Introduction: To compare a novel carboplatin-gemcitabine (CG) schedule with gemcitabine (G) monochemotherapy in elderly patients with advanced NSCLC. Methods: The records of all the consecutive elderly patients referred to our Department of Oncology for advanced NSCLC were reviewed. Overall survival was the main outcome, time to progression, response rate and safety were the secondary end points. Results: Fifty patients (40 males and 10 females, mean age 75 years, range 68-87 years) were included into the analysis. 30 patients (60%) were treated with the CG and 20 (40%) with G. Median survival was 12.4 months for the entire population, and 14.9 and 5.3 months for CG and G(p=0.043) respectively. 7(14%) and 2(4%) partial regressions were observed in CG and G groups,(p=0.085), with a median time to progression of 5.1 months for the entire population, and 7.3 and 3.5 months for CG and G(p=0.237). Grade III neutropenia was observed in 8(16%) and 2(4%) patients treated with CG and G, respectively; grade IV neutropenia in 2(4%) and 2(4%) patients, grade III anemia in 2(4%) and 1(2%) patients, and grade III thrombocytopenia in 1(2) patient, respectively (p=0.527). Grade II fatigue was observed in 5(10%) and 2(4%) patients, grade III diarrhea in 3(6%) and 1(2%) patients treated with CG and G, respectively (p=0.722). Conclusions: Carboplatin-gemcitabine seems to be more effective that gemcitabine alone in elderly patients with advanced NSCLC, without any worsening of the safety profile. The data, extracted from an outcome analysis, confirm what has been observed in previous clinical trials.
