Table 1.
Baseline patient, tumor, and treatment characteristics
| CF-WBI (n=149) | HF-WBI (n=138) | P* | |||
|---|---|---|---|---|---|
| N | % | N | % | ||
| Patient characteristics | |||||
| Age at diagnosis (years) | 0.55 | ||||
| 40–49 | 13 | 9 | 19 | 14 | |
| 50–59 | 55 | 37 | 46 | 33 | |
| 60–69 | 59 | 40 | 51 | 37 | |
| 70 and older | 22 | 15 | 22 | 16 | |
| Race | 0.68 | ||||
| White Non-Hispanic | 116 | 78 | 99 | 72 | |
| Hispanic | 16 | 11 | 20 | 15 | |
| Black Non-Hispanic | 15 | 10 | 17 | 12 | |
| Asian Non-Hispanic | 2 | 1 | 2 | 1 | |
| Menopausal Status | 0.23 | ||||
| Premenopausal | 9 | 6 | 13 | 9 | |
| Perimenopausal | 8 | 5 | 3 | 2 | |
| Postmenopausal | 132 | 89 | 122 | 88 | |
| Bra Cup Size | 0.53 | ||||
| A | 13 | 9 | 7 | 5 | |
| B | 31 | 21 | 34 | 25 | |
| C | 50 | 34 | 46 | 33 | |
| D | 40 | 27 | 35 | 25 | |
| DD | 12 | 8 | 16 | 12 | |
| DDD | 2 | 1 | 0 | 0 | |
| EE | 1 | 1 | 0 | 0 | |
| BMI Quartile (kg/cm2) | 0.08 | ||||
| <24.48 | 35 | 24 | 37 | 27 | |
| 24.48 – <29.18 | 38 | 26 | 35 | 25 | |
| 29.18 – <33.64 | 30 | 20 | 40 | 29 | |
| >33.64 | 46 | 31 | 26 | 19 | |
| Physician-Assessed Cosmesis | 0.16 | ||||
| Excellent-Good | 135 | 91 | 131 | 95 | |
| Fair-Poor | 14 | 10 | 7 | 5 | |
|
| |||||
| Tumor characteristics | |||||
| Tumor Behavior | 0.07 | ||||
| Invasive | 110 | 74 | 114 | 83 | |
| DCIS | 39 | 26 | 24 | 17 | |
| Tumor Grade | 0.46 | ||||
| 1 | 40 | 27 | 34 | 25 | |
| 2 | 70 | 47 | 73 | 53 | |
| 3 | 39 | 26 | 30 | 22 | |
| Unclassified† | 0 | 0 | 1 | 1 | |
| Margin Status | 0.67 | ||||
| negative, ≥ 2 mm | 133 | 89 | 121 | 88 | |
| negative, < 2 mm | 16 | 11 | 17 | 12 | |
| Quadrant | 0.28 | ||||
| Central | 16 | 11 | 27 | 20 | |
| Lower Inner | 9 | 6 | 7 | 5 | |
| Lower Outer | 22 | 15 | 17 | 12 | |
| Upper Inner | 22 | 15 | 15 | 11 | |
| Upper Outer | 80 | 54 | 72 | 52 | |
| Estrogen Receptor Status | 0.39 | ||||
| Positive | 130 | 87 | 118 | 86 | |
| Negative | 18 | 12 | 16 | 12 | |
| Not tested | 1 | 1 | 4 | 3 | |
| Progesterone Receptor Status | 0.42 | ||||
| Positive | 112 | 75 | 102 | 74 | |
| Negative | 36 | 24 | 32 | 23 | |
| Not tested | 1 | 1 | 4 | 3 | |
| Her2-neu Status | 0.43 | ||||
| Positive | 12 | 8 | 11 | 8 | |
| Negative | 102 | 69 | 103 | 75 | |
| Not tested | 35 | 24 | 24 | 17 | |
| Pathologic Stage among patients with invasive cancer without neoadjuvant therapy (n=196)‡ | |||||
| pT1mic-pT1a | 16 | 17 | 12 | 12 | 0.44 |
| pT1b | 24 | 26 | 23 | 23 | |
| pT1c | 43 | 46 | 48 | 47 | |
| pT2 | 11 | 12 | 19 | 19 | |
| pN0 | 79 | 84 | 89 | 87 | 0.02 |
| pN1mic | 14 | 15 | 6 | 6 | |
| pN1a | 1 | 1 | 7 | 7 | |
| Clinical and Pathologic Stage among patients with invasive cancer with neoadjuvant therapy (n=28)‡ | |||||
| cT1c | 2 | 12 | 2 | 17 | 0.76 |
| cT2 | 14 | 88 | 10 | 84 | |
| cN0 | 13 | 81 | 11 | 92 | 0.44 |
| cN1a | 3 | 19 | 1 | 8 | |
| pT0 | 7 | 44 | 5 | 42 | 0.68 |
| pTis | 1 | 6 | 2 | 17 | |
| pT1a | 2 | 13 | 0 | 0 | |
| pT1b | 0 | 0 | 0 | 0 | |
| pT1c | 4 | 25 | 3 | 25 | |
| pT2 | 2 | 13 | 2 | 17 | |
| pN0 | 16 | 100 | 12 | 100 | . |
|
| |||||
| Treatment characteristics | |||||
| Chemotherapy | 0.67 | ||||
| None | 106 | 71 | 96 | 70 | |
| Neoadjuvant | 16 | 11 | 12 | 9 | |
| Adjuvant | 27 | 18 | 30 | 22 | |
| Treatment Location | 0.16 | ||||
| Houston-area | 141 | 95 | 132 | 96 | |
| Banner MD Anderson | 4 | 3 | 0 | 0 | |
| Orlando Health | 4 | 3 | 6 | 4 | |
Abbreviations: CF (conventionally fractionated), DCIS (ductal carcinoma in situ), HF (hypofractionated), WBI (whole breast irradiation)
Fisher’s exact test used for race, estrogen receptor status, progesterone receptor status, and bra cup size. Chi-square test used for all other comparisons.
This patient’s cancer was diagnosed on core biopsy but grade could not be assigned. There was no residual disease in the lumpectomy specimen.
Staging information is only presented for patients with invasive breast cancer. A total of 63 patients had DCIS. Because DCIS typically does not undergo pathologic staging of the axillary nodes, patients with DCIS are not included in the comparison of stage by randomization arm. Additionally, staging is different for patients treated with upfront surgery compared to those treated with neoadjuvant chemotherapy, which is the reason that these two groups of patients are separated in the table.
ER positive: ≥ 1% of cells stained for estrogen receptor; PR positive: ≥ 1% of cells stained for progesterone receptor; Her2-neuNeu positive: 3+ by immunohistochemistry or gene amplification by fluorescence in situ hybridization