2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours

EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours

Background: Benefits of prophylactic hematopoietic colony-stimulating factors (CSFs) in adults and children receiving cancer chemotherapy or undergoing stem-cell transplantation (SCT) are unclear. Purpose: To determine whether prophylactic CSFs decrease mortality, infections, and febrile neutropenia more than does placebo or no therapy in patients with cancer and in patients undergoing SCT. Data Sources: Electronic searches of Ovid MEDLINE and EMBASE from inception until April 2007 and of the Cochrane Central Register of Controlled Trials until the second quarter of 2006. Study Selection: We selected 148 trials that were reported in any language that randomly assigned patients to CSFs or to either placebo or no therapy. Prophylactic CSFs were given concurrently with or after initiation of chemotherapy. Data Extraction: Two reviewers independently extracted data onto standardized forms. Data Synthesis: Short-term all-cause mortality appeared to be similar between the prophylactic CSF and the control groups (7.6% vs. 8.0%; relative risk, 0.95 [95% CI, 0.84 to 1.08]; absolute risk reduction, 0.4% [CI, 0.5% to 1.4%]). Risks for infection-related death with CSFs and placebo or no therapy were 3.1% and 3.8%, respectively (relative risk, 0.82 [CI, 0.66 to 1.02]; absolute risk reduction, 0.8% [CI, 0.0% to 1.5%]). Use of CSFs reduced the following more than did placebo or no therapy: documented infections (median rate, 38.9% vs. 43.1%; rate ratio, 0.85 [CI, 0.79 to 0.92]), microbiologically documented infections (median rate, 23.5% vs. 28.6%; rate ratio, 0.86 [CI, 0.77 to 0.96]), and episodes of febrile neutropenia (median rate, 25.3% vs. 44.2%; rate ratio, 0.71 [CI, 0.63 to 0.80]). Limitations: Trial designs, including assessments of infections, and participants were heterogeneous. Estimates of mortality effects were imprecise. Conclusions: Prophylactic CSFs may have little or no effect on mortality but do decrease rates of infection in patients receiving cancer chemotherapy or those undergoing SCT.

Meta-analysis: effect of prophylactic hematopoietic colony-stimulating factors on mortality and outcomes of infection.

Epidemiology of Febrile Neutropenia

Patients with breast cancer receiving chemotherapy have an increased risk of infection mediated through a low number of protective white blood cells (neutropenia). Neutropenia is a common toxicity of many chemotherapy agents and is caused by the suppression of the bone marrow. The first sign of infection is usually a fever, which indicates a potentially life-threatening condition if it occurs during severe neutropenia (febrile neutropenia (FN)). FN requires hospital care including the administration of intravenous antibiotics and possible delays in the continuation of chemotherapy. Colony-stimulating factors (CSFs) are drugs administered during chemotherapy in order to prevent or reduce the incidence or duration of FN and neutropenia. This review included eight trials in which 2156 patients with breast cancer had randomly received CSFs or placebo or no treatment during chemotherapy. These trials were carried out between 1995 and 2008. Prophylactic treatment with CSFs significantly reduced the risk of developing FN by 73%. The estimated number of patients needed to be treated with CSFs in order to prevent one event of FN was 12. Although a significant decrease in mortality of all causes during chemotherapy and CSF therapy was noted, there was no reduction in infection-related mortality. 
There was no significant effect observed that planned chemotherapy schedules could be better maintained if CSFs were administered or that the number of patients with neutropenia decreased with CSFs. Notably, CSFs significantly reduced the need for hospital care yet frequently caused short-term adverse effects like bone pain and injection-site reactions. There were several limitations in this analysis: only a few trials could be included, the number of patients was low in many of these trials, and disease stages and chemotherapy treatments varied considerably. Moreover, the trial authors defined their outcomes differently, making comparisons across studies difficult. Information on the primary and secondary outcomes could not be obtained from all trials and the overall reporting quality was low. Many studies were dated and hence the administration of CSFs did not comply with current recommendations. 
Overall, CSFs have shown moderate evidence of beneﬁt in the prevention of FN in patients with breast cancer receiving chemotherapy. The evidence that the administration of CSFs could reduce early mortality of all causes was weak and substantiates the need of further studies. There was no reduction in risk of infection-related mortality with CSF treatment.

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Primary prophylactic colony-stimulating factors for the prevention of chemotherapy-induced febrile neutropenia in breast cancer patients

Dose intensification of epidoxorubicin and cyclophosphamide in metastatic breast cancer: a randomised study with two schedules of granulocyte-macrophage colony stimulating factor

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Dose intensification of epidoxorubicin and cyclophosphamide in metastatic breast cancer: a randomised study with two schedules of granulocyte-macrophage colony stimulating factor