Prescription Drug Information: Capecitabine 150mg (Page 5 of 11)

6.3 Breast Cancer

In Combination with Docetaxel

The following data are shown for the combination study with capecitabine and docetaxel in patients with metastatic breast cancer in Table 7 and Table 8. In the capecitabine and docetaxel combination arm the treatment was capecitabine administered orally 1250 mg/m2 twice daily as intermittent therapy (2 weeks of treatment followed by 1 week without treatment) for at least 6 weeks and docetaxel administered as a 1-hour intravenous infusion at a dose of 75 mg/m2 on the first day of each 3-week cycle for at least 6 weeks. In the monotherapy arm docetaxel was administered as a 1-hour intravenous infusion at a dose of 100 mg/m2 on the first day of each 3-week cycle for at least 6 weeks. The mean duration of treatment was 129 days in the combination arm and 98 days in the monotherapy arm. A total of 66 patients (26%) in the combination arm and 49 (19%) in the monotherapy arm withdrew from the study because of adverse reactions. The percentage of patients requiring dose reductions due to adverse reactions was 65% in the combination arm and 36% in the monotherapy arm. The percentage of patients requiring treatment interruptions due to adverse reactions in the combination arm was 79%. Treatment interruptions were part of the dose modification scheme for the combination therapy arm but not for the docetaxel monotherapy-treated patients.

– Not observed

NA = Not Applicable

Table 7 Percent Incidence of Adverse Events Considered Related or Unrelated to Treatment in ≥5% of Patients Participating in the Capecitabine and Docetaxel Combination vs Docetaxel Monotherapy Study
Adverse Event Capecitabine 1250 mg/m2 /bidWith Docetaxel75 mg/m2 /3 weeks(n=251) Docetaxel 100 mg/m2 /3 weeks(n=255)
Total % Grade 3% Grade 4% Total % Grade 3% Grade 4%
Number of Patients With atLeast One Adverse Event 99 76.5 29.1 97 57.6 31.8
Body System/Adverse Event
GI
Diarrhea 67 14 <1 48 5 <1
Stomatitis 67 17 <1 43 5
Nausea 45 7 36 2
Vomiting 35 4 1 24 2
Constipation 20 2 18
Abdominal Pain 30 <3 <1 24 2
Dyspepsia 14 8 1
Dry Mouth 6 <1 5
Skin and Subcutaneous
Hand-and-Foot Syndrome 63 24 NA 8 1 NA
Alopecia 41 6 42 7
Nail Disorder 14 2 15
Dermatitis 8 11 1
Rash Erythematous 9 <1 5
Nail Discoloration 6 4 <1
Onycholysis 5 1 5 1
Pruritus 4 5
General
Pyrexia 28 2 34 2
Asthenia 26 4 <1 25 6
Fatigue 22 4 27 6
Weakness 16 2 11 2
Pain in Limb 13 <1 13 2
Lethargy 7 6 2
Pain 7 <1 5 1
Chest Pain (non-cardiac) 4 <1 6 2
Influenza-like Illness 5 5
Neurological
Taste Disturbance 16 <1 14 <1
Headache 15 3 15 2
Paresthesia 12 <1 16 1
Dizziness 12 8 <1
Insomnia 8 10 <1
Peripheral Neuropathy 6 10 1
Hypoaesthesia 4 <1 8 <1
Metabolism
Anorexia 13 1 11 <1
Appetite Decreased 10 5
Weight Decreased 7 5
Dehydration 10 2 7 <1 <1
Eye
Lacrimation Increased 12 7 <1
Conjunctivitis 5 4
Eye Irritation 5 1
Musculoskeletal
Arthralgia 15 2 24 3
Myalgia 15 2 25 2
Back Pain 12 <1 11 3
Bone Pain 8 <1 10 2
Cardiac
Edema 33 <2 34 <3 1
Blood
Neutropenic Fever 16 3 13 21 5 16
Respiratory
Dyspnea 14 2 <1 16 2
Cough 13 1 22 <1
Sore Throat 12 2 11 <1
Epistaxis 7 <1 6
Rhinorrhea 5 3
Pleural Effusion 2 1 7 4
Infection
Oral Candidiasis 7 <1 8 <1
Urinary Tract Infection 6 <1 4
Upper Respiratory Tract 4 5 1
Vascular
Flushing 5 5
Lymphoedema 3 <1 5 1
Psychiatric
Depression 5 5 1
Table 8 Percent of Patients With Laboratory Abnormalities Participating in the Capecitabine and Docetaxel Combination vs Docetaxel Monotherapy Study
Adverse Event Capecitabine 1250 mg/m2 /bidWith Docetaxel75 mg/m2 /3 weeks(n=251) Docetaxel 100 mg/m2 /3 weeks(n=255)
Body System/Adverse Event Total% Grade 3% Grade 4% Total % Grade 3 % Grade 4 %
Hematologic
Leukopenia 91 37 24 88 42 33
Neutropenia/Granulocytopenia 86 20 49 87 10 66
Thrombocytopenia 41 2 1 23 1 2
Anemia 80 7 3 83 5 <1
Lymphocytopenia 99 48 41 98 44 40
Hepatobiliary
Hyperbilirubinemia 20 7 2 6 2 2

Monotherapy

The following data are shown for the study in stage IV breast cancer patients who received a dose of 1250 mg/m2 administered twice daily for 2 weeks followed by a 1-week rest period. The mean duration of treatment was 114 days. A total of 13 out of 162 patients (8%) discontinued treatment because of adverse reactions/intercurrent illness.

Table 9 Percent Incidence of Adverse Reactions Considered Remotely, Possibly or Probably Related to Treatment in ≥5% of Patients Participating in the Single Arm Trial in Stage IV Breast Cancer

– Not observed

NA = Not Applicable

Adverse Event Phase 2 Trial in Stage IV Breast Cancer(n=162)
Body System/Adverse Event Total % Grade 3% Grade 4%
GI
Diarrhea 57 12 3
Nausea 53 4
Vomiting 37 4
Stomatitis 24 7
Abdominal Pain 20 4
Constipation 15 1
Dyspepsia 8
Skin and Subcutaneous
Hand-and-Foot Syndrome 57 11 NA
Dermatitis 37 1
Nail Disorder 7
General
Fatigue 41 8
Pyrexia 12 1
Pain in Limb 6 1
Neurological
Paresthesia 21 1
Headache 9 1
Dizziness 8
Insomnia 8
Metabolism
Anorexia 23 3
Dehydration 7 4 1
Eye
Eye Irritation 15
Musculoskeletal
Myalgia 9
Cardiac
Edema 9 1
Blood
Neutropenia 26 2 2
Thrombocytopenia 24 3 1
Anemia 72 3 1
Lymphopenia 94 44 15
Hepatobiliary
Hyperbilirubinemia 22 9 2

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