Table 3.
Adverse Events of Grade 2 or Higher.*
| Adverse Event | WBI (N = 927) | WBI+RNI (N = 893) | P Value† | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 2 | Grade 3 | Grade 4 | Total | Grade 2 | Grade 3 | Grade 4 | Total | ||
| no. of patients with event (%) | |||||||||
| Acute | |||||||||
| Fatigue | 156 | 13 | 0 | 169 (18.2) | 154 | 16 | 0 | 170 (19.0) | 0.67 |
| Pain‡ | 35 | 5 | 0 | 40 (4.3) | 46 | 7 | 0 | 53 (5.9) | 0.14 |
| Pneumonitis§ | 2 | 0 | 0 | 2 (0.2) | 11 | 0 | 0 | 11 (1.2) | 0.01 |
| Radiation dermatitis | 349 | 23 | 0 | 372 (40.1) | 397 | 45 | 0 | 442 (49.5) | <0.001 |
| Delayed | |||||||||
| Cardiac¶ | 2 | 2 | 0 | 4 (0.4) | 0 | 6 | 2 | 8 (0.9) | 0.26 |
| Lymphedema∥ | 38 | 4 | 0 | 42 (4.5) | 65 | 10 | 0 | 75 (8.4) | 0.001 |
| Neuropathy** | 16 | 1 | 0 | 17 (1.8) | 16 | 5 | 1†† | 22 (2.5) | 0.42 |
| Pneumonitis or fibrosis§‡‡ | 2 | 1 | 0 | 3 (0.3) | 4 | 0 | 0 | 4 (0.4) | 0.72 |
| Joint | 12 | 2 | 0 | 14 (1.5) | 21 | 0 | 0 | 21 (2.4) | 0.23 |
| Skin§§ | 38 | 2 | 0 | 40 (4.3) | 51 | 11 | 0 | 62 (6.9) | 0.02 |
| Subcutaneous tissue | 19 | 0 | 0 | 19 (2.0) | 34 | 3 | 0 | 37 (4.1) | 0.01 |
| Second cancer¶¶ | NA | NA | NA | 93 (10.0) | NA | NA | NA | 98 (11.0) | 0.54 |
Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria, version 2.0. Events were considered to be acute if they occurred within 3 months after the completion of radiation and delayed if they occurred more than 3 months after completion. NA denotes not applicable.
P values were calculated by means of Fisher's exact test for the between-group comparison of the proportion of patients with an adverse event of grade 2 or higher.
Listed are events that were attributed to radiation.
Grade 2 events were radiographic changes requiring the use of glucocorticoids or diuretics; grade 3 events were radiographic changes and those requiring the use of oxygen.
Cardiac events included left ventricular failure, cardiac ischemia or infarction, supraventricular arrhythmia, and pericardial effusion.
Grade 2 events were moderate lymphedema requiring compression; grade 3 events were severe lymphedema limiting function.
Neuropathy includes both sensory and motor events.
One patient was reported to have transient grade 4 motor neuropathy in the ipsilateral arm.
Included in this category are two patients with pulmonary fibrosis in the WBI+RNI group.
Included in this category are late radiation changes such as atrophy or telangiectasia.
Excluded from this category are skin and contralateral breast cancers.