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Impact of fludarabine‐based induction therapy on outcome of FLT 3−/ NPM 1+ cytogenetically normal acute myeloid leukemia
Author(s) -
Tiribelli Mario,
Geromin Antonella,
Damiani Daniela
Publication year - 2017
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.24651
Subject(s) - idarubicin , fludarabine , cytarabine , medicine , induction chemotherapy , transplantation , npm1 , oncology , myeloid leukemia , chemotherapy , gastroenterology , antimetabolite , hematopoietic stem cell transplantation , immunology , surgery , cyclophosphamide , biology , biochemistry , karyotype , chromosome , gene
To the Editor: We thank Ovanesov et al. for their letter and discussion of research concerning IVIg-associated thromboembolic adverse events (TEEs). We agree that our study does not rule out a causal relationship between IVIg and increased TEE risk. As they note, TEEs are rare events, limiting our power to rule out a clinically meaningful increased risk of TEEs in the trial populations included in our meta-analysis. Moreover, with regard to external generalizability, it is possible that the risk of TEEs varies by IVIg product and dose, as well as patient factors such as age and preexisting risk factors for TEEs. We agree with Ovanesov et al.—as well as the clinicians who have written to us with plausible case reports of IVIg-associated TEEs—that this remains a valid topic of concern for clinicians and regulatory authorities. IVIg is often used in serious health situations when there are no or few therapeutic alternatives. In considering whether IVIg treatment is appropriate, clinicians and patients must weigh the likely benefits and risks of treatment. We view the main contribution of our meta-analysis of 31 IVIg randomized controlled trials as helping to establish a rough upper bound ( 1%) for the absolute risk of IVIg-caused acute myocardial infarction, stroke, or venous thromboembolism among young and middle-aged adults with a low baseline risk of TEEs. However, data from observational studies of IVIg-associated TEEs should also be considered, particularly for assessing risk in patients of advanced age or with other major TEE risk factors.