18072 Background: Epirubicin is active for treatment of non-small cell lung carcinoma (NSCLC) but its optimal dose was undetermined. This study was designed to evaluate the efficacy and safety of gemcitabine plus conventional-dose epirubicin for stage IIIB/IV NSCLC. Methods: Patients with histological or cytological diagnosis of stage IIIB/IV NSCLC who had not received prior chemotherapy were eligible. Patients were randomized to GE (gemcitabine, 1,000 mg/m2 on days 1, 8, and 15 and epirubicin, 70 mg/m2 on day 15) or GC (gemcitabine, 1,000 mg/m2 on days 1, 8, and 15 and cisplatin, 80 mg/m2 on day 15). Treatment cycles were repeated every 4 weeks. Objective tumor response and toxicity were evaluated by using the World Health Organization criteria. Results: No significant difference in baseline characteristics between patients randomized to GC (n=41) and GE (n=39) arms were found. The objective response rate was 31.0% (95% C.I. 16.4% to 45.5) for GC and 37.2.0% (95% C.I. 22.2% to 52.3%) for GE. The median time-to-treatment-failure and overall survival were 6.1 months (95% C.I. 4.9 to 7.4 months) and 13.2 months (95% C.I. 8.9 to 17.5 months) for GC and 6.2 months (95% C.I. 5.2 to 7.2 months) and 21.2 months (95% C.I. 14.6 to 27.8 months) for GE, respectively. More grade 3/4 neutropenia (71.8%) was noted in GE than in GC (43.9%). Febrile neutropenia was also more common in GE (4 patients) than in GC (1 patient). However, delay of protocol treatment due to leukopenia was similar between the 2 arms. Data on the expresssion of the excission repair cross-complimentation 1 (ERCC1), evaluated by immunohistochemical study for patients with available tumor tissue, will be presented. Conclusions: Gemcitabine plus conventional-dose epirubicin is an effective and well-tolerated regimen for patients with stage IIIB/IV NSCLC. No significant financial relationships to disclose.
Significance of overall concurrent chemoradiotherapy duration on survival outcomes of stage IIIB/C non-small-cell lung carcinoma patients: Analysis of 956 patients
