Gemcitabine, oxaliplatin and weekly high-dose 5-FU as 24-h infusion in chemonaive patients with advanced or metastatic pancreatic adenocarcinoma: a multicenter phase II trial of the Arbeitsgemeinschaft Internistische Onkologie (AIO).

Détails

ID Serval
serval:BIB_0988E08A59FB
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Gemcitabine, oxaliplatin and weekly high-dose 5-FU as 24-h infusion in chemonaive patients with advanced or metastatic pancreatic adenocarcinoma: a multicenter phase II trial of the Arbeitsgemeinschaft Internistische Onkologie (AIO).
Périodique
Annals of Oncology
Auteur(s)
Wagner A.D., Buechner-Steudel P., Wein A., Schmalenberg H., Lindig U., Moehler M., Behrens R., Kleber G., Kuss O., Fleig W.E.
ISSN
0923-7534 (Print)
ISSN-L
0923-7534
Statut éditorial
Publié
Date de publication
2007
Peer-reviewed
Oui
Volume
18
Numéro
1
Pages
82-87
Langue
anglais
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov'tPublication Status: ppublish
Résumé
BACKGROUND: Combinations of gemcitabine-oxaliplatin, gemcitabine-5-fluorouracil (5-FU) and 5-FU-oxaliplatin have synergistic activity and nonoverlapping adverse effect profiles. This trial assessed efficacy and safety of the triple combination gemcitabine-oxaliplatin and infusional 5-FU in patients with locally advanced (n=11) or metastatic (n=32) pancreatic adenocarcinoma.
PATIENTS AND METHODS: A total of 43 eligible patients were treated with intravenous infusions of gemcitabine (900 mg/m2 over 30 min), followed by oxaliplatin (65 mg/m2 over 2 h) and 5-FU (1500 mg/m2 over 24 h) on days 1 and 8 of a 21-day cycle.
RESULTS: Among all 43 patients, the tumor response rate was 19% [95% confidence interval 7% to 30%]. Nine patients were nonassessable for response because they did not complete the first two cycles of chemotherapy due to rapid disease progression, early death or treatment refusal. One patient was lost to follow-up. Median time to progression and overall survival were 5.7 and 7.5 months. Principal grade III/IV toxic effects were leucopenia in 11 (2%), thrombocytopenia in 13 (2%), nausea in 13 (0%), anorexia 16 (7%) and sensory neuropathy in 18 (0%) of patients. Unexpected cardiotoxicity was observed in this trial.
CONCLUSION: Response rates and survival of the three-drug combination compare favorably with single-agent gemcitabine, but do not exceed results for doublets.
Mots-clé
Adenocarcinoma/drug therapy, Adenocarcinoma/secondary, Aged, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Deoxycytidine/administration & dosage, Deoxycytidine/analogs & derivatives, Disease Progression, Disease-Free Survival, Female, Fluorouracil/administration & dosage, Humans, Infusions, Intravenous, Male, Middle Aged, Organoplatinum Compounds/administration & dosage, Pancreatic Neoplasms/drug therapy, Pancreatic Neoplasms/pathology, Quality of Life, Survival Rate, Time Factors, Treatment Outcome
Pubmed
Web of science
Open Access
Oui
Création de la notice
24/07/2015 7:47
Dernière modification de la notice
20/08/2019 12:31
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