Oxaliplatin combined with continuous infusion of 5-fluorouracil as first-line chemotherapy in patients with metastatic or recurrent gastric adenocarcinoma.
BACKGROUND
The aim of this clinical study was to evaluate the efficacy of combination chemotherapy of oxaliplatin, leucovorin and continuous-infusion 5-fluorouracil (5-FU) for advanced gastric cancer.


METHODS
Patients with previously untreated gastric cancer with measurable disease received oxaliplatin (100 mg/m(2), day 1), followed by leucovorin (100 mg/m(2), day 1) and 5-FU (2,400 mg/m(2), days 1-2), which was repeated every 2 weeks. The primary endpoint was overall response rate (ORR) and secondary endpoints were progression-free survival (PFS), overall survival (OS) and toxicity.


RESULTS
Forty-eight patients were enrolled, and 45 were evaluable for response. A total of 320 cycles of chemotherapy were administered (median 6 cycles per patient). One complete response (2.1%) and 19 partial responses (39.6%) were noted, resulting in an ORR of 41.7% (95% confidence interval, CI: 27.7-55.6%) by intent-to-treat analysis. With a median follow-up duration of 22 months, the median PFS was 5.3 (95% CI: 2.8-7.8) months and the median OS was 13.6 (95% CI: 9.3-17.9) months. There was 1 treatment-related death, and the most common grade 3/4 toxicity was neutropenia (36.1%). Three patients discontinued treatment because of serum creatinine elevation.


CONCLUSIONS
This study reaffirms the efficacy of oxaliplatin in advanced gastric cancer, but its dose of 100 mg/m(2) remains to be reconsidered in Korean patients.
Lim
Jae Yun
JY
Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Cho
Jae Yong
JY
Oh
Kyung Jin
KJ
Choi
Seung Ho
SH
Lee
Sang In
SI
Jeung
Hei-Cheul
HC
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil