The survival advantage conferred by adding oxaliplatin to adjuvant chemotherapy with fluorouracil (5-FU) in stage III colon cancer, as previously shown in patients in randomized controlled trials, extends to patients in the general population, including older and minority group patients and those with higher comorbidity. These results, reported in the Journal of the National Cancer Institute, were obtained by comparing data for 4,060 patients from five observational sources to pooled data for 8,292 patients from five randomized controlled trials.1 “To mirror the trial cohorts, we restricted our analyses to patients diagnosed before age 75 years,” the researchers noted.
“The survival advantage associated with the addition of oxaliplatin to adjuvant 5-FU was evident across diverse practice settings,” the researchers stated. The 3-year overall survival for patients receiving oxaliplatin was 86% for the randomized controlled trials and ranged from 79% to 88% for the observational sources. “The association between oxaliplatin treatment and better survival was maintained in older and minority group patients, as well as those with higher comorbidity,” the authors remarked. .
The authors pointed out that while the “addition of oxaliplatin to 5-FU unequivocally improves outcomes of patients enrolled in [randomized controlled trials], those patients are substantially younger, healthier, and less racially and/or ethnically diverse” than the general population of patients with cancer. In addition, the oxaliplatin/5-FU combination “has a greater risk of severe cytopenias, nausea and vomiting, diarrhea, and peripheral neuropathy than 5-FU alone,” which could limit its use among more diverse patients in community settings. Results showed, however, that adjuvant chemotherapy with oxaliplatin improved survival in “patients cared for across the spectrum of treatment venues in the United States: at specialty cancer centers, academic oncology groups, community oncology practices, and Veterans Administration hospitals,” the researchers reported.
“In summary, our analyses suggest that the benefit of oxaliplatin evident in clinical trials appears to manifest in day-to-day practice,” they concluded. “Physicians and patients should be reassured from our findings that oxaliplatin is associated with marginally but consistently superior survival for patients [with stage III colon cancer] diagnosed before age 75 years in community settings.” ■
1. Sanoff HK, Carpenter WR, Martin CF, et al: Comparative effectiveness of oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy for stage III colon cancer. J Natl Cancer Inst 104:211-227, 2012.