Table 1.
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.