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Annals of Oncology Advance Access published online on November 13, 2009
Annals of Oncology, doi:10.1093/annonc/mdp525
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Phase II trial of single-agent oral vinorelbine in elderly (≥70 years) patients with advanced non-small-cell lung cancer and poor performance status

A. Camerini1,*, C. Valsuani1, F. Mazzoni2, O. Siclari1, C. Puccetti1, S. Donati1, M. Rondini1, G. Tartarelli1, P. Puccinelli1, F. Di Costanzo2 and D. Amoroso1

1 Department of Medical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Lucca
2 Department of Medical Oncology, Careggi Hospital and Istituto Toscano Tumori, Firenze, Italy

* Correspondence to: Dr A. Camerini, Medical Oncology, Versilia Hospital, via Aurelia 335, 55041 Lido di Camaiore (LU), Italy. Tel: +3905846058676; Fax: +3905846058699; E-mail: andreacamerini{at}katamail.com

Background: Elderly patients with advanced non-small-cell lung cancer (NSCLC) with poor performance status (PS) are a special population requiring particular attention. Single-agent oral vinorelbine could be an attractive option.

Patients and methods: A total of 43 patients with stage IIIB–IV NSCLC and Eastern Cooperative Oncology Group (ECOG) PS of two or more with good functional status were prospectively recruited. Oral vinorelbine was administered at the dose of 60 mg/m2 on days 1–8 every 3 weeks. Primary end points were response rate and safety.

Results: Overall response rate was 18.6% with 8 partial responses; 18 of 43 (41.8%) experienced stable disease lasting >12 weeks and 17 of 43 (39.6%) disease progression for an overall clinical benefit of 60.4%. Median time to progression was 4.0 (range 2–22) months and median overall survival 8.0 (range 3–35) months. Treatment was well tolerated. Of 187 cycles, we did not observe any grade 3/4 toxicity with the exception of a single not-febrile G3 neutropenia. Regardless of severity, main toxic effects observed were nausea in 48.1% and vomiting in 22.9% of patients, anemia in 43.2%, fatigue in 32.6% and leukopenia in 23.2%.

Conclusion: Single-agent oral vinorelbine is extremely safe in elderly patients with advanced NSCLC and ECOG PS of two or more and may represent a valid option in this very special population.

elderly, non-small-cell lung cancer, vinorelbine

Received for publication September 10, 2009. Revision received October 8, 2009. Accepted for publication October 9, 2009.


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