Table 2.
Physician-Reported Maximal Acute Toxicities (NCI CTCAE v4.0)
| CF-WBI (n=149) | HF-WBI (n=138) | P* | |||
|---|---|---|---|---|---|
| N | % | N | % | ||
| Any Grade ≥ 2 Acute Toxicity | <0.001 | ||||
| None | 33 | 22 | 73 | 53 | |
| Any | 116 | 78 | 65 | 47 | |
| Any Grade ≥ 3 Acute Toxicity | 0.001 | ||||
| None | 141 | 95 | 138 | 100 | |
| Any | 8 | 5 | 0 | 0 | |
| Fatigue | |||||
| 0 | 23 | 15 | 29 | 21 | 0.02 |
| 1 | 101 | 68 | 97 | 70 | |
| 2 | 20 | 13 | 12 | 9 | |
| 3 | 5 | 3 | 0 | 0 | |
| Pruritus | <0.001 | ||||
| 0 | 29 | 20 | 63 | 46 | |
| 1 | 110 | 74 | 69 | 50 | |
| 2 | 10 | 7 | 6 | 4 | |
| Breast Pain | 0.001 | ||||
| 0 | 39 | 26 | 62 | 45 | |
| 1 | 97 | 65 | 69 | 50 | |
| 2 | 13 | 9 | 7 | 5 | |
| Shoulder Arthralgia | 0.46 | ||||
| 0 | 124 | 83 | 120 | 87 | |
| 1 | 24 | 16 | 16 | 12 | |
| 2 | 0 | 0 | 2 | 1 | |
| 3 | 1 | 1 | 0 | 0 | |
| Dermatitis | <0.001 | ||||
| 0 | 1 | 1 | 8 | 6 | |
| 1 | 45 | 30 | 80 | 58 | |
| 2 | 101 | 68 | 50 | 36 | |
| 3 | 2 | 1 | 0 | 0 | |
| Hyperpigmentation | 0.002 | ||||
| 0 | 45 | 30 | 60 | 44 | |
| 1 | 74 | 50 | 66 | 48 | |
| 2 | 30 | 20 | 12 | 9 | |
| Breast Edema | 0.10 | ||||
| 0 | 94 | 63 | 98 | 71 | |
| 1 | 51 | 34 | 39 | 28 | |
| 2 | 4 | 3 | 1 | 1 | |
| 3 | 0 | 0 | 0 | 0 | |
| Wound Complications, Non-Infectious | 0.61 | ||||
| 0 | 147 | 99 | 137 | 99 | |
| 1 | 2 | 1 | 1 | 1 | |
| Skin Ulceration | 0.19 | ||||
| 0 | 142 | 95 | 136 | 99 | |
| 1 | 5 | 3 | 1 | 1 | |
| 2 | 2 | 1 | 1 | 1 | |
| Seroma | 0.19 | ||||
| 0 | 127 | 85 | 109 | 79 | |
| 1 | 21 | 14 | 28 | 20 | |
| 2 | 1 | 1 | 1 | 1 | |
| Breast Infection | 0.46 | ||||
| 0 | 145 | 97 | 136 | 99 | |
| 2 | 4 | 3 | 2 | 1 | |
| Wound Infection | 0.96 | ||||
| 0 | 148 | 99 | 137 | 99 | |
| 2 | 1 | 1 | 1 | 1 | |
| Soft Tissue Necrosis of the Chest Wall/Thorax | . | ||||
| 0 | 149 | 100 | 138 | 100 | |
| Upper Extremity Edema | 0.51 | ||||
| 0 | 141 | 95 | 134 | 97 | |
| 1 | 8 | 5 | 3 | 2 | |
| 2 | 0 | 0 | 1 | 1 | |
| All others | 0.20 | ||||
| 0 | 133 | 89 | 128 | 93 | |
| 1 | 12 | 8 | 9 | 7 | |
| 2 | 4 | 3 | 1 | 1 | |
Abbreviations: CF (conventionally fractionated), HF (hypofractionated), NCI CTCAE (National Cancer Institute Common Toxicity Criteria Adverse Events), WBI (whole breast irradiation)
*
Cochran-Armitage test for trend used for all P-values except chi-square used for any grade ≥ 2 toxicity and Fisher’s exact test used for any grade ≥ 3 toxicity.
Acute toxicities were recorded on a weekly basis during radiation using a structured template which specified these toxicities and their definitions. Any subsequent toxicity occurring within 42 days of treatment completion was also included in this analysis of acute toxicity.