|
TOP
|
|
Erbitux(六)
|
2 |
37 |
2 |
|
Emesis |
29 |
2 |
23 |
4 |
|
Diarrhea |
19 |
2 |
13 |
1 |
|
Dyspepsia |
14 |
0 |
9 |
1 |
|
Metabolic/Nutritional |
|
|
|
|
|
Weight Loss |
84 |
11 |
72 |
7 |
|
Dehydration |
25 |
6 |
19 |
8 |
|
Alanine Transaminase, high3 |
43 |
2 |
21 |
1 |
|
Aspartate Transaminase, high3 |
38 |
1 |
24 |
1 |
|
Alkaline Phosphatase, high3 |
33 |
<1 |
24 |
0 |
|
Respiratory |
|
|
|
|
|
Pharyngitis |
26 |
3 |
19 |
4 |
|
Skin/Appendages |
|
|
|
|
|
Acneform Rash4 |
87 |
17 |
10 |
1 |
|
Radiation Dermatitis |
86 |
23 |
90 |
18 |
|
Application Site Reaction |
18 |
0 |
12 |
1 |
|
Pruritus |
16 |
0 |
4 |
0 |
The overall incidence of late radiation toxicities (any grade) was higher in Erbitux in combination with radiation therapy compared with radiation therapy alone. The following sites were affected: salivary glands (65% versus 56%), larynx (52% versus 36%), subcutaneous tissue (49% versus 45%), mucous membrane (48% versus 39%), esophagus (44% versus 35%), skin (42% versus 33%). The incidence of Grade 3 or 4 late radiation toxicities was similar between the radiation therapy alone and the Erbitux plus radiation treatment groups.
Table 3 contains selected adverse events in 562 patients receiving best supportive care (BSC) alone or with Erbitux monotherapy for metastatic colorectal cancer in Study 3. Erbitux was administered at the recommended dose and schedule (400 mg/m initial dose, followed by 250 mg/m weekly).
The most frequently reported adverse events in 354 patients treated with Erbitux plus irinotecan in clinical trials were acneform rash (88%), asthenia/malaise (73%), diarrhea (72%), and nausea (55%). The most common Grades 3–4 adverse events included diarrhea (22%), leukopenia (17%), asthenia/malaise (16%), and acneform rash (14%).
Table 3: Incidence of Selected Adverse Events Occurring in ≥10% of Patients with Advanced Colorectal Carcinoma1 Treated with Erbitux Monotherapy
Body System
Preferred Term |
Erbitux plus BSC
(n=288) |
BSC alone
(n=274) |
Any
Grades2 |
Grades
3 and 4 |
Any
Grades |
Grades
3 and 4 |
|
% of Patients |
|
1 Adverse reactions occurring more frequently in Erbitux-treated patients compare |
|
