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

被引:35
作者
Mitry, E
Ducreux, M
Ould-Kaci, M
Boige, V
Seitz, JF
Bugat, R
Breau, JL
Bouché, O
Etienne, PL
Tigaud, JM
Morvan, F
Cvitkovic, E
Rougier, P
机构
[1] CHU Ambroise Pare, Serv Hepatogastroenterol & Oncol Digest, F-92100 Boulogne, France
[2] Inst Gustave Roussy, Villejuif, France
[3] Cvitkov & Associes Consultants, Le Kremlin Bicetre, France
[4] Inst J Paoli I Calmettes, F-13009 Marseille, France
[5] Ctr Claudius Regaud, Toulouse, France
[6] Hop Avicenne, F-93009 Bobigny, France
[7] CHU Robert Debre, Reims, France
[8] Clin Armoricaine Radiol, St Brieuc, France
[9] Ctr Hosp Intercommunal, Villeneuve St Georges, France
[10] Ctr Hosp R Dubos, Pontoise, France
来源
GASTROENTEROLOGIE CLINIQUE ET BIOLOGIQUE | 2006年 / 30卷 / 03期
关键词
D O I
10.1016/S0399-8320(06)73188-8
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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), infusionol 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/m(2) 2-h intravenous (i.v.) infusion combined with 5-FU (1000 mg/m(2)/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.
引用
收藏
页码:357 / 363
页数:7
相关论文
共 30 条
[1]   Gemcitabine and oxaliplatin for metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group phase II study [J].
Alberts, SR ;
Townley, PM ;
Goldberg, RM ;
Cha, SS ;
Sargent, DJ ;
Moore, DF ;
Krook, JE ;
Pitot, HC ;
Fitch, TR ;
Wiesenfeld, M ;
Mailliard, JA .
ANNALS OF ONCOLOGY, 2003, 14 (04) :580-585
[2]   Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: Eastern Cooperative Oncology Group Trial E2297 [J].
Berlin, JD ;
Catalano, P ;
Thomas, JP ;
Kugler, JW ;
Haller, DG ;
Benson, AB .
JOURNAL OF CLINICAL ONCOLOGY, 2002, 20 (15) :3270-3275
[3]   Use of the ratio of time to progression following first- and second-line therapy to document the activity of the combination of oxaliplatin with 5-fluorouracil in the treatment of colorectal carcinoma [J].
Bonetti, A ;
Zaninelli, M ;
Leone, R ;
Franceschi, T ;
Fraccon, AP ;
Pasini, F ;
Sabbioni, R ;
Cetto, GL ;
Sich, D ;
Brienza, S ;
Howell, SB .
ANNALS OF ONCOLOGY, 2001, 12 (02) :187-191
[4]   Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial [J].
Burris, HA ;
Moore, MJ ;
Andersen, J ;
Green, MR ;
Rothenberg, ML ;
Madiano, MR ;
Cripps, MC ;
Portenoy, RK ;
Storniolo, AM ;
Tarassoff, P ;
Nelson, R ;
Dorr, FA ;
Stephens, CD ;
VanHoff, DD .
JOURNAL OF CLINICAL ONCOLOGY, 1997, 15 (06) :2403-2413
[5]  
CANTORE M, 2002, P AN M AM SOC CLIN, V21, P96
[6]   Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma - A prospective, randomized phase III study of the Gruppo Oncologico dell'Italia Meridionale [J].
Colucci, G ;
Giuliani, F ;
Gebbia, V ;
Biglietto, M ;
Rabitti, P ;
Uomo, G ;
Cigolari, S ;
Testa, A ;
Maiello, E ;
Lopez, M .
CANCER, 2002, 94 (04) :902-910
[7]   Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer [J].
de Gramont, A ;
Figer, A ;
Seymour, M ;
Homerin, M ;
Hmissi, A ;
Cassidy, J ;
Boni, C ;
Cortes-Funes, H ;
Cervantes, A ;
Freyer, G ;
Papamichael, D ;
Le Bail, N ;
Louvet, C ;
Hendler, D ;
de Braud, F ;
Wilson, C ;
Morvan, F ;
Bonetti, A .
JOURNAL OF CLINICAL ONCOLOGY, 2000, 18 (16) :2938-2947
[8]   Randomized phase II study evaluating oxaliplatin alone, oxaliplatin combined with infusional 5-FU, and infusional 5-FU alone in advanced pancreatic carcinoma patients [J].
Ducreux, M ;
Mitry, E ;
Ould-Kaci, M ;
Boige, V ;
Seitz, JF ;
Bugat, R ;
Breau, JL ;
Bouchè, O ;
Etienne, PL ;
Tigaud, JM ;
Morvan, F ;
Cvitkovic, E ;
Rougier, P .
ANNALS OF ONCOLOGY, 2004, 15 (03) :467-473
[9]   Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer [J].
Glimelius, B ;
Hoffman, K ;
Sjoden, PO ;
Jacobsson, G ;
Sellstrom, H ;
Enander, LK ;
Linne, T ;
Svensson, C .
ANNALS OF ONCOLOGY, 1996, 7 (06) :593-600
[10]   Gemcitabine and cisplatin in the treatment of advanced or metastatic pancreatic cancer [J].
Heinemann, V ;
Wilke, H ;
Mergenthaler, HG ;
Clemens, M ;
König, H ;
Illiger, HJ ;
Arning, M ;
Schalhorn, A ;
Possinger, K ;
Fink, U .
ANNALS OF ONCOLOGY, 2000, 11 (11) :1399-1403