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| |
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
|
- 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
