J Korean Cancer Assoc.  1998 Feb;30(1):55-62.

Phase 2 Trial of FLP ( 5-FU , Leucovorin , Cisplatin ) Combination Chemotherapy for Advanced Gastric Cancer

• Park YI
• Lee MH
• Han SW
• Park WJ
• Kim DG
• Lee J
• Ahn JS
• Rhee JA
• Woo IS
• Park YS

Abstract

PURPOSE
Advanced gastric cancer, the most common malignancy in Korea is a kind of systemic disease. At dignosis, 50~80% of patients have systemic cancer. Therefore, the most patients require systemic chemotherapy. Cisplatin and 5-FU have been suggested to be active in the treatment of gastric cancer, a high response rate was observered with a combination of 5-FU infusion and cisplatin, and the biochemical modulation of 5-FU by leucovorin has been demonstrated to enhance the activity of 5-FU in gastrointestinal tract cancer.
MATERIALS AND METHODS
The patients with advanced gastric cancer whose disease had relapsed or unresectable were treated with 5-FU(800 mg/m2 12 hr IV infusion, D 1~5), leucovorin(20 mg/m2 IV, D 1~5, max. 30 mg), cisplatin(100 mg/m2 15min IV dripping, D1). The cycles of treatment were repeated at 3-weeks intervals.
RESULTS
Between Sep. 1994 and Aug. 1996, previously untreated 44 patients(39 eligible patients) were admitted to this study, the median age was 55 years(range 17~73) and male to female ratio was 20:19. The rate of complete remission was 5%(2/39), the rate of partial remission was 21%(8/39). The median-response duration was 26 weeks(5+~38+ ). The median-time to progression was 25 weeks(4+~62+). The range of overall survival time was from 4 to 62+ weeks. 24 weeks survival rate was 71.5% but the median survival time was not reached. The leukopenia and anemia were the main hematologic toxicities. Non-hematologic side effects were nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy. These toxicities were observed commnonly, but tolerable. Two treatment-related deaths were associated with sepsis.
CONCLUSION
Based on these results, FLP combination chemotherapy seems to be a moderate efficacy for advanced gastric cancer with tolerable toxicities. To confirm the efficacy further, the long-term follow up and a large scale of clinical studies are needed.

Keyword

FLP combination chemotherapy; Advanced stomach cancer

MeSH Terms

Anemia
Cisplatin*
Diarrhea
Drug Therapy
Drug Therapy, Combination*
Female
Fluorouracil*
Follow-Up Studies
Gastrointestinal Neoplasms
Humans
Korea
Leucovorin*
Leukopenia
Male
Nausea
Peripheral Nervous System Diseases
Sepsis
Stomach Neoplasms*
Stomatitis
Survival Rate
Vomiting
Cisplatin
Fluorouracil
Leucovorin