Meta-analysis of randomized controlled trials of granulocyte colony-stimulating factor prophylaxis in adult cancer patients receiving chemotherapy

Abstract

Granulocyte colony-stimulating factor (G-CSF) reduces the severity and duration of neutropenia associated with cancer chemotherapy [1-5]. In the pivotal phase III trial in patients with small cell lung cancer, patients were randomized to either G-CSF or placebo following combination chemotherapy in a double-blind fashion [3]. A significant difference in the cumulative risk of febrile neutropenia (FN) between the control (77%) and the G-CSF (40%) groups was observed despite the allowed use of secondary G-CSF prophylaxis after an initial occurrence of FN in the control group (P < 0.001). Several additional clinical trials of prophylactic G-CSF in patients with various malignancies receiving different treatment regimens have been reported [6-11]. The effectiveness of prophylactic G-CSF varies across disease groups and treatment regimens with the majority of reported trials employing relatively small sample size. There is, therefore, a need for a comprehensive systematic review of all relevant randomized controlled trials (RCTs) of primary prophylaxis with G-CSF in solid tumor and malignant lymphoma patients. In addition to providing more precise estimates of the clinical efficacy and toxicity, such an overview should permit an evaluation of the impact of G-CSF on other clinical outcomes including infection-related and all-cause treatment-related mortality. © 2011 Springer Science+Business Media, LLC.