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Background: No reference second-line treatment of small-cell lung cancer is available. The aim of the present phase II randomized trial (Groupe Français de Pneumo-Cancérologie 0501) was to compare, in patients with progressive small-cell lung cancer after first-line platinum-based chemotherapy, oral multidrug chemotherapy (lomustine, cyclophosphamide, etoposide) and intravenous therapy with cyclophosphamide, doxorubicin, and vincristine (CAV) in terms of efficacy and tolerance. The primary endpoint was overall survival. The secondary endpoints were progression-free survival, response rate, and tolerance., Patients and Methods: The study randomized 131 patients (76.7% male; median age, 61 ± 8.1 years, 85.5% with a performance status of 0-1), 65 to oral therapy and 66 to the CAV arm. No statistically significant differences were found in the baseline patient characteristics., Results: The OS and PFS was 6.1 and 3 months for the oral arm and 5.8 and 3.1 months for the CAV arm, respectively. The control disease rate was 61.6% and 45.5% in oral and CAV arms, respectively. No unexpected adverse events occurred, and no statistically significant difference was found between the 2 arms in terms of toxicity (grade 4 hematologic adverse events in 32.3% and 31.8% of patients in the oral and CAV arms, respectively)., Conclusion: Compared with CAV, oral therapy in this setting appears as feasible as, but not superior to, the efficacy in the CAV arm., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: A large proportion of elderly patients (>70 years) with newly diagnosed NSCLC are shown to be frail by a comprehensive geriatric assessment. This population is more vulnerable to adverse effects of chemotherapy and might thus benefit more from targeted therapy. The objective of this study was to assess the cost-effectiveness of erlotinib followed by chemotherapy after progression, compared with the reverse strategy, in frail elderly patients with advanced NSCLC participating in a prospective randomized phase II trial (GFPC 0505)., Materials and Methods: Outcomes (progression-free survival and overall survival) and costs (limited to direct medical costs, from the third-party payer perspective) were collected prospectively until second progression. Costs after progression and health utilities (based on disease states and grade 3-4 toxicities) were derived from the literature., Results: Median overall survival, QALYs, and total costs for the erlotinib-first strategy were 3.9 months, 0.33, and €15,233, respectively, compared with 4.4 months, 0.35, and €15,363 for the chemotherapy-first strategy. There was no significant difference between the 2 strategies in term of cost-effectiveness (respectively €47,381 and €44,350 per QALY)., Conclusion: No difference in cost-effectiveness was found between an erlotinib-first strategy and a chemotherapy-first strategy in frail elderly patients with NSCLC., (Copyright © 2013 Elsevier Inc. All rights reserved.)