Dosage Form: tablet, film coated
FULL PRESCRIBING INFORMATION
Xeloda Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important Xeloda-Warfarin drug interaction was demonstrated in a clinical pharmacology trial [see Warnings and Precautions (5.2) and Drug Interactions (7.1)]. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking Xeloda concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time Xeloda was introduced. These events occurred within several days and up to several months after initiating Xeloda therapy and, in a few cases, within 1 month after stopping Xeloda. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.
Indications and Usage for Xeloda
Colorectal Cancer
- Xeloda is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Xeloda was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing single-agent Xeloda in the adjuvant treatment of Dukes' C colon cancer.
- Xeloda is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with Xeloda monotherapy. Use of Xeloda instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.
Breast Cancer
- Xeloda in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
- Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents). Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
Xeloda Dosage and Administration
Xeloda tablets should be swallowed whole with water within 30 minutes after a meal. Xeloda dose is calculated according to body surface area.
Standard Starting Dose
Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)
The recommended dose of Xeloda is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles (see Table 1).
Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months [ie, Xeloda 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks)].
| Dose Level 1250 mg/m2 Twice a Day | Number of Tablets to be Taken at Each Dose (Morning and Evening) | ||
|---|---|---|---|
| Surface Area (m2) | Total Daily Dose* (mg) | 150 mg | 500 mg |
| |||
| ≤ 1.25 | 3000 | 0 | 3 |
| 1.26-1.37 | 3300 | 1 | 3 |
| 1.38-1.51 | 3600 | 2 | 3 |
| 1.52-1.65 | 4000 | 0 | 4 |
| 1.66-1.77 | 4300 | 1 | 4 |
| 1.78-1.91 | 4600 | 2 | 4 |
| 1.92-2.05 | 5000 | 0 | 5 |
| 2.06-2.17 | 5300 | 1 | 5 |
| ≥ 2.18 | 5600 | 2 | 5 |
In Combination With Docetaxel (Metastatic Breast Cancer)
In combination with docetaxel, the recommended dose of Xeloda is 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m2 as a 1-hour intravenous infusion every 3 weeks. Pre-medication, according to the docetaxel labeling, should be started prior to docetaxel administration for patients receiving the Xeloda plus docetaxel combination. Table 1 displays the total daily dose of Xeloda by body surface area and the number of tablets to be taken at each dose.
Dose Management Guidelines
General
Xeloda dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of Xeloda should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies (14)]. Toxicity due to Xeloda administration may be managed by symptomatic treatment, dose interruptions and adjustment of Xeloda dose. Once the dose has been reduced, it should not be increased at a later time. Doses of Xeloda omitted for toxicity are not replaced or restored; instead the patient should resume the planned treatment cycles.
The dose of phenytoin and the dose of coumarin-derivative anticoagulants may need to be reduced when either drug is administered concomitantly with Xeloda [see Drug Interactions (7.1)].
Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)
Xeloda dose modification scheme as described below (see Table 2) is recommended for the management of adverse reactions.
| Toxicity NCIC Grades* | During a Course of Therapy | Dose Adjustment for Next Treatment (% of starting dose) |
|---|---|---|
| ||
| Grade 1 | Maintain dose level | Maintain dose level |
| Grade 2 | ||
| -1st appearance | Interrupt until resolved to grade 0-1 | 100% |
| -2nd appearance | 75% | |
| -3rd appearance | 50% | |
| -4th appearance | Discontinue treatment permanently | - |
| Grade 3 | ||
| -1st appearance | Interrupt until resolved to grade 0-1 | 75% |
| -2nd appearance | 50% | |
| -3rd appearance | Discontinue treatment permanently | - |
| Grade 4 | ||
| -1st appearance | Discontinue permanently OR If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1 | 50% |
In Combination With Docetaxel (Metastatic Breast Cancer)
Dose modifications of Xeloda for toxicity should be made according to Table 2 above for Xeloda. At the beginning of a treatment cycle, if a treatment delay is indicated for either Xeloda or docetaxel, then administration of both agents should be delayed until the requirements for restarting both drugs are met.
The dose reduction schedule for docetaxel when used in combination with Xeloda for the treatment of metastatic breast cancer is shown in Table 3.
| Toxicity NCIC Grades* | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|
| |||
| 1st appearance | Delay treatment until resolved to grade 0-1; Resume treatment with original dose of 75 mg/m2 docetaxel | Delay treatment until resolved to grade 0-1; Resume treatment at 55 mg/m2 of docetaxel. | Discontinue treatment with docetaxel |
| 2nd appearance | Delay treatment until resolved to grade 0-1; Resume treatment at 55 mg/m2 of docetaxel. | Discontinue treatment with docetaxel | - |
| 3rd appearance | Discontinue treatment with docetaxel | - | - |
Adjustment of Starting Dose in Special Populations
Renal Impairment
No adjustment to the starting dose of Xeloda is recommended in patients with mild renal impairment (creatinine clearance = 51 to 80 mL/min [Cockroft and Gault, as shown below]). In patients with moderate renal impairment (baseline creatinine clearance = 30 to 50 mL/min), a dose reduction to 75% of the Xeloda starting dose when used as monotherapy or in combination with docetaxel (from 1250 mg/m2 to 950 mg/m2 twice daily) is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Subsequent dose adjustment is recommended as outlined in Table 2 and Table 3 (depending on the regimen) if a patient develops a grade 2 to 4 adverse event [see Warnings and Precautions (5.5)]. The starting dose adjustment recommendations for patients with moderate renal impairment apply to both Xeloda monotherapy and Xeloda in combination use with docetaxel.
| Cockroft and Gault Equation: | |
| (140 - age [yrs]) (body wt [kg]) | |
| Creatinine clearance for males = | ————————————— |
| (72) (serum creatinine [mg/dL]) | |
| Creatinine clearance for females = 0.85 × male value | |
Geriatrics
Physicians should exercise caution in monitoring the effects of Xeloda in the elderly. Insufficient data are available to provide a dosage recommendation.
Dosage Forms and Strengths
Xeloda is supplied as biconvex, oblong film-coated tablets for oral administration. Each light peach-colored tablet contains 150 mg of capecitabine and each peach-colored tablet contains 500 mg of capecitabine.
Contraindications
Dihydropyrimidine Dehydrogenase (DPD) Deficiency
Xeloda is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
Severe Renal Impairment
Xeloda is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Hypersensitivity
Xeloda is contraindicated in patients with known hypersensitivity to capecitabine or to any of its components. Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil.
Warnings and Precautions
General
Patients receiving therapy with Xeloda should be monitored by a physician experienced in the use of cancer chemotherapeutic agents. Most adverse reactions are reversible and do not need to result in discontinuation, although doses may need to be withheld or reduced [see Dosage and Administration (2.2)].
Diarrhea
Xeloda can induce diarrhea, sometimes severe. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated. In 875 patients with either metastatic breast or colorectal cancer who received Xeloda monotherapy, the median time to first occurrence of grade 2 to 4 diarrhea was 34 days (range from 1 to 369 days). The median duration of grade 3 to 4 diarrhea was 5 days. National Cancer Institute of Canada (NCIC) grade 2 diarrhea is defined as an increase of 4 to 6 stools/day or nocturnal stools, grade 3 diarrhea as an increase of 7 to 9 stools/day or incontinence and malabsorption, and grade 4 diarrhea as an increase of ≥10 stools/day or grossly bloody diarrhea or the need for parenteral support. If grade 2, 3 or 4 diarrhea occurs, administration of Xeloda should be immediately interrupted until the diarrhea resolves or decreases in intensity to grade 1. Following a reoccurrence of grade 2 diarrhea or occurrence of any grade 3 or 4 diarrhea, subsequent doses of Xeloda should be decreased [see Dosage and Administration (2.2)]. Standard antidiarrheal treatments (eg, loperamide) are recommended.
Necrotizing enterocolitis (typhlitis) has been reported.
Coagulopathy
Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely with great frequency and the anticoagulant dose should be adjusted accordingly [see Boxed Warning and Drug Interactions (7.1)].
Cardiotoxicity
The cardiotoxicity observed with Xeloda includes myocardial infarction/ischemia, angina, dysrhythmias, cardiac arrest, cardiac failure, sudden death, electrocardiographic changes, and cardiomyopathy. These adverse reactions may be more common in patients with a prior history of coronary artery disease.
Dihydropyrimidine Dehydrogenase Deficiency
Rarely, unexpected, severe toxicity (eg, stomatitis, diarrhea, neutropenia and neurotoxicity) associated with 5-fluorouracil has been attributed to a deficiency of dihydropyrimidine dehydrogenase (DPD) activity. A link between decreased levels of DPD and increased, potentially fatal toxic effects of 5-fluorouracil therefore cannot be excluded.
Renal Insufficiency
Patients with moderate renal impairment at baseline require dose reduction [see Dosage and Administration (2.3)]. Patients with mild and moderate renal impairment at baseline should be carefully monitored for adverse reactions. Prompt interruption of therapy with subsequent dose adjustments is recommended if a patient develops a grade 2 to 4 adverse event as outlined in Table 2 [see Dosage and Administration (2.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
Pregnancy
Xeloda may cause fetal harm when given to a pregnant woman. Capecitabine caused embryolethality and teratogenicity in mice and embryolethality in monkeys when administered during organogenesis. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving Xeloda, the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)].
Hand-and-Foot Syndrome
Hand-and-foot syndrome (palmar-plantar erythrodysesthesia or chemotherapy-induced acral erythema) is a cutaneous toxicity. Median time to onset was 79 days (range from 11 to 360 days) with a severity range of grades 1 to 3 for patients receiving Xeloda monotherapy in the metastatic setting. Grade 1 is characterized by any of the following: numbness, dysesthesia/paresthesia, tingling, painless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt normal activities. Grade 2 hand-and-foot syndrome is defined as painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patient's activities of daily living. Grade 3 hand-and-foot syndrome is defined as moist desquamation, ulceration, blistering or severe pain of the hands and/or feet and/or severe discomfort that causes the patient to be unable to work or perform activities of daily living. If grade 2 or 3 hand-and-foot syndrome occurs, administration of Xeloda should be interrupted until the event resolves or decreases in intensity to grade 1. Following grade 3 hand-and-foot syndrome, subsequent doses of Xeloda should be decreased [see Dosage and Administration (2.2)].
Hyperbilirubinemia
In 875 patients with either metastatic breast or colorectal cancer who received at least one dose of Xeloda 1250 mg/m2 twice daily as monotherapy for 2 weeks followed by a 1-week rest period, grade 3 (1.5-3 × ULN) hyperbilirubinemia occurred in 15.2% (n=133) of patients and grade 4 (>3 × ULN) hyperbilirubinemia occurred in 3.9% (n=34) of patients. Of 566 patients who had hepatic metastases at baseline and 309 patients without hepatic metastases at baseline, grade 3 or 4 hyperbilirubinemia occurred in 22.8% and 12.3%, respectively. Of the 167 patients with grade 3 or 4 hyperbilirubinemia, 18.6% (n=31) also had postbaseline elevations (grades 1 to 4, without elevations at baseline) in alkaline phosphatase and 27.5% (n=46) had postbaseline elevations in transaminases at any time (not necessarily concurrent). The majority of these patients, 64.5% (n=20) and 71.7% (n=33), had liver metastases at baseline. In addition, 57.5% (n=96) and 35.3% (n=59) of the 167 patients had elevations (grades 1 to 4) at both prebaseline and postbaseline in alkaline phosphatase or transaminases, respectively. Only 7.8% (n=13) and 3.0% (n=5) had grade 3 or 4 elevations in alkaline phosphatase or transaminases.
In the 596 patients treated with Xeloda as first-line therapy for metastatic colorectal cancer, the incidence of grade 3 or 4 hyperbilirubinemia was similar to the overall clinical trial safety database of Xeloda monotherapy. The median time to onset for grade 3 or 4 hyperbilirubinemia in the colorectal cancer population was 64 days and median total bilirubin increased from 8 µm/L at baseline to 13 µm/L during treatment with Xeloda. Of the 136 colorectal cancer patients with grade 3 or 4 hyperbilirubinemia, 49 patients had grade 3 or 4 hyperbilirubinemia as their last measured value, of which 46 had liver metastases at baseline.
In 251 patients with metastatic breast cancer who received a combination of Xeloda and docetaxel, grade 3 (1.5 to 3 × ULN) hyperbilirubinemia occurred in 7% (n=17) and grade 4 (>3 × ULN) hyperbilirubinemia occurred in 2% (n=5).
If drug-related grade 3 to 4 elevations in bilirubin occur, administration of Xeloda should be immediately interrupted until the hyperbilirubinemia decreases to ≤3.0 X ULN [see recommended dose modifications under Dosage and Administration (2.2)].
Hematologic
In 875 patients with either metastatic breast or colorectal cancer who received a dose of 1250 mg/m2 administered twice daily as monotherapy for 2 weeks followed by a 1-week rest period, 3.2%, 1.7%, and 2.4% of patients had grade 3 or 4 neutropenia, thrombocytopenia or decreases in hemoglobin, respectively. In 251 patients with metastatic breast cancer who received a dose of Xeloda in combination with docetaxel, 68% had grade 3 or 4 neutropenia, 2.8% had grade 3 or 4 thrombocytopenia, and 9.6% had grade 3 or 4 anemia.
Patients with baseline neutrophil counts of <1.5 × 109/L and/or thrombocyte counts of <100 × 109/L should not be treated with Xeloda. If unscheduled laboratory assessments during a treatment cycle show grade 3 or 4 hematologic toxicity, treatment with Xeloda should be interrupted.
Geriatric Patients
Patients ≥80 years old may experience a greater incidence of grade 3 or 4 adverse reactions. In 875 patients with either metastatic breast or colorectal cancer who received Xeloda monotherapy, 62% of the 21 patients ≥80 years of age treated with Xeloda experienced a treatment-related grade 3 or 4 adverse event: diarrhea in 6 (28.6%), nausea in 3 (14.3%), hand-and-foot syndrome in 3 (14.3%), and vomiting in 2 (9.5%) patients. Among the 10 patients 70 years of age and greater (no patients were >80 years of age) treated with Xeloda in combination with docetaxel, 30% (3 out of 10) of patients experienced grade 3 or 4 diarrhea and stomatitis, and 40% (4 out of 10) experienced grade 3 hand-and-foot syndrome.
Among the 67 patients ≥60 years of age receiving Xeloda in combination with docetaxel, the incidence of grade 3 or 4 treatment-related adverse reactions, treatment-related serious adverse reactions, withdrawals due to adverse reactions, treatment discontinuations due to adverse reactions and treatment discontinuations within the first two treatment cycles was higher than in the <60 years of age patient group.
In 995 patients receiving Xeloda as adjuvant therapy for Dukes' C colon cancer after resection of the primary tumor, 41% of the 398 patients ≥65 years of age treated with Xeloda experienced a treatment-related grade 3 or 4 adverse event: hand-and-foot syndrome in 75 (18.8%), diarrhea in 52 (13.1%), stomatitis in 12 (3.0%), neutropenia/granulocytopenia in 11 (2.8%), vomiting in 6 (1.5%), and nausea in 5 (1.3%) patients. In patients ≥65 years of age (all randomized population; capecitabine 188 patients, 5-FU/LV 208 patients) treated for Dukes' C colon cancer after resection of the primary tumor, the hazard ratios for disease-free survival and overall survival for Xeloda compared to 5-FU/LV were 1.01 (95% C.I. 0.80 – 1.27) and 1.04 (95% C.I. 0.79 – 1.37), respectively.
Hepatic Insufficiency
Patients with mild to moderate hepatic dysfunction due to liver metastases should be carefully monitored when Xeloda is administered. The effect of severe hepatic dysfunction on the disposition of Xeloda is not known [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Combination With Other Drugs
Use of Xeloda in combination with irinotecan has not been adequately studied.
Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adjuvant Colon Cancer
Table 4 shows the adverse reactions occurring in ≥5% of patients from one phase 3 trial in patients with Dukes' C colon cancer who received at least one dose of study medication and had at least one safety assessment. A total of 995 patients were treated with 1250 mg/m2 twice a day of Xeloda administered for 2 weeks followed by a 1-week rest period, and 974 patients were administered 5-FU and leucovorin (20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5-FU on days 1-5 every 28 days). The median duration of treatment was 164 days for capecitabine-treated patients and 145 days for 5-FU/LV-treated patients. A total of 112 (11%) and 73 (7%) capecitabine and 5-FU/LV-treated patients, respectively, discontinued treatment because of adverse reactions. A total of 18 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 8 (0.8%) patients randomized to Xeloda and 10 (1.0%) randomized to 5-FU/LV.
Table 5 shows grade 3/4 laboratory abnormalities occurring in ≥1% of patients from one phase 3 trial in patients with Dukes' C colon cancer who received at least one dose of study medication and had at least one safety assessment.
| Adjuvant Treatment for Colon Cancer (N=1969) | ||||
|---|---|---|---|---|
| Xeloda (N=995) | 5-FU/LV (N=974) | |||
| Body System/ Adverse Event | All Grades | Grade 3/4 | All Grades | Grade 3/4 |
| Gastrointestinal Disorders | ||||
| Diarrhea | 47 | 12 | 65 | 14 |
| Nausea | 34 | 2 | 47 | 2 |
| Stomatitis | 22 | 2 | 60 | 14 |
| Vomiting | 15 | 2 | 21 | 2 |
| Abdominal Pain | 14 | 3 | 16 | 2 |
| Constipation | 9 | - | 11 | <1 |
| Upper Abdominal Pain | 7 | <1 | 7 | <1 |
| Dyspepsia | 6 | <1 | 5 | - |
| Skin and Subcutaneous Tissue Disorders | ||||
| Hand-and-Foot Syndrome | 60 | 17 | 9 | <1 |
| Alopecia | 6 | - | 22 | <1 |
| Rash | 7 | - | 8 | - |
| Erythema | 6 | 1 | 5 | <1 |
| General Disorders and Administration Site Conditions | ||||
| Fatigue | 16 | <1 | 16 | 1 |
| Pyrexia | 7 | <1 | 9 | <1 |
| Asthenia | 10 | <1 | 10 | 1 |
| Lethargy | 10 | <1 | 9 | <1 |
| Nervous System Disorders | ||||
| Dizziness | 6 | <1 | 6 | - |
| Headache | 5 | <1 | 6 | <1 |
| Dysgeusia | 6 | - | 9 | - |
| Metabolism and Nutrition Disorders | ||||
| Anorexia | 9 | <1 | 11 | <1 |
| Eye Disorders | ||||
| Conjunctivitis | 5 | <1 | 6 | <1 |
| Blood and Lymphatic System Disorders | ||||
| Neutropenia | 2 | <1 | 8 | 5 |
| Respiratory Thoracic and Mediastinal Disorders | ||||
| Epistaxis | 2 | - | 5 | - |
| Adverse Event | Xeloda (n=995) Grade 3/4 % | IV 5-FU/LV (n=974) Grade 3/4 % |
|---|---|---|
| ||
| Increased ALAT (SGPT) | 1.6 | 0.6 |
| Increased calcium | 1.1 | 0.7 |
| Decreased calcium | 2.3 | 2.2 |
| Decreased hemoglobin | 1.0 | 1.2 |
| Decreased lymphocytes | 13.0 | 13.0 |
| Decreased neutrophils* | 2.2 | 26.2 |
| Decreased neutrophils/granulocytes | 2.4 | 26.4 |
| Decreased platelets | 1.0 | 0.7 |
| Increased bilirubin† | 20 | 6.3 |
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 Xeloda 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 Xeloda and 32 (5.4%) randomized to 5-FU/LV.
| Adverse Event | Xeloda (n=596) | 5-FU/LV (n=593) | ||||
|---|---|---|---|---|---|---|
| Total % | Grade 3 % | Grade 4 % | Total % | Grade 3 % | Grade 4 % | |
| – Not observed | ||||||
| NA = Not Applicable | ||||||
| ||||||
| 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 | – |
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