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Table 2 Baseline characteristics of patients with OS ≥24 versus < 24 months in the axitinib titration arm

From: Patients with metastatic renal cell carcinoma who benefit from axitinib dose titration: analysis from a randomised, double-blind phase II study

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)  
  1. 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
  2. aExcluded 3 patients who were censored <24 months in OS
  3. bFisher’s exact test was used for all, except weight, for which Cochran-Armitage trend test was used
  4. cOther includes sarcomatoid and clear cell with sarcomatoid differentiation in 1 patient each