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.
Original language | English (US) |
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Pages (from-to) | 456-464 |
Number of pages | 9 |
Journal | International journal of hematology |
Volume | 97 |
Issue number | 4 |
DOIs | |
State | Published - Apr 2013 |
Funding
Acknowledgments This study was sponsored by Wyeth Pharmaceuticals. Medical writing support was provided by Marcia Skoglund, PhD, at Healthcare Consulting and was funded by Wyeth. Wyeth was acquired by Pfizer Inc. in October 2009. This research was supported by Wyeth Pharmaceuticals.
Keywords
- Acute myeloid leukemia
- Gemtuzumab ozogamicin
- Mylotarg
ASJC Scopus subject areas
- Hematology