A phase II trial of etoposide, folinic acid, fluorouracil and epirubicin in advanced pancreatic carcinoma.
OBJECTIVE
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.


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.
Dept. of Medical and Experimental Oncology, Oncology Institute Bari, Italy.
E
E
Maiello
V
V
Gebbia
F
F
Giuliani
A
A
Testa
F
F
Giotta
N
N
Gebbia
G
G
Colucci
D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols; D019008:Drug Resistance, Neoplasm; D015251:Epirubicin / Q000627:therapeutic use*; D005047:Etoposide / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use*; D008297:Male; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology
D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D015251:Epirubicin; D005047:Etoposide; D002955:Leucovorin; D005472:Fluorouracil