1. ¹Department of Medical Oncology and Radiotherapy, EA 4003, Nancy-University and Centre Alexis Vautrin, 6 avenue de Bourgogne, 54511 Vandoeuvre-lès-Nancy, France
2. ²Department of Medical Oncology, Institut Paoli Calmettes, 232 boulevard Sainte Marguerite, 13009 Marseille, France
3. ³Gastroenterology Unit, Centre Antoine Lacassagne, 33 avenue Valombrose, 06189 Nice, France
4. ⁴Department of Gastroenterology, La Timone Hospital, Université de la Méditerranée, 264 rue Saint Pierre, 13005 Marseille France
5. ⁵Gastroenterology Unit, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94805 Villejuif, France
6. ⁶Department of Medical Oncology, Val d'Aurelle Paul-Lamarque Centre, 208 rue des Apothicaires, 34298 Montpellier, France
7. ⁷Institute of Oncology, University Hospital, 2 avenue Foch, 29200 Brest, France
8. ⁸Oncology unit, Sanofi-Aventis France, 9 boulevard Romain Rolland, 75014 Paris, France

Correspondence: Professor T Conroy, E-mail: t.conroy@nancy.fnclcc.fr

Received 25 April 2008; Revised 1 September 2008; Accepted 10 September 2008; Published online 7 October 2008.

Abstract

This dose escalation study was designed to determine the maximum tolerated dose (MTD) and recommended doses (RDs) of 5-fluorouracil (5FU), folinic acid and oxaliplatin (FOLFOX) with concomitant radiotherapy in inoperable/metastatic oesophageal squamous cell carcinoma or adenocarcinoma. Patients received three courses of LV5FU2 regimen (folinic acid 200 mg m^-2, bolus 5FU 300–400 mg/m², continuous infusion 5FU 400–600 mg m^-2 on days 1 and 2) and escalating doses of oxaliplatin 50 to 100 mg m^-2 on day 1 (FOLFOX). This regimen was repeated every 2 weeks, concomitant to a 50-gray radiotherapy per 5 weeks. Three more cycles were delivered after completion of radiation therapy. Three to six patients were allocated to each of the five dose levels until MTD was reached. Thirty-three patients were enroled and 21 had metastatic disease. Maximum tolerated dose was oxaliplatin 100 mg m^-2, and continuous infusion 5FU was 600 mg m^-2 day^- (level 5). The most common toxicities were neutropenia, dysphagia and oesophagitis. The RDs were those of FOLFOX-4 regimen (oxaliplatin 85 mg m^-2 and full doses of LV5FU2). The overall response was 48.5%, including 12% complete response. Response rate on primary tumour was 62.9%. This FOLFOX-4 regimen was reasonably well tolerated and effective in inoperable/metastatic oesophageal carcinoma and warrants additional investigation.