Phase III study comparing a semimonthly with a monthly regimen of fluorouracil and leucovorin as adjuvant treatment for stage II and III colon cancer patients: Final results of GERCOR C96.1

Journal of Clinical Oncology

Volumn 25, Issue 24, 2007, Pages 3732-3738

  André, Thierry ^a   Quinaux, Emmanuel ^b   Louvet, Christophe ^b   Colin, Philippe ^b   Gamelin, Erik ^b   Bouche, Olivier ^b   Achille, Emmanuel ^b   Piedbois, Pascal ^b   Tubiana Mathieu, Nicole ^b   Boutan Laroze, Arnaud ^b   Flesch, Michel ^b   Lledo, Gérard ^b   Raoul, Yves ^b   Debrix, Isabelle ^b   Buyse, Marc ^b   De Gramont, Aimery ^b  

^a HÔPITAL TENON   (France)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

FLUOROURACIL; FOLINIC ACID; OXALIPLATIN;

ADJUVANT THERAPY; ADULT; AGED; ARTICLE; CANCER PATIENT; CANCER STAGING; CLINICAL TRIAL; COLON CANCER; CONFIDENCE INTERVAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG MEGADOSE; FACTORIAL DESIGN; FEMALE; FOLLOW UP; HAZARD RATIO; HUMAN; LOG RANK TEST; LOW DRUG DOSE; MALE; METASTASIS; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RACEMIC MIXTURE; RANDOMIZED CONTROLLED TRIAL; RELAPSE; TREATMENT DURATION; TREATMENT RESPONSE;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; COLONIC NEOPLASMS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FLUOROURACIL; FOLLOW-UP STUDIES; HUMANS; LEUCOVORIN; NEOPLASM RECURRENCE, LOCAL; PROGNOSIS; SURVIVAL RATE;

EID: 34548488936     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.12.2234     Document Type: Article

References (23)

1. Obrand DI, Gordon PH: Incidence and patterns of recurrence following curative resection for colorectal carcinoma. Dis Colon Rectum 40:15-24, 1997
2. Advanced Colorectal Cancer Meta-Analysis Project: Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: Evidence in terms of response rate. J Clin Oncol 10:896-903, 1992
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 15:808-815, 1997
4. 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 18:2938-2947, 2000
5. Tournigand C, André T, Louvet C, et al: FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: A randomized GERCOR study. J Clin Oncol 22:229-237, 2004
6. 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 22:23-30, 2004
7. Moertel CG, Fleming TR, Macdonald JS, et al: Levamisole and fluorouracil as adjuvant therapy of resected colon carcinoma. N Engl J Med 322:352-358, 1990
8. Wolmark N, Rockette H, Mamounas E, et al: Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole, and fluorouracil, leucovorin, and levamisole in patients with Dukes' B and C carcinoma of the colon: Results from National Surgical Adjuvant Breast and Bowel Project C-04. J Clin Oncol 17:3553-3559, 1999
9. Haller DG, Catalano PJ, Macdonald JS, et al: Phase III study of fluorouracil, leucovorin, and levamisole in high-risk stage II and III colon cancer/final report of Intergroup 0089. J Clin Oncol 23:8671-8678, 2005
10. André T, Sargent D, Tabernero J, et al: For the GERCOR (French Oncology Research Group): Current issues in adjuvant treatment of stage II colon cancer. Ann Surg Oncol 13:887-898, 2006
11. O'Connell MJ, Laurie JA, Kahn M, et al: Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol 16:295-300, 1998
12. André T, Boni C, Mounedji-Boudiaf L, et al: Oxaliplatin, 5-fluorouracil and leucovorin as adjuvant treatment of colon cancer: Results of the international randomized MOSAIC trial. N Engl J Med 23:2343-2351, 2004
13. André T, Colin P, Louvet C, et al: For the GERCOR Group, Paris France: Bimonthly regimen of 5-fluorouracil and leucovorin (LV5FU2) as adjuvant therapy in stage II, and III colon cancer: 4-year results of a randomized trial. J Clin Oncol 21:2896-2903, 2003
14. André T, Colin P, Louvet C, et al: Randomized adjuvant study comparing two schemes of 5-fluorouracil and leucovorin in stage B2 and C colon adenocarcinoma: Study design and preliminary safety results. Semin Oncol 28:35-40, 2001 (supp 1)
15. Saini A, Norman AR, Cunningham D, et al: Twelve weeks of protracted venous infusion of fluorouracil is as effective as 6 months of bolus 5FU and folinic acid as adjuvant treatment in colorectal cancer. Br J Cancer 16:1859-1865, 2003
16. Poplin EA, Benedetti JK, Estes NC, et al: Phase III Southwest Oncology Group 9415/Intergroup 0153 randomized trial of fluorouracil, leucovorin, and levamisole vs. fluorouracil continuous infusion and levamisole for adjuvant treatment of stage III and high-risk stage II colon cancer. J Clin Oncol 23:1819-1825, 2005
17. Carrato A, Köhne C, Bedenne L, et al: For AIO/CAO, FFCD, TTD, EORTC: Folinic acid modulated bolus 5-FU or infusional 5-FU or infusional 5-FU adjuvant treatment of patients of UICC stage III colon cancer: Preliminary analysis of the PETACC-2-study. J Clin Oncol 24:161s, 2006 (abstr 3563)
18. Hickish T, Boni C, Navarro M, et al: Stage II patients in the "MOSAIC" trial evaluating oxaliplatin/5FU/LV as adjuvant treatment of colon cancer: A subpopulation analysis. Ann Oncol 15:iii76, 2004 (suppl 3; abstr 284P)
19. Andre T, Toumigand C, Achille E, et al: GERCOR (French Oncology Research Group): Adjuvant treatment of colon cancer Mosaic study's main results. Bull Cancer 93:S5-S9, 2006 (suppl 1)
20. O'Connel MJ for the Adjuvant Colon Cancer Endpoints (ACCENT) Group: Survival following recurrence in patients with adjuvant colon cancer: Findings from the 20,800 patient ACCENT Dataset: NSAPB Foundation, Pittsburgh, PA. American Society of Clinical Oncology Gastrointestinal Symposium 223: January 19-21, 2007 (abstr 277), Orlando, FL
21. Renehan AG, Egger M, Saunders MP, et al: Impact on survival of intensive follow up after curative resection for colorectal cancer: Systematic review and meta-analysis of randomised trials. BMJ 324:813, 2002
22. Douillard JY, Cunningham D, Roth A, et al: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: A multicentre randomised trial. Lancet 355:1041-1047, 2000
23. Van Cutsem E, Labianca R, Hossfeld D, et al: Randomized phase III trial comparing infused-irinotecan/5-fluorouracil (5FU)/folinic acid (AF) vs. 5FU/FA (AF) in stage III colon cancer patients (PETACC-3: V307). J Clin Oncol 23:3s, 2005 (abstr 8)