Sequential versus combination chemotherapy for the treatment of advanced colorectal cancer (FFCD 2000-05): An open-label, randomised, phase 3 trial

The Lancet Oncology

Volumn 12, Issue 11, 2011, Pages 1032-1044

  Ducreux, Michel ^a,b   Malka, David ^a   Mendiboure, Jean ^a   Etienne, Pierre Luc ^c   Texereau, Patrick ^d   Auby, Dominique ^d   Rougier, Philippe ^e   Gasmi, Mohamed ^f   Castaing, Marine ^a   Abbas, Moncef ^a   Michel, Pierre ^g   Gargot, Dany ^d   Azzedine, Ahmed ^h   Lombard Bohas, Catherine ⁱ   Geoffroy, Patrick ^j   Denis, Bernard ^k   Pignon, Jean Pierre ^a   Bedenne, Laurent ^l   Bouché, Olivier ^m  

^a INSTITUT GUSTAVE ROUSSY   (France)

^b UNIVERSITÉ PARIS SACLAY   (France)

^c Clinique Armoricaine   (France)

^d CENTRE HOSPITALIER   (France)

^e HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

^f HÔPITAL NORD   (France)

^g HÔPITAL CHARLES NICOLLE   (France)

^h CENTRE HOSPITALIER D AVIGNON   (France)

ⁱ EDOUARD HERRIOT HOSPITAL   (France)

^j Clinique Saint Vincent   (France)

^k Pasteur Hospital   (France)

^l DIJON UNIVERSITY HOSPITAL   (France)

^m SERVICE DE DERMATOLOGIE   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BLOOD TOXICITY; BOLUS INJECTION; CANCER COMBINATION CHEMOTHERAPY; CANCER MORTALITY; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; COLORECTAL CANCER; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEMALE; HUMAN; INFUSION; INOPERABLE CANCER; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SEQUENTIAL INJECTION ANALYSIS; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CHI-SQUARE DISTRIBUTION; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; FRANCE; HUMANS; KAPLAN-MEIER ESTIMATE; LEUCOVORIN; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; PROPORTIONAL HAZARDS MODELS; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 80053384385     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(11)70199-1     Document Type: Article

References (40)

1. Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010, 127:2893-2917.
2. Ferlay J, Parkin DM, Steliarova-Foucher E Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 2010, 46:765-781.
3. De Gramont A, Bosset JF, Milan C, et al. Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol 1997, 15:808-815.
4. Kohne CH, Van Cutsem E, Wils J, et al. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European organisation for research and treatment of cancer gastrointestinal group study 40986. J Clin Oncol 2005, 23:4856-4865.
5. Van Cutsem E, Twelves C, Cassidy J, et al. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol 2001, 19:4097-4106.
6. Hoff PM, Ansari R, Batist G, et al. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol 2001, 19:2282-2292.
7. Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer: meta-analysis group in cancer. J Clin Oncol 1998, 16:301-308.
8. Grothey A, Sargent D, Goldberg RM, Schmoll HJ Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 2004, 22:1209-1214.
9. Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000, 355:1041-1047.
10. Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2000, 343:905-914.
11. De Gramont A, Figer A, Seymour M, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000, 18:2938-2947.
12. Giacchetti S, Perpoint B, Zidani R, et al. Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 2000, 18:136-147.
13. Punt CJ New options and old dilemmas in the treatment of patients with advanced colorectal cancer. Ann Oncol 2004, 15:1453-1459.
14. Goldberg RM, Sargent DJ, Morton RF, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004, 22:23-30.
15. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004, 350:2335-2342.
16. Seymour MT, Maughan TS, Ledermann JA, et al. Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet 2007, 370:143-152.
17. Tournigand C, Andre T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 2004, 22:229-237.
18. Tournigand C, Cervantes A, Figer A, et al. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-go fashion in advanced colorectal cancer-a GERCOR study. J Clin Oncol 2006, 24:394-400.
19. Grothey A, Deschler B, Kroening H, et al. Bolus 5-fluorouracil (5-FU)/folinic acid (FA) (Mayo) vs weekly high-dose 24H 5-Fu infusion/FA + oxaliplatin (OXA) in advanced colorectal cancer (CRC): results of a phase III study. Proc Am Soc Clin Oncol 2001, 20(suppl):496.
20. Kim GP, Sargent DJ, Mahoney MR, et al. Phase III noninferiority trial comparing irinotecan with oxaliplatin, fluorouracil, and leucovorin in patients with advanced colorectal carcinoma previously treated with fluorouracil: N9841. J Clin Oncol 2009, 27:2848-2854.
21. Grothey A, Sargent D Overall survival of patients with advanced colorectal cancer correlates with availability of fluorouracil, irinotecan, and oxaliplatin regardless of whether doublet or single-agent therapy is used first line. J Clin Oncol 2005, 23:9441-9442.
22. Falcone A, Ricci S, Brunetti I, et al. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol 2007, 25:1670-1676.
23. Souglakos J, Kalykaki A, Vamvakas L, et al. Phase II trial of capecitabine and oxaliplatin (CAPOX) plus cetuximab in patients with metastatic colorectal cancer who progressed after oxaliplatin-based chemotherapy. Ann Oncol 2007, 18:305-310.
24. WHO handbook for reporting results of cancer treatment 1979, WHO, World Health Organization, Geneva.
25. Andre T, Louvet C, Maindrault-Goebel F, et al. CPT-11 (irinotecan) addition to bimonthly, high-dose leucovorin and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancer. GERCOR. Eur J Cancer 1999, 35:1343-1347.
26. Common toxicity criteria (version 2) National Cancer Institute, (accessed Aug 25, 2011). http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcv2nom-4-30-99-final3.pdf.
27. Boige V, Mendiboure J, Pignon JP, et al. Pharmacogenetic assessment of toxicity and outcome in patients with metastatic colorectal cancer treated with LV5FU2, FOLFOX, and FOLFIRI: FFCD 2000-05. J Clin Oncol 2010, 28:2556-2564.
28. Schemper M, Smith TL A note on quantifying follow-up in studies of failure time. Control Clin Trials 1996, 17:343-346.
29. Kohne CH, Cunningham D, Di CF, et al. Clinical determinants of survival in patients with 5-fluorouracil-based treatment for metastatic colorectal cancer: results of a multivariate analysis of 3825 patients. Ann Oncol 2002, 13:308-317.
30. Aaronson NK, Ahmedzai S, Bergman B, et al. The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993, 85:365-376.
31. Koopman M, Antonini NF, Douma J, et al. Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial. Lancet 2007, 370:135-142.
32. Cunningham D, Sirohi B, Pluzanska A, et al. Two different first-line 5-fluorouracil regimens with or without oxaliplatin in patients with metastatic colorectal cancer. Ann Oncol 2009, 20:244-250.
33. Van Cutsem E, Kohne CH, Hitre E, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009, 360:1408-1417.
34. Douillard JY, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol 2010, 28:4697-4705.
35. Seymour MT, Thompson LC, Wasan HS, et al. Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): an open-label, randomised factorial trial. Lancet 2011, 377:1749-1759.
36. Folprecht G, Grothey A, Alberts S, et al. Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates. Ann Oncol 2005, 16:1311-1319.
37. Sobrero AF, Maurel J, Fehrenbacher L, et al. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol 2008, 26:2311-2319.
38. Braun MS, Richman SD, Quirke P, et al. Predictive biomarkers of chemotherapy efficacy in colorectal cancer: results from the UK MRC FOCUS trial. J Clin Oncol 2008, 26:2690-2698.
39. Boige V, Malka D, Pignon JP, Laurent-Puig P Response to authors. J Clin Oncol 2011, 29:356-357.
40. Hurwitz HI, Fehrenbacher L, Hainsworth JD, et al. Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer. J Clin Oncol 2005, 23:3502-3508.