Table 3.
Physician-Assessed Maximal Toxicities at Six Months (NCI CTCAE v4.0)
| CF-WBI (n=142) | HF-WBI (n=129) | P* | |||
|---|---|---|---|---|---|
| N | % | N | % | ||
| Combined | |||||
| Any grade 2 or higher | 0.81 | ||||
| None | 96 | 68 | 89 | 69 | |
| Any | 46 | 32 | 40 | 31 | |
| Any grade 3 or higher | 0.18 | ||||
| None | 140 | 99 | 129 | 100 | |
| Any | 2 | 1 | 0 | 0 | |
|
| |||||
| Constitutional | |||||
| Fatigue | 0.01 | ||||
| 0 | 89 | 63 | 94 | 73 | |
| 1 | 44 | 31 | 35 | 27 | |
| 2 | 9 | 6 | 0 | 0 | |
|
| |||||
| Dermatology/Skin | |||||
| Hyperpigmentation | 0.65 | ||||
| 0 | 49 | 35 | 54 | 42 | |
| 1 | 82 | 58 | 60 | 47 | |
| 2 | 11 | 8 | 15 | 12 | |
| Skin Induration | 0.43 | ||||
| 0 | 121 | 85 | 104 | 81 | |
| 1 | 19 | 13 | 24 | 19 | |
| 2 | 2 | 1 | 1 | 1 | |
| Dermatitis | 0.73 | ||||
| 0 | 121 | 85 | 111 | 86 | |
| 1 | 20 | 14 | 18 | 14 | |
| 2 | 1 | 1 | 0 | 0 | |
| Telangiectasia | 0.60 | ||||
| 0 | 138 | 97 | 126 | 98 | |
| 1 | 3 | 2 | 3 | 2 | |
| 2 | 1 | 1 | 0 | 0 | |
| Skin Ulceration | |||||
| 0 | 142 | 100 | 129 | 100 | . |
| Wound Complications, Non-Infectious | |||||
| 0 | 142 | 100 | 129 | 100 | . |
|
| |||||
| Infection | |||||
| Breast Infection | 0.83 | ||||
| 0 | 141 | 99 | 128 | 99 | |
| 2 | 0 | 0 | 1 | 1 | |
| 3 | 1 | 1 | 0 | 0 | |
| Wound Infection | |||||
| 0 | 142 | 100 | 129 | 100 | . |
|
| |||||
| Lymphatics | |||||
| Upper Extremity Edema | 0.92 | ||||
| 0 | 140 | 99 | 127 | 98 | |
| 1 | 2 | 1 | 2 | 2 | |
| Breast Edema | 0.78 | ||||
| 0 | 114 | 80 | 97 | 75 | |
| 1 | 21 | 15 | 30 | 23 | |
| 2 | 7 | 5 | 2 | 2 | |
|
| |||||
| Musculoskeletal/Soft Tissue | |||||
| Fibrosis - Superficial Soft Tissue | 0.89 | ||||
| 0 | 111 | 78 | 100 | 78 | |
| 1 | 30 | 21 | 28 | 22 | |
| 2 | 1 | 1 | 1 | 1 | |
| Fibrosis - Deep Connective Tissue | 0.26 | ||||
| 0 | 121 | 85 | 104 | 81 | |
| 1 | 21 | 15 | 24 | 19 | |
| 2 | 0 | 0 | 1 | 1 | |
| Seroma | 0.80 | ||||
| 0 | 127 | 89 | 114 | 88 | |
| 1 | 14 | 10 | 13 | 10 | |
| 2 | 0 | 0 | 2 | 2 | |
| Soft Tissue Necrosis of the Chest Wall/Thorax | |||||
| 0 | 142 | 100 | 129 | 100 | |
|
| |||||
| Pain | |||||
| Breast Pain | 0.89 | ||||
| 0 | 99 | 70 | 92 | 71 | |
| 1 | 41 | 29 | 32 | 25 | |
| 2 | 2 | 1 | 5 | 34 | |
| Other Pain | 0.49 | ||||
| 0 | 132 | 93 | 123 | 95 | |
| 1 | 9 | 6 | 5 | 4 | |
| 2 | 1 | 1 | 1 | 1 | |
|
| |||||
| Pulmonary | |||||
| Cough | 0.14 | ||||
| 0 | 141 | 99 | 125 | 97 | |
| 1 | 1 | 1 | 4 | 3 | |
| Dyspnea | 0.14 | ||||
| 0 | 142 | 100 | 127 | 98 | |
| 1 | 0 | 0 | 2 | 2 | |
| Pneumonitis | |||||
| 0 | 142 | 100 | 129 | 100 | |
|
| |||||
| Sexual/Reproductive Function | |||||
| Nipple/Areolar | 0.93 | ||||
| 0 | 117 | 82 | 106 | 82 | |
| 1 | 21 | 15 | 19 | 15 | |
| 2 | 4 | 3 | 4 | 3 | |
| Breast Atrophy | 0.72 | ||||
| 0 | 93 | 66 | 82 | 64 | |
| 1 | 33 | 23 | 31 | 24 | |
| 2 | 16 | 11 | 16 | 12 | |
|
| |||||
| Other | |||||
| All others combined | 0.30 | ||||
| 0 | 136 | 96 | 126 | 98 | |
| 1 | 5 | 4 | 3 | 2 | |
| 2 | 1 | 1 | 0 | 0 | |
Abbreviations: CF (conventionally fractionated), HF (hypofractionated), NCI CTCAE (National Cancer Institute Common Toxicity Criteria Adverse Events), WBI (whole breast irradiation)
*
P-value from Cochran-Armitage test for trend, with the exception of any grade 2 or higher and any grade 2 or higher, where P-value is from chi-square test.
These toxicities were recorded by the treating physician using a structured template which specified these toxicities and their definitions