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|Title:||Rationale and design of MILES-3 and MILES-4 studies: two randomized phase 3 trials comparing single-agent chemotherapy versus cisplatin-based doublets in elderly patients with advanced non--small-cell lung cancer||Authors:||Gridelli, Cesare
Di Maio, Massimo
Favaretto, Adolfo G
Burgio, Marco A
|Keywords:||Advanced NSCLC;Cisplatin;Elderly;Gemcitabine;Pemetrexed;Randomized trial||Keywords Plus:||THYMIDYLATE SYNTHASE;PLUS GEMCITABINE;III TRIALS;CARBOPLATIN;THERAPY||Mesh headings:||Adenocarcinoma;Antineoplastic Combined Chemotherapy Protocols;Carcinoma, Non-Small-Cell Lung;Lung Neoplasms;Quality of Life;Research Design||Secondary Mesh headings:||Aged;Cisplatin;Deoxycytidine;Female;Follow-Up Studies;Glutamates;Guanine;Humans;Lymphatic Metastasis;Male;Neoplasm Staging;Pemetrexed;Prognosis;Prospective Studies;Survival Rate||Issue Date:||Mar-2014||Publisher:||CIG MEDIA GROUP, LP||Journal:||Clinical lung cancer||Abstract:||
Platinum-based chemotherapy is the cornerstone of treatment of advanced non-small-cell lung cancer (NSCLC) patients, but the efficacy of adding cisplatin to single-agent chemotherapy remains to be demonstrated in prospective phase III trials dedicated to elderly patients. Furthermore, the superiority of cisplatin/pemetrexed over cisplatin/gemcitabine in non-squamous NSCLC has not been confirmed prospectively. We present the rationale and design of two open-label, multicenter, randomized phase III trials for elderly patients with advanced NSCLC∶ Multicenter Italian Lung cancer in the Elderly Study (MILES)-3 and MILES-4. The aim is to evaluate the efficacy of adding cisplatin to single-agent chemotherapy (both trials) and the efficacy of pemetrexed versus gemcitabine in non-squamous tumors (MILES-4).
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