title: Economic considerations in comparing whole abdominal radiotherapy with combination doxorubicin-cisplatin chemotherapy in advanced endometrial carcinoma: how much economic data should be collected?
abstract: The key features of this study from the perspective of designing an economic analysis are that the resources consumed and the expected toxic effects are likely to be quite different in the two study arms, median survival will be measured in years, and the initial treatment assignment may affect the clinical course and resource consumption of the terminal phases of illness. Collecting complete data on all the costs associated with treatment, short-term toxic effects, long-term toxic effects, and treatment of recurrent disease as well as tracking the complex clinical course of patients over many years of follow-up would be an enormous undertaking. However, "phase II" or historical data on the costs and outcomes of care associated with each of these two treatment regimens would allow for a more tailored approach. But perhaps the first question that should be answered in designing an economic analysis to accompany a clinical trial is whether the resulting data are likely to be important. This study does not fulfill one of the main criteria for judging the appropriateness of including an economic analysis--large resource consequences. Fewer than 6000 cases of stage III or IV endometrial cancer occur annually in the United States, of which only a portion would be appropriate for the alternative treatment strategies evaluated in this protocol. Therefore, although the clinical question posed by this protocol is appropriate and important, the aggregate economic consequences of choosing one treatment approach over the other may not be of sufficient magnitude to justify the investment in a prospective economic analysis conducted alongside the clinical trial.
authors.affiliation: Center for Outcomes and Policy Research and Division of Cancer Epidemiology and Control, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Mass 02115, USA.
authors.forename: J C
authors.initials: JC
authors.lastname: Weeks
mesh_terms: D000005:Abdomen / Q000528:radiation effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D017326:Clinical Trials, Phase III as Topic / Q000191:economics*; D003362:Cost-Benefit Analysis; D004317:Doxorubicin / Q000008:administration & dosage; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D005260:Female; D006801:Humans
chemical_list: D004317:Doxorubicin; D002945:Cisplatin