TABLE 3.
Comparison of patients with cefepime-associated neurological toxicity and those without any neurological signs and/or symptoms
| Parameter | Value for group |
P value | |
|---|---|---|---|
| Cefepime-associated neurological toxicity (n = 6) | No neurological signs/symptoms (n = 22) | ||
| No. (%) of male patients | 6 (100) | 9 (41) | 0.02 |
| Median age (yr) (range) | 63 (56-74) | 56 (32-78) | 0.08 |
| Median wt (kg) (range) | 80 (66-85) | 72 (40-111) | 0.21 |
| No. (%) of patients with malignancy | |||
| Hematological | 6 (100) | 19 (86) | 1.00 |
| Solid tumor | 0 (0) | 3 (14) | 1.00 |
| No. (%) of patients with infection | |||
| Bacteremia | 1 (17) | 10 (45) | 0.36 |
| Other than bacteremia | 5 (83) | 12 (55) | 0.36 |
| No. (%) of patients taking comedications with potential neurological toxicity | |||
| High-dose cytarabinea | 0 (0) | 2 (9) | 1.00 |
| Intrathecal chemotherapyb | 2 (33) | 5 (23) | 0.62 |
| Opioid comedications | 2 (33) | 6 (27) | 1.00 |
| Amphotericin B-voriconazole | 1 (17)-0 (0) | 0 (0)-1 (5) | 0.39 |
| No. (%) of patients taking medications with potential nephrotoxicity | |||
| Vancomycin | 3 (50)c,d | 4 (18)c,d | 0.14 |
| Aminoglycosides | 0 (0) | 1 (5)d | 1.00 |
| Amphotericin B | 1 (17) | 0 (0) | 0.21 |
| GFR (ml/min) (range) | |||
| At start of cefepime therapy | 57 (52-70) | 72 (23-196) | 0.06 |
| Normalized for 70-kg body wte | 54 (43-67) | 72 (19-184) | 0.04 |
| At time of cefepime trough measurement | 45 (41-65) | 81 (27-226) | 0.02 |
| Normalized for 70-kg body wte | 43 (36-58) | 89 (23-189) | 0.006 |
| Median cefepime dose (g/day) per 100 ml/min GFR (range) | |||
| At start of cefepime therapy | 10.5 (8.6-11.5) | 8.2 (3.1-15.4) | 0.02 |
| Normalized for 70-kg body wte | 11.3 (9.0-14.0) | 7.9 (3.3-16.7) | 0.006 |
| At time of cefepime trough measurement | 13.2 (9.2-14.3) | 7.1 (2.7-12.0) | 0.002 |
| Normalized for 70-kg body wte | 14.2 (10.3-16.7) | 6.8 (3.2-12.8) | 0.0003 |
| Median cefepime trough (mg/liter) (range) | 28 (15-38) | 7.2 (2.1-21.0) | <0.0001 |
a
Cytarabine at 1,000 to 2,000 mg/m2/day for 3 to 6 days (within 14 days before the start of cefepime therapy).
b
Methotrexate at 15 mg, cytarabine at 30 mg, and hydrocortisone at 30 mg (within 14 days before the start of cefepime therapy).
c
Vancomycin trough blood concentrations were in the recommended range, 5 to 10 mg/liter.
d
No ototoxicity was detected clinically in patients receiving short-course therapies (i.e., <7 days) with aminoglycosides or glycopeptides.
e
The GFR has been normalized for a body weight of 70 kg in order to account for the potential imbalance due to body weight variations.