D Karacetin1, O Incekara. 1. Sişli Etfal Hospital, Radiation Oncology Clinic, Istanbul, Turkey.
Abstract
PURPOSE: 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. PATIENTS AND 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). CONCLUSION: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.
RCT Entities:
PURPOSE: 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. PATIENTS AND 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). CONCLUSION: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.
Authors: Greg Knight; Craig C Earle; Roxanne Cosby; Natalie Coburn; Youssef Youssef; Richard Malthaner; Rebecca K S Wong Journal: Gastric Cancer Date: 2012-03-31 Impact factor: 7.370