x"},{"key":"R12-091095","doi-asserted-by":"publisher","DOI":"10.3109\/10428199109064874"},{"key":"R13-091095","doi-asserted-by":"publisher","DOI":"10.1007\/s00282-996-0161-2"},{"key":"R14-091095","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.annonc.a010796"},{"key":"R15-091095","unstructured":"Carella  AM,   Carlier  P,   Pungolino  E,  et al:   Idarubicin in combination with intermediate-dose cytarabine and VP-16 in the treatment of refractory or rapidly relapsed patients with acute myeloid leukemia.  Leukemia 7:  196,1993-199,"},{"key":"R16-091095","doi-asserted-by":"publisher","DOI":"10.1038\/sj.leu.2401066"},{"key":"R17-091095","unstructured":"Vogler  WR,   McCarley  DL,   Stagg  M,  et al:   A phase III trial of high-dose cytosine arabinoside with or without etoposide in relapsed and refractory acute myelogenous leukemia:  A Southeastern Cancer Study Group trial.   Leukemia 8:  1847,1994-1853,"},{"key":"R18-091095","doi-asserted-by":"publisher","DOI":"10.1038\/sj.leu.2401474"},{"key":"R19-091095","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V83.8.2086.2086"},{"key":"R21-091095","doi-asserted-by":"publisher","DOI":"10.1016\/0145-2126(84)90001-8"},{"key":"R22-091095","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V67.4.1048.1048"},{"key":"R23-091095","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V79.7.1811.1811"},{"key":"R24-091095","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1991.9.3.478"},{"key":"R25-091095","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-199211000-00012"},{"key":"R26-091095","unstructured":"van der Jagt  RH,   Badger  CC,   Appelbaum  FR,  et al:   Localization of radiolabeled antimyeloid antibodies in a human acute leukemia xenograft tumor model.  Cancer Res 52:  89,1992-94,"},{"key":"R27-091095","doi-asserted-by":"publisher","DOI":"10.1126\/science.2717946"},{"key":"R28-091095","unstructured":"Hamann  PR,   Hinman  LM,   Hollander  IJ,  et al:   Anti-CD33 calicheamicin hybrid conjugates for the treatment of acute myelogenous leukemia.  Proc Am Assoc Cancer Res 37:  471,1996  (abstr)"},{"key":"R29-091095","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V93.11.3678"},{"key":"R31-091095","doi-asserted-by":"crossref","unstructured":"Leith  CP,   Kopecky  KJ,   Godwin  J,  et al:   Acute myeloid leukemia in the elderly:  Assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy\u2014A Southwest Oncology Group study.   Blood 89:  3323,1997-3329,","DOI":"10.1182\/blood.V89.9.3323"},{"key":"R32-091095","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V94.7.2217.419k02_2217_2224"},{"key":"R33-091095","doi-asserted-by":"publisher","DOI":"10.1038\/256495a0"},{"key":"R34-091095","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.11.3691"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.2001.19.13.3244","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T17:43:26Z","timestamp":1653500606000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2001.19.13.3244"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2001,7,1]]},"references-count":32,"journal-issue":{"issue":"13","published-print":{"date-parts":[[2001,7,1]]}},"alternative-id":["10.1200\/JCO.2001.19.13.3244"],"URL":"https:\/\/doi.org\/10.1200\/jco.2001.19.13.3244","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2001,7,1]]}}}