Capecitabine (Page 5 of 14)
6.2 Metastatic Colorectal Cancer
Monotherapy
Table 6 shows the adverse reactions occurring in ≥5% of patients from pooling the two phase 3 trials in first line metastatic colorectal cancer. A total of 596 patients with metastatic colorectal cancer were treated with 1250 mg/m2 twice a day of capecitabine administered for 2 weeks followed by a 1-week rest period, and 593 patients were administered 5-FU and leucovorin in the Mayo regimen (20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5-FU, on days 1 to 5, every 28 days). In the pooled colorectal database the median duration of treatment was 139 days for capecitabine-treated patients and 140 days for 5-FU/LV-treated patients. A total of 78 (13%) and 63 (11%) capecitabine and 5-FU/LV-treated patients, respectively, discontinued treatment because of adverse reactions/intercurrent illness. A total of 82 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 50 (8.4%) patients randomized to capecitabine and 32 (5.4%) randomized to 5-FU/LV.
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Adverse Event | Capecitabine (n=596) | 5-FU/LV (n=593) | ||||
Total % | Grade 3 % | Grade 4 % | Total % | Grade 3 % | Grade 4 % | |
Number of Patients With > One Adverse Event | 96 | 52 | 9 | 94 | 45 | 9 |
Body System/Adverse Event | ||||||
GI | ||||||
Diarrhea | 55 | 13 | 2 | 61 | 10 | 2 |
Nausea | 43 | 4 | – | 51 | 3 | <1 |
Vomiting | 27 | 4 | <1 | 30 | 4 | <1 |
Stomatitis | 25 | 2 | <1 | 62 | 14 | 1 |
Abdominal Pain | 35 | 9 | <1 | 31 | 5 | – |
Gastrointestinal Motility Disorder | 10 | <1 | – | 7 | <1 | – |
Constipation | 14 | 1 | <1 | 17 | 1 | – |
Oral Discomfort | 10 | – | – | 10 | – | – |
Upper GI Inflammatory Disorders | 8 | <1 | – | 10 | 1 | – |
Gastrointestinal Hemorrhage | 6 | 1 | <1 | 3 | 1 | – |
Ileus | 6 | 4 | 1 | 5 | 2 | 1 |
Skin and Subcutaneous | ||||||
Hand-and-Foot Syndrome | 54 | 17 | NA | 6 | 1 | NA |
Dermatitis | 27 | 1 | – | 26 | 1 | – |
Skin Discoloration | 7 | <1 | – | 5 | – | – |
Alopecia | 6 | – | – | 21 | <1 | – |
General | ||||||
Fatigue/Weakness | 42 | 4 | – | 46 | 4 | – |
Pyrexia | 18 | 1 | – | 21 | 2 | – |
Edema | 15 | 1 | – | 9 | 1 | – |
Pain | 12 | 1 | – | 10 | 1 | – |
Chest Pain | 6 | 1 | – | 6 | 1 | <1 |
Neurological | ||||||
Peripheral Sensory Neuropathy | 10 | – | – | 4 | – | – |
Headache | 10 | 1 | – | 7 | – | – |
Dizziness * | 8 | <1 | – | 8 | <1 | – |
Insomnia | 7 | – | – | 7 | – | – |
Taste Disturbance | 6 | 1 | – | 11 | <1 | 1 |
Metabolism | ||||||
Appetite Decreased | 26 | 3 | <1 | 31 | 2 | <1 |
Dehydration | 7 | 2 | <1 | 8 | 3 | 1 |
Eye | ||||||
Eye Irritation | 13 | – | – | 10 | <1 | – |
Vision Abnormal | 5 | – | – | 2 | – | – |
Respiratory | ||||||
Dyspnea | 14 | 1 | – | 10 | <1 | 1 |
Cough | 7 | <1 | 1 | 8 | – | – |
Pharyngeal Disorder | 5 | – | – | 5 | – | – |
Epistaxis | 3 | <1 | – | 6 | – | – |
Sore Throat | 2 | – | – | 6 | – | – |
Musculoskeletal | ||||||
Back Pain | 10 | 2 | – | 9 | <1 | – |
Arthralgia | 8 | 1 | – | 6 | 1 | – |
Vascular | ||||||
Venous Thrombosis | 8 | 3 | <1 | 6 | 2 | – |
Psychiatric | ||||||
Mood Alteration | 5 | – | – | 6 | <1 | – |
Depression | 5 | – | – | 4 | <1 | – |
Infections | ||||||
Viral | 5 | <1 | – | 5 | <1 | – |
Blood and Lymphatic | ||||||
Anemia | 80 | 2 | <1 | 79 | 1 | <1 |
Neutropenia | 13 | 1 | 2 | 46 | 8 | 13 |
Hepatobiliary | ||||||
Hyperbilirubinemia | 48 | 18 | 5 | 17 | 3 | 3 |
– Not observed |
NA = Not Applicable
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