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Journal of Clinical Oncology, Vol 18, Issue 16 (August), 2000: 2938-2947
© 2000 American Society for Clinical Oncology

Leucovorin and Fluorouracil With or Without Oxaliplatin as First-Line Treatment in Advanced Colorectal Cancer

By A. de Gramont, A. Figer, M. Seymour, M. Homerin, A. Hmissi, J. Cassidy, C. Boni, H. Cortes-Funes, A. Cervantes, G. Freyer, D. Papamichael, N. Le Bail, C. Louvet, D. Hendler, F. de Braud, C. Wilson, F. Morvan, A. Bonetti

From the Service de Médecine Interne-Oncologie, Hôpital Saint-Antoine, Paris; Debiopharm, Charenton; Service d’Oncologie Médicale, Centre Hospitalier Lyon Sud, Pierre-Benite; and Centre Hospitalier René Dubos, Pontoise, France; Institute of Oncology, Belinson Medical Center, Petach Tikva, Israel; Imperial Cancer Research Fund Cancer Medicine Research Unit, University of Leeds; Department of Medicine and Therapeutics, University of Aberdeen, Aberdeen; Department of Medical Oncology, St Bartholomew’s Hospital, London; and Addenbrooke’s National Health Service Trust, Cambridge, United Kingdom; Servizio di Oncologia Medica, Arcispedale S. Maria Nuova, Reggio Emilia; Instituto Europeo di Oncologia, Milan; and Clinical Oncology Centre, Service d’Oncologie Médicale, Div Oncologia Medica Azienda, Ospedaliera di Verona, Verona, Italy; Servicio de Oncología, the Hospital 12 de Octubre, Madrid; and Servicio de Onco-Hematologia, Hospital Clinico Universitario, Valencia, Spain.

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

PURPOSE: In a previous study of treatment for advanced colorectal cancer, the LV5FU2 regimen, comprising leucovorin (LV) plus bolus and infusional fluorouracil (5FU) every 2 weeks, was superior to the standard North Central Cancer Treatment Group/Mayo Clinic 5-day bolus 5FU/LV regimen. This phase III study investigated the effect of combining oxaliplatin with LV5FU2, with progression-free survival as the primary end point.

PATIENTS AND METHODS: Four hundred twenty previously untreated patients with measurable disease were randomized to receive a 2-hour infusion of LV (200 mg/m2/d) followed by a 5FU bolus (400 mg/m2/d) and 22-hour infusion (600 mg/m2/d) for 2 consecutive days every 2 weeks, either alone or together with oxaliplatin 85 mg/m2 as a 2-hour infusion on day 1.

RESULTS: Patients allocated to oxaliplatin plus LV5FU2 had significantly longer progression-free survival (median, 9.0 v 6.2 months; P = .0003) and better response rate (50.7% v 22.3%; P = .0001) when compared with the control arm. The improvement in overall survival did not reach significance (median, 16.2 v 14.7 months; P = .12). LV5FU2 plus oxaliplatin gave higher frequencies of National Cancer Institute common toxicity criteria grade 3/4 neutropenia (41.7% v 5.3% of patients), grade 3/4 diarrhea (11.9% v 5.3%), and grade 3 neurosensory toxicity (18.2% v 0%), but this did not result in impairment of quality of life (QoL). Survival without disease progression or deterioration in global health status was longer in patients allocated to oxaliplatin treatment (P = .004).

CONCLUSION: The LV5FU2-oxaliplatin combination seems beneficial as first-line therapy in advanced colorectal cancer, demonstrating a prolonged progression-free survival with acceptable tolerability and maintenance of QoL.


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Cetuximab in combination with weekly 5-fluorouracil/folinic acid and oxaliplatin (FUFOX) in untreated patients with advanced colorectal cancer: a phase Ib/II study of the AIO GI Group
Ann. Onc., August 1, 2008; 19(8): 1442 - 1449.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
T. McKibbin, C. R. Frei, R. E. Greene, P. Kwan, J. Simon, and J. M. Koeller
Disparities in the Use of Chemotherapy and Monoclonal Antibody Therapy for Elderly Advanced Colorectal Cancer Patients in the Community Oncology Setting
Oncologist, August 1, 2008; 13(8): 876 - 885.
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 JCOHome page
H. S. Hochster, L. L. Hart, R. K. Ramanathan, B. H. Childs, J. D. Hainsworth, A. L. Cohn, L. Wong, L. Fehrenbacher, Y. Abubakr, M. W. Saif, et al.
Safety and Efficacy of Oxaliplatin and Fluoropyrimidine Regimens With or Without Bevacizumab As First-Line Treatment of Metastatic Colorectal Cancer: Results of the TREE Study
J. Clin. Oncol., July 20, 2008; 26(21): 3523 - 3529.
[Abstract] [Full Text] [PDF]

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 Therapeutic Advances in GastroenterologyHome page
J. M. Carethers
Review: Systemic treatment of advanced colorectal cancer: Tailoring therapy to the tumor
Therapeutic Advances in Gastroenterology, July 1, 2008; 1(1): 33 - 42.
[Abstract] [PDF]

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 GutHome page
A Walther, R Houlston, and I Tomlinson
Association between chromosomal instability and prognosis in colorectal cancer: a meta-analysis
Gut, July 1, 2008; 57(7): 941 - 950.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. S. Braun, S. D. Richman, P. Quirke, C. Daly, J. W. Adlard, F. Elliott, J. H. Barrett, P. Selby, A. M. Meade, R. J. Stephens, et al.
Predictive Biomarkers of Chemotherapy Efficacy in Colorectal Cancer: Results From the UK MRC FOCUS Trial
J. Clin. Oncol., June 1, 2008; 26(16): 2690 - 2698.
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 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]

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 Ann OncolHome page
L. B. J. van Iersel, H. Gelderblom, A. L. Vahrmeijer, E. L. van Persijn van Meerten, F. G. J. Tijl, H. Putter, H. H. Hartgrink, P. J. K. Kuppen, J. W. R. Nortier, R. A. E. M. Tollenaar, et al.
Isolated hepatic melphalan perfusion of colorectal liver metastases: outcome and prognostic factors in 154 patients
Ann. Onc., June 1, 2008; 19(6): 1127 - 1134.
[Abstract] [Full Text] [PDF]

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 Am J Health Syst PharmHome page
R. N. Schwartz
Management of early and advanced colorectal cancer: Therapeutic issues
Am. J. Health Syst. Pharm., June 1, 2008; 65(11_Supplement_4): S8 - S14.
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 Am J Health Syst PharmHome page
J. R. Hecht
Current and emerging therapies for metastatic colorectal cancer: Applying research findings to clinical practice
Am. J. Health Syst. Pharm., June 1, 2008; 65(11_Supplement_4): S15 - S21.
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 JCOHome page
A. F. Sobrero, J. Maurel, L. Fehrenbacher, W. Scheithauer, Y. A. Abubakr, M. P. Lutz, M. E. Vega-Villegas, C. Eng, E. U. Steinhauer, J. Prausova, et al.
EPIC: Phase III Trial of Cetuximab Plus Irinotecan After Fluoropyrimidine and Oxaliplatin Failure in Patients With Metastatic Colorectal Cancer
J. Clin. Oncol., May 10, 2008; 26(14): 2311 - 2319.
[Abstract] [Full Text] [PDF]

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 JCOHome page
E. Gamelin, R. Delva, J. Jacob, Y. Merrouche, J. L. Raoul, D. Pezet, E. Dorval, G. Piot, A. Morel, and M. Boisdron-Celle
Individual Fluorouracil Dose Adjustment Based on Pharmacokinetic Follow-Up Compared With Conventional Dosage: Results of a Multicenter Randomized Trial of Patients With Metastatic Colorectal Cancer
J. Clin. Oncol., May 1, 2008; 26(13): 2099 - 2105.
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 Ann OncolHome page
B. Glimelius, H. Sorbye, L. Balteskard, P. Bystrom, P. Pfeiffer, K. Tveit, R. Heikkila, N. Keldsen, M. Albertsson, H. Starkhammar, et al.
A randomized phase III multicenter trial comparing irinotecan in combination with the Nordic bolus 5-FU and folinic acid schedule or the bolus/infused de Gramont schedule (Lv5FU2) in patients with metastatic colorectal cancer
Ann. Onc., May 1, 2008; 19(5): 909 - 914.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. Cassidy, S. Clarke, E. Diaz-Rubio, W. Scheithauer, A. Figer, R. Wong, S. Koski, M. Lichinitser, T.-S. Yang, F. Rivera, et al.
Randomized Phase III Study of Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid Plus Oxaliplatin As First-Line Therapy for Metastatic Colorectal Cancer
J. Clin. Oncol., April 20, 2008; 26(12): 2006 - 2012.
[Abstract] [Full Text] [PDF]

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 JCOHome page
L. B. Saltz, S. Clarke, E. Diaz-Rubio, W. Scheithauer, A. Figer, R. Wong, S. Koski, M. Lichinitser, T.-S. Yang, F. Rivera, et al.
Bevacizumab in Combination With Oxaliplatin-Based Chemotherapy As First-Line Therapy in Metastatic Colorectal Cancer: A Randomized Phase III Study
J. Clin. Oncol., April 20, 2008; 26(12): 2013 - 2019.
[Abstract] [Full Text] [PDF]

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 JCOHome page
C. C.W. Chan, A. Tan, and H. Salman
Colon Cancer 15 Years After Ureterosigmoidostomy
J. Clin. Oncol., April 1, 2008; 26(10): 1755 - 1757.
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 The OncologistHome page
C.-H. Kohne, G. Folprecht, R. M. Goldberg, E. Mitry, and P. Rougier
Chemotherapy in Elderly Patients with Colorectal Cancer
Oncologist, April 1, 2008; 13(4): 390 - 402.
[Abstract] [Full Text] [PDF]

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 JCOHome page
G. Folprecht, M. T. Seymour, L. Saltz, J.-Y. Douillard, H. Hecker, R. J. Stephens, T. S. Maughan, E. Van Cutsem, P. Rougier, E. Mitry, et al.
Irinotecan/Fluorouracil Combination in First-Line Therapy of Older and Younger Patients With Metastatic Colorectal Cancer: Combined Analysis of 2,691 Patients in Randomized Controlled Trials
J. Clin. Oncol., March 20, 2008; 26(9): 1443 - 1451.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. Lievre, J.-B. Bachet, V. Boige, A. Cayre, D. Le Corre, E. Buc, M. Ychou, O. Bouche, B. Landi, C. Louvet, et al.
KRAS Mutations As an Independent Prognostic Factor in Patients With Advanced Colorectal Cancer Treated With Cetuximab
J. Clin. Oncol., January 20, 2008; 26(3): 374 - 379.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. Grothey, E. E. Hedrick, R. D. Mass, S. Sarkar, S. Suzuki, R. K. Ramanathan, H. I. Hurwitz, R. M. Goldberg, and D. J. Sargent
Response-Independent Survival Benefit in Metastatic Colorectal Cancer: A Comparative Analysis of N9741 and AVF2107
J. Clin. Oncol., January 10, 2008; 26(2): 183 - 189.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
E. Van Cutsem, S. Siena, Y. Humblet, J.-L. Canon, J. Maurel, E. Bajetta, B. Neyns, D. Kotasek, A. Santoro, W. Scheithauer, et al.
An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy
Ann. Onc., January 1, 2008; 19(1): 92 - 98.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. Folprecht, J. Tabernero, C.-H. Kohne, C. Zacharchuk, L. Paz-Ares, F. Rojo, S. Quinn, E. Casado, R. Salazar, R. Abbas, et al.
Phase I Pharmacokinetic/Pharmacodynamic Study of EKB-569, an Irreversible Inhibitor of the Epidermal Growth Factor Receptor Tyrosine Kinase, in Combination with Irinotecan, 5-Fluorouracil, and Leucovorin (FOLFIRI) in First-Line Treatment of Patients with Metastatic Colorectal Cancer
Clin. Cancer Res., January 1, 2008; 14(1): 215 - 223.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
T. M. Pawlik, R. D. Schulick, and M. A. Choti
Expanding Criteria for Resectability of Colorectal Liver Metastases
Oncologist, January 1, 2008; 13(1): 51 - 64.
[Abstract] [Full Text] [PDF]

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 J Oncol Pharm PractHome page
N. Kitada, T. Dan, K. Takara, T. Tsuji, H. Yamasaki, T. Yokoyama, and M. Watari
Oxaliplatin-induced hypersensitivity reaction displaying marked elevation of immunoglobulin E
Journal of Oncology Pharmacy Practice, December 1, 2007; 13(4): 233 - 235.
[Abstract] [PDF]

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 ChestHome page
M. Garrido, A. O'Brien, S. Gonzalez, J. M. Clavero, and E. Orellana
Cryptogenic Organizing Pneumonitis During Oxaliplatin Chemotherapy for Colorectal Cancer: Case Report
Chest, December 1, 2007; 132(6): 1997 - 1999.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
Y. Becouarn, P. Senesse, S. Thezenas, E. Boucher, A. Adenis, L. Cany, J. H. Jacob, F. Cvitkovic, C. Montoto-Grillot, and M. Ychou
A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer
Ann. Onc., December 1, 2007; 18(12): 2000 - 2005.
[Abstract] [Full Text] [PDF]


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