First-Line Chemotherapy With Planned Sequential Administration Of Gemcitabine (G) Followed By Docetaxel (D) In Elderly Advanced Non-Small-Cell Lung Cancer (Nsclc) Patients: A Multicenter Phase Ii Study

19092 Background: Single-agent chemotherapy (G or vinorelbine) is currently a standard treatment for elderly advanced NSCLC patients. The combination of G+D was active but not well tolerated in this subset (Hainsworth et al, Clin Lung Cancer 2003). Modified schedule of D (37.5 mg/m2 on day 1 and 8 every 3 weeks) was active and well tolerated in pre-treated elderly advanced NSCLC patients (Tibaldi et al, Clin Lung Cancer, 2006). Aim of this study was to evaluate the activity and the toxicity of a sequential regimen of G followed by D in elderly advanced NSCLC patients. Methods: Chemo-naïve elderly patients (> 70 years old) with histologically or cytologically confirmed stage IIIB (positive pleural effusion or metastatic supraclavear lymph nodes) or IV NSCLC and a performance status (PS) 0–2 were treated with G 1200 mg/m2 on Day 1 and 8 every 3 weeks for 3 cycles followed by, in case of non-progressive disease, D 37.5 mg/m2 on Day 1 and 8 every 3 weeks for further 3 cycles. Results: Fifty-six patients were enrolled into the study: 46 male and 10 women; 7 PS 0, 38 PS1, 11 PS2; median age was 76 years (range 70–84). The median number of major comorbidities was 2. Toxicity was mild; afebrile grade 3 neutropenia was observed in 3 patients (5.4%) and grade 3 thrombocytopenia in 2 patients (3.6%); non-haematological grade 3–4 toxicities were: fatigue in 5 patients (8.9%), and diarrhoea and mucositis in 2 patients each (3.6%). According to intention-to-treat analysis, the objective response rate was 16.0% (95% C.I. 7.6%-28.3%); 23 patients (41.0%) had stable disease and 24 patients (43%) had progressive disease. Five patients who had a stable disease after three courses of G obtained a conversion to partial response by D. Median time to progression was 4.8 months (95% C.I 3.6–6.0 months) and median duration of survival was 8.0 months (95% C.I 5.6–10.5 months). The 1-year survival rate was 34%. Conclusion: Sequential chemotherapy with G and D seems a well-tolerated and effective regimen in elderly advanced NSCLC patients. No significant financial relationships to disclose.