PURPOSE: Several studies have evaluated the efficacy of the recombinant colony-stimulating factors in reducing the severity and duration of neutropenia and the risk of infection associated with dose-intensive cancer chemotherapy. We performed a meta-analysis to define better the magnitude of this effect and to assess the generalizability of the results among different diseases and types of treatment. MATERIALS AND METHODS: We used electronic databases and citation lists to identify controlled clinical trials of the prophylactic efficacy of the colony-stimulating factors on neutropenic complications. We selected randomized trials of the use of recombinant colony-stimulating factors before the onset of fever or neutropenia following systemic chemotherapy for solid tumors or malignant lymphomas. RESULTS: We identified eight controlled trials (n = 1144 patients) of prophylactic colony-stimulating factors, including five trials of filgrastim (recombinant granulocyte colony-stimulating factors) and three studies of lenograstim (glycosylated granulocyte recombinant colony-stimulating factors). Five trials were double-blind and placebo-controlled; three included untreated controls. Use of recombinant colony-stimulating factors was associated with a reduced risk of febrile neutropenia (odds ratio [OR] = 0.38; 95% confidence interval [CI]: 0.29 to 0.49), documented infection (OR = 0.51; 95% CI: 0.36 to 0.73), and infection-related mortality (OR = 0.60; 95% CI: 0.30 to 1.22), but a greater risk of bone pain (OR = 2.9; 95% CI: 1.6 to 4.8). CONCLUSION: In this meta-analysis, recombinant colony-stimulating factors were effective in reducing the risk of febrile neutropenia and documented infection associated with several malignancies and dose-intensive treatment regimens.
PURPOSE: Several studies have evaluated the efficacy of the recombinant colony-stimulating factors in reducing the severity and duration of neutropenia and the risk of infection associated with dose-intensive cancer chemotherapy. We performed a meta-analysis to define better the magnitude of this effect and to assess the generalizability of the results among different diseases and types of treatment. MATERIALS AND METHODS: We used electronic databases and citation lists to identify controlled clinical trials of the prophylactic efficacy of the colony-stimulating factors on neutropenic complications. We selected randomized trials of the use of recombinant colony-stimulating factors before the onset of fever or neutropenia following systemic chemotherapy for solid tumors or malignant lymphomas. RESULTS: We identified eight controlled trials (n = 1144 patients) of prophylactic colony-stimulating factors, including five trials of filgrastim (recombinant granulocyte colony-stimulating factors) and three studies of lenograstim (glycosylated granulocyte recombinant colony-stimulating factors). Five trials were double-blind and placebo-controlled; three included untreated controls. Use of recombinant colony-stimulating factors was associated with a reduced risk of febrile neutropenia (odds ratio [OR] = 0.38; 95% confidence interval [CI]: 0.29 to 0.49), documented infection (OR = 0.51; 95% CI: 0.36 to 0.73), and infection-related mortality (OR = 0.60; 95% CI: 0.30 to 1.22), but a greater risk of bone pain (OR = 2.9; 95% CI: 1.6 to 4.8). CONCLUSION: In this meta-analysis, recombinant colony-stimulating factors were effective in reducing the risk of febrile neutropenia and documented infection associated with several malignancies and dose-intensive treatment regimens.
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