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Table 4 Characteristics and results of patients with slight progression in the control and study groups

From: Dose escalation can maximize therapeutic potential of sunitinib in patients with metastatic renal cell carcinoma

Specifications of patients with slight progression

NSP = 48

Control group Before June 30, 2013

NCG = 23

Study group

After June 30, 2013

NSG = 25

p

Mean age, years ± SE

62.87 ± 1.73

60.74 ± 1.52

0.358

Gender

 male

17 (73.9%)

22 (88.0%)

0.190

 female

6 (26.1%)

3 (12.0%)

MSKCC score, mean ± SE

1.61 ± 0.1

1.60 ± 0.1

0.952

Number of metastatic sites, mean ± SE

2.17 ± 0.24

2.36 ± 0.21

0.559

Location of metastases

 Lungs

19 (82.6%)

20 (80%)

0.556

 Bone

7 (30.4%)

9 (36%)

0.460

 Distant lymph node

8 (34.8%)

12 (48%)

0.263

 Liver

3 (13%)

4 (16%)

0.549

 Suprarenal gland

1 (4.3%)

3 (12%)

0.337

Comorbidities

 Hypertension

4 (17.4%)

5 (20%)

0.556

 Other cardiovascular disorders

2 (8.7%)

3 (12%)

0.541

 Diabetes

2 (8.7%)

2 (8%)

0.663

 Secondary tumors

0

1

0.521

Nephrectomy

 No

6 (26.1%)

0 (0.0%)

0.008

 Yes

17 (73.9%)

25 (100.0%)

Time from diagnosis to initiation of sunitinib

 < 1 year

11 (47.8%)

15 (60.0%)

0.289

 > 1 year

12 (52.2%)

10 (40.0%)

Hemoglobin level

 < normal range

6 (26.1%)

3 (12.0%)

0.190

 > normal range

17 (73.9%)

22 (88.0%)

Elevated corrected calcium level

 > 2.5 mmol/L

2 (8.7%)

1 (4.0%)

0.468

 < 2.5 mmol/L

21 (91.3%)

24 (96.0%)

Elevated LDH level

 > 1.5× normal level

2 (8.7%)

0 (0.0%)

0.224

 < 1.5× normal level

21 (91.3%)

25 (100.0%)

Elevated corrected calcium level

 > 2.5 mmol/L

2 (8.7%)

1 (4.0%)

0.468

 < 2.5 mmol/L

21 (91.3%)

24 (96.0%)

Karnofsky performance status

 < 80

0 (0.0%)

1 (4.0%)

0.521

  ≥ 80

23 (100.0%)

24 (96.0%)

Dose reduction rate

 No

10 (43.5%)

16 (64.0%)

0.226

 Level 1 (37.5 mg)

11 (47.8%)

6 (24.0%)

 Level 2 (25 mg)

2 (8.7%)

3 (12.0%)

Dose escalation rate

 No

23 (100.0%)

7 (28.0%)

< 0.001

 Level 1 (62.5 mg)

0 (0.0%)

14 (56.0%)

 Level 2 (75 mg)

0 (0.0%)

4 (16.0%)

Dosing scheme modification

 No

19 (82.6%)

18 (72.0%)

0.300

 Yes

4 (17.4%)

7 (28.0%)

Therapeutic lines after sunitinib 0 / 1 / 2 (%)

6 (30) / 13 (65) / 1 (5)

3 (15) / 13 (65) / 4 (20)

0.247

mOS after sunitinib therapy

9.33 ± 2.0

9.76 ± 2.5

0.599

mPFS

14.2 ± 1.3

39.7 ± 5.1

0.037

mOS

27.9 ± 2.5

57.5 ± 10.7

0.044

median follow-up time (range) (months)

30.9 (11.2–89.5)

45.7 (13.9–84.5)

0.061

  1. Bold p-values are significant ‹0.05, mOS median overall survival, mPFS median progression-free survival, MSKCC Memorial Sloan Kettering Cancer Center, N number of analyzed patients, p p-value, SE standard error, SP slight progression