Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: a meta-analysis.

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.