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Clin Lung Cancer. 2014 Mar;15(2):166-70. doi: 10.1016/j.cllc.2013.11.011. Epub 2013 Nov 20.

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.

Author information

1
Medical Oncology, S.G. Moscati Hospital, Avellino, Italy.
2
Clinical Trials Unit, Istituto Nazionale Tumori Fondazione G. Pascale-IRCCS, Napoli, Italy.
3
Medical Oncology, Vito Fazzi Hospital, Lecce, Italy.
4
Medical Oncology, Sacco Hospital, Milano, Italy.
5
Medical Oncology 2, Istituto Oncologico Veneto-IRCCS, Padova, Italy.
6
Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRCCS, Meldola (FO), Italy.
7
Medical Oncology, A.Perrino Hospital, Brindisi, Italy; IEO Istituto Europeo di Oncologia-IRCCS, Milano, Italy.
8
Medical Oncology, Dipartimento di Medicina Clinica e Chirurgia, Federico II University, Napoli, Italy.
9
Medical Oncology, Second University, Napoli, Italy.
10
Medical Oncology, Guglielmo da Saliceto Hospital, Piacenza, Italy.
11
Medical Oncology, Garibaldi Nesima Hospital, Catania, Italy.
12
Thoraco-pulmonary Medical Oncology, Istituto Nazionale Tumori-Fondazione Pascale IRCCS, Napoli, Italy.
13
Medical Statistics, Department of Mental Health and Preventive Medicine, Second University, Napoli, Italy.
14
Clinical Trials Unit, Istituto Nazionale Tumori Fondazione G. Pascale-IRCCS, Napoli, Italy. Electronic address: francesco.perrone@usc-intnapoli.net.

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.

KEYWORDS:

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

PMID:
24418693
DOI:
10.1016/j.cllc.2013.11.011
[Indexed for MEDLINE]

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