Clinical Study

A Pilot Study of Oxaliplatin, Fluorouracil and Folinic Acid (FOLFOX-6) as First-Line Chemotherapy in Advanced or Recurrent Gastric Cancer
Hui-Yan Luo, Rui-Hua Xu, Li Zhang, Yu-Hong Li, Yan-Xia Shi, Tong-Yu Lin, Bing Han, Feng Wang, Miao-Zhen Qiu, You-Jian He, Zhong-Zhen Guan

Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in Southern China, Guangzhou, People's Republic of China

Address of Corresponding Author

Chemotherapy 2008;54:228-235 (DOI: 10.1159/000140467)

  Key Words

• Oxaliplatin
• Fluorouracil
• Folinic acid
• Gastric cancer

  Abstract

Background: To evaluate the efficacy and toxicity of an oxaliplatin, fluorouracil (5-FU), and folinic acid (FOLFOX-6) combination therapy in patients with advanced or recurrent gastric cancer. Methods: Patients with previously untreated advanced or recurrent gastric cancer received oxaliplatin 100 mg/m² and leucovorin 400 mg/m² (2-hour intravenous infusion) followed by a 5-FU bolus of 400 mg/m² (10-min infusion) and then 5-FU 2,600-3,000 mg/m² (46-hour continuous infusion). The chemotherapy was repeated every 14 days. Results: Fifty-one patients were enrolled in this study. Of these, 46 were assessable for efficacy, and all patients were assessable for toxicity. Three of 51 patients achieved a complete response, and 18 had partial responses, giving an overall response rate of 41.2%. Stable disease was observed in 11 (21.6%) patients and progressive disease in 14 (27.5%). The median time to progression was 5.4 months, and the median overall survival was 12.1 months. NCI-CTC grade 3/4 hematological toxicities were neutropenia and anemia in 9.8 and 7.8% of the patients, respectively. Grade 3 peripheral neuropathy was recorded in 3 (5.9%) patients. Other NCI-CTC grade 3 or 4 toxicities included diarrhea in 3 patients (5.9%) and vomiting in 5 (9.8%). There were no treatment-related deaths. Conclusions: This oxaliplatin/5-FU/folinic acid regimen shows good efficacy and an acceptable toxicity profile in advanced or recurrent gastric cancer patients; further clinical trials are warranted.

Copyright © 2008 S. Karger AG, Basel

  Author Contacts

Rui-Hua Xu, MD, PhD
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
651 Dong Feng Road East
Guangzhou 510060 (People's Republic of China)
Tel. +86 20 8736 3468, Fax +86 20 8734 3468, E-Mail xurh@mail.sysu.edu.cn

  Article Information

Received: March 19, 2007
Accepted after revision: November 22, 2007
Published online: June 18, 2008
Number of Print Pages : 8
Number of Figures : 2, Number of Tables : 3, Number of References : 47