الفهرس 
EPIDEMIOLOGYOnly 14 pages are availabe for public view
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Abstract
Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (NSCLC) have advanced disease (stage IIIB or IV) that is only amenable to palliative chemotherapy. Several randomized studies and a meta-analysis have demonstrated an advantage of chemotherapy over best supportive care alone in advanced NSCLC in terms of improvement in quality of life (QOL) and overall survival (OS) [1], [2], [3], [4] and [5]. The standard primary treatment for patients with advanced NSCLC is a two-drug, platinum-based combination with one of the new-generation agents such as gemcitabine, vinorelbine, paclitaxel, or docetaxel [6].
Several phases II and III trials of gemcitabine and cisplatin combination have consistently shown high overall response rates (ORR), with improvements in time to progression (TTP) and OS [7], [8], [9], [10] and [11]. However, the optimal number of initial chemotherapy cycles in advanced NSCLC is still a matter of discussion. Responses are usually seen after receiving 2–3 cycles, and several studies evaluating more prolonged initial chemotherapy have found no evidence of additional benefit [12], [13] and [14]. Therefore, four treatment cycles are recommended to elicit the maximum benefit from a platinum-containing combination, with a reduced risk of toxicity caused by prolonged treatment during a relatively short period of survival.
Patients who have an objective response or disease stabilization following initial chemotherapy are likely to benefit from receiving maintenance therapy when the tumor burden is low. Since initial therapy usually involves a two-drug combination, the concept of single-agent maintenance therapy, has certain advantages for select patients. Using a drug with known single-agent activity for maintenance therapy in NSCLC, it is theoretically possible to slow disease progression and improve disease-related symptoms, with minimal side effects. Based on this rationale, investigators of the Central European Cooperative Oncology Group (CECOG) conducted a phase III, randomized, multicenter study to evaluate the effects of gemcitabine maintenance therapy following gemcitabine plus cisplatin initial therapy in patients with advanced NSCLC. The primary objective was to show a significant difference in TTP in patients treated with single-agent gemcitabine or best supportive care. The secondary efficacy end points included ORR, response duration, OS, toxicity, and symptom control.