A Phase 2 study of combination therapy with arsenic trioxide and gemtuzumab ozogamicin in patients with myelodysplastic syndromes or secondary acute myeloid leukemia
dc.contributor.author | Sekeres, Mikkael A. | en_US |
dc.contributor.author | Maciejewski, Jaroslaw P. | en_US |
dc.contributor.author | Erba, Harry P. | en_US |
dc.contributor.author | Afable, Manuel | en_US |
dc.contributor.author | Englehaupt, Ricki | en_US |
dc.contributor.author | Sobecks, Ronald | en_US |
dc.contributor.author | Advani, Anjali | en_US |
dc.contributor.author | Seel, Sherry | en_US |
dc.contributor.author | Chan, Josephine | en_US |
dc.contributor.author | Kalaycio, Matt E. | en_US |
dc.date.accessioned | 2011-03-10T16:03:15Z | |
dc.date.accessioned | 2011-03-10T16:03:15Z | |
dc.date.available | 2012-04-30T18:27:22Z | en_US |
dc.date.issued | 2011-03-15 | en_US |
dc.identifier.citation | Sekeres, Mikkael A.; Maciejewski, Jaroslaw P.; Erba, Harry P.; Afable, Manuel; Englehaupt, Ricki; Sobecks, Ronald; Advani, Anjali; Seel, Sherry; Chan, Josephine; Kalaycio, Matt E. (2011). "A Phase 2 study of combination therapy with arsenic trioxide and gemtuzumab ozogamicin in patients with myelodysplastic syndromes or secondary acute myeloid leukemia." Cancer 117(6): 1253-1261. <http://hdl.handle.net/2027.42/83195> | en_US |
dc.identifier.issn | 0008-543X | en_US |
dc.identifier.issn | 1097-0142 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/83195 | |
dc.description.abstract | BACKGROUND: Higher-risk myelodysplastic syndromes (MDS) are similar pathobiologically to acute myeloid leukemia (AML), particularly in older adults. AML therapies thus may have activity in MDS. In the current study, phase 2 study data of arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) in CD33-positive patients with MDS and secondary AML (sAML) were presented. METHODS: Between June 2004 and February 2006, 30 patients with higher-risk MDS or sAML received ATO (at a dose of 0.25 mg/kg intravenously for 5 days during Week 1, then twice weekly during Weeks 2-12) and GO (at a dose of 3 mg/m 2 on Day 8) for 1 or 2 cycles of 12 weeks each. The primary endpoint was response as per MDS or AML International Working Group (IWG) criteria. Adverse events were collected throughout treatment. Patients were followed for a minimum of 3 years for survival. RESULTS: The median patient age was 69 years. A total of 18 patients had MDS, 12 had sAML, and 19 had been previously treated. Seventeen patients (57%) completed ≥1 cycle, and 7 patients (23%) completed 2 cycles. IWG responses occurred in 9 patients (30%) according to IWG MDS criteria (including 2 of 7 patients who failed hypomethylating agents) and 3 of 12 AML patients (25%) according to IWG AML criteria. Grade 3/4 (according to National Cancer Institute Common Toxicity Criteria [version 3.0]) thrombocytopenia occurred in 47% of patients, neutropenia in 63%, and anemia in 37% of patients. The median overall survival was 9.7 months (28.6 months in responders and 7.6 months in nonresponders; P <.001). Patients who completed 2 cycles of therapy spent a median of 13 days in the hospital. CONCLUSIONS: Combination therapy with ATO and GO was found to have acceptable response rates and toxicity, and may be a viable treatment option to standard induction therapy, particularly for patients who fail therapy with hypomethylating agents. Cancer 2011. © 2010 American Cancer Society. | en_US |
dc.publisher | Wiley Subscription Services, Inc., A Wiley Company | en_US |
dc.subject.other | Life and Medical Sciences | en_US |
dc.subject.other | Cancer Research, Oncology and Pathology | en_US |
dc.title | A Phase 2 study of combination therapy with arsenic trioxide and gemtuzumab ozogamicin in patients with myelodysplastic syndromes or secondary acute myeloid leukemia | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Oncology and Hematology | en_US |
dc.subject.hlbsecondlevel | Public Health | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | University of Michigan, Ann Arbor, Michigan | en_US |
dc.contributor.affiliationother | Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio ; Fax: (216) 636-0636 ; Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Cleveland Clinic Taussig Cancer Institute, Desk R35, 9500 Euclid Avenue, Cleveland, OH 44195 | en_US |
dc.contributor.affiliationother | Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio | en_US |
dc.contributor.affiliationother | Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio | en_US |
dc.contributor.affiliationother | Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio | en_US |
dc.contributor.affiliationother | Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio | en_US |
dc.contributor.affiliationother | Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio | en_US |
dc.contributor.affiliationother | Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio | en_US |
dc.contributor.affiliationother | Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio | en_US |
dc.contributor.affiliationother | Leukemia Program, Department of Hematologic Oncology and Blood Disorders, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio | en_US |
dc.identifier.pmid | 20960521 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/83195/1/25686_ftp.pdf | |
dc.identifier.doi | 10.1002/cncr.25686 | en_US |
dc.identifier.source | Cancer | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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