Table 2.
Toxicity of L612 HuMAb administration
Patient | Dose and number of courses | Infusion ratea (per hour) | Toxicityb | ||
---|---|---|---|---|---|
First infusion | Second infusion | Third infusion | |||
1 | 960 mg (473 mg/m2) | 20 mg | NS | – | – |
2 | 960 mg (612 mg/m2) | 20 mg | Tumor pain | – | – |
3 | 960 mg (593 mg/m2)×2c | 20 mg | Pruritus/rash | NS | – |
4 | 1,440 mg (911 mg/m2)×2c | 30 mg | NS | NS | – |
5 | 1,440 mg (727 mg/m2) | 30 mg | Pruritus/rash | – | – |
6 | 1,440 mg (692 mg/m2)×2c | 30 mg | Pruritus/rash | NS | – |
7 | 1,920 mg (753 mg/m2)×2c | 40 mg | Pruritus/rash | NS | – |
8 | 1,920 mg (1,060 mg/m2) | 40 mg | NS | – | – |
9 | 1,920 mg (1,223 mg/m2)×3c | 40 mg | Pruritus/rash | Pruritus/rash | Pruritus/rash |
aContinuous infusion for 48 h
b NS, not significant; itching/rash were mild and transient
cPatients 3, 4, 6, 7, and 9 received a second infusion with the same dose 5, 44, 7, 4 and 5 weeks, respectively, after the first infusion. Patient 9 received a third infusion with the same dose 14 weeks after the second infusion