Capecitabine 500mg (Page 5 of 13)
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 | – |
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.
– 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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