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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