Table 1.

Demographics, prognostic factors, and treatment profiles of patients enrolled in E75 phase II trial by low expressors versus overexpressors (A) and HER2/neu expression level (B)

A
LE control (n = 44)LE vaccine (n = 56)POE control (n = 22)OE vaccine (n = 29)P
Median age, y55565052
Range, y31-8227-770.732-7537-680.1
Race
    White, %86.489.30.872.786.20.3
    Other, %13.610.70.827.313.80.3
Tumor size
    T2-T4, %38.633.90.731.834.50.9
Histologic grade
    Grade 3, %27.230.40.863.662.10.9
NP, %54.558.90.790.155.20.06
Hormone receptor negative, %15.919.60.827.362.10.02*
Chemotherapy, %72.775.00.886.496.60.3
XRT, %84.175.00.372.775.9NS
Hormonal therapy, %81.876.80.663.641.40.2
Herceptin, %0.20.2NS9.124.10.3
B

0 Control (n = 5)
0 Vaccine (n = 7)
P
1+ Control (n = 15)
1+ Vaccine (n = 25)
P
2+ Control (n = 24)
2+ Vaccine (n = 26)
P
3+ Control (n = 13)
3+ Vaccine (n = 19)
P
Median age, y5060545450574951
Range, y38-7431-740.444-8242-710.431-7527-770.231-7437-620.2
Race
    White, %100.071.40.573.384.00.487.592.30.761.589.50.1
    Other, %0.028.6NS26.716.0NS12.57.7NS40.510.5NS
Tumor size
    T2-T4, %40.014.30.566.728.00.05*29.246.20.238.536.80.8
Histologic grade
    Grade 3, %20.014.30.633.336.00.737.538.50.961.557.90.8
NP, %0.00.0NS80.060.00.379.280.80.8100.042.10.003*
Hormone receptor negative, %20.014.30.613.328.00.416.711.50.938.563.20.2
Chemotherapy, %80.042.90.380.076.00.987.596.20.592.394.70.6
XRT, %100.042.90.0866.776.00.787.596.20.569.294.70.1
Hormonal therapy, %80.085.70.680.072.00.979.273.10.653.873.70.3
Herceptin, %0.00.0NS0.00.0NS8.37.70.97.710.50.7
  • Abbreviation: LE, low expressor; OE, overexpressor; NP, node positive; XRT, X-ray therapy; NS, not significant.

  • * Statistically significant difference.