Introduction
Patients and methods
Patients
Statistical analysis
Results
Characteristics | No. (%) |
---|---|
Age | |
<35 years | 35 (3.49) |
35–49 years | 358 (35.72) |
50–59 years | 303 (30.23) |
>60 years | 297 (29.64) |
Missing | 9 (0.89) |
Median age* | 52.9 (26–81) |
Menopause | |
Yes | 488 (48.70) |
No | 298 (29.75) |
Uncertain | 33 (3.29) |
Missing data | 183 (18.26) |
Nodal status | |
N− | 451 (45.01) |
N+ | 522 (52.1) |
Nx | 14 (1.39) |
Missing data | 15 (1.50) |
Tumor size | |
T1 | 538 (53.69) |
T2 | 351 (35.03) |
≥T3 | 94 (9.38) |
Missing data | 19 (1.90) |
Histological grade | |
III | 601 (59.99) |
II | 323 (32.23) |
I | 13 (1.29) |
Missing data | 65 (6.49) |
HER2 status | |
HER2-positive 3+ | 834 (83.23) |
HER2-positive 2+/FISH amplified | 168 (16.77) |
Hormone receptor status | |
ER−/PgR− | 377 (37.63) |
ER−/PgR+ | 28 (2.79) |
ER−/PgR unknown | 2 (0.2) |
ER+/PgR+ | 441 (44.01) |
ER+/PgR− | 133 (13.27) |
ER+/PgR unknown | 10 (1.0) |
ER unknown/PgR unknown | 10 (1.0) |
ER unknown/PgR+ | 1 (0.10) |
Surgery for primary tumors | |
Mastectomy | 406 (40.51) |
Quadrantectomy | 552 (55.09) |
Lumpectomy | 32 (3.19) |
Missing data | 12 (1.20) |
Histological type | |
Ductal | 856 (85.43) |
Lobular | 52 (5.19) |
Mixed | 25 (2.50) |
Other | 63 (6.28) |
Missing data | 6 (0.6) |
Therapy | |
Neoadjuvant or adjuvant chemotherapy | |
No anthracyclines | 157 (15.67) |
Anthracyclines-no taxanes | 390 (38.92) |
Anthracyclines-taxanes | 455 (45.41) |
Hormone therapy | |
Yes | 551 (54.99) |
Aromatase inhibitors | 333/551 (60.44) |
Tamoxifen | 218/551 (39.56) |
Trastuzumab | |
Every 3 weeks | 980 (97.80) |
Weekly | 18 (1.80) |
Unspecified time of administration | 4 (0.40) |
Time of trastuzumab treatment | |
1-year | 874 (87.23) |
From ≥9 to <12 months | 18 (1.80) |
From ≥6 to <9 months | 73 (7.28) |
From ≥3 to <6 months | 21 (2.09) |
Less than 3 months | 16 (1.60) |
Time of trastuzumab treatment | No. of cases | % | Reasons for withdrawal | |||
---|---|---|---|---|---|---|
Progression N (%) | Cardiac toxicities N (%) | Non-cardiac toxicities N (%) | Clinical decision N (%) | |||
Less than 3 months | 16 | 1.60 | 0 | 9 (56.25) | 5 (31.25) | 2 (12.50) |
From ≥3 to <6 months | 21 | 2.09 | 1 (4.76) | 8 (38.10) | 4 (19.04) | 8 (38.10) |
From ≥6 to <9 months | 73 | 7.28 | 4 (5.48) | 10 (13.70) | 18 (24.66) | 41 (56.16) |
From ≥9 to <12 months | 18 | 1.80 | 0 | 1 (5.55) | 2 (11.11) | 15 (83.34) |
1 year | 874 | 87.23 | – | – | – | – |
Total | 1,002 | 100 | 5 (0.49) | 28 (2.79) | 29 (2.89) | 66 (6.58) |
Events | No. (%) n = 1,002 |
---|---|
Other neoplasia | 9 (0.90) |
Breast carcinoma events | 107 (10.70) |
Local | 18 (1.80) |
Contralateral | 1 (0.10) |
Distant metastases | 88 (8.78) |
Parameters | Non-relapsed | Relapsed |
p
a
|
---|---|---|---|
Age (year) | 53 (26.81) | 52 (30.80) | – |
Postmenopause (no./total, %) | 428/695 (61.58) | 53/83 (63.85) | 0.7213 |
ER-neg (no./total, %) | 343/875 (39.20) | 63/107 (58.90) | <0.0001 |
PgR-neg (no./total, %) | 436/868 (50.23) | 70/105 (66.7) | 0.0018 |
Tumor size (no./total, %) | |||
T1 | 496/870 (57.01) | 36/104 (34.61) | <0.0001 |
T2 | 305/870 (35.06) | 42/104 (40.38) | |
≥T3 | 68/870 (7.81) | 26/104 (25.00) | |
Vascular invasion (no./total, %) | 220/655 (33.60) | 43/80 (53.75) | 0.0005 |
Lymphoid infiltration (no./total, %) | 204/587 (34.75) | 38/70 (54.28) | 0.0023 |
Necrosis (no./total, %) | 193/637 (30.30) | 29/75 (38.67) | 0.1481 |
Grade III (no./total, %) | 518/830 (62.41) | 77/99 (77.78) | 0.0026 |
N+ (no./total, %) | 448/873 (51.32) | 81/105 (77.14) | <0.0001 |
Chemotherapy | |||
Anthracyclines-no taxanes | 365/886 (41.20) | 29/107 (27.10) | |
Anthracyclines-taxanes | 375/886 (42.33) | 64/107 (59.81) | 0.0024 |
No anthracyclines | 146/886 (16.48) | 14/107 (13.08) |
Parameters | Univariate analysis | Multivariate analysis | ||||
---|---|---|---|---|---|---|
HR | 95 % CI |
p
| HR | 95 % CI |
p
| |
Lymph nodes (pos vs. neg) | 2.839 | 1.800–4.478 | <0.0001 | 3.633 | 1.600–8.249 | 0.0020 |
Grade (III vs. II/I) | 2.019 | 1.257–3.243 | 0.0037 | |||
ER (pos vs. neg) | 0.467 | 0.317–0.686 | 0.0001 | 0.552 | 0.314–0.968 | 0.0382 |
PgR (pos vs. neg) | 0.533 | 0.355–0.799 | 0.0023 | |||
Size (>T1 vs. ≤T1) | 2.286 | 1.526–3.425 | <0.0001 | |||
Menopause (yes vs. no) | 1.144 | 0.731–1.791 | 0.5566 | |||
Necrosis (yes vs. no) | 1.433 | 0.900–2.280 | 0.1296 | |||
Lymphoid infiltration (yes vs. no) | 2.351 | 1.468–3.765 | 0.0004 | 1.912 | 1.061–3.444 | 0.0310 |
Vascular invasion (yes vs. no) | 2.172 | 1.400–3.372 | 0.0005 | 1.853 | 1.028–3.338 | 0.0400 |
Anthracycline-taxanes vs. anthracycline-no taxanes | 2.452 | 1.484–4.058 | 0.0005 | |||
No anthracycline vs. anthracycline- no taxanes | 1.719 | 0.846–0.0494 | 0.1345 |
Parameters | Early recurrences (0–18 months) n = 44 | Late recurrences (>18 months) n = 63 |
p
a
|
---|---|---|---|
Age (year, range) | 52 (30–75) | 51 (32–80) | |
Postmenopause (no./total, %) | 18/29 (62.07) | 35/54 (64.81) | 0.8150 |
ER-neg (no./total, %) | 26/44 (59.09) | 37/63 (58.73) | 1 |
PgR-neg (no./total, %) | 28/43 (65.12) | 42/62 (67.74) | 0.8348 |
Tumor size (no./total, %) | |||
T1 | 20/43 (46.51) | 16/61 (26.23) | |
T2 | 14/43 (32.56) | 28/61 (45.90) | 0.1005 |
≥T3 | 9/43 (20.93) | 17/61 (27.87) | |
Vascular invasion (no./total, %) | 15/31 (48.39) | 28/49 (57.14) | 0.4952 |
Lymphoid infiltration (no./total, %) | 18/33 (54.56) | 20/37 (54.05) | 1 |
Necrosis (no./total, %) | 12/35 (34.28) | 17/40 (42.50) | 0.4872 |
Grade III (no./total, %) | 32/40 (80.0) | 45/59 (76.27) | 0.8065 |
N+ (no./total, %) | 32/43 (74.42) | 49/62 (79.03) | 0.6400 |
Chemotherapy | |||
Anthracycline-no taxanes | 12/44 (27.27) | 17/53 (26.98) | |
Anthracycline-taxanes | 26/44 (59.09) | 38/63 (60.32) | 0.9877 |
No anthracyclines | 6/44 (13.64) | 8/63 (12.70) |
Site of distant relapse | Earlya (0–18 months)n = 39 (%) | Latea (>18 months)n = 49 (%) |
p
b
|
---|---|---|---|
Central nervous system | 9 (23.07) | 6 (12.24) | 0.2545 |
Bone | 14 (35.89) | 7 (14.28) | 0.0240 |
Liver | 4 (10.26) | 8 (16.32) | 0.2927 |
Lung | 4 (10.26) | 9 (18.37) | 0.3712 |
Visceral | 0 (0) | 3 (6.12) | 0.2512 |
Lymph node | 3 (7.69) | 8 (16.32) | 0.3333 |
Multiple | 4 (10.26) | 7 (14.28) | 0.7484 |
Unspecified | 1 (2.56) | 1 (2.04) | 1 |