Cesare Gridelli1, 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. 1. *Division of Medical Oncology, "SG Moscati" Hospital, Avellino, Italy; †Department of Oncology, University of Turin, AOU San Luigi Orbassano, Turin, Italy; ‡Medical Oncology 1, "Fondazione IRCCS Istituto Nazionale dei Tumori", Milan, Italy; §Department of Oncology, San Paolo Hospital, Milan, Italy; ‖Second Medical Oncology Unit, "Istituto Oncologico Veneto", Padua, Italy; ¶European Institute of Oncology, Milan, Italy; #Department of Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola (FC), Italy; **Division of Medical Oncology, S. Maria della Misericordia Hospital, Perugia, Italy; ††Lung Cancer Unit, National Institute for Cancer Research, Genoa, Italy; ‡‡Medical Oncology Department, Santa Chiara Hospital, Trento, Italy; §§Medical Oncology Unit, San Vincenzo Hospital, Taormina, Catania, Italy; ‖‖Oncology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy; ¶¶Medical Oncology Department, AUSL Bologna, Italy; ##Medical Oncology Unit, "Giovanni Paolo II" National Cancer Centre, Bari, Italy; ***Department of Oncology, Azienda Ospedaliera Treviglio, Treviglio (BG), Italy; †††Department of Oncology, University Hospital of Udine, Udine, Italy; ‡‡‡Department of Oncology, Ospedale Niguarda Ca' Granda, Milan, Italy; §§§AstraZeneca, Basiglio (MI), Italy; ‖‖‖LB Research, Cantù (CO), Italy; and ¶¶¶Medical Oncology, Second University of Naples, Naples, Italy.
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.
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.
Authors: Bob T Li; Tristan A Barnes; David L Chan; Jarushka Naidoo; Adrian Lee; Mustafa Khasraw; Gavin M Marx; Mark G Kris; Stephen J Clarke; Alexander Drilon; Charles M Rudin; Nick Pavlakis Journal: Lung Cancer Date: 2016-10-17 Impact factor: 5.705