This Article Full Text Full Text (PDF) eLetters: Submit a response to this article Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services E-mail this article link to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Reprints/Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Gridelli, C. Search for Related Content PubMed PubMed Citation Articles by Gridelli, C.

The ELVIS Trial: A Phase III Study of Single-Agent Vinorelbine as First-Line Treatment in Elderly Patients with Advanced Non-Small Cell Lung Cancer

National Cancer Institute, Division of Medical Oncology B, Naples, Italy

Correspondence: Cesare Gridelli, M.D., National Cancer Institute, Division of Medical Oncology B, Via Semmola, Naples 80131 Italy. Telephone: 39-081-590-3269; Fax: 39-081-590-3822; e-mail: cgridelli{at}sirio-oncology.it

In a phase III trial, 191 patients aged over 70 with stage IIIB/IV non-small cell lung cancer were randomized to receive best supportive care (BSC) alone or BSC plus vinorelbine on days 1 and 8, q 21 days for up to six cycles. Increasing difficulties in recruitment meant that the investigators, blinded to the results, stopped the trial early. Data from 161 patients have been analyzed. The vinorelbine regimen was well tolerated. Grade 3/4 neutropenia occurred in 10% of patients and grade 2/3 anemia in 16%. The principle nonhematological toxicities were constipation and fatigue. An objective response rate was recorded in 19.7% of the 76 patients treated with vinorelbine. The survival experience of these patients was significantly superior to that among control patients. The median duration of survival was longer (28 versus 21 weeks) and patients receiving vinorelbine were significantly more likely to survive to one year (32% versus 14%). The relative risk of death in the vinorelbine group was 0.65 (95% confidence interval: 0.45-0.93). Quality of life was extensively investigated using European Organization for Research and Treatment of Cancer scales. While aspects of quality-of-life issues that were directly related to drug toxicity (such as nausea and constipation) were lower in the vinorelbine group, patients who received vinorelbine fared better than controls on measures related to lung cancer symptoms and pain and on social, cognitive, and physical functioning.

Key Words. Vinorelbine • Best Supportive Care • ELVIS

This article has been cited by other articles:

				E. A. Chrischilles, J. F. Pendergast, K. L. Kahn, R. B. Wallace, D. C. Moga, D. P. Harrington, C. I. Kiefe, J. C. Weeks, D. W. West, S. Y. Zafar, et al. Adverse Events Among the Elderly Receiving Chemotherapy for Advanced Non-Small-Cell Lung Cancer J. Clin. Oncol., February 1, 2010; 28(4): 620 - 627. [Abstract] [Full Text] [PDF]

				G. R. Simon Treatment of Older Patients With Non-Small-Cell Lung Cancer: Walking the Therapeutic Tightrope J. Clin. Oncol., February 1, 2010; 28(4): 523 - 526. [Full Text] [PDF]

				A. Camerini, C. Valsuani, F. Mazzoni, O. Siclari, C. Puccetti, S. Donati, M. Rondini, G. Tartarelli, P. Puccinelli, F. Di Costanzo, et al. Phase II trial of single-agent oral vinorelbine in elderly (>=70 years) patients with advanced non-small-cell lung cancer and poor performance status Ann. Onc., November 13, 2009; (2009) mdp525v1. [Abstract] [Full Text] [PDF]

				H. Wakelee, S. Dubey, and D. Gandara Optimal Adjuvant Therapy for Non-Small Cell Lung Cancer--How to Handle Stage I Disease Oncologist, March 1, 2007; 12(3): 331 - 337. [Abstract] [Full Text] [PDF]