Advertisement
Journal of Clinical Oncology  
Search for:
Limit by:
  Browse by Subject or Issue
Home Search or Browse JCO My JCO Subscriptions Customer Service Site Map

Journal of Clinical Oncology, Vol 24, No 3 (January 20), 2006: pp. 394-400
© 2006 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.03.0106
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Purchase Article
Right arrow View Shopping Cart
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a colleague
Right arrow Similar articles in this journal
Right arrow Alert me to new issues of the journal
Right arrow Save to my personal folders
Right arrow Download to citation manager
Right arrowRights & Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Tournigand, C.
Right arrow Articles by de Gramont, A.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Tournigand, C.
Right arrow Articles by de Gramont, A.
Social Bookmarking
Add to CiteULike   Add to Complore   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Facebook   Add to Reddit   Add to Technorati   Add to Twitter  
What's this?

OPTIMOX1: A Randomized Study of FOLFOX4 or FOLFOX7 With Oxaliplatin in a Stop-and-Go Fashion in Advanced Colorectal Cancer—A GERCOR Study

Christophe Tournigand, Andres Cervantes, Arie Figer, Gérard Lledo, Michel Flesch, Marc Buyse, Laurent Mineur, Elisabeth Carola, Pierre-Luc Etienne, Fernando Rivera, Isabel Chirivella, Nathalie Perez-Staub, Christophe Louvet, Thierry André, Isabelle Tabah-Fisch, Aimery de Gramont

From the Hôpital Saint-Antoine; Hôpital Tenon; Sanofi-Aventis, Paris; Clinique Saint Jean, Lyon; Hôpital Devron, Dijon; Clinique Sainte Catherine, Avignon; Hôpital de Senlis, Senlis; Clinique Radiologique Armoricaine, Saint Brieuc, France; Hospital Clínico Universitario, Valencia; Hospital Universitario Marques de Valdecilla, Santander, Spain; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; and International Drug Development Institute, Brussels, Belgium.

Address reprint requests to A. de Gramont, MD, Hôpital Saint-Antoine, 184, rue du Faubourg Saint-Antoine, 75571 Paris Cedex 12, France; e-mail: aimery.de-gramont{at}sat.ap-hop-paris.fr

Purpose In metastatic colorectal cancer, a combination of leucovorin (LV) and fluorouracil (FU) with oxaliplatin (FOLFOX) 4 is a standard first-line regimen. The cumulative neurotoxicity of oxaliplatin often requires therapy to be stopped in patients who are still responding. This study evaluates a new strategy of intermittent oxaliplatin treatment that is based on FOLFOX7, a simplified leucovorin and fluorouracil regimen with high-dose oxaliplatin.

Patients and Methods Previously untreated patients were randomly assigned to either FOLFOX4 administered every 2 weeks until progression (arm A) or FOLFOX7 for six cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7 (arm B).

Results Six hundred twenty patients were enrolled, including an exploratory cohort of 95 elderly or poor prognosis patients. Median progression-free survival and survival times were 9.0 and 19.3 months, respectively, in patients allocated to arm A compared with 8.7 and 21.2 months, respectively, in patients allocated to arm B (P = not significant). Response rates were 58.5% with arm A and 59.2% with arm B. National Cancer Institute Common Toxicity Criteria grade 3 or 4 toxicity was observed in 54.4% of the patients in arm A v 48.7% of patients in arm B. From cycle 7, fewer patients experienced grade 3 or 4 toxicity in arm B. Grade 3 sensory neuropathy was observed in 17.9% of the patients in arm A v 13.3% of patients in arm B (P = .12). In arm B, oxaliplatin was reintroduced in only 40.1% of the patients but achieved responses or stabilizations in 69.4% of these patients.

Conclusion Oxaliplatin can be safely stopped after six cycles in a FOLFOX regimen. Further study is needed to fully evaluate oxaliplatin reintroduction.

Supported by the GERCOR, Paris, France.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Facebook Facebook   Add to Reddit Reddit   Add to Technorati Technorati   Add to Twitter Twitter    What's this?


This article has been cited by other articles:


Home page
 Ann OncolHome page
E. D. Saad, A. Katz, P. M. Hoff, and M. Buyse
Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature
Ann. Onc., November 9, 2009; (2009) mdp523v1.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
R. K. Ramanathan, M. L. Rothenberg, A. de Gramont, C. Tournigand, R. M. Goldberg, S. Gupta, and T. Andre
Incidence and evolution of oxaliplatin-induced peripheral sensory neuropathy in diabetic patients with colorectal cancer: a pooled analysis of three phase III studies
Ann. Onc., November 3, 2009; (2009) mdp509v1.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
A. Grothey and D. J. Sargent
Reply to F. Montagnani et al
J. Clin. Oncol., October 1, 2009; 27(28): e134 - e135.
[Full Text] [PDF]

Home page
 Therapeutic Advances in Medical OncologyHome page
A. Grothey
Review: Medical treatment of advanced colorectal cancer in 2009
Therapeutic Advances in Medical Oncology, September 1, 2009; 1(2): 55 - 68.
[Abstract] [PDF]

Home page
 Ann OncolHome page
B. Chibaudel, C. Tournigand, P. Artru, T. Andre, A. Cervantes, A. Figer, G. Lledo, M. Flesch, M. Buyse, L. Mineur, et al.
FOLFOX in patients with metastatic colorectal cancer and high alkaline phosphatase level: an exploratory cohort of the GERCOR OPTIMOX1 study
Ann. Onc., August 1, 2009; 20(8): 1383 - 1386.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
T. Andre, C. Boni, M. Navarro, J. Tabernero, T. Hickish, C. Topham, A. Bonetti, P. Clingan, J. Bridgewater, F. Rivera, et al.
Improved Overall Survival With Oxaliplatin, Fluorouracil, and Leucovorin As Adjuvant Treatment in Stage II or III Colon Cancer in the MOSAIC Trial
J. Clin. Oncol., July 1, 2009; 27(19): 3109 - 3116.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
F.-C. Bidard, C. Tournigand, T. Andre, M. Mabro, A. Figer, A. Cervantes, G. Lledo, L. Bengrine-Lefevre, F. Maindrault-Goebel, C. Louvet, et al.
Efficacy of FOLFIRI-3 (irinotecan D1,D3 combined with LV5-FU) or other irinotecan-based regimens in oxaliplatin-pretreated metastatic colorectal cancer in the GERCOR OPTIMOX1 study
Ann. Onc., June 1, 2009; 20(6): 1042 - 1047.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
D. J. Sargent, C. H. Kohne, H. K. Sanoff, B. M. Bot, M. T. Seymour, A. de Gramont, R. Porschen, L. B. Saltz, P. Rougier, C. Tournigand, et al.
Pooled Safety and Efficacy Analysis Examining the Effect of Performance Status on Outcomes in Nine First-Line Treatment Trials Using Individual Data From Patients With Metastatic Colorectal Cancer
J. Clin. Oncol., April 20, 2009; 27(12): 1948 - 1955.
[Abstract] [Full Text] [PDF]

Home page
 Am Soc Clin Oncol Ed BookHome page
A. Grothey
Optimized Treatment of Metastatic Colorectal Cancer
ASCO Educational Book, January 1, 2009; 2009(1): 209 - 211.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
T. McKibbin and J. M. Koeller
In Reply
Oncologist, January 1, 2009; 14(1): 106 - 107.
[Full Text] [PDF]

Home page
 JCOHome page
H. K. Sanoff, D. J. Sargent, M. E. Campbell, R. F. Morton, C. S. Fuchs, R. K. Ramanathan, S. K. Williamson, B. P. Findlay, H. C. Pitot, and R. M. Goldberg
Five-Year Data and Prognostic Factor Analysis of Oxaliplatin and Irinotecan Combinations for Advanced Colorectal Cancer: N9741
J. Clin. Oncol., December 10, 2008; 26(35): 5721 - 5727.
[Abstract] [Full Text] [PDF]

Home page
 J Oncol PractHome page
K. M. Field, S. Kosmider, M. Jefford, R. Jennens, M. Green, and P. Gibbs
Chemotherapy Treatments for Metastatic Colorectal Cancer: Is Evidence-Based Medicine in Practice?
J. Oncol. Pract, November 1, 2008; 4(6): 271 - 276.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
B. H. O'Neil and R. M. Goldberg
Innovations in Chemotherapy for Metastatic Colorectal Cancer: An Update of Recent Clinical Trials
Oncologist, October 1, 2008; 13(10): 1074 - 1083.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
S. J. Cohen, C. J.A. Punt, N. Iannotti, B. H. Saidman, K. D. Sabbath, N. Y. Gabrail, J. Picus, M. Morse, E. Mitchell, M. C. Miller, et al.
Relationship of Circulating Tumor Cells to Tumor Response, Progression-Free Survival, and Overall Survival in Patients With Metastatic Colorectal Cancer
J. Clin. Oncol., July 1, 2008; 26(19): 3213 - 3221.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
C. Qvortrup, M. Yilmaz, D. Ogreid, A. Berglund, L. Balteskard, J. Ploen, T. Fokstuen, H. Starkhammar, H. Sorbye, K. Tveit, et al.
Chronomodulated capecitabine in combination with short-time oxaliplatin: a Nordic phase II study of second-line therapy in patients with metastatic colorectal cancer after failure to irinotecan and 5-flourouracil
Ann. Onc., June 1, 2008; 19(6): 1154 - 1159.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
D. Machover, A. Ulusakarya, and E. Goldschmidt
Modulation of FU With High-Dose Folinic Acid Is Effective for Treatment of Patients With Gastric Carcinoma
J. Clin. Oncol., January 1, 2008; 26(1): 164 - 164.
[Full Text] [PDF]

Home page
 JCOHome page
P. A. Tang, S. M. Bentzen, E. X. Chen, and L. L. Siu
Surrogate End Points for Median Overall Survival in Metastatic Colorectal Cancer: Literature-Based Analysis From 39 Randomized Controlled Trials of First-Line Chemotherapy
J. Clin. Oncol., October 10, 2007; 25(29): 4562 - 4568.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
H. Sorbye, C.-H. Kohne, D. J. Sargent, and B. Glimelius
Patient characteristics and stratification in medical treatment studies for metastatic colorectal cancer: A proposal for standardization of patient characteristic reporting and stratification
Ann. Onc., October 1, 2007; 18(10): 1666 - 1672.
[Abstract] [Full Text] [PDF]

Home page
 Jpn J Clin OncolHome page
T. Yoshino, N. Boku, Y. Onozawa, S. Hironaka, A. Fukutomi, Y. Yamaguchi, N. Hasuike, K. Yamazaki, N. Machida, and H. Ono
Efficacy and Safety of an Irinotecan plus Bolus 5-Fluorouracil and L-Leucovorin Regimen for Metastatic Colorectal Cancer in Japanese Patients: Experience in a Single Institution in Japan
Jpn. J. Clin. Oncol., September 1, 2007; 37(9): 686 - 691.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
C. Allegra, C. Blanke, M. Buyse, R. Goldberg, A. Grothey, N. J. Meropol, L. Saltz, A. Venook, G. Yothers, and D. Sargent
End Points in Advanced Colon Cancer Clinical Trials: A Review and Proposal
J. Clin. Oncol., August 20, 2007; 25(24): 3572 - 3575.
[Full Text] [PDF]

Home page
 JCOHome page
G. K. Dy, J. E. Krook, E. M. Green, D. J. Sargent, T. Delaunoit, R. F. Morton, C. S. Fuchs, R. K. Ramanathan, S. K. Williamson, B. P. Findlay, et al.
Impact of Complete Response to Chemotherapy on Overall Survival in Advanced Colorectal Cancer: Results From Intergroup N9741
J. Clin. Oncol., August 10, 2007; 25(23): 3469 - 3474.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
D. Sargent and A. Grothey
Sound Footing or Slippery Slope? The Value of Secondary Analyses of Randomized Trials
J. Clin. Oncol., August 1, 2007; 25(22): 3191 - 3193.
[Full Text] [PDF]

Home page
 JCOHome page
A. de Gramont, M. Buyse, J. C. Abrahantes, T. Burzykowski, E. Quinaux, A. Cervantes, A. Figer, G. Lledo, M. Flesch, L. Mineur, et al.
Reintroduction of Oxaliplatin Is Associated With Improved Survival in Advanced Colorectal Cancer
J. Clin. Oncol., August 1, 2007; 25(22): 3224 - 3229.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
H. K. Sanoff, H. Bleiberg, and R. M. Goldberg
Managing Older Patients With Colorectal Cancer
J. Clin. Oncol., May 10, 2007; 25(14): 1891 - 1897.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
W.-S. Wang, J.-K. Lin, T.-C. Lin, W.-S. Chen, J.-K. Jiang, H.-S. Wang, T.-J. Chiou, J.-H. Liu, C.-C. Yen, and P.-M. Chen
Oral Glutamine Is Effective for Preventing Oxaliplatin-Induced Neuropathy in Colorectal Cancer Patients
Oncologist, March 1, 2007; 12(3): 312 - 319.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
T Andre, C Tournigand, L Mineur, R Fellague-Chebra, M Flesch, M Mabro, M Hebbar, S Postel Vinay, F. Bidard, C Louvet, et al.
Phase II study of an optimized 5-fluorouracil-oxaliplatin strategy (OPTIMOX2) with celecoxib in metastatic colorectal cancer: a GERCOR study
Ann. Onc., January 1, 2007; 18(1): 77 - 81.
[Abstract] [Full Text] [PDF]

Home page
 Mayo Clin Proc.Home page
S. Gill, A. W. Blackstock, and R. M. Goldberg
Colorectal Cancer
Mayo Clin. Proc., January 1, 2007; 82(1): 114 - 129.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
R. M. Goldberg, M. L. Rothenberg, E. Van Cutsem, A. B. Benson III, C. D. Blanke, R. B. Diasio, A. Grothey, H.-J. Lenz, N. J. Meropol, R. K. Ramanathan, et al.
The Continuum of Care: A Paradigm for the Management of Metastatic Colorectal Cancer
Oncologist, January 1, 2007; 12(1): 38 - 50.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
D. D. Rosa, G. F.V. Ismael, E. de Azambuja, S. Braga, F. Cardoso, and H. Bleiberg
OPTIMOX1 in Advanced Colorectal Cancer: Lack of Evidence for a Stop-and-Go Strategy
J. Clin. Oncol., November 10, 2006; 24(32): 5176 - 5177.
[Full Text] [PDF]

Home page
 JCOHome page
A. de Gramont, C. Tournigand, and M. Buyse
In Reply
J. Clin. Oncol., November 10, 2006; 24(32): 5177 - 5177.
[Full Text] [PDF]

Home page
 JCOHome page
N. J. Meropol
Turning Point for Colorectal Cancer Clinical Trials
J. Clin. Oncol., July 20, 2006; 24(21): 3322 - 3324.
[Full Text] [PDF]


About
JCO		 Editorial
Roster		 Advertising
Information		 Librarians &
Institutions		 Rights &
Permissions		 PDA Services

Copyright © 2006 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
Terms and Conditions of Use
  HighWire Press HighWire Press™ assists in the publication of JCO Online