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Prevention of Chemotherapy-Induced Febrile Neutropenia by Prophylactic Antibiotics Plus or Minus Granulocyte Colony-Stimulating Factor in Small-Cell Lung Cancer: A Dutch Randomized Phase III Study

From the Departments of Medical Oncology, Epidemiology and Biostatistics, Pulmonology, and Medical Technology Assessment, Radboud University Nijmegen Medical Centre; Rijnstate Hospital, Arnhem; Jeroen Bosch Hospital, GZG 's-Hertogenbosch; Hospital Gelderse Vallei Ede; Hospital Koningin Beatrix Winterswijk; Canisius Wilhelmina Hospital Nijmegen; Diaconessenhuis Meppel; Trial Office Comprehensive Cancer Centre E, Nijmegen, the Netherlands

Address reprint requests to Johanna N. Timmer-Bonte, MD, 550 Department of Medical Oncology, Radboud University Nijmegen Medical Centre, PO Box 9101 6500 HB, Nijmegen, the Netherlands; e-mail: J.Timmer{at}onco.umcn.nl

PURPOSE: Febrile neutropenia (FN) is a major complication of chemotherapy. Antibiotics as well as granulocyte colony-stimulating factor (G-CSF) are effective in preventing FN. This multicenter randomized phase III trial determines whether the addition of G-CSF to antibiotic prophylaxis can further reduce the incidence of FN in patients with small-cell lung cancer (SCLC) at the risk of FN.

PATIENTS AND METHODS: Patients (N = 175) were stratified for stage of disease, performance status, age, and prior chemotherapy treatment, and were randomly assigned for treatment with cyclophosphamide, doxorubicin, and etoposide (CDE), followed by prophylactic antibiotics alone (ciprofloxacin and roxithromycin) or by antibiotics in combination with G-CSF on days 4 to 13.

RESULTS: In cycle 1, 20 patients (24%) in the antibiotics group developed FN compared with nine patients (10%) in the antibiotics plus G-CSF group (P = .01). In cycles 2 to 5, the incidences of FN were practically the same in both groups (17% v 11%). Only the treatment parameters (odds ratio, 0.33; 95% CI, 0.14 to 0.78) and age (1.067 per year; 95% CI, 1.013 to 1.0124) were related to the probability of FN in cycle 1.

CONCLUSION: Primary G-CSF prophylaxis added to primary antibiotic prophylaxis is effective in reducing FN and infections in SCLC patients at the risk of FN with the first cycle of CDE chemotherapy. For patients with similar risk of FN, the combined use of prophylactic antibiotics plus G-CSF can be considered, specifically in the first cycle of chemotherapy.

Supported by a research grant from the Dutch Healthcare Insurance Board.

Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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