PROSPECTIVE ECONOMIC-EVALUATION ACCOMPANYING A TRIAL OF GM-CSF IL-3 IN PATIENTS UNDERGOING AUTOLOGOUS BONE-MARROW TRANSPLANTATION FOR HODGKINS AND NON-HODGKINS-LYMPHOMA/

Our objective was to assess the economic impact of a new cytokine ther apy that was being compared to standard therapy as supportive care in patients receiving autologous bone marrow transplantation for treatmen t of lymphoma, We performed an economic study accompanying a multicent er, randomized, controlled clinical trial in academic medical centers, One hundred and fifteen patients consented to participate in a parall el economic study of a randomized controlled trial of sequential IL-3 followed by GM-CSF vs GM-CSF alone after autologous bone marrow transp lantation. We measured costs and quality-adjusted survival over a 13-m onth follow-up period, For the 13-month study period, the total cost e stimates were $79 892 (95% CI $69 343 to $90 544) for patients receivi ng GM-CSF alone and $89 651 (95% CI $79 769 to $102 114) for patients receiving IL3/GM-CSF. The difference was not statistically significant . During the 13-month study period, the total number of quality-adjust ed life-months in the GM-CSF arm was 6.67 (95% CI 5.75 to 7.56) months , while the total number of quality-adjusted life-months in the IL-3 a rm was 6.26 (95% CI 5.34 to 7.15) months, The difference in quality-ad justed life-months between the two treatment arms was not statisticall y significant. We conclude that economic analysis of a phase In clinic al trial of IL-3/GM-CSF compared with GM-CSF alone showed no significa nt effect of IL-3 on the costs of care for patients undergoing bone ma rrow transplantation for a period of up to 13 months after the procedu re, This study demonstrates the feasibility of prospective economic ev aluation within phase III trials of new cancer therapies, Data from th is type of economic protocol could be used to help physicians, patient s and managed care organizations understand the effect of new treatmen ts from both a clinical and an economic perspective.