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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; Rossi, Antonio; Di Maio, Massimo; Leo, Silvana; Filipazzi, Virginio; Favaretto, Adolfo G.; Burgio, Marco A.; Cinieri, Saverio; Bianco, Roberto; Ciardiello, Fortunato; Cavanna, Luigi; Bordonaro, Roberto; Costanzo, Raffaele; Sandomenico, Claudia; Gallo, Ciro; Perrone, Francesco; Morabito, Alessandro
- Abstract
Background: 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: Multi-center 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). Patients and Methods: Both trials are dedicated to first-line therapy of patients older than 70 years with advanced NSCLC, ECOG performance status 0-1. In the MILES-3 trial, patients are randomized in a 1:1 ratio to gemcitabine or cisplatin/gemcitabine. In the MILES-4 study patients with non-squamous histology are randomized, in a factorial design with 1:1:1:1 ratio, to four arms: gemcitabine (A), cisplatin/gemcitabine (B), pemetrexed (C), cisplatin/pemetrexed (D). Two comparisons are planned: A+C vs B+D to test the role of cisplatin; A+B vs C+D to test the role of pemetrexed. Primary endpoint of both trials is overall survival. Secondary and exploratory endpoints include progression-free survival, response rate, toxicity, and quality of life. Conclusions: MILES-3 and MILES-4 results will add important evidence about the role of cisplatin-based doublets and pemetrexed in the first-line therapy of elderly patients with advanced NSCLC.
- Publication
Clinical Lung Cancer, 2014, Vol 15, Issue 2, p166
- ISSN
1525-7304
- Publication type
Article
- DOI
10.1016/j.cllc.2013.11.011