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Table 1 Patients’ characteristics

From: Long-term relationship between everolimus blood concentration and clinical outcomes in Japanese patients with metastatic renal cell carcinoma: a prospective study

 

Total

Continuation

Discontinuation or dose reduction by adverse events

P value

Patients, n

10

4

6

 

Age (years)a

63 (32–74)

61 (51–64)

65 (32–74)

0.3329 b

Male/Female

5/5

1/3

4/2

0.5238 c

Body weight (kg)a

57.7 (46.0–65.8)

58.9 (51.3–63.4)

52.9 (46.0–65.8)

0.4555 b

Body surface area (m2)a

1.57 (1.37–1.74)

1.59 (1.47–1.70)

1.56 (1.37–1.74)

0.7476 b

Body mass index (kg/m2)a

22.1 (16.3–26.2)

23.0 (20.9–26.2)

21.2 (16.3–23.8)

0.2410 b

Aspartate aminotransferase (UI/L)a

27 (16–43)

29 (17–43)

27 (16–42)

0.6689 b

Alanine aminotransferase (UI/L)a

17 (12–47)

26 (12–47)

17 (13–42)

1.0000 b

Serum creatinine (mg/dL)a

0.84 (0.61–1.47)

0.68 (0.61–0.92)

0.99 (0.66–1.47)

0.0691 b

eGFR (mL/min/1.73 m2)a

64.9 (38.2–113.0)

70.0 (64.5–76.0)

50.9 (38.2–113.0)

0.3938 b

ECOG PS, n

0

6

2

4

0.7143 c

1

3

2

1

 

2 or more

1

0

1

 

Number of prior systemic therapies, n

 2

1

1

0

0.3333 c

 3

7

2

5

 

 4 or more

2

1

1

 

Initial dose, n

 10 mg/day

8

2

6

0.1333c

 7.5 mg/day

1

1

0

 

 5 mg/day

1

1

0

 

Everolimus blood concentration on day 8 after starting everolimus administration (ng/mL)a

15.3 (8.1–28.0)

8.2 (8.1–9.8)

18.0 (13.7–28.0)

0.0139b

Everolimus blood concentration just before discontinuation or dose reduction (ng/mL)a

14.8 (6.4–58.4)

9.7 (6.4–17.1)

22.9 (12.5–58.4)

0.0142b

Change of everolimus blood concentration just before discontinuation or dose reduction from day 8 (absolute value, ng/mL)a

1.65 (0.03–36.60)

2.00 (0.03–8.90)

1.40 (0.20–36.60)

0.3374b

  1. eGFR: estimated glomerular filtration rate, ECOG PS: Eastern Cooperative Oncology Group Performance Status, a: Values are reported as median (range), b: Continuous variables evaluated by Wilcoxon rank sum test and c: categorical variables by Fisher exact test