Comparative effectiveness of oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy for stage III colon cancer.

TitleComparative effectiveness of oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy for stage III colon cancer.
Publication TypeJournal Article
Year of Publication2012
AuthorsSanoff, Hanna K., William R. Carpenter, Christopher F. Martin, Daniel J. Sargent, Jeffrey A. Meyerhardt, Til Stürmer, Jason P. Fine, Jane Weeks, Joyce Niland, Katherine L. Kahn, Maria J. Schymura, and Deborah Schrag
JournalJ Natl Cancer Inst
Volume104
Issue3
Pagination211-27
Date Published2012 Feb 08
ISSN1460-2105
KeywordsAdolescent, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Chemotherapy, Adjuvant, Clinical Trials, Phase III as Topic, Colonic Neoplasms, Comparative Effectiveness Research, Confounding Factors, Epidemiologic, Female, Fluorouracil, Humans, Kaplan-Meier Estimate, Male, Medical Record Linkage, Medicare, Meta-Analysis as Topic, Middle Aged, Neoplasm Staging, Organoplatinum Compounds, Oxaliplatin, Proportional Hazards Models, Randomized Controlled Trials as Topic, Registries, SEER Program, Treatment Outcome, United States
Abstract

BACKGROUND: The addition of oxaliplatin to adjuvant 5-fluorouracil (5-FU) improves survival of patients with stage III colon cancer in randomized clinical trials (RCTs). However, RCT participants are younger, healthier, and less racially diverse than the general cancer population. Thus, the benefit of oxaliplatin outside RCTs is uncertain.SUBJECTS AND METHODS: Patients younger than 75 years with stage III colon cancer who received chemotherapy within 120 days of surgical resection were identified from five observational data sources-the Surveillance, Epidemiology, and End Results registry linked to Medicare claims (SEER-Medicare), the New York State Cancer Registry (NYSCR) linked to Medicaid and Medicare claims, the National Comprehensive Cancer Network (NCCN) Outcomes Database, and the Cancer Care Outcomes Research & Surveillance Consortium (CanCORS). Overall survival (OS) was compared among patients treated with oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy. Overall survival for 4060 patients diagnosed during 2004-2009 was compared with pooled data from five RCTs (the Adjuvant Colon Cancer ENdpoinTs [ACCENT] group, n = 8292). Datasets were juxtaposed but not combined using Kaplan-Meier curves. Covariate and propensity score adjusted proportional hazards models were used to calculate adjusted survival hazard ratios (HR). Stratified analyses examined effect modifiers. All statistical tests were two-sided.RESULTS: The survival advantage associated with the addition of oxaliplatin to adjuvant 5-FU was evident across diverse practice settings (3-year OS: RCTs, 86% [n = 1273]; SEER-Medicare, 80% [n = 1152]; CanCORS, 88% [n = 129]; NYSCR-Medicaid, 82% [n = 54]; NYSCR-Medicare, 79% [n = 180]; and NCCN, 86% [n = 438]). A statistically significant improvement in 3-year overall survival was seen in the largest cohort, SEER-Medicare, and in the NYSCR-Medicare cohort (non-oxaliplatin-containing vs oxaliplatin-containing adjuvant therapy, adjusted HR of death: pooled RCTs: HR = 0.80, 95% CI = 0.70 to 0.92, P = .002; SEER-Medicare: HR = 0.70, 95% CI = 0.60 to 0.82, P < .001; NYSCR-Medicare patients aged ≥65 years: HR = 0.58, 95% CI = 0.38 to 0.90, P = .02). The association between oxaliplatin treatment and better survival was maintained in older and minority group patients, as well as those with higher comorbidity.CONCLUSION: The addition of oxaliplatin to 5-FU appears to be associated with better survival among patients receiving adjuvant colon cancer treatment in the community.

DOI10.1093/jnci/djr524
Alternate JournalJ Natl Cancer Inst
Original PublicationComparative effectiveness of oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy for stage III colon cancer.
PubMed ID22266473
PubMed Central IDPMC3274510
Grant ListU01 CA093348 / CA / NCI NIH HHS / United States
R01CA131847 / CA / NCI NIH HHS / United States
R01AG023178 / AG / NIA NIH HHS / United States
U01 CA093324 / CA / NCI NIH HHS / United States
U01 CA093326 / CA / NCI NIH HHS / United States
P01 CA142538 / CA / NCI NIH HHS / United States
U01 CA25224 / CA / NCI NIH HHS / United States
2P30DK034987 / DK / NIDDK NIH HHS / United States
U01 CA093332 / CA / NCI NIH HHS / United States
U01 CA093344 / CA / NCI NIH HHS / United States
R01 AG023178 / AG / NIA NIH HHS / United States
U01 CA093329 / CA / NCI NIH HHS / United States
U01 CA01013 / CA / NCI NIH HHS / United States
K05 CA166208 / CA / NCI NIH HHS / United States
Project: