benefit from randomized controlled trial (TAX326) that enrolled patients with unresectable stage IIIB or IV non-small cell lung cancer and no history of prior chemotherapy. Adverse reactions were described using the NCI Common Toxicity Criteria except where otherwise noted. Table 6 - Adverse Reactions Regardless of Relationship to Treatment in Chemotherapy- Naïve Advanced Non-Small Cell Lung Cancer Patients Receiving Docetaxel in Combination with Cisplatin * Replaces NCI term Allergy COSTART term and grading system. Adverse Reaction Docetaxel 75 mg/m2 + Cisplatin 75 mg/m2 n=406 % Vinorelbine 25 mg/m2 + Cisplatin 100 mg/m2 n=396 % Neutropenia Any Grade 3/4 91 74 90 78 Febrile Neutropenia 5 5 Thrombocytopenia Any Grade 3/4 15 3 15 4 Anemia 89 94 Any Grade 3/4 7 25 Infection 35 37 Any Grade 3/4 8 8 Fever in absence of infection 33 29 Any Grade 3/4 < 1 1 Hypersensitivity Reaction * 12 4 Any Grade 3/4 3 < 1 Fluid Retention 54 42 Any All severe or life-threatening events 2 2 Pleural effusion Any 23 22 All severe or life-threatening events 2 2 Peripheral edema Any 34 18 All severe or life-threatening events <1> <1 Weight gain Any 15 9 All severe or life-threatening events> <1> <1 Neurosensory Any 47 42 Grade 3/4 4 4 Neuromotor Any 19 17 Grade 3/4 3 6 Skin Any 16 14 Grade 3/4> <1 1 Nausea Any 72 76 Grade 3/4 10 17 Vomiting Any 55 61 Grade 3/4 8 16 Diarrhea Any 47 25 Grade 3/4 7 3 Anorexia Any 42 40 All severe or life-threatening events 5 5 Stomatitis Any 24 21 Grade 3/4 2 1 Alopecia Any 75 42 Grade 3> <1 0 Asthenia Any 74 75 All severe or life-threatening events 12 14 Nail Disorder Any 14> <1 All severe events> <1 0 Myalgia Any 18 12 All severe events> <1> <1 Deaths within 30 days of last study treatment occurred in 31 patients (7.6%) in the docetaxel+cisplatin arm and 37 patients (9.3%) in the vinorelbine+cisplatin arm. Deaths within 30 days of last study treatment attributed to study drug occurred in 9 patients (2.2%) in the docetaxel+cisplatin arm and 8 patients (2%) in the vinorelbine+cisplatin arm. The second comparison in the study most valuable
any one 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 absolutely everyone
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