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Annals of Oncology Advance Access published online on May 26, 2005
Annals of Oncology, doi:10.1093/annonc/mdi249
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© 2005 European Society for Medical Oncology
Received March 4, 2004
Revised March 21, 2005
Accepted March 22, 2005

Original article

Phase II trial of oxaliplatin, leucovorin and fluorouracil in patients with advanced carcinoma of the esophagus

A. M. Mauer 1*, E. H. Kraut 2, S. A. Krauss 1, R. H. Ansari 1, K. Kasza 1, L. Szeto 1, E. E. Vokes 1, and for the University of Chicago Phase II Network

1 University of Chicago Section of Hematology/Oncology and University of Chicago Cancer Research Center, Chicago, IL;, USA
2 The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA

* To whom correspondence should be addressed.
A. M. Mauer, E-mail: amauer{at}medicine.bsd.uchicago.edu


  Abstract

Background: The aim of the study was to evaluate the efficacy and tolerability of the combination of oxaliplatin, fluorouracil and leucovorin in patients with advanced esophagus cancer.

Patients and methods: Thirty-five patients with recurrent or metastatic esophageal adenocarcinoma or squamous cell carcinoma were enrolled. Up to one prior chemotherapy regimen was allowed. All patients had bi-dimensionally measurable disease. Patients received oxaliplatin 85 mg/m2 as a 2-h infusion on day 1. Leucovorin (500 mg/m2) followed by fluorouracil bolus (400 mg/m2) and 22-h continuous infusion fluorouracil (600 mg/m2) was administered on days 1 and 2. Granulocyte colony stimulating factor was not routinely administered unless the patient developed febrile neutropenia or prolonged neutropenia. Treatment was repeated every 14 days.

Results: Of the thirty-five patients enrolled, all were evaluated for toxicity and 34 were evaluated for response. The overall response rate was 40% (95% confidence interval, 24% to 57%) with complete and partial response rates of 3% and 37%, respectively. The median response duration was 4.6 months, and the median overall survival was 7.1 months. One-year survival was 31%. The major toxicity noted was cumulative neutropenia, with 29% developing grade 4 toxicity. There was one treatment-related death secondary to neutropenic sepsis. The most common non-hematologic toxicity encountered with this regimen was cumulative peripheral neuropathy, with 26% experiencing grade 2 or 3 toxicity.

Conclusions: The combination of oxaliplatin, leucovorin, and fluorouracil shows significant anti-tumor activity and a favorable toxicity profile in patients with metastatic carcinoma of the esophagus.

Keywords: oxaliplatin; fluorouracil; leucovorin; esophagus cancer.
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