title: Phase II study with 5-fluorouracil and ginkgo biloba extract (GBE 761 ONC) in patients with pancreatic cancer.
abstract: The aim of the study was to evaluate the efficacy and tolerability of as well as the quality of life under treatment with 5-fluorouracil (CAS 51-21-8, 5-FU) combined with parenteral GBE 761 ONC (i.e. the ginkgo biloba special extract EGb 761) in patients with pancreatic cancer. Forty-eight patients with locally or metastatic advanced pancreatic cancer were treated within a phase II study. The treatment was repeated every three weeks until progression. Response to therapy was evaluated after 2 and 4 treatment courses. Thirty-two patients were evaluable for response. Progressive disease was observed in 22 (68.8%) patients, no change in 7 (21.9%) patients and partial response in 3 (9.4%) patients (overall response = 9.4%). GBE 761 ONC was well tolerated. Adverse events which occurred during the study consisted mainly of myelosuppression and gastrointestinal symptoms and were judged as 5-FU-related or consisted of liver toxicity, respectively, and were judged as tumour-related. These results suggest a good benefit-risk ratio of the combination of 5-FU and GBE 761 ONC in the treatment of pancreatic cancer. In comparison with the results of studies with either 5-FU or gemcitabine as single agents the combination of 5-FU/GBE 761 ONC shows comparable response rates. The toxicity of the 5-FU/GBE 761 ONC combination was low. This combination therapy therefore warrants further clinical investigation, such as a controlled clinical trial against 5-FU or gemcitabine monotherapy.
authors.affiliation: Department Medical Oncology, Tumour Biology Centre, Albert-Ludwigs-University Freiburg i. Br., Germany.
authors.forename: B
authors.initials: B
authors.lastname: Hauns
authors.forename: B
authors.initials: B
authors.lastname: Häring
authors.forename: S
authors.initials: S
authors.lastname: Köhler
authors.forename: K
authors.initials: K
authors.lastname: Mross
authors.forename: P
authors.initials: P
authors.lastname: Robben-Bathe
authors.forename: C
authors.initials: C
authors.lastname: Unger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005419:Flavonoids / Q000009:adverse effects / Q000627:therapeutic use*; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D020441:Ginkgo biloba; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010936:Plant Extracts; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D000096983:Ginkgo Extract
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D005419:Flavonoids; D005472:Fluorouracil; D010936:Plant Extracts; C063170:Ginkgo biloba extract; D000096983:Ginkgo Extract