Patients included in clinical trials are “selected”, and they usually differ from those commonly treated. Methods: From 1999 to 2004, in the Medical Oncology Department of Padua (Italy), 70 metastatic colorectal cancers were treated with FOLFOX4.
Results
Our results, compared with those of the registration trial (response rate, duration of response and progression-free survival) appeared lower; overall survival was improved.
Conclusions
The number of therapeutic regimens more than their type influenced the results.
AndréT., LouvetC., RaymondE., TournigandC., de GramontA.: Bimonthly high-dose leucovorin, 5-fluorouracil 48hour infusion and oxaliplatin (FOLFOX3) for metastatic colorectal cancer resistant to the same LV5FU regimen.Ann Oncol, 9: 1251–1253, 1998.
2.
De GramontA., BossetJ.F., MilanC., RougierP., BoucheO., EtienneP.L., MorvanF., LouvetC., GuillotT., FrancoisE., BedenneL.: Randomized trial comparing monthly low dose leucovorin and 5-fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus continuous infusion for advanced colorectal cancer: a French Intergroup Study.J Clin Oncol, 15: 808–815, 1997.
3.
De GramontA., VignoudJ., TournigandC., LouvetC., AndreT., VaretteC., RaymondE., MoreauS., Le BailN., KrulikM.: Oxaliplatin with high-dose leucovorin and 5fluorouracil 48-hour continuous infusion in pretreated metastatic colorectal cancer.Eur J Cancer, 33: 214–219, 1997.
4.
De GramontA., FigerA., SeymourM., HomerinM., HmissiA., CassidyJ., BoniC., Cortes-FunesH., CervantesA., FreyerG., PapamichaelD., Le BailN., LouvetC., HendlerD., de BraudF., WilsonC., MorvanF., BonettiA.: Leucovorin and fluorouracil with or without oxaliplatin as first-line therapy for metastatic colorectal cancer.J Clin Oncol, 18: 2938–2947, 2000.
5.
Common Terminology Criteria for Adverse Events. Version 3.0 (CTCAE), December 12, 2003.
6.
SeymourM.T., SlevinM., KerrD.J., CunninghamD., JamesR.D., LedermannJ.A., PerrenT.J., McAdamW.A., HarperP.G., NeoptolemosJ.P., NicholsonM., DuffyA.M., StephensR.J., StenningS.P., TaylorI.: Randomised trial assessing the addition of interferon-2-alpha to fluorouracil and leucovorin in advanced colorectal cancer.J Clin Oncol, 14: 2280–2288, 1996.
7.
LaufmanL.R., BukowskiR.M., CollierM.A., SullivanB.A., McKinnisR.A., ClendenninN.J., GuaspariA., BrenckmanWDJr.: A randomised, double-blind trial of fluorouracil plus placebo versus fluorouracil plus oral leucovorin in patients with metastatic colorectal cancer.J Clin Oncol, 11: 1888–1893, 1993.
8.
BlijhamG.H., WagenerT., WilsJ., de GreveJ., BusetM., BleibergH., LacaveA., DalmarkM., SelleslagJ., ColletteL., SahmoudT.: Modulation of high-dose infusional fluorouracil by low-dose methotrexate in patients with advanced or metastatic colorectal cancer: Final results of a randomized European Organization for Research and Treatment of Cancer study.J Clin Oncol, 14: 2266–2273, 1996.
9.
TournigandC., AndrèT., AchilleE., LledoG., FleshM., Mery-MignardD., QuinauxE., CouteauC., BuyseM., GanemG., LandiB., ColinP., LouvetC., de Gramont: A “Folfiri'’ followed by “folfox 6'’ or the reverse sequence in advanced colorectal cancer: a randomised GERCOR study.J Clin Oncol, 22: 229–237, 2004.
