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Abstract:
Conclusions
Sunitinib
is associated with a significant increase in the risk of developing
all-grade and high-grade neutropenia and thrombocytopenia and all-grade
anemia compared with control.
Background
The
incidence and risk of unique toxicities associated with a
multi-targeted tyrosine kinase inhibitor sunitinib, such as hypertension
and thromboembolic events, have been previously reported. However, the
incidence and risk of hematologic toxicities have been less well
characterized. We performed an up-to-date meta-analysis of trials to
evaluate the risk of sunitinib-related hematologic toxicities.
Methods
We
searched Medline and the American Society of Clinical Oncology online
database of meeting abstracts up to July 2012 for relevant clinical
trials. Eligible studies included phase II and III trials and expanded
access programs of sunitinib that reported adequate safety data profile
reporting neutropenia, thrombocytopenia or anemia. The summary
incidence, relative risk (RR) and 95% confidence intervals (CIs) were
calculated.
Results
A total of
8,526 patients from 60 trials of sunitinib as a single agent revealed
that the incidence of sunitinib-associated all-grade and high-grade
(Grades 3 and 4) hematologic toxicities were, respectively: neutropenia:
42.1% and 12.8%; thrombocytopenia: 44.7% and 10.7% and anemia: 50.4%
and 6.2%. Sunitinib-treated patients (2667 subjects from 10 randomized
trials) had a significantly increased risk of all-grade (RR = 3.58; 95%
CI, 1.71–7.49) and high-grade (RR = 3.32; 95% CI, 1.60–6.90)
neutropenia, all-grade (RR = 4.59; 95% CI, 2.76–7.63) and high-grade
(RR = 5.84; 95% CI, 2.22–15.41) thrombocytopenia and all-grade anemia
(RR = 1.15; 95% CI, 1.00–1.31).
Conclusions
Sunitinib
is associated with a significant increase in the risk of developing
all-grade and high-grade neutropenia and thrombocytopenia and all-grade
anemia compared with control.
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