Economic evaluation of antibiotic prophylaxis in small-cell lung cancer patients receiving chemotherapy: an EORTC double-blind placebo-controlled phase III study (08923)

• Published in: Annals of oncology Vol. 14; no. 2; pp. 248 - 257
• Main Authors: Tjan-Heijnen, V. C. G., Caleo, S., Postmus, P. E., Ardizzoni, A., Burghouts, J. T. M., Buccholz, E., Biesma, B., Gorlia, T., Crott, R., Giaccone, G., Debruyne, C., Manegold, C.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.02.2003
• Subjects: Administration, Oral; Adult; Aged; Antibiotic Prophylaxis; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - economics; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Small Cell - drug therapy; chemotherapy; Cost Savings; Cost-Benefit Analysis; Cyclophosphamide - administration & dosage; Double-Blind Method; Doxorubicin - administration & dosage; Drug toxicity and drugs side effects treatment; economic evaluation; Etoposide - administration & dosage; Female; Fever; Granulocyte Colony-Stimulating Factor - administration & dosage; Health Care Costs - statistics & numerical data; Hospitalization - statistics & numerical data; Humans; Incidence; Key words: antibiotic prophylaxis; Leukopenia - chemically induced; Leukopenia - economics; Leukopenia - prevention & control; Lung Neoplasms - drug therapy; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Placebos - administration & dosage; Risk Factors; small-cell lung cancer; Survival; Toxicity: blood; Antineoplastic agent; Phase III trial; Human; Lung disease; Drug combination; Leukopenia; small-cell lung cancer; Respiratory disease; Toxicity; Treatment efficiency; Controlled therapeutic trial; Hemopathy; Malignant tumor; Cost benefit analysis; Bronchopulmonary; Prevention; Antibiotic; Chemotherapy; Treatment; Bronchus disease; antibiotic prophylaxis; economic evaluation; Antibacterial agent; Small cell carcinoma
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdg073

Background: To determine whether the cost of prophylactic antibiotics during chemotherapy is offset by cost savings due to a decreased incidence of febrile leukopenia (FL). Patients and methods: Small-cell lung cancer (SCLC) patients were randomised to standard or intensified chemotherapy with granulocyte colony-stimulating factor to assess the impact on survival (n = 244). In addition, patients were randomised to prophylactic ciprofloxacin and roxithromycin or placebo to assess the impact on FL (n = 161). The economic evaluation examined the costs and effects of patients taking antibiotics versus placebo. Medical resource utilisation was documented prospectively, including 33 patients from one centre in The Netherlands (NL) and 49 patients from one centre in Germany (GE). The evaluation takes the perspective of the health insurance systems and of the hospitals. Sensitivity analyses were performed. Results: In the main trial, prophylactic antibiotics reduced the incidence of FL, hospitalisation due to FL and use of therapeutic antibiotics by 50%. In GE, the incidence of FL was not reduced by prophylaxis. This resulted in an average cost difference of only 35 Euros [95% confidence interval (CI) (–)1.713–2.263] in favour of prophylaxis (not significant). In NL, prophylaxis reduced the incidence of FL by nearly 50%, comparable with the results of the main trial, resulting in a cost difference of 2706 Euros [95% CI 810–5948], demonstrating savings in favour of prophylactic antibiotics of nearly 45%. Sensitivity analyses indicate that with an efficacy of prophylaxis of 50%, and with expected costs of antibiotic prophylaxis of 500 Euros or less, cost savings will incur over a broad range of baseline risks for FL; that is, a risk >10–20% for FL per cycle. Conclusions: Giving oral prophylactic antibiotics to SCLC patients undergoing chemotherapy is the dominant strategy in both GE and NL, demonstrating both cost-savings and superior efficacy. The sensitivity analyses demonstrate that, due to the efficacy of prophylactic antibiotics and their low unit cost, cost savings will incur over a broad range of baseline risks for FL. We recommend the use of prophylactic antibiotics in patients at risk for FL during chemotherapy.