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Annals of Oncology 13:721-729, 2002
© 2002 European Society for Medical Oncology

Original Paper

Vinorelbine and cisplatin in metastatic squamous cell carcinoma of the oesophagus: response, toxicity, quality of life and survival

T. Conroy1,+, P.-L. Etienne2, A. Adenis3, M. Ducreux4, B. Paillot5, J. Oliveira6, J.-F. Seitz7, E. Francois8, E. Van Cutsem9, D. J. T. Wagener10, F. Kohser11, S. Daamen12, M. Praet12, T. Gorlia12, B. Baron12 and J. Wils13

1Centre Alexis Vautrin, Vandoeuvre-lès-Nancy; 2Clinique Armoricaine de radiologie, St Brieuc; 3Centre Oscar Lambret, Lille; 4Institut Gustave Roussy, Villejuif; 5Hôpital Charles Nicolle, Rouen, France; 6Instituto Português de Oncologia, Lisboa, Portugal; 7Institut Paoli-Calmettes et CHU La Timone, Marseille; 8Centre Antoine Lacassagne, Nice, France; 9UZ Gasthuisberg, Leuven, Belgium; 10University Medical Center, Nijmegen, The Netherlands; 11Hôpital Pasteur, Colmar, France; 12EORTC Data Center, Brussels, Belgium; 13Laurentius Hospital, Roermond, The Netherlands

Received 25 June 2001; revised 11 September 2001; accepted 20 September 2001.

Background

Vinorelbine and cisplatin are active against squamous cell oesophageal carcinoma. The purpose of this phase II study was to evaluate the efficacy and safety of vinorelbine plus cisplatin in previously untreated patients with metastatic squamous cell oesophageal carcinoma and to estimate the progression-free survival, overall survival and quality of life (QoL) of the patient population.

Patients and methods

Seventy-one eligible patients were entered into a study of vinorelbine 25 mg/m2 on days 1 and 8 plus cisplatin 80 mg/m2 on day 1, every 3 weeks. Degree of dysphagia relief was monitored and QoL was measured using the EORTC QLQ-C30.

Results

All eligible patients were assessed for response and 24 achieved a confirmed partial response (33.8%; 95% confidence interval 23–46); the median duration of response was 6.8 months, progression-free survival was 3.6 months and median survival of the whole group was 6.8 months. Toxicity was mainly related to neutropenia (grade 3/4 in 41% of patients). At cycle 2, 43% of the patients reported at least a moderate improvement in global health status/QoL and 25% experienced a large improvement.

Conclusions

Vinorelbine plus cisplatin represents a well-tolerated active palliative regimen for patients with advanced squamous cell carcinoma of the oesophagus. This combination may offer a better therapeutic index than cisplatin–5-fluorouracil.

Key words: chemotherapy, cisplatin, oesophageal cancer, quality of life, vinorelbine


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