Table 1.
Patient characteristics at baseline
| Characteristics | Control Group(N = 37) | Experimental Group(N = 36) | All Patients(N = 73) | |||
|---|---|---|---|---|---|---|
| Breast cancer history | ||||||
| Age at breast cancer diagnosis | ||||||
| Years, median (range) | 47.5 | (29.7; 84.1) | 50.9 | (30.1; 75) | 50.2 | (29.7; 84.1) |
| Histology, n (%) | ||||||
| Invasive ductal carcinoma | 23 | 62% | 23 | 62% | 46 | 63% |
| Invasive lobular carcinoma | 9 | 24% | 9 | 25% | 18 | 25% |
| Other subtypes1 | 5 | 14% | 4 | 11% | 9 | 12% |
| Differentiation, n (%) | ||||||
| Moderate | 9 | 24% | 11 | 31% | 20 | 27% |
| Poor | 20 | 54% | 12 | 33% | 32 | 44% |
| Other | 1 | 3% | 1 | 3% | 2 | 3% |
| Unknown | 7 | 19% | 12 | 33% | 19 | 26% |
| T status per TNM at diagnosis of breast cancer | ||||||
| 1 | 5 | 14% | 9 | 25% | 14 | 19% |
| 2 | 12 | 32% | 9 | 25% | 21 | 29% |
| 3 | 5 | 14% | 4 | 11% | 9 | 12% |
| 4 | 5 | 14% | 2 | 6% | 7 | 10% |
| X (unknown) | 10 | 27% | 12 | 33% | 22 | 30% |
| N status per TNM at diagnosis of breast cancer | ||||||
| 0 | 6 | 16% | 8 | 22% | 14 | 19% |
| 1 | 11 | 30% | 10 | 28% | 21 | 29% |
| 2 | 5 | 14% | 2 | 6% | 7 | 10% |
| 3 | 2 | 5% | 2 | 6% | 4 | 5% |
| X (unknown) | 13 | 35% | 14 | 39% | 27 | 37% |
| M status per TNM at diagnosis of breast cancer | ||||||
| 0 | 22 | 59% | 21 | 58% | 43 | 59% |
| 1 | 5 | 14% | 8 | 22% | 13 | 18% |
| X (unknown) | 10 | 27% | 7 | 19% | 17 | 23% |
| Estrogen receptor status, n (%) | ||||||
| Negative | 11 | 30% | 9 | 25% | 20 | 27% |
| Positive | 24 | 65% | 27 | 75% | 51 | 70% |
| Unknown | 2 | 5% | 0 | 0% | 2 | 3% |
| Progesterone receptor status, n (%) | ||||||
| Negative | 17 | 46% | 11 | 31% | 28 | 38% |
| Positive | 18 | 49% | 24 | 67% | 42 | 58% |
| Unknown | 2 | 5% | 1 | 3% | 3 | 4% |
| HER-2 status, n (%) | ||||||
| Negative | 25 | 68% | 30 | 83% | 55 | 75% |
| Positive | 9 | 24% | 2 | 6% | 11 | 15% |
| Unknown | 3 | 8% | 4 | 11% | 7 | 10% |
| Triple-negative tumor, n (%) | ||||||
| No | 28 | 76% | 29 | 81% | 57 | 78% |
| Yes | 7 | 19% | 5 | 14% | 12 | 16% |
| Unknown | 2 | 5% | 2 | 6% | 4 | 5% |
| LM presentation | ||||||
| Age at LM diagnosis | ||||||
| Years, median (range) | 59 | (31; 87) | 57 | (41; 76) | 57 | (31; 87) |
| Body mass index classification at LM diagnosis | ||||||
| Underweight | 2 | 5% | 2 | 6% | 4 | 5% |
| Normal range | 16 | 43% | 18 | 50% | 34 | 47% |
| Overweight | 6 | 16% | 11 | 31% | 17 | 23% |
| Obese | 11 | 30% | 5 | 14% | 16 | 22% |
| Unknown | 2 | 5% | 0 | 0% | 2 | 3% |
| Systemic therapy before LM diagnosis, n (%) | 37 | 100% | 34 | 94% | 71 | 97% |
| Number of lines, median (range) | 3 | (1; 11) | 2 | (0; 8) | 3 | (0; 11) |
| Prior surgery for brain metastases, n (%) | 3 | 8% | 2 | 6% | 5 | 7% |
| Prior central nervous system radiotherapy, n (%) | 10 | 27% | 5 | 14% | 15 | 21% |
| Focal radiotherapy alone | 6 | 16% | 3 | 8% | 9 | 12% |
| Whole brain radiotherapy (± focal) | 4 | 11% | 2 | 6% | 6 | 8% |
| Neurological symptoms or signs, n (%) | 33 | 89% | 34 | 94% | 67 | 92% |
| MRI findings suggestive of LM diagnosis, n (%) | 37 | 100% | 34 | 94% | 71 | 97% |
| CSF cytology at LM diagnosis within 14 days prior to randomization, n (%) | ||||||
| Positive | 29 | 78% | 26 | 72% | 55 | 75% |
| Negative | 6 | 16% | 8 | 22% | 14 | 19% |
| Equivocal | 2 | 5% | 2 | 6% | 4 | 5% |
| CSF protein (7 missing data) | ||||||
| g/L, median (range) | 0.8 | (0.2; 7.1) | 0.7 | (0.3; 21.8) | 0.8 | (0.2; 21.8) |
| Patient characteristics at LM diagnosis | ||||||
| Time interval (years) between breast cancer diagnosis and LM diagnosis | ||||||
| Years, median (range) | 4.5 | (0.4; 25.4) | 7.3 | (0.1; 24) | 4.7 | (0.1; 25.4) |
| Breast cancer manifestations at LM diagnosis | ||||||
| Brain metastases, n (%) | 15 | 41% | 8 | 22% | 23 | 32% |
| Non-CNS metastatic sites, n (%) | 35 | 95% | 34 | 94% | 69 | 95% |
| Liver | 19 | 51% | 19 | 53% | 38 | 52% |
| Lung/pleura | 16 | 43% | 17 | 47% | 33 | 45% |
| Bone/bone marrow | 26 | 70% | 30 | 83% | 56 | 77% |
| Cutaneous | 6 | 16% | 4 | 11% | 10 | 14% |
| Lymph nodes | 14 | 38% | 5 | 14% | 19 | 26% |
| Other | 12 | 32% | 8 | 22% | 20 | 27% |
| LM as one of the initial sites of metastases (n, %) | 5 | 14% | 4 | 11% | 9 | 12% |
| ECOG performance status at LM diagnosis, n (%) | ||||||
| 0 | 7 | 19% | 3 | 8% | 10 | 14% |
| 1 | 16 | 43% | 15 | 42% | 31 | 42% |
| 2 | 14 | 38% | 17 | 47% | 31 | 42% |
| 4 | 0 | 0% | 1 | 3% | 1 | 1% |
| Montreal Cognitive Assessment (MoCA) | ||||||
| Score, median (range) | 25 | (9; 30) | 26 | (5; 30) | 26 | (5; 30) |
| Unknown | 7 | 1 | 8 | |||
| Medical Research Council scale at LM diagnosis | ||||||
| No neurological deficit | 11 | 30% | 5 | 14% | 16 | 22% |
| Light functional neurological disorder, allowing useful work | 15 | 41% | 14 | 39% | 29 | 40% |
| Moderate functional neurological disorder | 10 | 27% | 11 | 31% | 21 | 29% |
| Major functional neurological disorder | 1 | 3% | 4 | 11% | 5 | 7% |
| Unknown | 0 | 0% | 2 | 6% | 2 | 3% |
1 Other subtypes histology: 4 mixed ductal and lobular, 1 atypical medullary carcinoma, 1 ductal and micro papillary, 3 breast cancers not otherwise specified.