Gupta, S., Singh, P.K., Bhatt, M.L., Pant, M.C., Gupta, R., & Negi, M.P. (2010). Efficacy of granulocyte colony stimulating factor as a secondary prophylaxis along with full-dose chemotherapy following a prior cycle of febrile neutropenia. Bioscience Trends, 4, 273–278.

The purpose of the study was to evaluate the feasibility and efficacy of G-CSF secondary prophylaxis in patients with solid tumors undergoing chemotherapy.

Patients in the study required IV antibiotics filgrastim 300 mg per day subcutaneously starting 24–30 hours after the last chemotherapy dose in a subsequent cycle. A total of 8–9 alternate day doses were given. If no other dose limiting toxicity was seen, patients received full chemotherapy dosing with filgrastim support for following treatment cycles. Duration of hospital stay, days on antibiotic therapy, incidence of fever, time to resolve fever, dose reductions or delays, neutrophil recovery time, and incidence of adverse events were recorded. Results compared to findings in the same patients during the previous chemotherapy cycle.

• The total sample size was 50.
• Participants had a median age of 47, with a range of 22–75.
• The most common cancer types were lymphoma and breast cancer.
• Fifty-eight percent were receiving adriamycin-containing regimens.
   

Single-site location in India

Active antitumor treatment

Prospective, single group, observational study

No specific measure definitions were provided.

Neutrophil recovery time, duration of fever, duration of antibiotics and duration of hospitalization, cycle delays, and chemotherapy dose reductions declined with each course of chemotherapy. The decrease in all measures was significant across four treatment cycles (p < 0.01).

Study findings provide some support the use of colony-stimulating factor as secondary prophylaxis in patients receiving myelosuppressive chemotherapy. A number of study limitations limit the strength of these findings.

• Small sample (less than 100 participants)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not described  
• Measurement validity/reliability questionable
• The stated sample size varies in the report from 54 to 50, and authors stated that two patients who developed overwhelming febrile neutropenia during the study were eliminated from analysis, demonstrating no intent to treat analysis.
• No definition of neutropenia for determination of recovery time is provided.

This study provides limited evidence supporting the use of colony-stimulating factors as secondary prophylaxis in patients receiving chemotherapy. CSF was given every other day in this trial, adding to the body of evidence in which the frequency of administration varies. Secondary prophylaxis can play an important role in sustaining the treatment dosages of chemotherapy cycles.