Incidence of sinusoidal obstruction syndrome following mylotarg (gemtuzumab ozogamicin): A prospective observational study of 482 patients in routine clinical practice Journal Article
| Authors: | Tallman, M. S.; McDonald, G. B.; DeLeve, L. D.; Baer, M. R.; Cook, M. N.; Graepel, G. J.; Kollmer, C. |
| Article Title: | Incidence of sinusoidal obstruction syndrome following mylotarg (gemtuzumab ozogamicin): A prospective observational study of 482 patients in routine clinical practice |
| Abstract: | The purpose of this prospective observational study was to determine the incidence of hepatic sinusoidal obstruction syndrome (SOS), following gemtuzumab ozogamicin (GO) therapy in routine clinical practice. Patients receiving GO for acute myeloid leukemia (AML) were eligible. Assessments were requested to be performed weekly for 6 weeks after the start of GO therapy or 4 weeks after the last dose (whichever was later), and after 6 months. The primary outcome variable was the incidence of SOS as judged by a panel of independent experts. A total of 512 patients were enrolled at 54 US centers and 482 were evaluable. The incidence of SOS in this study population was 9.1 % (44/482; 95 % confidence interval 6.9-12.0 %). Of the 44 patients classified as having SOS, 8 were mild, 17 moderate, and 19 severe; 33 died within 6 months (20 of disease progression and 13 of SOS and multiorgan failure). Most (68 %) patients in the study died within 6 months; most of these deaths (73 %) were due to progression of AML. Serious adverse events occurred in 85 % of patients, most (81 %) due to AML, febrile neutropenia, pyrexia, and sepsis. GO administered in routine clinical practice carries an overall 9.1 % risk of SOS and a 2.7 % risk of death from SOS and multiorgan failure. No risk factors were identified for the development of SOS. © The Japanese Society of Hematology 2013. |
| Keywords: | adult; cancer survival; treatment outcome; aged; middle aged; acute granulocytic leukemia; major clinical study; leukemia, myeloid, acute; disease course; mortality; ascites; treatment duration; antineoplastic agents; cancer patient; antineoplastic agent; prospective study; prospective studies; clinical practice; liver toxicity; nausea; incidence; risk factors; creatinine; creatinine blood level; kidney failure; risk factor; hematuria; risk assessment; monoclonal antibody; alanine aminotransferase blood level; aspartate aminotransferase blood level; dyspnea; fever; pneumonia; tumor lysis syndrome; hypoxia; alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; bilirubin; acute kidney failure; cause of death; drug fatality; hypotension; disease severity; rigor; chemically induced disorder; hepatomegaly; graft versus host reaction; pleura effusion; observational study; anaphylaxis; bilirubin blood level; lung infiltrate; heart arrest; multiple organ failure; gemtuzumab ozogamicin; adult respiratory distress syndrome; weight gain; liver venoocclusive disease; hepatic veno-occlusive disease; aminoglycoside; aminoglycosides; lung edema; respiratory distress; acute myeloid leukemia; liver vein obstruction; upper abdominal pain; gemtuzumab; antibodies, monoclonal, humanized; mylotarg; humans; human; male; female; article |
| Journal Title: | International Journal of Hematology |
| Volume: | 97 |
| Issue: | 4 |
| ISSN: | 0925-5710 |
| Publisher: | Springer Japan KK |
| Date Published: | 2013-04-01 |
| Start Page: | 456 |
| End Page: | 464 |
| Language: | English |
| DOI: | 10.1007/s12185-013-1275-2 |
| PUBMED: | 23460018 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Export Date: 9 May 2014 -- CODEN: IJHEE -- Source: Scopus |
