Background
Methods
Design and patients
Selection criteria
Vitamin D analysis
Clinical staging and pathology
Statistical considerations
Results
Patients
Vitamin D level |
p
| ||
---|---|---|---|
< 20 ng/ml | ≥ 20 ng/ml | ||
Population | 42% (136) | 58% (191) | |
Median age | 49.5 | 50 |
0.1
|
Histological type |
0.3
| ||
Ductal carcinoma | 83.9% (99) | 85.9% (122) | |
Lobular carcinoma | 7.6 (9) | 9.9% (14) | |
Other | 8.5% (10) | 4.2% (6) | |
NA | (18) | (49) | |
Tumor subtypes |
0.02
| ||
HER2+ | 20.6% (28) | 34.2% (65) | |
HR+/HER2- | 47.1% (64) | 41.6% (79) | |
TNBC | 32.4% (44) | 24.2% (46) | |
NA | 0 | 1 | |
Tumor size |
0.7
| ||
T1 | 12.5% (17) | 9.4% (17) | |
T2 | 56.6% (77) | 62.6%(119) | |
T3 | 19.1% (26) | 19.5% (37) | |
T4 | 11.8% (16) | 8.9% (17) | |
NA | 0 | 1 | |
Nodal status |
0.4
| ||
N0 | 43.7% (59) | 19.5% (93) | |
N1 | 46.7% (63) | 43.6% (82) | |
N2 | 8.9% (12) | 5.3% (10) | |
N3 | 0.7% (1) | 1.6% (3) | |
NA | 1 | 3 | |
SBR grade |
0.8
| ||
II | 46.6% (62) | 45.5% (85) | |
III | 53.4% (71) | 54.5%(102) | |
NA | 3 | 4 | |
Clinical stage |
0.96
| ||
I-II | 72.8% (99) | 73% (138) | |
III | 27.2% (37) | 27% (51) | |
NA | 0 | 2 |
Pathological complete response and vitamin D levels
No pCR | pCR | Total | |
---|---|---|---|
Age | |||
< 50 | 44.5% (98) | 55.1% (59) |
p = 0.07
|
≥50 | 55.5% (122) | 44.9% (48) | |
Tumor subtypes | |||
HER2+ | 20.5% (45) | 45.3% (48) |
p < 0.01
|
HR+/Her2- | 54.5% (120) | 21.7% (23) | |
TNBC | 25% (55) | 33% (35) | |
Grade SBR | |||
II | 51.9% (111) | 34% (36) |
p < 0.01
|
III | 48.1% (103) | 66% (70) | |
Clinical stage | |||
I-II | 68.9% (151) | 81.1% (86) |
p = 0.02
|
III | 31.1% (68) | 18.9% (20) | |
Vitamin D level | |||
< 20 ng/mL | 45.5% (100) | 33.6% (36) |
p = 0.04
|
≥ 20 ng/mL | 54.5% (120) | 66.4% (71) |
pCR | OR | 95% CI |
p
|
---|---|---|---|
Age | |||
< 50 | |||
≥ 50 | 0.45 | 0.3–0.7 |
0.001
|
Clinical stage | |||
I-II | |||
III | 0.34 | 0.2–0.6 |
0.0001
|
Histological grade (SBR) | |||
II | |||
III | 1.19 | 0.7–1.9 |
0.5
|
Tumor subtypes | |||
HER2+ | 1.6 | 0.7–3.8 |
0.2
|
HR+/Her2- | |||
TNBC | 1.0 | 0.5–2.3 |
0.9
|
VD level | |||
< 20 ng/mL | |||
≥ 20 ng/mL | 0.43 | 0.2–0.8 |
0.01
|
Survival
5 years-OS (%) | 95%CI |
p
| |
---|---|---|---|
Age |
0.2
| ||
< 50 | 86 | 0.79–0.91 | |
≥ 50 | 82 | 0.76–0.88 | |
VD level |
0.3
| ||
< 20 ng/mL | 82% | 0.75–0.88 | |
≥ 20 ng/mL | 85% | 0.79–0.9 | |
Clinical stage |
0.00001
| ||
I-II | 89% | 0.84–0.93 | |
III | 72% | 0.61–0.80 | |
pCR |
0.0007
| ||
no | 79% | 0.73–0.84 | |
yes | 94% | 0.86–0.98 | |
Tumor subtypes |
0.00001
| ||
HER2+ | 90% | 0.82–0.95 | |
HR+/Her2- | 92% | 0.86–0.96 | |
TNBC | 65% | 0.53–0.74 | |
SBR grade |
0.4
| ||
II | 86% | 0.79–0.91 | |
III | 83% | 0.76–0.88 |
HR | 95%CI |
p
| |
---|---|---|---|
Age (years) | |||
Range (26–74) | |||
Median: 49.5 | |||
< 50 | |||
≥ 50 | 1.2 | 0.7–2.3 |
0.5
|
VD level | |||
< 20 ng/mL | |||
≥ 20 ng/mL | 1.03 | 0.6–1.8 |
0.9
|
Clinical stage | |||
I-II | |||
III | 2.8 | 1.6–5.0 |
0.001
|
Tumor subtypes | |||
HER2+ | 1.77 | 0.8–4.1 |
0.1
|
HR+/HER2- | |||
TNBC | 6.5 | 3.1–13.7 |
0.0001
|
pCR | |||
no | |||
yes | 0.2 | 0.09–0.5 |
0.001
|
SBR grade | |||
II | |||
III | 0.86 | 0.5–1.6 |
0.6
|
5 years-PFS (%) | 95%CI |
p
| |
---|---|---|---|
Age |
0.1
| ||
< 50 | 82 | 0.75–0.88 | |
≥ 50 | 75 | 0.67–0.81 | |
VD level |
0.2
| ||
< 20 ng/mL | 76 | 0.67–0.82 | |
≥ 20 ng/mL | 80 | 0.73–0.85 | |
Clinical stage |
0.00001
| ||
I-II | 84 | 0.78–0.89 | |
III | 62 | 0.51–0.72 | |
pCR |
0.0002
| ||
no | 72 | 0.65–0.78 | |
yes | 92 | 0.84–0.96 | |
Tumor subtypes |
0.00001
| ||
HER2+ | 84 | 0.74–0.90 | |
HR+/HER2- | 84 | 0.77–0.90 | |
TNBC | 62 | 0.51–0.72 | |
SBR grade |
0.3
| ||
II | 79 | 0.71–0.85 | |
III | 78 | 0.71–0.84 |
HR | 95%CI |
p
| |
---|---|---|---|
Age | |||
< 50 | |||
≥ 50 | 1.4 | 0.84–2.3 |
0.2
|
VD level | |||
< 20 ng/mL | |||
≥ 20 ng/mL | 0.9 | 0.6–1.5 |
0.8
|
Clinical stage | |||
I-II | |||
III | 2.4 | 1.4–3.9 |
0.001
|
Tumor subtypes | |||
HER2+ | 1.6 | 0.30–1.21 |
0.2
|
HR+/HER2- | |||
TNBC | 4.3 | 1.42–4.80 |
0.002
|
pCR | |||
no | |||
yes | 0.25 | 0.12–0.50 |
0.0001
|
SBR grade | |||
II | |||
III | 0.94 | 0.52–1.70 |
0.8
|