Freyer, G., Jovenin, N., Yazbek, G., Villanueva, C., Hussain, A., Berthune, A., . . . Falandry, C. (2013). Granocyte-colony stimulating factor (G-CSF) has significant efficacy as secondary prophylaxis of chemotherapy-induced neutropenia in patients with solid tumors: Results of a prospective study. Anticancer Research, 33, 301–307.

To prevent the recurrence of neutropenic events (NEs) in patients with solid tumors and identify potential predictive factors of recurrence of NEs

The study was a prospective, multi-center, observational study to describe prophylactic strategies, including cycle delay, dose reduction, and granulocyte colony-stimulating factor (G-CSF), that were developed to prevent the recurrence of an NE subsequent to a previous episode in patients with solid tumors, and to evaluate their respective efficacy (primary endpoint). Secondary objectives assessed the recurrence rate of NEs and factors predictive of recurrence.

• N = 548  
• MEDIAN AGE = 63 years (range: 18–92 years)
• MALES: 31%, FEMALES: 69%
• KEY DISEASE CHARACTERISTICS: 40% were patients with breast cancer; no hematologic malignancy
• OTHER KEY SAMPLE CHARACTERISTICS: 43.6% of patients were older than 65 years; 59.9% were treated for metastatic disease

• SITE: Multi-site   
• SETTING TYPE: Outpatient   
• LOCATION: 62 cancer centers in France

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

• Observational

• Incidence of febrile neutropenia, treatment delays, and chemotherapy dose reductions
• Neutropenic events defined as any episode of febrile neutropenia (single temperature elevation over one hour) or any episode of neutropenia with a significant impact in terms of cycle delay or dose reduction

During cycle A, 16.1% experienced febrile neutropenia, 7.7% experienced neutropenic fever, and 76.3% experienced all-grade neutropenia. Cycle B was delayed in 44.5%, dose reductions occurred in 22.3%, and prophylactic G-CSF was given to 85% (59.7% received pegfilgrastim). The incidence of cycle delay and chemotherapy dose reduction decreased with further cycles of chemotherapy. The median number of G-CSF administrations with subsequent cycles, excluding pegfilgrastim, was five. The proportion of patients who experienced an NE was 29% when receiving G-CSF versus 68% for patients who did not. Only use of G-CSF was associated with a lower recurrence rate of febrile episodes (p < .001). In multivariate analysis, factors associated with a greater rate of NE occurrence were prior episode of febrile neutropenia, lung or colorectal cancer, metastatic disease, and prior radiotherapy.

Only the prophylactic administration of G-CSF was found to be an independent predictor of lower recurrence rate of NEs.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)

Teaching needs to be done related to G-CSF administration and the necessity of use. Further research is needed in G-CSF prophylaxis and the quality-of-life impact of other methods such as delay/dose reduction.