Table 1.
Demographic and baseline characteristics (full analysis set).
| Demographic variable | All patients (N = 3246) | CNS metastasis (n = 51) | Prior chemotherapy (n = 194) | ECOG PS 2 (n = 112) | VM + prior chemotherapy (n = 146) | VM + ECOG PS 2 (n = 77) |
|---|---|---|---|---|---|---|
| Median age, y (range) | 58.0 (20–92) | 56.0 (23–79) | 53.0 (24–88) | 64.0 (29–86) | 53.5 (24–88) | 64.0 (29–86) |
| Age ≥65 years, n (%) | 1073 (33.1) | 12 (23.5) | 39 (20.1) | 55 (49.1) | 29 (19.9) | 38 (49.4) |
| Race, n (%) | ||||||
| Caucasian | 2553 (78.7) | 39 (76.5) | 163 (84.0) | 81 (72.3) | 118 (80.8) | 55 (71.4) |
| Asian | 227 (7.0) | 6 (11.8) | 8 (4.1) | 13 (11.6) | 8 (5.5) | 7 (9.1) |
| Black | 29 (0.9) | 0 | 3 (1.5) | 1 (0.9) | 3 (2.1) | 1 (1.3) |
| Other/unknown | 437 (13.5) | 6 (11.8) | 20 (10.3) | 17 (15.2) | 17 (11.6) | 14 (18.2) |
| ECOG PS 1–2, n (%) | 1273 (39.2) | 25 (49) | 83 (42.8) | 112 (100) | 67 (45.9) | 77 (100) |
| Histologic grade, n (%) | ||||||
| Well differentiated | 297 (9.1) | 6 (11.8) | 21 (10.8) | 9 (8.0) | 17 (11.6) | 9 (11.7) |
| Moderately differentiated | 1306 (40.2) | 17 (33.3) | 72 (37.1) | 46 (41.1) | 47 (32.2) | 29 (37.7) |
| Poorly differentiated | 626 (19.3) | 12 (23.5) | 35 (18.0) | 19 (17.0) | 26 (17.8) | 13 (16.9) |
| Undifferentiated | 30 (0.9) | 0 | 2 (1.0) | 0 | 1 (0.7) | 0 |
| Unknown or missing | 987 (30.4) | 16 (31.4) | 64 (33.0) | 38 (33.9) | 55 (37.7) | 26 (33.8) |
| Disease status, n (%) | ||||||
| De novoa | 1041 (32.1) | 15 (29.4) | 51 (26.3) | 44 (39.3) | 28 (19.2) | 30 (39.0) |
| Non-de novob | 2201(67.8) | 36 (70.6) | 143 (73.7) | 67 (59.8) | 118 (80.8) | 46 (59.7) |
| Metastatic sites, n (%) | ||||||
| 0 | 15 (0.5) | 0 | 0 | 1 (0.9) | 0 | 0 |
| 1 | 903 (27.8) | 3 (5.9) | 47 (24.2) | 21 (18.8) | 17 (11.6) | 0 |
| 2 | 923 (28.4) | 10 (19.6) | 56 (28.9) | 26 (23.2) | 43 (29.5) | 22 (28.6) |
| 3 | 644 (19.8) | 12 (23.5) | 36 (18.6) | 23 (20.5) | 33 (22.6) | 20 (26.0) |
| 4 | 375 (11.6) | 10 (19.6) | 24 (12.4) | 14 (12.5) | 22 (15.1) | 12 (15.6) |
| ≥5 | 386 (11.9) | 16 (31.4) | 31 (16.0) | 27 (24.1) | 31 (21.2) | 23 (29.9) |
| Site of metastasis, n (%) | ||||||
| CNS | 51 (1.6) | 51 (100) | 11 (5.7) | 2 (1.8) | 10 (6.8) | 1 (1.3) |
| Viscera | 1992 (61.4) | 35 (68.6) | 146 (75.3) | 77 (68.8) | 146 (100) | 77 (100) |
| Bone | 2409 (74.2) | 39 (76.5) | 154 (79.4) | 102 (91.1) | 109 (74.7) | 68 (88.3) |
| Chemotherapy for advanced disease, n (%) | 194 (6.0) | 11 (5.7) | 194 (100) | 2 (1.8) | 146 (100) | 4 (5.2) |
CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; VM, visceral metastases.
Note: Some patients were included in >1 subgroup—see Fig. 1 for full details. Notably, all 146 patients in the VM + prior chemotherapy subgroup were also included in the prior chemotherapy subgroup, and all 77 patients in the VM + ECOG PS 2 subgroup were also included in the ECOG PS 2 subgroup.
De novo includes patients with no date of first recurrence/progression or with a first recurrence/progression within 90 days of initial diagnosis without prior antineoplastic medication [24].
Non-de novo disease was calculated as the time from initial diagnosis to first recurrence/progression, categorized as ≤12 months, >12 to ≤24 months, and ≥24 months [24].