Archive for October 2014
effective r the hematologic toxicities or where otherwise noted. Table 5 - Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy * * Normal Baseline LFTs: Transaminases 1.5 times ULN or alkaline phosphatase 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN Febrile Neutropenia: ANC grade 4 with fever >38 C with intravenous antibiotics and/or hospitalization. Not Applicable; Not Done COSTART term and grading system Adverse Reaction Docetaxel 75 mg/m 2 n=176 % Best Supportive Care n=49 % Vinorelbine/ Ifosfamide n=119 % Neutropenia Any Grade 3/4 84 65 14 12 83 57 Leukopenia Any Grade 3/4 84 49 6 0 89 43 Thrombocytopenia Any Grade 3/4 8 3 0 0 8 2 Anemia Any Grade 3/4 91 9 55 12 91 14 Febrile Neutropenia 6 NA 1 Infection Any Grade 3/4 34 10 29 6 30 9 Treatment Related Mortality 3 NA 3 Hypersensitivity Reactions Any Grade 3/4 6 3 0 0 1 0 Fluid Retention Any Severe 34 3 ND 23 3 Neurosensory Any Grade 3/4 23 2 14 6 29 5 Neuromotor Any Grade 3/4 16 5 8 6 10 3 Skin Any Grade 3/4 20 1 6 2 17 1 Gastrointestinal Nausea Any Grade 3/4 Vomiting Any Grade 3/4 Diarrhea Any Grade 3/4 34 5 22 3 23 3 31 4 27 2 6 0 31 8 22 6 12 4 Alopecia 56 35 50 Asthenia Any Severe 53 18 57 39 54 23 Stomatitis Any Grade 3/4 26 2 6 0 8 1 Pulmonary Any Grade 3/4 41 21 49 29 45 19 Nail Disorder Any Severe 11 1 0 0 2 0 Myalgia Any Severe 6 0 0 0 3 0 Arthralgia Any Severe 3 0 2 0 2 1 Taste Perversion Any Severe 6 1 0 0 0 0 Combination therapy with docetaxel in chemotherapy-naïve advanced unresectable or metastatic NSCLC Table 6 presents safety data from two arms of an open label costs

effective r the hematologic toxicities or where otherwise noted. Table 5 - Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy * * Normal Baseline LFTs: Transaminases 1.5 times ULN or alkaline phosphatase 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN Febrile Neutropenia: ANC grade 4 with fever >38 C with intravenous antibiotics and/or hospitalization. Not Applicable; Not Done COSTART term and grading system Adverse Reaction Docetaxel 75 mg/m 2 n=176 % Best Supportive Care n=49 % Vinorelbine/ Ifosfamide n=119 % Neutropenia Any Grade 3/4 84 65 14 12 83 57 Leukopenia Any Grade 3/4 84 49 6 0 89 43 Thrombocytopenia Any Grade 3/4 8 3 0 0 8 2 Anemia Any Grade 3/4 91 9 55 12 91 14 Febrile Neutropenia 6 NA 1 Infection Any Grade 3/4 34 10 29 6 30 9 Treatment Related Mortality 3 NA 3 Hypersensitivity Reactions Any Grade 3/4 6 3 0 0 1 0 Fluid Retention Any Severe 34 3 ND 23 3 Neurosensory Any Grade 3/4 23 2 14 6 29 5 Neuromotor Any Grade 3/4 16 5 8 6 10 3 Skin Any Grade 3/4 20 1 6 2 17 1 Gastrointestinal Nausea Any Grade 3/4 Vomiting Any Grade 3/4 Diarrhea Any Grade 3/4 34 5 22 3 23 3 31 4 27 2 6 0 31 8 22 6 12 4 Alopecia 56 35 50 Asthenia Any Severe 53 18 57 39 54 23 Stomatitis Any Grade 3/4 26 2 6 0 8 1 Pulmonary Any Grade 3/4 41 21 49 29 45 19 Nail Disorder Any Severe 11 1 0 0 2 0 Myalgia Any Severe 6 0 0 0 3 0 Arthralgia Any Severe 3 0 2 0 2 1 Taste Perversion Any Severe 6 1 0 0 0 0 Combination therapy with docetaxel in chemotherapy-naïve advanced unresectable or metastatic NSCLC Table 6 presents safety data from two arms of an open label costs

October 31, 2014 Add Comment
music r the hematologic toxicities or where otherwise noted. Table 5 - Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in...
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