Table 2.
Patient toxicity in the National Surgical Adjuvant Breast and Bowel Project R-04 study*
| Toxicity | Pre-amendment | Post-amendment | ||||
|---|---|---|---|---|---|---|
| 5-FU, % (n=141) |
CAPE, % (n=146) |
5-FU, % (n=317) |
5-FU + OX, % (n=322) |
CAPE, % (n=319) |
CAPE + OX, % (n=322) |
|
| Greatest toxicity: Grade 3 | 28.4 | 35.6 | 25.6 | 37.0 | 26.6 | 36.6 |
| Greatest toxicity: Grade 4 | 2.8 | 2.7 | 0.6 | 2.8 | 2.2 | 3.7 |
| Greatest toxicity: Grade 5 | 0.7 | 0.7 | 0.3 | 0.3 | 1.3 | 1.6 |
| Greatest toxicity: Grades 3–5 | 31.9 | 39.0 | 26.5 | 40.1 | 30.1 | 41.9 |
| Toxicity, % of grades observed | ||||||
| Diarrhea: Grades 3-5 | 15.6 | 17.1 | 6.9 | 16.5 | 6.9 | 16.5 |
| Nausea : Grade 3 | 1.4 | 2.7 | 0.3 | 0.6 | 1.3 | 2.2 |
| Vomiting: Grade 3 | 0 | 3.4 | 0.3 | 1.6 | 0 | 1.2 |
| Fatigue: Grade 3 | 3.5 | 6.8 | 1.3 | 4.0 | 2.2 | 5.9 |
| Abdominal pain: Grade 3 | 2.1 | 3.4 | 1.6 | 2.8 | 0.3 | 1.9 |
| Anal pain: Grade 3 | 1.4 | 5.5 | 3.2 | 4.0 | 3.4 | 3.1 |
| Radiation dermatitis: Grades 3–5 | 2.1 | 7.5 | 2.5 | 2.2 | 2.5 | 1.2 |
| Dehydration: Grade 3 | 5.0 | 8.2 | 0.3 | 2.8 | 2.2 | 4.0 |
| Hand-foot syndrome: Grade 3 | 1.4 | 3.4 | 0.3 | 0 | 0.3 | 0.3 |
| Periph. sens. neurop.:Grades 2–4 | 2.1 | 2.1 | 0.6 | 5.6 | 2.2 | 6.5 |
*5-FU = 5-flourouracil; CAPE = capecitabine; OX = oxaliplatin.