Capecitabine 150mg (Page 4 of 13)

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

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2019. All Rights Reserved.