Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Inclusion Criteria:
Chemotherapy- and radiotherapy-naïve patients with histologically or cytologically
diagnosis of stage IIIB or IV NSCLC and who were ≧ 70 years old with measurable or
assessable disease were eligible for this trial. They had to have a life expectancy of at
least 3 months. Additional entry criteria were as follows: (a) a performance status (PS) 0
to 2 on the Eastern Cooperative Oncology Group scale; (b) adequate function of bone marrow
(leukocyte count ≧ 4,000/μL, absolute neutrophil count ≧ 2,000/μL, hemoglobin
concentration ≧ 9.5 g/dL, platelet count ≧ 100,000/μL), kidney (serum creatinine ≦ 1.2
mg/dL), liver (total bilirubin ≦ 1.5 times the institutional upper limits of normal,
transaminase of AST and ALT ≦ 2.5 times the institutional upper limits of normal).
Exclusion Criteria:
Patients with symptomatic brain metastasis or apparent dementia were ineligible. Patients
with active concomitant malignancy, massive pleural effusion or ascites, active infection,
severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus,
ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.-