Prescription Drug Information: Capecitabine 150mg (Page 4 of 11)

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 1-5, 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.

Table 6 Pooled Phase 3 Colorectal Trials: Percent Incidence of Adverse Reactions in ≥5% of Patients
- Not observed* Excluding vertigoNA = Not Applicable
Adverse Event Capecitabine(n=596) 5-FU/LV(n=593)
Total% Grade 3% Grade 4% Total % Grade 3% Grade 4%
Number of Patients With > OneAdverse 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

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