Gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a phase II study of the Niigata Lung Cancer Treatment Group

INTERVENTION: Patients will receive an infusion of gemcitabine on days 1 and 8. They will also receive an infusion of carboplatin on day 8. CONDITION: Non‐small cell lung cancer PRIMARY OUTCOME: Response rate SECONDARY OUTCOME: Safety,survival,toxicity, QOL INCLUSION CRITERIA: Patients enrolled in this trial had histologically or cytologically confirmed stage IIIb or IV NSCLC. Patients with stage IIIb disease who were not candidates for thoracic radiation and those with stage IV disease were eligible, if they had not received previous chemotherapy, had measurable disease, and had a life expectancy of at least 3 months. Additional entry criteria were age 75=< years, performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and adequate bone marrow (leukocyte count > 4,000/mL, neutrophil count > 2,000/mL, hemoglobin concentration > 9.5g/dL, platelet count > 100,000 /mL), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < 100, total bilirubin < 2.0 mg/dL), and pulmonary (PaO2 > 60 torr) functions.