PMID- 22294436 OWN - NLM STAT- MEDLINE DCOM- 20121024 LR - 20211021 IS - 1097-0142 (Electronic) IS - 0008-543X (Print) IS - 0008-543X (Linking) VI - 118 IP - 17 DP - 2012 Sep 1 TI - Comparison of adverse events during 5-fluorouracil versus 5-fluorouracil/oxaliplatin adjuvant chemotherapy for stage III colon cancer: a population-based analysis. PG - 4309-20 LID - 10.1002/cncr.27422 [doi] AB - BACKGROUND: In clinical trials, combined 5-fluorouracil (5FU) plus oxaliplatin improves the survival of patients who have resected, stage III colon cancer with manageable toxicity. However, the tolerability of this in the general population of patients with colon cancer is uncertain. METHODS: Adverse outcomes were compared in patients with stage III colon cancer who received either 5FU or 5FU/oxaliplatin within 120 days of undergoing resection versus a control group of patients with stage II colon cancer who did not receive chemotherapy in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database and in data from the New York State Cancer Registry linked to Medicare and Medicaid. Hospitalizations, emergency room (ER) visits, and outpatient adverse events (AEs) were measured in claims from 30 days to 9 months after patients underwent resection. Multiple logistic regression was used to calculate adjusted odds ratios of events by treatment. Propensity score matching was used to minimize selection bias. RESULTS: Adverse outcomes were more frequent for chemotherapy recipients. AE rates were higher in patients who received 5FU/oxaliplatin (81%) compared with patients who received 5FU alone (72%), in the SEER-Medicare data. The effect of oxaliplatin on AEs was greater in older patients: The odds ratio was 2.10 (95% confidence interval, 1.53-2.87) for patients aged >/= 75 years versus 1.75 (95% confidence interval, 1.39-2.21) for patients aged <75 years. ER use was high in Medicaid patients (83% of those who received chemotherapy), but neither ER use nor hospitalization was increased by oxaliplatin. The 60-day mortality rate was 1% to 3% for patients who received 5FU alone and 1% to 2% for patients who received combined 5FU/oxaliplatin. CONCLUSIONS: The incremental harms of adjuvant chemotherapy with 5FU/oxaliplatin versus 5FU alone were modest in patients with stage III colon cancer who were insured by Medicare and Medicaid. The additional harms in patients aged >/= 75 years largely were restricted to outpatient events and did not extend to an increased rate of hospitalization or early death. CI - Copyright (c) 2012 American Cancer Society. FAU - Sanoff, Hanna K AU - Sanoff HK AD - Department of Medicine, Division of Hematology and Oncology, University of Virginia, Charlottesville, Virginia, USA. FAU - Carpenter, William R AU - Carpenter WR FAU - Freburger, Janet AU - Freburger J FAU - Li, Ling AU - Li L FAU - Chen, Kun AU - Chen K FAU - Zullig, Leah L AU - Zullig LL FAU - Goldberg, Richard M AU - Goldberg RM FAU - Schymura, Maria J AU - Schymura MJ FAU - Schrag, Deborah AU - Schrag D LA - eng GR - R01CA131847/CA/NCI NIH HHS/United States GR - R25 CA116339/CA/NCI NIH HHS/United States GR - 1 R25 CA11633901/CA/NCI NIH HHS/United States GR - K05 CA169384/CA/NCI NIH HHS/United States GR - R01 CA131847/CA/NCI NIH HHS/United States PT - Comparative Study PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, U.S. Gov't, Non-P.H.S. PT - Research Support, U.S. Gov't, P.H.S. DEP - 20120131 PL - United States TA - Cancer JT - Cancer JID - 0374236 RN - 0 (Organoplatinum Compounds) RN - 04ZR38536J (Oxaliplatin) RN - U3P01618RT (Fluorouracil) SB - IM MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/*adverse effects MH - Chemotherapy, Adjuvant MH - Colonic Neoplasms/*drug therapy/pathology MH - Female MH - Fluorouracil/administration & dosage/*adverse effects MH - Humans MH - Male MH - Middle Aged MH - Organoplatinum Compounds/*adverse effects MH - Oxaliplatin MH - Population Surveillance PMC - PMC3543676 MID - NIHMS428952 COIS- Financial Disclosure Authors report no financial COI. EDAT- 2012/02/02 06:00 MHDA- 2012/10/25 06:00 PMCR- 2013/03/01 CRDT- 2012/02/02 06:00 PHST- 2011/11/04 00:00 [received] PHST- 2011/12/09 00:00 [revised] PHST- 2011/12/19 00:00 [accepted] PHST- 2012/02/02 06:00 [entrez] PHST- 2012/02/02 06:00 [pubmed] PHST- 2012/10/25 06:00 [medline] PHST- 2013/03/01 00:00 [pmc-release] AID - 10.1002/cncr.27422 [doi] PST - ppublish SO - Cancer. 2012 Sep 1;118(17):4309-20. doi: 10.1002/cncr.27422. Epub 2012 Jan 31.