Table 2.
Baseline characteristics of patients with OS ≥24 versus < 24 months in the axitinib titration arm
| Baseline Characteristics, n (%) | OS ≥24 months n = 33 | OS < 24 months n = 20a | p-valueb | |
|---|---|---|---|---|
| Age, years | < 65 | 19 (58) | 17 (85) | 0.0670 |
| ≥65 | 14 (42) | 3 (15) | ||
| Sex | Male | 21 (64) | 15 (75) | 0.5457 |
| Female | 12 (36) | 5 (25) | ||
| Race | White | 28 (85) | 18 (90) | 0.2672 |
| Asian | 5 (15) | 1 (5) | ||
| Other | 0 | 1 (5) | ||
| Weight, kg | ≤65 | 7 (21) | 5 (25) | 1.0000 |
| > 65, ≤76 | 12 (36) | 7 (35) | ||
| > 76, ≤89 | 8 (24) | 3 (15) | ||
| > 89 | 6 (18) | 5 (25) | ||
| ECOG PS | 0 | 23 (70) | 11 (55) | 0.3775 |
| ≥1 | 10 (30) | 9 (45) | ||
| Histological classification | Clear cell | 33 (100) | 18 (90) | 0.1379 |
| Otherc | 0 | 2 (10) | ||
| Prior nephrectomy | Yes | 32 (97) | 16 (80) | 0.0611 |
| No | 1 (3) | 4 (20) | ||
| No. of metastatic sites | ≤2 | 17 (52) | 2 (10) | 0.0028 |
| ≥3 | 16 (48) | 18 (90) | ||
| Site of metastasis | Lung only | 4 (12) | 0 | 0.2848 |
| Lung + others | 29 (88) | 20 (100) | ||
| Site of metastasis, individual | ||||
| Lung | 19 (58) | 16 (80) | 0.1368 | |
| Lymph node | 15 (45) | 15 (75) | 0.0476 | |
| Kidney | 7 (21) | 4 (20) | 1.0000 | |
| Liver | 5 (15) | 9 (45) | 0.0252 | |
| Adrenal | 10 (30) | 4 (20) | 0.5274 | |
| Bone | 2 (6) | 5 (25) | 0.0896 | |
| Pancreas | 2 (6) | 0 | 0.5210 | |
| Time from histopathological diagnosis to treatment | ||||
| ≥1 year | 21 (64) | 3 (15) | 0.0007 | |
| < 1 year | 12 (36) | 17 (85) | ||
| Time from metastatic diagnosis to treatment | ||||
| ≥1 year | 4 (12) | 1 (5) | 0.6388 | |
| < 1 year | 29 (88) | 19 (95) | ||
| Sum of longest diameter for target lesion | ||||
| ≤Median | 17 (52) | 7 (35) | 0.2702 | |
| >Median | 16 (48) | 13 (65) | ||
| Presence of metastases (de novo) at initial diagnosis | ||||
| No | 22 (67) | 12 (60) | 0.7689 | |
| Yes | 11 (33) | 8 (40) | ||
| Baseline LDH | ≤1.5 × ULN | 33 (100) | 18 (90) | 0.1379 |
| > 1.5 × ULN | 0 | 2 (10) | ||
| Baseline Hb | ≥LLN | 22 (67) | 5 (25) | 0.0047 |
| <LLN | 11 (33) | 15 (75) | ||
| Baseline Neu | ≤ULN | 32 (97) | 15 (75) | 0.0240 |
| >ULN | 1 (3) | 5 (25) | ||
| Baseline Plt | ≤ULN | 27 (82) | 10 (50) | 0.0288 |
| >ULN | 6 (18) | 10 (50) | ||
Abbreviations: ECOG PS Eastern Cooperative Oncology Group performance status, Hb haemoglobin, LDH lactate dehydrogenase, LLN lower limit of normal, Neu neutrophil, OS overall survival, Plt platelet, ULN upper limit of normal
aExcluded 3 patients who were censored <24 months in OS
bFisher’s exact test was used for all, except weight, for which Cochran-Armitage trend test was used
cOther includes sarcomatoid and clear cell with sarcomatoid differentiation in 1 patient each