Oxaliplatin combined with 5-FU in second line treatment of advanced pancreatic adenocarcinoma : Results of a phase II trial

The efficacy and benefit of second-line chemotherapy in advanced pancreatic adenocarcinoma has never been demonstrated although it is regularly used. A randomized phase II study evaluating oxaliplatin alone (OXA), infusional 5-fluorouracil alone (5-FU) and an oxaliplatin/infusional 5-FU combination...

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Published in:Gastroentérologie clinique et biologique 2006-03, Vol.30 (3), p.357-363
Main Authors: MITRY, Emmanuel, DUCREUX, Michel, MORVAN, Francois, CVITKOVIC, Esteban, ROUGIER, Philippe, OULD-KACI, Mahmoud, BOIGE, Valérie, SEITZ, Jean-Francois, BUGAT, Roland, BREAU, Jean-Luc, BOUCHE, Olivier, ETIENNE, Pierre-Luc, TIGAUD, Jean-Marie
Format: Article
Language:English
Subjects:
Adenocarcinoma - drug therapy
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Disease Progression
Female
Fluorouracil - administration & dosage
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical sciences
Middle Aged
Organoplatinum Compounds - administration & dosage
Pancreatic Neoplasms - drug therapy
Tumors
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Summary:The efficacy and benefit of second-line chemotherapy in advanced pancreatic adenocarcinoma has never been demonstrated although it is regularly used. A randomized phase II study evaluating oxaliplatin alone (OXA), infusional 5-fluorouracil alone (5-FU) and an oxaliplatin/infusional 5-FU combination (OXFU) in untreated advanced pancreatic adenocarcinoma has been conducted. In this trial, a second-line treatment with the OXFU regimen (OXA 130 mg/m2 2-h intravenous (i.v.) infusion combined with 5-FU (1000 mg/m2/day, continuous i.v., days 1-4), every 3 weeks) was offered to patients progressing after single agent treatment. Eighteen out of 32 patients (12 males, median age 57 years) treated in the single agent arms received the OXFU combination in second-line treatment. WHO performance status was at least 2 in 61% of the patients. There was no objective response and 3 patients (17%) had a disease stabilisation. Median time to progression from the start of second-line treatment was 0.9 months. Median overall survival was 4.9 months from the start of front-line therapy and 1.3 months from the start of second-line therapy. The results of this trial bring arguments to support a modest value of second-line chemotherapy for advanced pancreatic adenocarcinoma.
ISSN:0399-8320
DOI:10.1016/S0399-8320(06)73188-8