A pilot study of oxaliplatin, fluorouracil and folinic acid (FOLFOX-6) as first-line chemotherapy in advanced or recurrent gastric cancer.
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/m(2) and leucovorin 400 mg/m(2) (2-hour intravenous infusion) followed by a 5-FU bolus of 400 mg/m(2) (10-min infusion) and then 5-FU 2,600-3,000 mg/m(2) (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.
Luo
Hui-Yan
HY
Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in Southern China, Guangzhou, People's Republic of China.
Xu
Rui-Hua
RH
Zhang
Li
L
Li
Yu-Hong
YH
Shi
Yan-Xia
YX
Lin
Tong-Yu
TY
Han
Bing
B
Wang
Feng
F
Qiu
Miao-Zhen
MZ
He
You-Jian
YJ
Guan
Zhong-Zhen
ZZ
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin; D010865:Pilot Projects; D012008:Recurrence; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D015996:Survival Rate
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil