Evaluation of haematopoietic growth factors: defining relevant clinical endpoints in growth factor trials.
Initial evaluation of the therapeutic efficacy of haemopoietic growth factors involves assessment of their effects on the blood count, in various clinical situations. However, hard clinical data are also needed. Microbiologically documented infection is the ideal parameter but is difficult to measure. Consequently, the surrogate parameters of duration of fever and antibiotic usage are used instead. Febrile neutropenia is not a clinical endpoint, but merely a useful indicator to begin antibiotic therapy. To date, cost evaluations of growth factor use have relied on retrospective analyses of relevant clinical data including antibiotic usage, parenteral nutrition requirements, and duration of hospitalisation. Growth factors can reduce all these parameters in selected situations. Clinical data also suggest that growth factors facilitate chemotherapy dose optimisation and intensification, although the degree of intensification appears limited (20-40%). Currently, it is unclear whether such therapy confers benefit in terms of remission rates and survival.
Linch
D C
DC
Department of Haematology, University College London Medical School, U.K.
D000970:Antineoplastic Agents / Q000008:administration & dosage; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D004334:Drug Administration Schedule; D016298:Hematopoietic Cell Growth Factors / Q000627:therapeutic use*; D006801:Humans; D009369:Neoplasms / Q000097:blood*
D000970:Antineoplastic Agents; D016298:Hematopoietic Cell Growth Factors