PMID- 16633299 OWN - NLM STAT- MEDLINE DCOM- 20060830 LR - 20220311 IS - 0399-8320 (Print) IS - 0399-8320 (Linking) VI - 30 IP - 3 DP - 2006 Mar TI - Oxaliplatin combined with 5-FU in second line treatment of advanced pancreatic adenocarcinoma. Results of a phase II trial. PG - 357-63 AB - BACKGROUND: The efficacy and benefit of second-line chemotherapy in advanced pancreatic adenocarcinoma has never been demonstrated although it is regularly used. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: The results of this trial bring arguments to support a modest value of second-line chemotherapy for advanced pancreatic adenocarcinoma. FAU - Mitry, Emmanuel AU - Mitry E AD - CHU Ambroise Pare, Boulogne. emmanuel.mitry@apr.aphp.fr FAU - Ducreux, Michel AU - Ducreux M FAU - Ould-Kaci, Mahmoud AU - Ould-Kaci M FAU - Boige, Valerie AU - Boige V FAU - Seitz, Jean-Francois AU - Seitz JF FAU - Bugat, Roland AU - Bugat R FAU - Breau, Jean-Luc AU - Breau JL FAU - Bouche, Olivier AU - Bouche O FAU - Etienne, Pierre-Luc AU - Etienne PL FAU - Tigaud, Jean-Marie AU - Tigaud JM FAU - Morvan, Francois AU - Morvan F FAU - Cvitkovic, Esteban AU - Cvitkovic E FAU - Rougier, Philippe AU - Rougier P LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - France TA - Gastroenterol Clin Biol JT - Gastroenterologie clinique et biologique JID - 7704825 RN - 0 (Organoplatinum Compounds) RN - 04ZR38536J (Oxaliplatin) RN - U3P01618RT (Fluorouracil) SB - IM MH - Adenocarcinoma/*drug therapy MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Disease Progression MH - Female MH - Fluorouracil/administration & dosage MH - Humans MH - Male MH - Middle Aged MH - Organoplatinum Compounds/administration & dosage MH - Oxaliplatin MH - Pancreatic Neoplasms/*drug therapy EDAT- 2006/04/25 09:00 MHDA- 2006/08/31 09:00 CRDT- 2006/04/25 09:00 PHST- 2006/04/25 09:00 [pubmed] PHST- 2006/08/31 09:00 [medline] PHST- 2006/04/25 09:00 [entrez] AID - s0399-8320(06)73188-8 [pii] AID - 10.1016/s0399-8320(06)73188-8 [doi] PST - ppublish SO - Gastroenterol Clin Biol. 2006 Mar;30(3):357-63. doi: 10.1016/s0399-8320(06)73188-8.