Introduction
Patients and methods
Data source
Cohort definition
Statistical analysis
Results
Patient and tumour characteristics in the adjuvant setting
Characteristic | < 70 (n = 996) | ≥ 70 (n = 144) | ||
---|---|---|---|---|
Median | Min–Max | Median | Min–Max | |
Age at start of therapy, years | 55.1 | 21.6–69.9 | 72.8 | 70.0–85.5 |
Characteristic |
n
| % |
n
| % |
---|---|---|---|---|
BMI at enrolmenta
| ||||
Underweight | 5 | 0.5 | 1 | 0.7 |
Normal | 454 | 45.6 | 41 | 28.5 |
Overweight | 294 | 29.5 | 53 | 36.8 |
Obese | 223 | 22.4 | 44 | 30.6 |
Unknown | 20 | 2.0 | 5 | 3.5 |
Patients with any comorbidityb,c,e
| 470 | 47.2 | 118 | 81.9 |
Hypertension | 240 | 24.1 | 82 | 56.9 |
Diabetes mellitus | 69 | 6.9 | 2 | 14.6 |
Cardiovascular disease | 34 | 3.4 | 18 | 12.5 |
Charlson comorbidity indexd
| ||||
CCI = 0 | 814 | 81.7 | 89 | 61.8 |
CCI ≥ 1 | 182 | 18.3 | 55 | 38.2 |
Receptor status at diagnosis | ||||
HR-positive, HER2-negative | 569 | 57.1 | 82 | 56.9 |
HR-positive, HER2-positive | 176 | 17.7 | 19 | 13.2 |
HR-negative, HER2-positive | 77 | 7.7 | 10 | 6.9 |
Triple negative | 147 | 14.8 | 26 | 18.1 |
Unknown | 27 | 2.7 | 7 | 4.9 |
Tumour stage at diagnosis | ||||
I | 268 | 26.9 | 26 | 18.1 |
II | 443 | 44.5 | 60 | 41.7 |
III | 141 | 14.2 | 38 | 26.4 |
Unknownf
| 144 | 14.5 | 20 | 13.9 |
Tumour grading at diagnosis | ||||
G1 | 74 | 7.4 | 11 | 7.6 |
G2 | 540 | 54.2 | 64 | 44.4 |
G3 | 371 | 37.2 | 65 | 45.1 |
GX | 11 | 1.1 | 4 | 2.8 |
Node stage at diagnosis | ||||
N0 | 502 | 50.4 | 58 | 40.3 |
N1 | 341 | 34.2 | 47 | 32.6 |
N2 | 84 | 8.4 | 22 | 15.3 |
N3 | 56 | 5.6 | 15 | 10.4 |
Unknown | 13 | 1.3 | 2 | 1.4 |
Patient and tumour characteristics in the palliative setting
Characteristic | < 70 (n = 842) | ≥ 70 (n = 334) | ||
---|---|---|---|---|
Median | Min–Max | Median | Min–Max | |
Age at diagnosis, years | 53.2 | 22.3–69.6 | 71.6 | 37.1–90.2 |
Age at start of therapy, years | 59.1 | 22.5–70.0 | 75.1 | 70.0–92.8 |
Characteristic |
n
| % |
n
| % |
---|---|---|---|---|
BMI at enrolmenta
| ||||
Underweight | 7 | 0.8 | 6 | 1.8 |
Normal | 344 | 40.9 | 123 | 36.8 |
Overweight | 262 | 31.1 | 115 | 34.4 |
Obese | 173 | 20.5 | 60 | 18.0 |
Unknown | 56 | 6.7 | 30 | 9.0 |
Patients with comorbidityd,e
| 415 | 49.3 | 250 | 74.9 |
Hypertension | 241 | 28.6 | 165 | 49.4 |
Diabetes mellitus | 55 | 6.5 | 65 | 19.5 |
Cardiovascular disease | 20 | 2.4 | 36 | 10.8 |
CCI = 0f
| 688 | 81.7 | 192 | 57.5 |
CCI ≥ 1 | 154 | 18.3 | 142 | 42.5 |
Receptor status at diagnosis | ||||
HR-positive, HER2-negative | 389 | 46.2 | 159 | 47.6 |
HR-positive, HER2-positive | 162 | 19.2 | 54 | 16.2 |
HR-negative, HER2-positive | 78 | 9.3 | 21 | 6.3 |
Triple negative | 93 | 11.0 | 28 | 8.4 |
Unknown | 120 | 14.3 | 72 | 21.6 |
Tumour grading at diagnosis | ||||
G1/2 | 428 | 50.8 | 183 | 54.8 |
G3/4 | 314 | 37.3 | 115 | 34.4 |
GX/Unknown | 100 | 11.9 | 36 | 10.8 |
Resection of primary tumour | ||||
R0 | 636 | 75.5 | 250 | 74.9 |
R1/2 | 63 | 7.5 | 35 | 10.5 |
RX/unknown | 143 | 17.0 | 49 | 14.7 |
Metastasis at diagnosis | ||||
No (metachronous, M0) | 489 | 58.1 | 184 | 55.1 |
Yes (synchronous, M1) | 248 | 29.5 | 97 | 29.0 |
MXb/Unknown | 105 | 12.5 | 53 | 15.9 |
Location of metastasesd,g
| ||||
Visceral ± nonvisceral | 494 | 58.7 | 191 | 57.2 |
Nonvisceral only | 302 | 35.9 | 123 | 36.8 |
Unknown | 46 | 5.5 | 20 | 6.0 |
Bone only | 207 | 24.6 | 86 | 25.7 |
Liver only | 76 | 9.0 | 33 | 9.9 |
Lung only | 56 | 6.7 | 32 | 9.6 |
Brain | 27 | 3.2 | 3 | 0.9 |
Multiple and/or other locationc
| 430 | 51.1 | 160 | 47.9 |
Unknown | 46 | 5.5 | 20 | 6.0 |
Number of metastatic sitesd
| ||||
= 1 | 445 | 52.9 | 179 | 53.6 |
> 1 | 351 | 41.7 | 135 | 40.4 |
Unknown | 46 | 5.4 | 20 | 6.0 |
Preceding adjuvant therapy | 490 | 58.2 | 170 | 50.9 |
Treatment
Treatment response and outcome data
Adjuvant setting (prospectively enrolled patients) | < 70 (n = 951) | ≥ 70 (n = 139) | ||
---|---|---|---|---|
Patients receiving chemotherapy (n, %) | 714 | 75.1% | 92 | 66.2% |
Number of cycles (median, min–max)a
| 6.0 | 3.0–6.0 | 4.0 | 3.0–6.0 |
Duration of CTx in months (median, 95% CI)b
| 3.5 | NA–NA | 3.5 | 3.5–3.6 |
End of CTx documentedc (n, %) | 709 | 99.3% | 91 | 98.9% |
Patients receiving targeted therapy (n, %) | 192 | 20.2% | 28 | 20.1% |
Number of cycles (median, range)d
| 17.0 | 13.0–18.0 | 18 | 12.0–18.0 |
Duration of TT in months (median, 95% CI) | 14.7 | 14.2–15.6 | 15.2 | 11.7–16.6 |
End of TT documentedc (n, %) | 189 | 98.4% | 27 | 96.4% |
Patients receiving endocrine therapy (n, %) | 615 | 64.7% | 90 | 64.7% |
Duration of ET in months (median, 95% CI) | 59.5 | 58.5–61.9 | 59.2 | 43.2–NA |
End of ET documentedc (n, %) | 159 | 25.9% | 25 | 27.8% |
Disease-free survival—all patients and treatments | 951 | 100% | 139 | 100% |
Events (n, %) | 110 | 11.6% | 19 | 13.7% |
Median DFS | NA | NA | ||
Survival rate (%, 95% CI) | ||||
12 months | 96.3% | 94.8–97.3 | 94.0% | 88.3–97.0 |
24 months | 91.4% | 89.2–93.1 | 90.2% | 83.4–94.4 |
36 months | 87.8% | 85.3–89.9 | 85.5% | 77.1–91.0 |
Palliative first-line setting (prospectively enrolled patients) | < 70 (n = 554) | ≥ 70 (n = 239) | ||
---|---|---|---|---|
Patients receiving endocrine therapy (n, %) | 132 | 23.8% | 85 | 35.6% |
Duration of ET in months (median, 95% CI) | 15.9 | 13.3–20.2 | 15.4 | 10.9–20.1 |
Best response | ||||
CR/PR | 26 | 19.7% | 12 | 14.1% |
SD | 46 | 34.8% | 27 | 31.8% |
PD | 24 | 18.2% | 19 | 22.4% |
Missing | 36 | 27.3% | 27 | 31.8% |
Patients receiving chemotherapy (n, %) | 422 | 76.2% | 154 | 64.4% |
Duration of CTxa in months (median, 95% CI) | 5.1 | 4.6–5.8 | 3.8 | 3.5–4.9 |
Best response | ||||
CR/PR | 173 | 41.0% | 52 | 33.8% |
SD | 115 | 27.3% | 41 | 26.6% |
PD | 66 | 15.6% | 34 | 22.1% |
Missing | 68 | 16.1% | 27 | 17.5% |
Progression-free survival | 420 | 75.8% | 152 | 63.6% |
Events (n, %) | 237 | 56.2% | 102 | 66.2% |
Median PFS (months, 95% CI) | 12.2 | 10.8–13.3 | 7.6 | 6.6–8.9 |
Overall survival—all patients and treatments | 554 | 100% | 239 | 100% |
Events (n, %) | 275 | 49.6% | 146 | 61.1% |
Median OS (months, 95% CI) | 39.7 | 34.9–44.2 | 24.9 | 19.9–30.1 |
Survival rate (%, 95% CI) | ||||
12 months | 83.8% | 80.4–86.7 | 71.6% | 65.3–77.0 |
24 months | 68.2% | 63.9–72.1 | 51.6% | 44.7–58.0 |
36 months | 53.5% | 48.8–57.9 | 37.8% | 31.0–44.5 |