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Annals of Oncology 13:1763-1770, 2002
© 2002 European Society for Medical Oncology

Original Paper

A multicentre phase II trial of primary chemotherapy with cisplatin and protracted venous infusion 5-fluorouracil followed by chemoradiation in patients with carcinoma of the oesophagus

J. S. Waters1, D. Tait1, D. Cunningham1,+, A. R. Padhani1, M. E. Hill1, S. Falk2, F. Lofts3, A. Norman1, J. Oates1 and A. Hill1

1 Cancer Research Campaign Section of Medicine and Gastrointestinal Unit, Royal Marsden Hospital and Institute of Cancer Research, Sutton; 2 Bristol Oncology Centre, Bristol; 3 Department of Medical Oncology, St George’s Hospital, London, UK

Received 17 November 2001; revised 17 April 2002; accepted 13 May 2002

Background:

We undertook a multicentre phase II trial to evaluate the safety and efficacy of primary chemotherapy followed by chemoradiation for localised adenocarcinoma or squamous carcinoma of the oesophagus.

Patients and methods:

Chemotherapy comprised five 3-weekly cycles of cisplatin and protracted continuous infusion 5-fluorouracil, with conformally planned radiotherapy commencing at the start of the fifth cycle.

Results:

The planned treatment programme was completed by 39 of 72 patients (54%), and a further 13% completed chemotherapy and proceeded to surgical oesophagectomy. Response rates to chemotherapy and to the entire treatment programme were 47% [95% confidence interval (CI) 34% to 60%] and 56% (CI 43% to 68%). The dysphagia score improved in 54% of patients. The median survival duration was 14.6 months with 1- and 2-year survival rates of 58.7% and 44.1%, respectively. Grade III/IV chemotherapy-related toxicity occurred in 38% of patients, and there were no treatment-related deaths.

Conclusions:

This is a feasible and active treatment regimen providing palliative benefits for patients with poor-prognosis localised oesophageal cancer.

Key words: chemotherapy, cisplatin, 5-fluorouracil, oesophagus, radiotherapy


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