Table 1.
Exposure–response population baseline demographics and disease characteristics by ramucirumab C min,ss quartile
| Placebo + FOLFIRI N = 481 n (%) |
Ramucirumab + FOLFIRI Q1 N = 106 n (%) |
Ramucirumab + FOLFIRI Q2 N = 106 n (%) |
Ramucirumab + FOLFIRI Q3 N = 106 n (%) |
Ramucirumab + FOLFIRI Q4 N = 107 n (%) |
|
|---|---|---|---|---|---|
| Age | |||||
| <65 years | 287 (59.7) | 70 (66.0) | 63 (59.4) | 67 (63.2) | 65 (60.7) |
| ≥65 years | 194 (40.3) | 36 (34.0) | 43 (40.6) | 39 (36.8) | 42 (39.3) |
| Gender | |||||
| Female | 183 (38.0) | 45 (42.5) | 58 (54.7) | 45 (42.5) | 56 (52.3) |
| Male | 298 (62.0) | 61 (57.5) | 48 (45.3) | 61 (57.5) | 51 (47.7) |
| Race | |||||
| White | 372 (77.3) | 73 (68.9) | 70 (66.0) | 80 (75.5) | 87 (81.3) |
| Asian | 92 (19.1) | 26 (24.5) | 31 (29.2) | 22 (20.8) | 18 (16.8) |
| Other | 13 (2.7) | 5 (4.7) | 5 (4.7) | 4 (3.8) | 2 (1.9) |
| Missing | 4 (0.8) | 2 (1.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Region | |||||
| Europe | 216 (44.9) | 45 (42.5) | 47 (44.3) | 40 (37.7) | 52 (48.6) |
| North America | 120 (24.9) | 24 (22.6) | 24 (22.6) | 33 (31.1) | 29 (27.1) |
| Other | 145 (30.1) | 37 (34.9) | 35 (33.0) | 33 (31.1) | 26 (24.3) |
| ECOG PS | |||||
| 0 | 238 (49.5) | 42 (39.6) | 52 (49.1) | 68 (64.2) | 58 (54.2) |
| 1+ | 243 (50.5) | 63 (59.4) | 54 (50.9) | 37 (34.9) | 48 (44.9) |
| Missing | 0 (0.0) | 1 (0.9) | 0 (0.0) | 1 (0.9) | 1 (0.9) |
| Time to disease progression after first-line therapy | |||||
| <6 months | 111 (23.1) | 31 (29.2) | 22 (20.8) | 21 (19.8) | 21 (19.6) |
| ≥6 months | 370 (76.9) | 75 (70.8) | 84 (79.2) | 85 (80.2) | 86 (80.4) |
| KRAS Status | |||||
| Mutant | 234 (48.6) | 52 (49.1) | 48 (45.3) | 59 (55.7) | 57 (53.3) |
| Wild-type | 247 (51.4) | 54 (50.9) | 58 (54.7) | 47 (44.3) | 50 (46.7) |
| Number of metastatic sites | |||||
| 1 | 146 (30.4) | 35 (33.0) | 41 (38.7) | 29 (27.4) | 28 (26.2) |
| 2 | 177 (36.8) | 40 (37.7) | 40 (37.7) | 42 (39.6) | 45 (42.1) |
| ≥3 | 158 (32.8) | 31 (29.2) | 25 (23.6) | 35 (33.0) | 34 (31.8) |
| Liver only metastasis | |||||
| No | 394 (81.9) | 86 (81.1) | 82 (77.4) | 92 (86.8) | 91 (85.0) |
| Yes | 87 (18.1) | 20 (18.9) | 24 (22.6) | 14 (13.2) | 16 (15.0) |
| Site of primary tumor | |||||
| Colon | 318 (66.1) | 58 (54.7) | 63 (59.4) | 82 (77.4) | 71 (66.4) |
| Rectal | 158 (32.8) | 48 (45.3) | 43 (40.6) | 22 (20.8) | 35 (32.7) |
| Colorectal | 5 (1.0) | 0 (0.0) | 0 (0.0) | 2 (1.9) | 1 (0.9) |
| Carcinoembryonic antigen | |||||
| <200 µg/L | 359 (74.6) | 77 (72.6) | 77 (72.6) | 84 (79.2) | 79 (73.8) |
| ≥200 µg/L | 91 (18.9) | 23 (21.7) | 23 (21.7) | 16 (15.1) | 21 (19.6) |
| Missing | 31 (6.4) | 6 (5.7) | 6 (5.7) | 6 (5.7) | 7 (6.5) |
| Time from first bevacizumab dose to last bevacizumab dose | |||||
| <3 months | 88 (18.3) | 13 (12.3) | 15 (14.2) | 14 (13.2) | 13 (12.1) |
| ≥3 months | 391 (81.3) | 93 (87.7) | 90 (84.9) | 91 (85.8) | 94 (87.9) |
| Missing | 2 (0.4)a | 0 (0.0) | 1 (0.9) | 1 (0.9) | 0 (0.0) |
Note Patients in each exposure quartile group were a non-randomized subset of the ITT population and potential imbalances in prognostic factors between the placebo arm and the quartile groups may be generated due to the loss of randomization. However, the multivariate Cox regression analysis was adjusted for all prognostic factors significantly associated with OS or PFS
C min,ss minimum concentration at steady state, ECOG PS Eastern Oncology Cooperative Group performance status, FOLFIRI folinic acid, 5-fluorouracil, and irinotecan; ITT intent-to-treat, OS overall survival, PFS progression-free survival, Q quartile