Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer

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

Research output: Contribution to journalArticle

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Abstract

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/m(2)/d) followed by a 5FU bolus (400 mg/m(2)/d) and 22-hour infusion (600 mg/m(2)/d) for 2 consecutive days every 2 weeks, either alone or together with oxaliplatin 85 mg/m(2) 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. (C) 2000 by American Society of Clinical Oncology.

Original languageEnglish
Pages (from-to)2938-2947
Number of pages10
JournalJournal of Clinical Oncology
Volume18
Publication statusPublished - 2000

Keywords

  • HIGH-DOSE LEUCOVORIN
  • RANDOMIZED TRIAL
  • CONTINUOUS-INFUSION
  • FOLINIC ACID
  • PHASE-II
  • 5-FLUOROURACIL REGIMEN
  • CLINICAL-TRIALS
  • CARCINOMA
  • LIFE
  • CHEMOTHERAPY

Cite this

de Gramont, A., Figer, A., Seymour, M., Homerin, M., Hmissi, A., Cassidy, J., ... Bonetti, A. (2000). Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. Journal of Clinical Oncology, 18, 2938-2947.

Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. / de Gramont, A ; Figer, A ; Seymour, M ; Homerin, M ; Hmissi, A ; Cassidy, J ; Boni, C ; Cortes-Funes, H ; Cervantes, A ; Freyer, G ; Papamichael, D ; Le Bail, N ; Louvet, C ; Hendler, D ; de Braud, F ; Wilson, C ; Morvan, F ; Bonetti, A .

In: Journal of Clinical Oncology, Vol. 18, 2000, p. 2938-2947.

Research output: Contribution to journalArticle

de Gramont, A, Figer, A, Seymour, M, Homerin, M, Hmissi, A, Cassidy, J, Boni, C, Cortes-Funes, H, Cervantes, A, Freyer, G, Papamichael, D, Le Bail, N, Louvet, C, Hendler, D, de Braud, F, Wilson, C, Morvan, F & Bonetti, A 2000, 'Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer', Journal of Clinical Oncology, vol. 18, pp. 2938-2947.
de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. Journal of Clinical Oncology. 2000;18:2938-2947.
de Gramont, A ; Figer, A ; Seymour, M ; Homerin, M ; Hmissi, A ; Cassidy, J ; Boni, C ; Cortes-Funes, H ; Cervantes, A ; Freyer, G ; Papamichael, D ; Le Bail, N ; Louvet, C ; Hendler, D ; de Braud, F ; Wilson, C ; Morvan, F ; Bonetti, A . / Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. In: Journal of Clinical Oncology. 2000 ; Vol. 18. pp. 2938-2947.
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title = "Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer",
abstract = "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/m(2)/d) followed by a 5FU bolus (400 mg/m(2)/d) and 22-hour infusion (600 mg/m(2)/d) for 2 consecutive days every 2 weeks, either alone or together with oxaliplatin 85 mg/m(2) 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. (C) 2000 by American Society of Clinical Oncology.",
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author = "{de Gramont}, A and A Figer and M Seymour and M Homerin and A Hmissi and J Cassidy and C Boni and H Cortes-Funes and A Cervantes and G Freyer and D Papamichael and {Le Bail}, N and C Louvet and D Hendler and {de Braud}, F and C Wilson and F Morvan and A Bonetti",
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TY - JOUR

T1 - Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer

AU - de Gramont, A

AU - Figer, A

AU - Seymour, M

AU - Homerin, M

AU - Hmissi, A

AU - Cassidy, J

AU - Boni, C

AU - Cortes-Funes, H

AU - Cervantes, A

AU - Freyer, G

AU - Papamichael, D

AU - Le Bail, N

AU - Louvet, C

AU - Hendler, D

AU - de Braud, F

AU - Wilson, C

AU - Morvan, F

AU - Bonetti, A

PY - 2000

Y1 - 2000

N2 - 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/m(2)/d) followed by a 5FU bolus (400 mg/m(2)/d) and 22-hour infusion (600 mg/m(2)/d) for 2 consecutive days every 2 weeks, either alone or together with oxaliplatin 85 mg/m(2) 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. (C) 2000 by American Society of Clinical Oncology.

AB - 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/m(2)/d) followed by a 5FU bolus (400 mg/m(2)/d) and 22-hour infusion (600 mg/m(2)/d) for 2 consecutive days every 2 weeks, either alone or together with oxaliplatin 85 mg/m(2) 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. (C) 2000 by American Society of Clinical Oncology.

KW - HIGH-DOSE LEUCOVORIN

KW - RANDOMIZED TRIAL

KW - CONTINUOUS-INFUSION

KW - FOLINIC ACID

KW - PHASE-II

KW - 5-FLUOROURACIL REGIMEN

KW - CLINICAL-TRIALS

KW - CARCINOMA

KW - LIFE

KW - CHEMOTHERAPY

M3 - Article

VL - 18

SP - 2938

EP - 2947

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

ER -