TY - JOUR
T1 - Comparison of outcomes after fluorouracil-based adjuvant therapy for stages II and III colon cancer between 1978 to 1995 and 1996 to 2007
T2 - Evidence of stage migration from the ACCENT database
AU - Shi, Qian
AU - Andre, Thierry
AU - Grothey, Axel
AU - Yothers, Greg
AU - Hamilton, Stanley R.
AU - Bot, Brian M.
AU - Haller, Daniel G.
AU - Van Cutsem, Eric
AU - Twelves, Chris
AU - Benedetti, Jacqueline K.
AU - O'Connell, Michael J.
AU - Sargent, Daniel J.
N1 - Publisher Copyright:
© 2013 by American Society of Clinical Oncology.
PY - 2013/10/10
Y1 - 2013/10/10
N2 - Purpose: With improved patient care, better diagnosis, and more treatment options after tumor recurrence, outcomes after fluorouracil (FU) -based treatment are expected to have improved over time in early-stage colon cancer. Data from 18,449 patients enrolled onto 21 phase III trials conducted from 1978 to 2002 were evaluated for potential differences in time to recurrence (TTR), time from recurrence to death (TRD), and overall survival (OS) with regard to FU-based adjuvant regimens. Methods: Trials were predefined as old versus newer era using initial accrual before or after 1995. Outcomes were compared between patients enrolled onto old- or newer-era trials, stratified by stage. Results: Within the first 3 years, recurrence rates were lower in newer- versus old-era trials for patients with stage II disease, with no differences among those with stage III disease. Both TRD and OS were significantly longer in newer-era trials overall and within each stage. The lymph node (LN) ratio (ie, number of positive nodes divided by total nodes harvested) in those with stage III disease declined over time. TTR improved slightly, with larger number of LNs examined in both stages. Conclusion: Improved TRD in newer trials supports the premise that more aggressive intervention (oxaliplatinand irinotecan-based chemotherapy and/or surgery for recurrent disease) improves OS for patients previously treated in the adjuvant setting. Lower recurrence rates with identical treatments in those with stage II disease enrolled onto newer-era trials reflect stage migration over time, calling into question historical data related to the benefit of FU-based adjuvant therapy in such patients.
AB - Purpose: With improved patient care, better diagnosis, and more treatment options after tumor recurrence, outcomes after fluorouracil (FU) -based treatment are expected to have improved over time in early-stage colon cancer. Data from 18,449 patients enrolled onto 21 phase III trials conducted from 1978 to 2002 were evaluated for potential differences in time to recurrence (TTR), time from recurrence to death (TRD), and overall survival (OS) with regard to FU-based adjuvant regimens. Methods: Trials were predefined as old versus newer era using initial accrual before or after 1995. Outcomes were compared between patients enrolled onto old- or newer-era trials, stratified by stage. Results: Within the first 3 years, recurrence rates were lower in newer- versus old-era trials for patients with stage II disease, with no differences among those with stage III disease. Both TRD and OS were significantly longer in newer-era trials overall and within each stage. The lymph node (LN) ratio (ie, number of positive nodes divided by total nodes harvested) in those with stage III disease declined over time. TTR improved slightly, with larger number of LNs examined in both stages. Conclusion: Improved TRD in newer trials supports the premise that more aggressive intervention (oxaliplatinand irinotecan-based chemotherapy and/or surgery for recurrent disease) improves OS for patients previously treated in the adjuvant setting. Lower recurrence rates with identical treatments in those with stage II disease enrolled onto newer-era trials reflect stage migration over time, calling into question historical data related to the benefit of FU-based adjuvant therapy in such patients.
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U2 - 10.1200/JCO.2013.49.4344
DO - 10.1200/JCO.2013.49.4344
M3 - Article
C2 - 23980089
AN - SCOPUS:84891589369
SN - 0732-183X
VL - 31
SP - 3656
EP - 3663
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 29
ER -