Table 2.
Univariable and multivariable analyses of competing risks TTB by treatment line in the competing risks population (n = 18 365)
| BLMM |
Progression outside BLMM and death before BLMM |
|||||
|---|---|---|---|---|---|---|
| Cumulative incidence at 12 months | sHR (95% CI) | Adjusted sHR (95% CI) | Cumulative incidence at 12 months | sHR (95% CI) | Adjusted sHR (95% CI) | |
| During first line | ||||||
| HER2-low (n = 5787) | 2.7 (2.3-3.1) | 1.00 | 1.00 | 48.7 (47.4-50.0) | 1.00 | 1.00 |
| HER2− (n = 9299) | 3.5 (3.1-3.9) | 1.24 (1.05-1.46) | 1.12 (0.94-1.32) | 53.2 (52.1-54.2) | 1.06 (1.02-1.10) | 1.02 (0.98-1.06) |
| HER2+ (n = 3109) | 6.3 (5.4-7.1) | 3.87 (3.29-4.55) | 2.70 (2.26-3.23) | 35.7 (34.1-37.4) | 0.54 (0.51-0.57) | 0.54 (0.51-0.57) |
| During second line | ||||||
| HER2-low (n = 3622) | 3.7 (3.1-4.4) | 1.00 | 1.00 | 73.6 (72.1-75.0) | 1.00 | 1.00 |
| HER2− (n = 5779) | 4.8 (4.2-5.4) | 1.32 (1.08-1.60) | 1.25 (1.02-1.53) | 73.3 (72.1-74.4) | 1.01 (0.97-1.05) | 1.00 (0.95-1.04) |
| HER2+ (n = 1217) | 8.5 (7.0-10.2) | 2.91 (2.31-3.66) | 2.41 (1.88-3.10) | 58.6 (55.7-61.4) | 0.64 (0.60-0.69) | 0.60 (0.55-0.65) |
| During third line | ||||||
| HER2-low (n = 2421) | 5.0 (4.1-5.9) | 1.00 | 1.00 | 80.3 (78.6-81.9) | 1.00 | 1.00 |
| HER2− (n = 3775) | 5.1 (4.4-5.8) | 0.99 (0.79-1.24) | 0.94 (0.75-1.19) | 80.1 (78.8-81.4) | 1.04 (0.98-1.09) | 1.02 (0.97-1.08) |
| HER2+ (n = 647) | 6.2 (4.5-8.3) | 1.40 (1.00-1.96) | 1.19 (0.82-1.73) | 74.9 (71.2-78.2) | 0.84 (0.76-0.92) | 0.76 (0.69-0.85) |
Patients with BLMM at treatment initiation and patients with <1 month of follow-up after treatment initiation were excluded from each analysis: 170 for first line, 7747 for second line and 11 522 for third line.
Adjusted sHR were calculated from the multivariable Fine and Gray model including HER2 status, age, histological grade, number and type of metastatic sites, MFI and hormone receptor status.
BLMM, brain and leptomeningeal metastases; CI, confidence interval; HER2, human epidermal growth factor receptor 2; sHR, subdistribution hazard ratios; TTB, time to BLMM defined as the time between treatment initiation and BLMM (event of interest) or progression outside BLMM and death before BLMM (competing event) or last contact (censored data).