In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 15_suppl ( 2009-05-20), p. 6513-6513
Abstract:
6513 Background: New treatments are approved based on results of RCTs, which have become larger and powered to detect smaller absolute benefits (Booth et al, J Clin Oncol 26, 2008).The purpose of this study was to evaluate temporal trends in absolute benefits of experimental medical therapies in RCTs. Methods: RCTs with 200 or more participants evaluating medical therapies for breast and colorectal cancer were identified by searching Medline from 1975 to 2007. For each trial, absolute benefits were determined as: (i) the difference in either 3-year event-free survival (EFS) or 5-year overall survival (OS) for adjuvant trials, or in median survival for metastatic trials, as per usual practice; and (ii) the area between time-to-event curves for the treatment arms relative to total area, up to a given time. Monthly incremental cost of new therapies approved by the FDA between 1995 and 2007 were determined for treatments for metastatic disease. Results: We identified 236 eligible RCTs, with 57% evaluating adjuvant treatments for breast (N=102) and colorectal cancer (N=33). Median absolute benefits of experimental treatments decreased substantially in the last decade (Table) and were in the range of only 1.3 to 2.7% when analyzed as the relative area between time-to-event curves. Among RCTs evaluating treatment for metastatic cancer there was no change in absolute benefits with time, but incremental monthly cost of new approved treatments increased with time (1995: median $U.S. 65; 2007: median $U.S. 6560, p 〈 0.0001). Conclusions: Evaluating absolute benefit as the relative area between time-to-event curves does not depend on the shape of the curves and is preferred. Over time, RCTs evaluating adjuvant treatment for breast and colorectal cancer show decreasing absolute benefit. New costly treatments may not assure meaningful clinical benefits. [Table: see text] No significant financial relationships to disclose.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2009.27.15_suppl.6513
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2009
detail.hit.zdb_id:
2005181-5
