European Surveillance of Infections and Their Risk Factors in Patients Treated for Cancer (ESIC)

A Study of the European Society of Biomodulation and Chemotherapy

Introduction

The response rates of prospective studies of empiric antimicrobial treatment vary considerably from 40-92%, due partly to differences in criteria for efficacy and to the heterogeneity of the study populations (1). In addition, all studies were therapeutically oriented and compared two or more therapeutic regimens. In contrast to randomized antibiotic treatment protocols, only a small number of studies have focused on the identification of risk factors.

At the moment, several questions regarding risk-factors of febrile episodes in patients with neutropenia are of particular interest. Therefore, there is a current need for prospective studies on infections in cancer patients that go beyond antibiotic therapy and focus on the risk factors, etiology, and outcome of infections together with antimicrobial resistance patterns. In Europe, there is a need for studies to encourage risk-adapted treatment, e.g. outpatient-based concepts.

Aims of the study

The European Surveillance of Treatment and Infections in Cancer Patients (ESIC) is prospectively conducting a study in patients undergoing treatment of cancer in order to identify the type and incidence of risk factors for developing infections and for an unfavorable outcome.

Study design

The following data will be documented for stratification:

1. Malignant disease being actively treated, e.g. solid tumor, leukemia, lymphoma or other hematological malignancy
2. Treatment regimen (chemotherapy, surgery, multimodal therapy, bone marrow or peripheral stem cell transplantation or others)
3. Stage of disease (de novo vs. relapse)

If the patient receives antibiotics for prophylaxis or treatment or acquires an infection the following data should be documented to identify risk factors:

1. Exposure to antimicrobial agents (treatment/prophylaxis vs. untreated/not receiving any prophylaxis).
2. Type of antineoplastic therapy.
3. Karnofsky-Index.
4. Severity and duration of neutropenia.
5. Occurrence, frequency and duration of febrile episodes.
6. MDI, CDI and UF.
7. Antibiotics used for prophylaxis and treatment.
8. Microorganisms from diagnostic cultures (excluding surveillance cultures).
9. Results of susceptibility testing (susceptible/intermediate/resistant) for antibiotics used for prophylaxis or treatment.
10. adverse drug reactions (ADR) possible, probably or certainly related to an antimicrobial agent
11. Clinical outcome according to the response criteria (documented on a case record form) of:

• the treatment of infections,
• the therapy of cancer (for every patient regardless of antibiotics or infection).

Both univariate and multivariate analysis with the logistic regression model will be done in each subgroup to identify possible risk factors for an unfavorable outcome and also for a fatal outcome.

The subgroups may be combined or restricted within groups depending on the hypothesis tested if the sample size permits: e.g. limit the survey to those receiving antineoplastic chemotherapy, or exclude individuals with solid tumors.

Conclusion

Only a large amount of prospectively collected and centrally validated data obtained from centers with a wide geographic distribution can help us to effectively identify and eliminate those risk factors associated not only with infection, but with a fatal outcome (infection related mortality). Recognition of the risk factors, including etiology and resistance to antimicrobial agents based on a large database, may help us better to organize therapeutic and prophylactic strategies with particular antimicrobial agents.

ã ESBiC Datacenter Munich, 1999