Intravenous high dose bolus therapy with @entity1199 ( @entity1199 ) is associated with low overall response rates (15%) and significant @entity137 . Phase II and III trials of a lower dose subcutaneous regimen of @entity1199 administered alone (n = 152) or in combination with @entity112 (n = 239) have recently been completed. This article describes a comprehensive safety and @entity137 analysis of the results of these two trials. The phase III trial demonstrated a survival benefit in @entity1 with liver metastases in the @entity112 / @entity1199 arm. Eligible @entity1 had stage IV @entity320 with at least one measurable lesion. @entity137 was graded using the National @entity5 Institute (NCI) common @entity137 scale. All reported adverse events were included in the analysis. Almost all @entity137 in each treatment group were NCI grade 1 or 2. The incidence of @entity137 expected to occur with @entity112 treatment, such as @entity551 /vasodilation, @entity10 and injection site reaction, were higher among @entity1 receiving @entity112 . With the exception of @entity10 , the incidence of grade 3 or 4 @entity137 was similar across the treatment groups. The addition of @entity112 to the subcutaneous @entity1199 regimen did not result in a difference in the incidence of drug interruption, dose modification or discontinuation. Study-related deaths were low and were not impacted by the addition of @entity112 to the @entity1199 regimen.

Treatment with XXXX and @entity1199 in @entity1 with advanced metastatic @entity320 : a detailed safety analysis.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'Toxicity', 'toxicities'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity112 :: ('MESH:D006632', 'Chemical') :: ['histamine', 'histamine dihydrochloride'] @entity1199 :: ('3558', 'Gene') :: ['IL2', 'interleukin-2'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache'] @entity551 :: ('MESH:D007022', 'Disease') :: ['hypotension'] @entity320 :: ('MESH:D008545', 'Disease') :: ['malignant melanoma']
@entity112 :: (MESH:D006632,Chemical) :: ['histamine dihydrochloride']
