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Annals of Oncology 14:1634-1639, 2003
© 2003 European Society for Medical Oncology

Original Paper

Oral vinorelbine in combination with cisplatin: a novel active regimen in advanced non-small-cell lung cancer

J. Jassem1,+, P. Kosmidis2, R. Ramlau3, K. Zarogoulidis4, L. Novakova5, J. Breton6, P.-L. Etienne7, C. Seebacher8, M. Grivaux9, A. Ojala10, D. Aubert11 and F. Lefresne11

1 Medical University of Gdansk, Gdansk, Poland; 2 Hygeia Center, Athens, Greece; 3 Lung Hospital, Poznan, Poland; 4 Aristotle University, Thessaloniki, Greece; 5 Kladno Hospital, Kladno, Czech Republic; 6 Belfort Hospital, Belfort; 7 Clinique Armoricaine de Radiologie, St Brieux, France; 8 Ospedale Maurizio, Bolzano, Italy; 9 Hospital Saint Faron, Meaux, France; 10 Tampere University Hospital, Tampere, Finland; 11 Institut de Recherche Pierre Fabre, Boulogne, France

Received 5 March 2003; revised 6 June 2003; accepted 8 August 2003

Background:

A phase II trial of alternating i.v. and oral vinorelbine in combination with cisplatin was designed to determine the response rate, safety profile, progression-free survival, overall survival and quality of life (QoL) in advanced non-small-cell lung cancer (NSCLC).

Patients and methods:

Fifty-six chemotherapy-naïve patients received cisplatin 100 mg/m2 and i.v. vinorelbine 25 mg/m2 on day 1, followed by oral vinorelbine 60 mg/m2 on days 8, 15 and 22, every 28 days.

Results:

After an independent review, the response rate was 33% [95% confidence interval (CI) 20% to 46%]. Median progression-free and overall survival were 5.5 months (95% CI 3.7–6.4) and 8.9 months (95% CI 8.8–11.7), respectively. The most frequent hematological toxicities were neutropenia (grade 3–4 in 73% of patients) and anemia (grade 3–4 in 11% of patients). Grade 3–4 infections and non-hematological toxicities occurred occasionally. QoL for lung cancer related symptoms was stable or improved.

Conclusions:

The efficacy and safety of the alternating vinorelbine schedule (i.v. on day 1, oral on days 8, 15 and 22) in combination with cisplatin in advanced NSCLC are similar to those of the standard regimen using exclusively i.v. vinorelbine, whereas ease of administration and patient comfort may favor the novel approach.

Key words: chemotherapy, cisplatin, non-small-cell lung cancer, oral vinorelbine


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[Abstract] [Full Text] [PDF]


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