- 作者：Cesare Gridelli ; Antonio Rossi ; Massimo Di Maio ; Silvana Leo ; Virginio Filipazzi ; Adolfo G. Favaretto ; Marco A. Burgio ; Saverio Cinieri ; Roberto Bianco ; Fortunato Ciardiello ; Luigi Cavanna ; Roberto Bordonaro ; Raffaele Costanzo ; Claudia S ; omenico ; Ciro Gallo ; Francesco Perrone ; Aless ; ro Morabito
- 关键词：Advanced NSCLC ; Cisplatin ; Elderly ; Gemcitabine ; Pemetrexed ; Randomized trial
- 刊名：Clinical Lung Cancer
- 出版年：March, 2014
- 年：2014
- 卷：15
- 期：2
- 页码：166-170
- 全文大小：327 K
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鈭?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).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鈭? ratio to gemcitabine or cisplatin/gemcitabine. In the MILES-4 study patients with non-squamous histology are randomized, in a factorial design with 1鈭?鈭?鈭? ratio, to four arms: gemcitabine (A), cisplatin/gemcitabine (B), pemetrexed (C), cisplatin/pemetrexed (D). Two comparisons are planned鈭?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.