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Gefitinib Versus Vinorelbine in Chemotherapy-Naïve Elderly Patients With Advanced Non–Small-Cell Lung Cancer (INVITE): A Randomized, Phase II Study

Lucio Crinò, Federico Cappuzzo, Petr Zatloukal, Martin Reck, Milos Pesek, Joyce C. Thompson, Hugo E.R. Ford, Fred R. Hirsch, Marileila Varella-Garcia, Serban Ghiorghiu, Emma L. Duffield, Alison A. Armour, Georgina Speake, Michael Cullen

From the Department of Medical Oncology, Perugia Hospital, Perugia; and Instituto Clinico Humanitas Istituto di Recovero e Cura a Carattere Scientifico, Rozzano, Italy; Third Faculty of Medicine, Charles University, Faculty Hospital Bulovka and Postgraduate Medical Institute, Prague; and Charles University Medical Faculty, Plzen, Czech Republic; Hospital Grobhansdorf, Groβhansdorf, Germany; Birmingham Heartlands Hospital; Queen Elizabeth Hospital, Birmingham; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge; and AstraZeneca, Macclesfield, Cheshire, United Kingdom; and University of Colorado Cancer Center, Aurora, CO

Corresponding author: Lucio Crinò, MD, Department of Medical Oncology, Perugia Hospital, S Andrea delle Fratte, 06156 Perugia, Italy; e-mail: lcrino{at}unipg.it

Purpose This phase II, open-label, parallel-group study compared gefitinib with vinorelbine in chemotherapy-naïve elderly patients with advanced non–small-cell lung cancer (NSCLC).

Methods Chemotherapy-naïve patients (age 70 years) were randomly assigned to gefitinib (250 mg/d orally) or vinorelbine (30 mg/m² infusion on days 1 and 8 of a 21-day cycle). The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), objective response rate (ORR), quality of life (QOL), pulmonary symptom improvement (PSI), and tolerability. Exploratory end points included epidermal growth factor receptor (EGFR) gene copy number by fluorescent in situ hybridization (FISH).

Results Patients were randomly assigned to gefitinib (n = 97) or to vinorelbine (n = 99). Hazard ratios (HR; gefitinib v vinorelbine) were 1.19 (95% CI, 0.85 to 1.65) for PFS and 0.98 (95% CI, 0.66 to 1.47) for OS. ORR and disease control rates were 3.1% (95% CI, 0.6 to 8.8) and 43.3% (for gefitinib) and 5.1% (95% CI, 1.7 to 11.4) and 53.5% (for vinorelbine), respectively. Overall QOL improvement and PSI rates were 24.3% and 36.6% (for gefitinib) and 10.9% and 31.0% (for vinorelbine), respectively. In the 54 patients who were EGFR FISH-positive, HRs were 3.13 (95% CI, 1.45 to 6.76) for PFS and 2.88 (95% CI, 1.21 to 6.83) for OS. There were fewer treatment-related grade 3 to 5 adverse events with gefitinib (12.8%) than with vinorelbine (41.7%).

Conclusion There was no statistical difference between gefitinib and vinorelbine in efficacy in chemotherapy-naïve, unselected elderly patients with advanced NSCLC, but there was better tolerability with gefitinib. Individuals who were EGFR FISH-positive benefited more from vinorelbine than from gefitinib; this unexpected finding requires further study.

Supported by AstraZeneca, Macclesfield, Cheshire, United Kingdom.

Presented in part at the 5th International Symposium on Targeted Anticancer Therapies, March 8-10, 2007, Amsterdam, the Netherlands, and at the 12th World Conference on Lung Cancer, September 2-6, 2007, Seoul, Korea.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00256711 [ClinicalTrials.gov] .

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