Annals of Oncology Advance Access originally published online on May 26, 2005
Annals of Oncology 2005 16(8):1320-1325; doi:10.1093/annonc/mdi249
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
© 2005 European Society for Medical Oncology
Phase II trial of oxaliplatin, leucovorin and fluorouracil in patients with advanced carcinoma of the esophagus
1 University of Chicago Section of Hematology/Oncology and University of Chicago Cancer Research Center, Chicago, IL; 2 The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA
Correspondence to: Dr A. M. Mauer, University of Chicago Medical Center, 5841 South Maryland Avenue, Chicago, Illinois 60637, USA. Email: amauer{at}medicine.bsd.uchicago.edu
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.
Key words: oxaliplatin, fluorouracil, leucovorin, esophagus cancer
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  E. Bolke, M. Peiper, W. Budach, D. Cunningham, and N. Starling Capecitabine and Oxaliplatin for Advanced Esophagogastric Cancer N. Engl. J. Med., May 1, 2008; 358(18): 1965 - 1965. [Full Text] [PDF]
|
|
|
|
 |
|
 D. Richards, D. McCollum, L. Wilfong, M. Sborov, K. A. Boehm, F. Zhan, and L. Asmar Phase II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer and/or adenocarcinoma of the gastroesophageal junction Ann. Onc., January 1, 2008; 19(1): 104 - 108. [Abstract] [Full Text] [PDF]
|
|