ONS Connect - August 2008 - (Page 34)

Table 14 - Adverse Experiences Reported in Patients with Stage II or III Colon Cancer receiving Adjuvant Treatment ( 5% of all patients, but with <1% NCI Grade 3/4 events) (continued) eloxatin + 5-FU/LV 5-FU/LV N=1111 N=1108 Adverse Event All All (WHO/Pref) Grades (%) Grades (%) Gastrointestinal Constipation 22 19 Taste Perversion 12 8 Dyspepsia 8 5 Metabolic Phosphate Alkaline 42 20 Increased Sensory Disturbance Neurology 8 1 The following table provides adverse events reported in the previously untreated for advanced colorectal cancer study (see CLINICAL STUDIES) by body system and decreasing order of frequency in the ELOXATIN and 5-FU/LV combination arm for events with overall incidences 5% but with incidences <1% NCI Grade 3/4 events. Table 16 - Adverse Experiences Reported in Patients Previously Untreated for Advanced Colorectal Cancer Clinical Trial ( 5% of all patients but with < 1% NCI Grade 3/4 events) ELOXATIN irinotecan ELOXATIN + 5-FU/LV + 5-FU/LV + irinotecan N=259 N=256 N=258 Adverse Event All All All (WHO/Pref) Grades (%) Grades (%) Grades (%) Allergy/Immunology Rash 11 4 7 Rhinitis Allergic 10 6 6 Cardiovascular Edema 15 13 10 Constitutional Symptoms/Pain/Ocular/Visual Headache 13 6 9 Weight Loss 11 9 11 Epistaxis 10 2 2 Tearing 9 1 2 Rigors 8 2 7 Dysphasia 5 3 3 Sweating 5 6 12 Arthralgia 5 5 8 Dermatology/Skin Alopecia 38 44 67 Flushing 7 2 5 Pruritus 6 4 2 Dry Skin 6 2 5 Gastrointestinal Taste perversion 14 6 8 Dyspepsia 12 7 5 Flatulence 9 6 5 Mouth Dryness 5 2 3 Hematology/Infection Fever no ANC 16 9 9 Hepatic/Metabolic/Laboratory/Renal Hypocalcemia 7 5 4 Elevated Creatinine 4 4 5 Neurology Insomnia 13 9 11 Depression 9 5 7 Dizziness 8 6 10 Anxiety 5 2 6 Adverse events were similar in men and women and in patients <65 and 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, leukopenia, fatigue and syncope. The following additional adverse events, at least possibly related to treatment and potentially important, were reported in 2% and <5% of the patients in the ELOXATIN and 5-FU/LV combination arm (listed in decreasing order of frequency): metabolic, pneumonitis, catheter infection, vertigo, prothrombin time, pulmonary, rectal bleeding, dysuria, nail changes, chest pain, rectal pain, syncope, hypertension, hypoxia, unknown infection, bone pain, pigmentation changes, and urticaria. Previously Treated Patients with Advanced Colorectal Cancer Four hundred and fifty patients (about 150 receiving the combination of ELOXATIN and 5-FU/LV) were studied in a randomized trial in patients with refractory and relapsed colorectal cancer (see CLINICAL STUDIES). The adverse event profile in this study was similar to that seen in other studies and the adverse reactions in this trial are shown in the tables below. Thirteen percent of patients in the ELOXATIN and 5-FU/LV combination arm and 18% in the 5-FU/LV arm of the previously treated study had to discontinue treatment because of adverse effects related to gastrointestinal, or hematologic adverse events, or neuropathies. Both 5-FU and ELOXATIN are associated with gastrointestinal and hematologic adverse events. When ELOXATIN is administered in combination with 5-FU, the incidence of these events is increased. The incidence of death within 30 days of treatment in the previously treated study, regardless of causality, was 5% with the ELOXATIN and 5-FU/LV combination, 8% with ELOXATIN alone, and 7% with 5-FU/LV. Of the 7 deaths that occurred on the ELOXATIN and 5-FU/LV combination arm within 30 days of stopping treatment, 3 may have been treatment related, associated with gastrointestinal bleeding or dehydration. The following table provides adverse events reported in the previously treated study (see CLINICAL STUDIES) by body system and in decreasing order of frequency in the ELOXATIN and 5-FU/LV combination arm for events with overall incidences 5% and for grade 3/4 events with incidences 1%. This table does not include hematologic and blood chemistry abnormalities; these are shown separately below. Table 17 – Adverse Experiences Reported In Previously Treated Colorectal Cancer Clinical Trial ( 5% of all patients and with 1% NCI Grade 3/4 events) 5-FU/LV ELOXATIN ELOXATIN + 5-FU/LV (N=142) (N=153) (N=150) Adverse Event All Grade All Grade All Grade (WHO/Pref) Grades 3/4 Grades 3/4 Grades 3/4 (%) (%) (%) (%) (%) (%) Any Event 98 41 100 46 99 73 Cardiovascular Dyspnea 11 2 13 7 20 4 Coughing 9 0 11 0 19 1 Edema 13 1 10 1 15 1 Thromboembolism 4 2 2 1 9 8 Chest Pain 4 1 5 1 8 1 Constitutional Symptoms/Pain Fatigue 52 6 61 9 68 7 Back Pain 16 4 11 0 19 3 Pain 9 3 14 3 15 2 Dermatology/Skin Injection Site Reaction 5 1 9 0 10 3 (oxaliplatin injection) Table 17 – Adverse Experiences Reported In Previously Treated Colorectal Cancer Clinical Trial ( 5% of all patients and with 1% NCI Grade 3/4 events) (continued) 5-FU/LV ELOXATIN ELOXATIN + 5-FU/LV (N=142) (N=153) (N=150) Adverse Event All Grade All Grade All Grade (WHO/Pref) Grades 3/4 Grades 3/4 Grades 3/4 (%) (%) (%) (%) (%) (%) Gastrointestinal Diarrhea 44 3 46 4 67 11 Nausea 59 4 64 4 65 11 Vomiting 27 4 37 4 40 9 Stomatitis 32 3 14 0 37 3 Abdominal Pain 31 5 31 7 33 4 Anorexia 20 1 20 2 29 3 Gastroesophageal 3 0 1 0 5 2 Reflux Hematology/Infection Fever 23 1 25 1 29 1 Febrile Neutropenia 1 1 0 0 6 6 Hepatic/Metabolic/Laboratory/Renal Hypokalemia 3 1 3 2 9 4 Dehydration 6 4 5 3 8 3 Neurology Neuropathy 17 0 76 7 74 7 Acute 10 0 65 5 56 2 Persistent 9 0 43 3 48 6 The following table provides adverse events reported in the previously treated study (see CLINICAL STUDIES) by body system and in decreasing order of frequency in the ELOXATIN and 5-FU/LV combination arm for events with overall incidences 5% but with incidences <1% NCI Grade 3/4 events. Table 18 - Adverse Experiences Reported In Previously Treated Colorectal Cancer Clinical Trial ( 5% of all patients but with < 1% NCI Grade 3/4 events) 5-FU/LV ELOXATIN ELOXATIN + 5-FU/LV (N=142) (N=153) (N=150) Adverse Event All All All (WHO/Pref) Grades (%) Grades (%) Grades (%) Allergy/Immunology Rhinitis 4 6 15 Allergic Reaction 1 3 10 Rash 5 5 9 Cardiovascular Peripheral Edema 11 5 10 Constitutional Symptoms/Pain/Ocular/Visual Headache 8 13 17 Arthralgia 10 7 10 Epistaxis 1 2 9 Abnormal Lacrimation 6 1 7 Rigors 6 9 7 Dermatology/Skin Hand-Foot Syndrome 13 1 11 Flushing 2 3 10 Alopecia 3 3 7 Gastrointestinal Constipation 23 31 32 Dyspepsia 10 7 14 Taste Perversion 1 5 13 Mucositis 10 2 7 Flatulence 6 3 5 Hepatic/Metabolic/Laboratory/Renal Hematuria 4 0 6 Dysuria 1 1 6 Neurology Dizziness 8 7 13 Insomnia 4 11 9 Pulmonary Upper Resp Tract 4 7 10 Infection Pharyngitis 10 2 9 Hiccup 0 2 5 Adverse events were similar in men and women and in patients <65 and 65 years, but older patients may have been more susceptible to dehydration, diarrhea, hypokalemia and fatigue. The following additional adverse events, at least possibly related to treatment and potentially important, were reported in 2% and <5% of the patients in the ELOXATIN and 5-FU/LV combination arm (listed in decreasing order of frequency): anxiety, myalgia, erythematous rash, increased sweating, conjunctivitis, weight decrease, dry mouth, rectal hemorrhage, depression, ataxia, ascites, hemorrhoids, muscle weakness, nervousness, tachycardia, abnormal micturition frequency, dry skin, pruritus, hemoptysis, purpura, vaginal hemorrhage, melena, somnolence, pneumonia, proctitis, involuntary muscle contractions, intestinal obstruction, gingivitis, tenesmus, hot flashes, enlarged abdomen, urinary incontinence. Hematologic The following tables list the hematologic changes occurring in 5% of patients, based on laboratory values and NCI grade, with the exception of those events occurring in adjuvant patients and anemia in the patients previously untreated for advanced colorectal cancer, respectively, which are based on AE reporting and NCI grade alone. Table 19 - Adverse Hematologic Experiences in Patients with Stage II or III Colon Cancer Receiving Adjuvant Therapy ( 5% of patients) ELOXATIN + 5-FU/LV 5-FU/LV (N=1108) (N=1111) Hematology Parameter All Grades Grade 3/4 All Grades Grade 3/4 (%) (%) (%) (%) Anemia 76 1 67 <1 Neutropenia 79 41 40 5 Thrombocytopenia 77 2 19 <1 ELOXATIN® Although specific events can vary, the overall frequency of adverse events was similar in men and women and in patients <65 and 65 years. However, the following grade 3/4 events were more common in females: diarrhea, fatigue, granulocytopenia, nausea and vomiting. In patients 65 years old, the incidence of grade 3/4 diarrhea and granulocytopenia was higher than in younger patients. Insufficient subgroup sizes prevented analysis of safety by race. The following additional adverse events, were reported in 2% and <5% of the patients in the ELOXATIN and infusional 5-FU/LV combination arm (listed in decreasing order of frequency): pain, leukopenia, weight decrease, coughing. Patients Previously Untreated for Advanced Colorectal Cancer Two hundred and fifty-nine patients were treated in the ELOXATIN and 5-FU/LV combination arm of the randomized trial in patients previously untreated for advanced colorectal cancer (see CLINICAL STUDIES). The adverse event profile in this study was similar to that seen in other studies and the adverse reactions in this trial are shown in the tables below. Both 5-FU and ELOXATIN are associated with gastrointestinal and hematologic adverse events. When ELOXATIN is administered in combination with 5-FU, the incidence of these events is increased. The incidence of death within 30 days of treatment in the previously untreated for advanced colorectal cancer study, regardless of causality, was 3% with the ELOXATIN and 5-FU/LV combination, 5% with irinotecan plus 5-FU/LV, and 3% with ELOXATIN plus irinotecan. Deaths within 60 days from initiation of therapy were 2.3% with the ELOXATIN and 5-FU/LV combination, 5.1% with irinotecan plus 5-FU/

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ONS Connect - August 2008

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