Table 2.
First 18 mo CTCAE v4.0 gastrointestinal toxicities (n = 165)
| First 18 mo gastrointestinal grade ≥ 2 toxicities | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm A | Arm B | |||||||||||
| Baseline (n = 82) | 5fx (n = 82) | W12 (n = 82) | Mo6 (n = 80) | Mo12 (n = 82) | Mo18 (n = 79) | Baseline (n = 83) | 5fx (n = 83) | W12 (n = 82) | Mo6 (n = 81) | Mo12 (n = 80) | Mo18 (n = 79) | |
| Grade 0 | ||||||||||||
| 65 (79%) | 49 (60%) | 67 (82%) | 64 (80%) | 59 (72%) | 55 (70%) | 63 (79%) | 56 (68%) | 60 (73%) | 59 (73%) | 59 (74%) | 59 (74%) | |
| Grade 1 | ||||||||||||
| Worst toxicity | 16 (20%) | 31 (38%) | 15 (18%) | 16 (20%) | 21 (26%) | 22 (28%) | 19 (20%) | 27 (32%) | 21 (26%) | 22 (27%) | 19 (24%) | 18 (23%) |
| Grade 2 | ||||||||||||
| Worst toxicity * | 1 (1%) | 2 (2%) | — | — | 2 (2%) | 2 (2%) | 1 (1%) | — | 1 (1%) | — | 2 (2%) | 3 (3%) |
| Diarrhea | 1 | |||||||||||
| Constipation | 1 | 1 | 1 | |||||||||
| Bleeding | 1 | 2 | 1 | 1 | 1 | 2 | ||||||
| Anal fissure | 1 | 1 | ||||||||||
| Proctitis | 1 | 1 | 1 | |||||||||
| Pain | 1 | 1 | ||||||||||
| Grade 3 | ||||||||||||
| Worst toxicity | — | — | — | — | — | — | — | — | — | — | — | |
Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events v4.0; 5fx = 5th fraction; W12 = week 12.
*
Some patients presented more than 1 grade 2 toxicity.