In the first of their studies to be published, the Consortium reports in the January 9 online issue of the Journal of the National Cancer Institute that adding the drug oxaliplatin to the standard of care chemotherapy 5-fluorouracil (5FU) is associated with better survival among patients receiving adjuvant colon cancer treatment in the community.
Hanna Sanoff, MD, assistant professor of medicine at the University of Virginia in Charlottesville, VA and study first author, said, “This research approach provides evidence for whether treatments work in the ‘real world’ – if they are as effective in a health care environment that is less precisely controlled and has more patient diversity than a typical clinical trial, where treatments are initially tested.”
Sanoff completed an internal medicine residency, a hematology/oncology fellowship, a master’s in public health and served on the faculty for three years at UNC prior to joining the faculty at UVA. She is a member of the UNC Cancer DEcIDE group.
William R. Carpenter, PhD, assistant professor of health policy and management at the UNC Gillings School of Global Public Health and principal investigator for the study at UNC, explains, “This study is important because it used comparative effectiveness research (CER), a research approach designed to inform health care decisions by providing new research-based evidence about the benefits and harms of health care interventions. Specifically, it seeks to examine these things in the general population that tends to be older, less healthy, and more racially diverse than the clinical trials populations.
“Oxaliplatin was approved by the FDA in part because of its demonstrated survival benefit in a clinical trials population; however, that population was younger, healthier, and less racially and ethnically diverse than most people who have colon cancer and use chemotherapy."
“This CER study examined multiple populations that together are much more representative of the population with colon cancer. As such, it provides good evidence that oxaliplatin is effective in the general population, and not just the clinical trials population. Findings that this new, expensive, and toxic drug was no better – or worse than – the prior standard of care (5FU) would have been troubling.” Carpenter is a member of UNC Lineberger Comprehensive Cancer Center.
Carpenter is PI of the DEcIDE Comparative Effectiveness Consortium Site at UNC and collaborates with Deborah Schrag, MD, PI of the Brigham and Women’s Hospital Cancer DEcIDE site. Carpenter is also director of UNC Lineberger Integrated Cancer Information and Surveillance System (ICISS).
These groups analyze large secondary datasets to understand comparative effectiveness issues in cancer care. He chairs the Consortium’s Data Committee in examination of data, data policies, and related issues relevant for cancer outcomes research.
Other UNC authors are: Christopher Martin, MS, research instructor, medicine; Til Sturmer, MD, MPH, professor of epidemiology; and Jason Fine, ScD, MSc, professor of biostatistics.