|
Sub-category:
Colorectal Cancer (including liver metastases)
Category:
Gastrointestinal (Colorectal) Cancer
Meeting:
2009 ASCO Annual Meeting
Abstract No:
4010
Citation:
J Clin Oncol 27:15s, 2009 (suppl; abstr 4010)
Author(s):
N. A. Jackson McCleary, J. Meyerhardt, E. Green, G. Yothers, A. de Gramont, E. Van Cutsem, M. O'Connell, C. Twelves, L. Saltz, D. Sargent, The ACCENT Collaborative Group; Dana-Farber Cancer Institute, Boston, MA; Mayo Clinic, Rochester, MN; University of Pittsburgh, Pittsburgh, PA; Hôpital Saint Antoine, Paris, France; University of Leuven, Leuven, Belgium; Allegheny General Hospital, Allegheny Cancer Center, Pittsburgh, PA; St James's University Hospital, Leeds, United Kingdom; Memorial Sloan-Kettering Cancer Center, New York, NY
Abstract:
Background: Prior studies suggested that older and younger pts with colon cancer receive similar benefit from IV fluoropyrimidine (FU) adjuvant (adj) therapy (rx). Combination and/or oral FU rx are increasingly given as adj rx. We sought to determine the impact of pts age <70 v ≥70 yrs on colon cancer recurrence and mortality from adj rx with these newer options. Methods: We used data from 10,499 pts <70 yrs and 2,170 pts ≥70 yrs in 6 phase III adj rx trials comparing IV FU to combinations with irinotecan, oxaliplatin or oral FU (capecitabine and UFT/LV) in stage II/III colon cancer from the ACCENT database. Endpoints were overall survival (OS; time to death), disease-free survival (DFS; time to recurrence or death), and time to recurrence (TTR; censoring at last follow-up). Cox models were stratified by age and adjusted for gender and stage; interaction testing was used to explore the differential benefit by age. Results: Approximately 75% of pts had stage III disease (74% age<70, 77% age≥70). OS, DFS, and TTR were statistically significantly improved for those in the experimental v control arms among pts <70 but not those >70 (table); the interaction between age and rx was statistically significant for all endpoints (p=0.01 for OS, DFS, and TTR). These results were consistent whether experimental rx was oxaliplatin-based, irinotecan-based or oral FU. Deaths in first 6 month of adj rx were not statistically significantly different between experimental and control arm. Conclusions: Our results show conclusively that pts >70 do not receive the same benefit from combination and/or oral FU as those <70. Any benefit, if present, compared to IV FU/LV would not be clinically meaningful. Outcomes of experimental (combination or oral FU) vs control (IV 5-FU) by treatment and age
|
| Treatment Arm | Endpoint HR (95% CI)
| Deaths within 6mo Experimental
v Control % (p-value) |
| OS* |
DFS* |
TTR* | |
| | Overall | | <70 | 0.84 (0.79,0.91) | 0.85 (0.79,0.91) | 0.85 (0.79,0.91) | 0.89 v 0.79 (p=0.6) | | ≥ 70 | 1.13 (0.96,1.32) | 1.11 (0.97,1.28) | 1.13 (0.97,1.32) | 2.71 v 2.11 (p=0.4) | | Oxaliplatin-based | | <70 | 0.81 (0.71,0.93) | 0.77 (0.68,0.86) | 0.76 (0.67,0.86) | 0.81 v 0.81 (p=1.0) | | ≥ 70 | 1.18 (0.90,1.57) | 1.04 (0.81,1.35) | 0.93 (0.70,1.24) | 2.57 v 1.37 (p=0.3) | | Irinotecan-based | | <70 | 0.88 (0.78,1.01) | 0.90 (0.80, 1.00) | 0.88 (0.79,0.98) | 0.90 v 0.43 (p=0.1) | | ≥ 70 | 1.14 (0.88,1.47) | 1.17 (0.93, 1.48) | 1.33 (1.02, 1.73) | 3.96 v 2.43 (p=0.3) | | Oral fluoropyrimidine | | <70 | 0.89 (0.78, 1.02) | 0.89 (0.79, 1.01) | 0.90 (0.79, 1.02) | 0.98 v 1.25 (p=0.5) | | ≥ 70 | 1.19 (0.90, 1.57) | 1.15 (0.92, 1.45) | 1.18 (0.91, 1.53) | 1.68 v 2.50 (p=0.4) |
| | *Values > 1 favor control rx. |
Abstract Disclosures
Faculty and Discussant Disclosures
Annual Meeting Planning Committee Disclosures
2009 Annual Meeting Proceedings Part I Errata
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by N. A. Jackson McCleary:
Presentations by N. A. Jackson McCleary:
Educational Book Manuscripts by N. A. Jackson McCleary:
|
