TY - JOUR
T1 - Comparative effectiveness of oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy for stage III colon cancer
AU - Sanoff, Hanna K.
AU - Carpenter, William R.
AU - Martin, Christopher F.
AU - Sargent, Daniel J.
AU - Meyerhardt, Jeffrey A.
AU - Stürmer, Til
AU - Fine, Jason P.
AU - Weeks, Jane
AU - Niland, Joyce
AU - Kahn, Katherine L.
AU - Schymura, Maria J.
AU - Schrag, Deborah
N1 - Funding Information:
The Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services (HHS) as part of the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program (Contract No. HSA290-2005-0016-I-TO7-WA1, 36-BWH-1 and HHSA290-2005-0040-I-TO4-WA1, 36-UNC). The authors of the report are responsible for its content. Statements in the report should not be construed as endorsement by the AHRQ or the US Department of HHS. The National Cancer Institute (R01CA131847 to D. Schrag, Principle Investigator) funded work on the Medicaid and SEER– Medicare data. The CanCORS study was supported by grants from the National Cancer Institute to the CanCORS Statistical Coordinating Center and Primary Data Collection and Research Centers (U01 CA093344, U01 CA093332, U01 CA093324, U01 CA093348, U01 CA093329, U01 CA01013, U01 CA093326), and by a grant from the Department of Veteran’s Affairs to the Durham VA Medical Center (CRS 02-164) and (HARO 03-438MO-03). The National Institute on Aging (R01AG023178, T. Stürmer, PI), The National Institute of Diabetes and Digestive and Kidney Diseases (2P30DK034987, Robert Sandler, PI), The ACCENT collaboration is funded by (U01 CA25224) The Centers for Disease Control and Prevention (CDC) through the Association of Schools of Public Health (ASPH), (S3888, M. J. Schymura, PI).
PY - 2012/2/8
Y1 - 2012/2/8
N2 - 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.
AB - 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.
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U2 - 10.1093/jnci/djr524
DO - 10.1093/jnci/djr524
M3 - Article
C2 - 22266473
AN - SCOPUS:84856854044
SN - 0027-8874
VL - 104
SP - 211
EP - 227
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
IS - 3
ER -