Table 1.

Clinicopathologic characteristics of all randomized patients.

Trastuzumab + NPS + GM-CSFTrastuzumab + GM-CSF
(n = 136)(n = 139)P value
Age (median)52.250.50.38
IQR43.7–60.842.0–59.0
RaceWhite109 (80.1%)97 (69.8%)0.20
Asian2 (1.5%)9 (6.5%)
Black13 (9.6%)20 (13.4%)
Hispanic10 (7.4%)9 (6.5%)
Unknown2 (1.5%)4 (2.9%)
Nottingham modified, Scarff–Bloom–Richardson gradeGrade 18 (5.9%)14 (10.1%)0.31
Grade 257 (41.9%)56 (40.3%)
Grade 369 (50.7%)69 (49.6%)
Hormone receptor statusER positive81 (59.6%)95 (68.3%)0.20
PR positive77 (56.6%)83 (59.7%)0.13
TNBC53 (39.0%)44 (31.7%)0.60
HER2 IHC1+89 (65.4%)89 (64.0%)0.81
2+47 (34.6%)50 (36.0%)
Breast surgeryBCT39 (28.7%)34 (24.5%)0.93
Mastectomy97 (71.4)104 (74.9%)
None0 (0.0%)1 (0.7%)
ChemotherapyNeoadjuvant72 (52.9%)76 (54.7%)0.85
Adjuvant59 (43.4%)57 (41.0%)
None5 (3.7%)6 (4.3%)
Radiotherapy with BCTAdjuvant39 (100.0%)34 (100.0%)1.00
None0 (0.0%)0 (0.0%)
Radiotherapy with mastectomyAdjuvant76 (78.4%)89 (85.6%)0.20
Neoadjuvant2 (2.1%)0 (0.0%)
None19 (21.6%)15 (14.4%)
Axillary surgeryAxillary dissection81 (59.6%)88 (63.3%)0.29
SLN biopsy55 (40.4%)48 (34.5%)
None0 (0.0%)3 (2.2%)
Clinical stage (for patients receiving neoadjuvant chemotherapy)Unknown1 (1.4%)2 (2.6%)0.39
00 (0%)1 (2.6%)
I4 (5.6%)3 (3.9%)
IIA16 (22.2%)13 (17.1%)
IIB19 (26.4%)18 (23.7%)
IIIA14 (19.4%)25 (32.9%)
IIIB7 (9.7%)2 (2.6%)
IIIC10 (13.9%)13 (17.1%)
IVa1 (1.4%)0 (0%)
Pathologic stage (for patients receiving neoadjuvant chemotherapy)Unknown1 (1.4%)0 (0.0%)0.77
05 (6.9%)4 (5.3%)
I11 (15.3%)9 (11.8%)
IIA16 (22.2%)15 (19.7%)
IIB12 (16.7%)11 (14.5%)
IIIA11 (15.3%)20 (26.3%)
IIIB4 (5.6%)3 (3.9%)
IIIC12 (16.7%)14 (18.4%)
Pathologic stage (for patients not receiving neoadjuvant chemotherapy)I10 (15.6%)9 (14.3%)0.98
IIA11 (17.2%)12 (19.0%)
IIB14 (21.9%)14 (22.2%)
IIIA21 (32.8%)18 (19.0%)
IIIB0 (0%)0 (0%)
IIIC8 (12.5%)10 (15.9%)
  • Abbreviations: BCT, breast-conserving therapy; ER, estrogen receptor; PR, progesterone receptor; SLN, sentinel lymph node.

  • aOne patient with pathologic stage IIB after completion of chemotherapy was enrolled and vaccinated. It was later discovered that the patient had metastatic disease prior to initiation chemotherapy and was enrolled in violation of the protocol. This patient was excluded from efficacy analyses due to ineligibility.