Phase II Study with 5-Fluorouracil and Ginkgo biloba Extract (GBE 761 ONC) in Patients with Pancreatic Cancer
| Autor: | Stephan Köhler, Klaus Mross, Petra Robben-Bathe, Clemens Unger, B. Hauns, B. Häring |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Antimetabolites Antineoplastic medicine.medical_specialty Pancreatic disease Adolescent Combination therapy Phases of clinical research Gastroenterology Internal medicine Pancreatic cancer Drug Discovery medicine Humans Prospective Studies Aged Flavonoids Plant Extracts business.industry Ginkgo biloba Middle Aged medicine.disease Antineoplastic Agents Phytogenic Survival Analysis Gemcitabine Surgery Pancreatic Neoplasms Treatment Outcome Tolerability Fluorouracil Female business Progressive disease medicine.drug |
| Zdroj: | Arzneimittelforschung. 49:1030-1034 |
| ISSN: | 1616-7066 0004-4172 |
| DOI: | 10.1055/s-0031-1300546 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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