Table 1.
Baseline characteristics
| Characteristic | Total (n = 62) | Not High TMB (n = 50) | High TMB (n = 12) | PTEN WT (n = 44) | PTEN Altered (n = 18) |
|---|---|---|---|---|---|
| Age, yrs, median (range) | 55 (32–76) | 55 (32–71) | 58 (42–76) | 56 (32–76) | 52 (37–76) |
| Female, N (%) | 62 (100) | 50 (100) | 12 (100) | 44 (100) | 18 (100) |
| ECOG-PS, N (%) | |||||
| 0 | 42 (68) | 32 (64) | 10 (83) | 31 (70) | 11 (61) |
| 1 | 20 (32) | 18 (36) | 2 (17) | 13 (30) | 7 (39) |
| Visceral metastases | 46 (74) | 35 (70) | 11 (92) | 31 (70) | 15 (83) |
| Prior therapies for metastatic disease | |||||
| Median (range) | 1 (0–6) | 1 (0–6) | 1 (0–2) | 1 (0–6) | 1 (0–6) |
| 0, N (%) | 25 (40) | 20 (40) | 5 (42) | 17 (39) | 8 (44) |
| 1, N (%) | 19 (31) | 15 (30) | 4 (33) | 14 (32) | 5 (28) |
| 2, N (%) | 13 (21) | 10 (20) | 3 (25) | 10 (23) | 3 (17) |
| ≥3, N (%) | 5 (8) | 5 (10) | 0 (0) | 3 (7) | 2 (11) |
| Previous therapy, N (%) | |||||
| Neo(adjuvant) therapy | 57 (92) | 64 (92) | 11 (92) | 41 (93) | 16 (89) |
| Taxanes | 56 (90) | 44 (88) | 12 (100) | 39 (89) | 17 (94) |
| Anthracycline | 51 (82) | 40 (80) | 11 (92) | 36 (82) | 15 (83) |
| Regimen, N (%) | |||||
| Monotherapy | 14 (23) | 10 (20) | 4 (33) | 12 (27) | 2 (11) |
| Combination | 49 (77) | 40 (80) | 8 (67) | 32 (73) | 16 (89) |
| PD-L1 statusa, N (%) | |||||
| Positive | 14 (38) | 11 (41) | 3 (30) | 11 (42) | 3 (27) |
| Negative | 23 (62) | 16 (59) | 7 (70) | 15 (58) | 8 (73) |
| ORR (%) | 35 | 30 | 58 | 48 | 6 |
a
The PD-L1 analysis included 37 patients.
Abbreviations: ECOG-PS: Eastern Cooperative Oncology Group performance status; ORR: objective response rate; TMB: tumor mutational burden; WT: wild type; yrs: years