Skip Navigation LinksHome > May 2014 - Volume 9 - Issue 5 > Phase II Randomized Study of Vandetanib Plus Gemcitabine or...
Journal of Thoracic Oncology:
doi: 10.1097/JTO.0000000000000120
Brief Reports

Phase II Randomized Study of Vandetanib Plus Gemcitabine or Gemcitabine Plus Placebo as First-Line Treatment of Advanced Non–Small-Cell Lung Cancer in Elderly Patients

Gridelli, Cesare MD*; Novello, Silvia MD; Zilembo, Nicoletta MD; Luciani, Andrea MD§; Favaretto, Adolfo Gino MD; De Marinis, Filippo MD; Genestreti, Giovenzio MD#; Crinò, Lucio MD**; Grossi, Francesco MD††; Caffo, Orazio MD‡‡; Ferraù, Francesco MD§§; Cruciani, Giorgio MD‖‖; Brandes, Alba Ariela MD¶¶; Galetta, Domenico MD##; Barni, Sandro MD***; Fasola, Gianpiero MD†††; Cerea, Giulio MD‡‡‡; Ferrari, Silvia MD§§§; Iannacone, Claudio MSc‖‖‖; Ciardiello, Fortunato MD¶¶¶

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Abstract

Introduction:

The aim of the present study was to evaluate the efficacy and tolerability of vandetanib plus gemcitabine (V/G) compared with gemcitabine alone in elderly patients with untreated advanced non–small-cell lung cancer.

Methods:

This was a phase II, randomized, double-blind study. A total of 124 elderly patients (mean age, 75 yr; age range, 70–84 yr; 73% men) received V/G (n = 61) or placebo plus gemcitabine (n = 63). Progression-free survival (PFS) was the primary endpoint. Secondary endpoints were overall survival, objective response rate, duration of response, disease control rate, time to deterioration of performance status, and safety outcomes.

Results:

PFS was significantly prolonged with V/G (median, 183 days; 95% confidence interval, 116–214) compared with placebo plus gemcitabine (median, 169 days; 95% confidence interval, 95–194; p = 0.047). No statistically significant differences between arms were observed in all secondary endpoints, including overall survival. The addition of vandetanib to gemcitabine was well tolerated. The rate of patients with ≥1 treatment-related adverse event was comparable in the two arms, pyrexia, dyspnea, and neutropenia being the most common adverse events.

Conclusions:

V/G combination was associated with a statistically significant prolongation of PFS compared with gemcitabine alone in untreated elderly patients with advanced non–small-cell lung cancer, with an acceptable safety profile.

Copyright © 2014 by the International Association for the Study of Lung Cancer

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