A randomized trial of 5-fluorouracil, leucovorin, cisplatin and epirubicin (PELF) versus 5-fluorouracil, leucovorin and etoposide (ELF) given as adjuvant chemotherapy to patients with resected advanced gastric adenocarcinomas.
OBJECTIVE
To compare the efficacy and toxicity between 2 regimens [5 fluorouracil (5-FU), leucovorin and etoposide (ELF) and 5-FU, leucovorin, cisplatin and epirubicin (PELF)] administered as postoperative adjuvant chemotherapy to patients with completely resected advanced gastric cancer.


METHODS
Between 1998-2002, 78 patients with advanced gastric cancer were randomly assigned to receive 6 cycles of adjuvant ELF or PELF combination chemotherapy after complete surgical tumor resection. Endpoints were disease-free survival (DFS), overall survival and treatment toxicity.


RESULTS
ELF was administered to 37 and PELF to 41 patients. Median overall survival was 12.3 months in the ELF group and 17.2 months in the PELF group (p=0.01), respectively. For the ELF group the median DFS was 17 weeks (range 7-160 weeks), while for the PELF group it was 35 weeks (range 12-172 weeks) (p=0.0004). Two-year overall survival was 8% (3 patients) in the ELF group and 24% (10 patients) in the PELF group (p=0.03). Grade 2 hematologic toxicity occurred in 21% (8 patients) in the ELF group and in 22% (9 patients) in the PELF group (p=0.5) and grade 3 in 29% (11 patients) in the ELF group and in 24% (10 patients) in the PELF group (p=0.2). Grade 2 non-hematologic toxicity was seen in 8% (3 patients) in the ELF group and in 17% (7 patients) in the PELF group (p=0.2). Grade 3 non-hematologic toxicity occurred in 29% (11 patients) in the ELF group and in 26.8% (11 patients in the PELF group) (p=0.2).


CONCLUSIONS
PELF combination chemotherapy resulted in DFS and overall survival advantage compared with ELF. No significant differences in hematologic or non-hematologic toxicities between the two groups were registered. PELF is superior to ELF and represents a valid option for the treatment of gastric cancer.
Karacetin
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D
Sişli Etfal Hospital, Radiation Oncology Clinic, Istanbul, Turkey.
Incekara
O
O