Lalami, Y., Paesmans, M., Aoun, M., Munoz-Bermeo, R., Reuss, K., Cherifi, S., . . . Klastersky, J. (2004). A prospective randomised evaluation of G-CSF or G-CSF plus oral antibiotics in chemotherapy-treated patients at high risk of developing febrile neutropenia. Supportive Care in Cancer, 12, 725–730.

The study focused on the secondary prevention of febrile neutropenia with G-CSF and antibiotics.

G-CSF (5 mcg/kg subcutaneous) or G-CSF with antibiotics (ciprofloxacin 500 mg by mouth every eight hours and amoxicillin 500 mg by mouth or clavulanate 125 mg by mouth every eight hours) daily starting 48 hours after chemotherapy and continuing until the absolute neutrophil count is greater than 2,000 cells/mm³. Patients were included in the study for one treatment cycle.
 

• The 48 eligible patients were adults who received chemotherapy for solid tumors and had experienced a prior episode of febrile neutropenia.
• Patients were scheduled to continue on the same regimen without dose reduction.
• Most patients were receiving treatment for breast, ovarian, or lung cancer.

Two sites in Europe.

Prospective, randomized pilot trial.

Patients were evaluated with:

• Regular complete blood counts
• Temperature monitoring once daily
• Observation for adverse effects of the prophylactic antibiotics.

In the event of a fever, the antibiotic prophylaxis was discontinued and a complete clinical evaluation for infection was completed.

No episodes of febrile neutropenia occurred in the G-CSF group, and only one incident of febrile neutropenia was reported in the combined group (p = 1). Reported side effects were similar and mild.

G-CSF reduced the risk of febrile neutropenia recurrence. Antibiotics did not provide any additional benefit in terms of prophylaxis.

• Not placebo controlled, not blinded.
• Patients were not stratified, and the groups were not balanced, particularly by disease and the number of prior chemotherapy cycles.
• The study was inadequately powered, since the frequency of the outcome measure was close to none (febrile neutropenia episodes).
• Cost implications were discussed but not in detail.