NDLI: Comparative Effectiveness of Oxaliplatin Versus 5-flourouricil in Older Adults: An Instrumental Variable Analysis.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Mack, Christina DeFilippo Brookhart, M. Alan Glynn, Robert J. Meyer, Anne Marie Carpenter, William R. Sandler, Robert S. Stürmer, Til
Spatial Coverage	United States
Description	Country affiliation: New Caledonia Author Affiliation: Mack CD ( From the aDepartment of Epidemiology, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC)
Abstract	BACKGROUND: Oxaliplatin was rapidly adopted for treatment of stage III colon cancer after FDA approval in November 2004, thus providing an opportunity to use calendar time as an instrumental variable in nonexperimental comparative effectiveness research. Assuming instrument validity, instrumental variable analyses account for unmeasured confounding and are particularly valuable in sub-populations of unresolved effectiveness, such as older individuals. METHODS: We examined stage III colon cancer patients ages 65+ years initiating chemotherapy between 2003 and 2008 using US population-based cancer registry data linked with Medicare claims (N = 3,660). Risk differences for all-cause mortality were derived from Kaplan-Meier survival curves. We examined instrumental variable strength and compared risk differences with propensity score estimates. RESULTS: Calendar time greatly affected oxaliplatin receipt. The calendar time instrument compared patients treated from January 2003 through September 2004 (N = 1,449) with those treated from March 2005 through May 2007 (N = 1,432), resulting in 54% compliance. The 1-, 2-, and 3-year local average treatment effect of the risk differences per 100 patients in the 'compliers' (95% confidence intervals) were -4.6 (-8.2, -0.44), -6.3 (-12, -0.16), and -9.2 (-15, -2.5), respectively. Corresponding propensity score-matched results were -1.9 (-4.0, 0.2), -3.4 (-6.2, -0.05), and -4.3 (-7.5, -0.96). CONCLUSIONS: Instrumental variable and propensity score analyses both indicate better survival among patients treated with oxaliplatin. As these results are based on different populations and assumptions, the instrumental variable analysis adds to evidence of oxaliplatin's effectiveness in older adults, who bear the greatest burden of colon cancer yet were underrepresented in clinical trials. In nonexperimental comparative effectiveness research of rapidly emerging therapies, the potential to use calendar time as an instrumental variable is worth consideration.
File Format	HTM / HTML
ISSN	10443983
e-ISSN	15315487
DOI	10.1097/EDE.0000000000000355
Journal	Epidemiology
Issue Number	5
Volume Number	26
Language	English
Publisher	Lippincott Williams & Wilkins
Publisher Date	2015-09-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Discipline Public Health Discipline Epidemiology Antineoplastic Agents Therapeutic Use Colonic Neoplasms Drug Therapy Fluorouracil Organoplatinum Compounds Mortality Pathology Comparative Effectiveness Research Kaplan-meier Estimate Neoplasm Staging Propensity Score Seer Program Time Factors Epidemiology Comparative Study Evaluation Studies Research Support, N.i.h., Extramural
Content Type	Text
Resource Type	Article
Subject	Epidemiology

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