Purpose: Pancreatic carcinoma is generally considered a chemotherapy-resistant malignant neoplasm and to date there is no established chemotherapeutic treatment for patients with advanced disease. Many new combination regimens have been investigated to improve results. Modiano et al. (ASCO 1993; 12: 303) with ELF regimen (etoposide, folinic acid, and 5-fluorouracil) plus interferon obtained 6/7 partial remission in patients with advanced pancreatic cancer. Considering these interesting results and the therapeutic activity of epirubicin in this disease, we started a study (GOIM 9405) to verify the efficacy and safety of the ELFE (ELF + Epirubicin) regimen. Patients and methods: Twenty-three patients with advanced pancreatic cancer received etoposide 80 mg/m2 day 1-3, folinic acid (levo-isomer form) 100 mg/m2 day 1-3, 5-fluorouracil 340 mg/m2 day 1-3, and epirubicin 60 mg/m2 day 1. Treatment was repeated every three weeks. Results: We obtained 3 PR, 4 SD and 13 PD. Overall response rate was 15% (95% CI: 3% to 38%) (intent to treat analysis: 13%; 95% CI: 3% to 34%). The median durations of response and survival were 9 and 5 months, respectively. Grade 3-4 WHO toxicity included diarrhoea (17%), mucositis (22%), leukopenia (17%). Conclusions: The ELFE regimen demonstrates scarce activity in patients with advanced pancreatic cancer, with mild toxicity.
A phase II trial of etoposide, folinic acid, fluorouracil and epirubicin in advanced pancreatic carcinoma
Gebbia, VInvestigation
;
1998-01-01
Abstract
Purpose: Pancreatic carcinoma is generally considered a chemotherapy-resistant malignant neoplasm and to date there is no established chemotherapeutic treatment for patients with advanced disease. Many new combination regimens have been investigated to improve results. Modiano et al. (ASCO 1993; 12: 303) with ELF regimen (etoposide, folinic acid, and 5-fluorouracil) plus interferon obtained 6/7 partial remission in patients with advanced pancreatic cancer. Considering these interesting results and the therapeutic activity of epirubicin in this disease, we started a study (GOIM 9405) to verify the efficacy and safety of the ELFE (ELF + Epirubicin) regimen. Patients and methods: Twenty-three patients with advanced pancreatic cancer received etoposide 80 mg/m2 day 1-3, folinic acid (levo-isomer form) 100 mg/m2 day 1-3, 5-fluorouracil 340 mg/m2 day 1-3, and epirubicin 60 mg/m2 day 1. Treatment was repeated every three weeks. Results: We obtained 3 PR, 4 SD and 13 PD. Overall response rate was 15% (95% CI: 3% to 38%) (intent to treat analysis: 13%; 95% CI: 3% to 34%). The median durations of response and survival were 9 and 5 months, respectively. Grade 3-4 WHO toxicity included diarrhoea (17%), mucositis (22%), leukopenia (17%). Conclusions: The ELFE regimen demonstrates scarce activity in patients with advanced pancreatic cancer, with mild toxicity.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
