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

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)733-737
Number of pages5
JournalJournal of Thoracic Oncology
Volume9
Issue number5
DOIs
Publication statusPublished - 2014

Keywords

  • Elderly
  • Gemcitabine
  • Non-small-cell lung cancer
  • Vandetanib

ASJC Scopus subject areas

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

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