Department of Internal Medicine, Kyung Hee University, School of Medicine, Seoul, Korea.
ABSTRACT
PURPOSE: In attempt to provide a feasible chemotherapeutic regimen for advanced gastric cancer patients, the combination of cisplatin, epirubicin, leucovorin and fluorouracil (PELF) has been developed. A trial was performed to confirm the clinical activity, in terms of response rate and toxicity and duration of survival, of the PELF combination chemotherapy.
MATERIALS AND METHODS: From April 1995 to July 1997, patients with measurable unresectable and/or metastatic gastric cancer received PELF combination chemotherapy. The regimen consisted of cisplatin 40 mg/m2 IV on days 1 and 5; epirubicin 30 mg/m2 IV on days 1 and 5; 5-fluorouracil 300 mg/m2 and leucovorin 20 mg/m2 IV on days 1 through 4. The cycle was repeated every 3 weeks.
RESULT: Among 21 evaluable patients, 1 patient achieved complete response (5.3%) and 8 patients, partial response (42.1%). The median survival of overall patients was 36 weeks, the median time to progression of 21 evaluable patients was 27 weeks. There was severe myelosuppression; leucopenia 73.1%, WHO grade 3~4 11.5% of cycles.
Non-hematologic toxicities were also severe nausea or vomiting in 100% of patients, grade 3~4 13.0% of patients, alopecia in 91.3% of patients, grade 3~4 52.2% of patients.
CONCLUSION: This study showed that the PELF combination is effective in overall response rates. However, it is not recommended for routine clinical use because of its toxicities. Further phase III study will be warranted.
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