Introduction
Methods
Patient characteristics and clinical protocol
Vaccine and vaccination series
Clinical recurrence of disease
Statistical analysis
Results
Demographics
Vaccine (n = 89) n (%) | Control (n = 91) n (%) | p value | |
---|---|---|---|
Median age (years) | 50.8 | 51.1 | 0.928 |
IQR | 44.3–57.6 | 44.4–58.6 | |
T stage | 0.702 | ||
T0 | 2 (2.2) | 2 (2.2) | |
Tis/mic | 1 (1.1) | 2 (2.2) | |
T1 | 40 (44.9) | 39 (42.9) | |
T2 | 34 (38.2) | 33 (36.3) | |
T3 | 6 (6.7) | 11 (12.1) | |
T4 | 4 (4.5) | 4 (4.4) | |
Tx | 2 (2.2) | 0 (0) | |
Nodal status | 0.234 | ||
Positive | 51 (57.3) | 60 (65.9) | |
Negative | 38 (42.7) | 31 (34.1) | |
Histology | 0.094 | ||
Ductal | 84 (94.4) | 77 (84.6) | |
Lobular | 2 (2.2) | 4 (4.4) | |
Other | 3 (3.4) | 10 (11.0) | |
Grade (differentiation) | 0.339 | ||
Well | 4 (4.5) | 9 (9.9) | |
Moderate | 34 (38.2) | 30 (33.0) | |
Poor | 51 (57.3) | 52 (57.1) | |
ER/PR status | 0.564 | ||
Positive | 55 (61.8) | 60 (65.9) | |
Negative | 34 (38.2) | 31 (34.1) | |
HER2 status | 0.750 | ||
Positive | 51 (57.3) | 50 (54.9) | |
Negative | 38 (42.7) | 41 (45.1) | |
Surgery | 0.341 | ||
Lumpectomy | 36 (40.4) | 33 (36.3) | |
Mastectomy | 46 (51.7) | 54 (59.3) | |
Both | 7 (7.9) | 3 (3.3) | |
None | 0 (0) | 1 (1.1) | |
Radiation therapy | 0.418 | ||
Adjuvant | 67 (75.3) | 74 (81.3) | |
Neoadjuvant | 1 (1.1) | 0 (0) | |
None | 21 (23.6) | 17 (18.7) | |
Chemotherapy | 0.668 | ||
Adjuvant | 65 (73.0) | 69 (75.8) | |
Neoadjuvant | 16 (18.0) | 14 (15.4) | |
Adjuvant and neoadjuvant | 1 (1.1) | 3 (3.3) | |
None | 7 (7.9) | 5 (5.5) | |
Trastuzumab therapy | 0.808 | ||
Adjuvant | 40 (44.9) | 38 (41.8) | |
Neoadjuvant | 4 (4.5) | 3 (3.3) | |
Adjuvant and neoadjuvant | 3 (3.4) | 4 (4.4) | |
None | 42 (47.2) | 46 (50.5) | |
Endocrine therapy | 0.482 | ||
Aromatase inhibitor | 29 (32.6) | 29 (31.9) | |
Tamoxifen | 24 (27.0) | 29 (31.9) | |
Other | 2 (2.2) | 0 (0) | |
None | 34 (38.2) | 33 (36.3) |
Vaccine (n = 154) n (%) | Control (n = 147) n (%) | p value | |
---|---|---|---|
Median age (years) | 49.0 | 50.4 | 0.503 |
IQR (years) | 42.5–57.6 | 42.7–57.6 | |
T stage | 0.706 | ||
T0 | 4 (2.6) | 3 (2.0) | |
Tis/mic | 2 (1.3) | 3 (2.0) | |
T1 | 64 (41.6) | 56 (38.1) | |
T2 | 57 (37.0) | 67 (45.6) | |
T3 | 19 (12.3) | 14 (9.5) | |
T4 | 5 (3.2) | 3 (2.0) | |
Tx | 3 (1.9) | 1 (0.7) | |
Nodal status | 0.946 | ||
Positive | 100 (64.9) | 96 (65.3) | |
Negative | 54 (35.1) | 51 (34.7) | |
Histology | 0.486 | ||
Ductal | 135 (87.7) | 124 (84.4) | |
Lobular | 10 (6.5) | 9 (6.1) | |
Other | 9 (5.8) | 14 (9.5) | |
Grade (differentiation) | 0.788 | ||
Well | 10 (6.5) | 8 (5.4) | |
Moderate | 66 (42.9) | 59 (40.1) | |
Poor | 78 (50.6) | 80 (54.4) | |
ER/PR status | 0.969 | ||
Positive | 95 (61.7) | 91 (61.9) | |
Negative | 59 (38.3) | 56 (38.1) | |
HER2 status | 0.443 | ||
Positive | 77 (50.0) | 67 (45.6) | |
Negative | 77 (50.0) | 80 (54.4) | |
HLA-A2 status | 0.579 | ||
Positive | 25 (16.2) | 25 (17.0) | |
Negative | 129 (83.8) | 121 (82.3) | |
Surgery | 0.370 | ||
Lumpectomy | 63 (40.9) | 48 (32.7) | |
Mastectomy | 84 (54.5) | 91 (61.9) | |
Both | 7 (4.5) | 7 (4.8) | |
None | 0 (0) | 1 (0.7) | |
Radiation therapy | 0.775 | ||
Adjuvant | 118 (76.6) | 110 (74.8) | |
Neoadjuvant | 2 (1.3) | 1 (0.7) | |
None | 34 (22.1) | 36 (24.5) | |
Chemotherapy | 0.403 | ||
Adjuvant | 109 (70.8) | 97 (66.0) | |
Neoadjuvant | 38 (24.7) | 36 (24.5) | |
Adjuvant and neoadjuvant | 2 (1.3) | 4 (2.7) | |
None | 5 (3.2) | 10 (6.8) | |
Trastuzumab therapy | 0.704 | ||
Adjuvant | 65 (42.2) | 55 (37.4) | |
Neoadjuvant | 5 (3.2) | 4 (2.7) | |
Adjuvant and neoadjuvant | 6 (3.9) | 4 (2.7) | |
None | 78 (50.6) | 84 (57.1) | |
Endocrine therapy | 0.546 | ||
Aromatase inhibitor | 46 (29.9) | 43 (29.3) | |
Tamoxifen | 50 (32.5) | 47 (32.0) | |
Ovarian ablation | 1 (0.6) | 0 (0) | |
Other | 2 (1.3) | 0 (0) | |
None | 55 (35.7) | 57 (38.8) |