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

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 Sandomenico, Ciro Gallo, Francesco Perrone, Alessandro Morabito

Research output: Contribution to journalArticlepeer-review

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 : 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 :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.

Original languageEnglish
Pages (from-to)166-170
Number of pages5
JournalClinical Lung Cancer
Volume15
Issue number2
DOIs
Publication statusPublished - Mar 2014

Keywords

  • Advanced NSCLC
  • Cisplatin
  • Elderly
  • Gemcitabine
  • Pemetrexed
  • Randomized trial

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

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