Table 2. Comparisons between patients with and without sarcopenia.
Sarcopenic (n = 11) | Non-sarcopenic (n = 29) | p | |
Sorafenib starting dose: n (%) | |||
200 mg bid | 6 (54.5) | 5 (17.2) | 0.04 |
400 mg bid (standard dose) | 5 (46.5) | 24 (82.8) | |
ECOG PS: n (%) | |||
0–1 | 8 | 22 | 1 |
2 | 3 | 7 | |
Characteristics: median (range) | |||
Age | 66 (42–78) | 62 (32–79) | 0.55 |
Weight (kg) | 71 (61–98) | 68 (40–93) | 0.21 |
Height (m) | 1.70 (1.53–1.91) | 1.70 (1.49–1.80) | 0.80 |
BMI (kg/m2) | 23.8 (18.7–37.3) | 23.9 (17.3–35.0) | 0.90 |
BSA (m2) | 1.83 (1.61–2.15) | 1.78 (1.29–2.13) | 0.09 |
Albuminemia at baseline (g/l) | 34 (28–39) | 38.5 (28–44) | 0.004 |
CRP at baseline (mg/l) | 9.3 (2.2–49) | 7.8 (1–104) | 0.80 |
Lumbar skeletal muscle index (cm2/m2)a | 34.6 (28.2–51.7) | 57.3 (38.9–70.1) | <0.001 |
Whole body lean body mass (kg) | 32.9 (23.9–58.4) | 52.3 (28.5–64.1) | 0.003 |
Sorafenib dose (mg) per kg of LBM, bid | 6.9 (4.6–16.8) | 7.5 (3.8–14.0) | 0.70 |
DLT from day 1 to day 28: n (%) | |||
Present | 9 (81.8) | 9 (31.0) | 0.005 |
Absent | 2 (19.2) | 20 (69.0) | |
Toxicity prevalence from day 1 to day 28: n (%) | |||
Hand-foot syndrome, all grades | 3 (27.3%) | 14 (48.3%) | 0.30 |
Grade 3 hand-foot syndrome | 1 (9.0%) | 5 (17.2%) | 1 |
Diarrhea, all grades | 6 (54.5%) | 8 (27.6%) | 0.15 |
Grade 3 diarrhea | 5 (45.5%) | 2 (6.9%) | 0.01 |
Asthenia, all grades | 5 (45.5%) | 10 (34.5%) | 0.72 |
Grade 3 asthenia | 2 (27.3%) | 2 (6.7%) | 0.30 |
Hypertension, all grades | 3 (27.3%) | 10 (34.5%) | 1 |
Grade 3 hypertensionb | 0 | 3 (10.3%) | 0.55 |
Sorafenib dose-adjusted AUC on day 28, mg/l.h: median (range) | 102.4 (48.0–137.8) | 53.7 (24.5–74.5) | 0.013 |
SD, standard deviation; ECOG, Eastern Cooperative Oncology Group Criteria Performance Status; BMI, Body Mass Index [weight(kg)/height(m)2]; BSA, Body Surface Area.
(d) Calculated from regression equation: whole lean body mass (kg) = 0.30×[[skeletal muscle at L3 using CT (cm2)]+6.06].
(b) Hypertension was not considered as a dose limiting toxicity.