engleski

Efficacy and safety of linezolid compared with vancomycin in a randomized, double-blind study of febrile neutropenic patients with cancer

Gram positive pathogens can cause serious infections in neutropenic patients with cancer, and vancomycin is often initiated empirically. Linezolid may offer an option for these patients. To compare safety and efficacy of linezolid and vancomycin in febrile neutropenic patients with cancer, we conducted a double-blind, multicenter, equivalence study. Eligible patients with proven or suspected gram-positive infection were randomized to receive linezolid or vancomycin. Clinical success rates 7 days post therapy (primary endpoint) were equivalent between groups in the intent-to-treat (ITT ; linezolid, 219/251 [87.3%] vs vancomycin, 202/237 [85.2%] ; 95% CI, -4.1, 8.1 ; P=0.52), modified ITT (MITT), clinically evaluable, and microbiologically evaluable (ME) analyses ; and subsets analyzed by malignancy and infection type. Mean time to defervescence was shorter for linezolid than vancomycin in the MITT (6.6 vs 8.5 days ; P=0.04) and ME subsets (5.9 vs 9.1 days ; P=0.01), although post hoc analyses revealed delayed recovery of absolute neutrophil counts (ANC) for linezolid in these subsets (P<0.05). There were no between-group differences in microbiologic success rates in the MITT (41/71 [57.7%] vs 29/58 [50.0%] ; P=0.38) and ME subsets, and mortality rates in the ITT (17/304 [5.6%] vs 23/301 [7.6%] ; P=0.31) and all subsets. Distribution of adverse events, including reported hematologic events, was similar between groups except that linezolid was associated with fewer drug-related adverse events (52/303 [17.2%] vs 72/300 [24.0%] ; P=0.04) and less drug-related renal failure (1/303 [0.3%] vs 7/300 [2.3%] ; P=0.04). Linezolid demonstrated equivalent efficacy and similar safety outcomes compared with vancomycin in febrile neutropenic patients with cancer.

febile neutropenia; linezolid; vancomycin; cancer

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