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. 2011 Oct 12;103(20):1498–1506. doi: 10.1093/jnci/djr310

Table 1.

ACCENT studies included in the analysis*

Study (reference) No. Race, %
Treatment type, %
White Black Surgery alone 5-FU or MOF 5-FU + LV or LEV 5-FU + LV + oxaliplatin or irinotecan
CALGB 89803 (4) 1176 92.9 7.1 49.4 50.6
INT 0035 (5) 849 93.2 6.8 51.1 48.9
NCCTG 894651 (6) 814 97.1 3.0 100.0
NCCTG 914653 (7) 607 96.9 3.1 100.0
S9415 (8) 906 90.9 9.1 100.0
NSABP C-01 (9) 965 81.9 18.1 68.2 31.8
NSABP C-02 (10) 646 90.6 9.4 49.9 50.1
NSABP C-03 (11) 988 91.2 8.8 50.2 49.8
NSABP C-04 (12) 1979 91.8 8.2 100.0
NSABP C-05 (13) 1999 91.5 8.5 100.0
NSABP C-06 (14) 1457 91.4 8.6 100.0
NSABP C-07 (15) 2225 92.4 7.6 50.6 49.4
Total 14611 91.7 8.3 9.7 7.7 71.0 11.6
*

ACCENT = Adjuvant Colon Cancer ENdpoinT; CALGB = Cancer and Leukemia Group B; INT = Intergroup; MOF = methyl-(CCNU) + vincristine (Oncovin) + 5-FU; LEV = levamisole; LV = leucovorin; NCCTG = North Central Cancer Treatment Group; S = Southwest Oncology Group; NSABP = National Surgical Adjuvant Breast and Bowel Project; 5-FU = 5-fluorouracil.

CALGB 89803 was a negative study evaluating the addition of Irinotecan to 5-FU + LV in stage III colon cancer. INT 0035 showed the superiority of 5-FU + LEV for disease-free survival compared with surgery alone. NCCTG 894651 compared 5-FU + LEV and 5-FU + LEV + LV both given for 6 and 12 months and found 6 months of 5-FU + LEV + LV equivalent to 12 months of 5-FU + LEV. NCCTG 914653 was a negative trial evaluating dose escalation of LEV along with 5-FU + LV compared with standard 5-FU + LEV + LV. S9415 compared infusional 5-FU + LEV to bolus 5-FU + LEV + LV and found similar efficacy with reduced toxicity for the infusional regimen. NSABP C-01 was a three-arm trial comparing surgery alone to Bacillus Calmette-Guérin immunotherapy (no difference in cancer outcomes) and to 5-FU, semustine, and vincristine (MOF) (MOF superior). NSABP C-02 found an advantage to infusional 5-FU over surgery alone. NSABP C-03 found 5-FU + LV superior to MOF. NSABP C-04 compared three arms 5-FU + LV, 5-FU + LEV, and 5-FU + LEV + LV and found 5-FU + LV superior to 5-FU + LEV with the three-drug regimen equivalent to 5-FU + LV. NSABP C-05 was a negative trial investigating the addition of interferon alpha to 5-FU + LV. NSABP C-06 found Uracil/Ftorafur equivalent to 5-FU + LV. NSABP C-07 showed that the addition of oxaliplatin to 5-FU + LV improved outcomes.

Total is sum of number of patients for individual trials or the percentage of patients from all studies pooled.