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.

@article{Gamelin2008IndividualFD,
  title={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.},
  author={E. Gamelin and R. Delva and J. Jacob and Y. Merrouche and J. Raoul and D. Pezet and E. Dorval and G. Piot and A. Morel and M. Boisdron-Celle},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2008},
  volume={26 13},
  pages={
          2099-105
        }
}
PURPOSE A phase III, multicenter, randomized study compared conventional dosing of fluorouracil (FU) plus folinic acid with pharmacokinetically guided FU dose adjustment in terms of response, tolerability, and survival. PATIENTS AND METHODS Two hundred eight patients with measurable metastatic colorectal cancer were randomly assigned to one of two arms: arm A (104 patients; 96 assessable), in which the FU dose was calculated based on body-surface area; and arm B (104 patients; 90 assessable… Expand

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References

SHOWING 1-10 OF 29 REFERENCES
Long-term weekly treatment of colorectal metastatic cancer with fluorouracil and leucovorin: results of a multicentric prospective trial of fluorouracil dosage optimization by pharmacokinetic monitoring in 152 patients.
TLDR
Individual 5-FU dose adjustment with pharmacokinetic monitoring provided a high survival rate and percentage of responses, with good tolerance, in a multicentric phase II prospective trial in advanced colorectal cancer. Expand
A phase II study of weekly 24-hour infusion with high-dose fluorouracil with leucovorin in colorectal carcinoma.
  • B. Ardalan, L. Chua, +7 authors L. Morrell
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 1991
TLDR
It is suggested that short-term infusional therapy of 5-FU and LV in patients with advanced metastatic colorectal cancer generates acceptable toxicity, with equivalent or superior survivability in previously treated and untreated patients versus alternative methods of administration of the two agents. Expand
A prospective randomized comparison of continuous infusion fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: a Mid-Atlantic Oncology Program Study.
TLDR
Administration of 5-FU as a continuous infusion for protracted periods clearly improves the therapeutic index for this agent in patients with advanced colon cancer with respect to response rate and reduced toxicity. Expand
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.
TLDR
The bimonthly regimen was more effective and less toxic than the monthly regimen and definitely increased the therapeutic ratio, however, there was no evidence of increased survival. Expand
Phase II trial of cisplatin, fluorouracil, and pure folinic acid for locally advanced head and neck cancer: a pharmacokinetic and clinical survey.
TLDR
A significant correlation was demonstrated between FU concentration and hematologic toxicity grade, mucositis grade, and nausea-vomiting/diarrhea grade and patients who failed to respond significantly exhibited lower FU and total folate concentrations than patients with a CR or PR. Expand
Relationship between fluorouracil systemic exposure and tumor response and patient survival.
  • G. Milano, M. Etienne, +4 authors F. Demard
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 1994
TLDR
The AUC remains significant in a multivariate analysis including tumor stage, demonstrating that the greater the FU systemic exposure, the longer the survival. Expand
Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer.
TLDR
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. Expand
Biochemical modulation of fluorouracil with leucovorin: confirmatory evidence of improved therapeutic efficacy in advanced colorectal cancer.
TLDR
The regimen of 5FU plus low-dose leucovorin has now been shown to offer a statistically significant survival advantage versus 5FU alone and versus5FU plus high-dose MTX, a regimen that had shown promise in earlier trials. Expand
Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial
TLDR
Irinotecan combined with fluorouracil and calcium folinate was well-tolerated and increased response rate, time to progression, and survival, with a later deterioration in quality of life. Expand
A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer.
TLDR
The FOLFOX regimen of oxaliplatin and infused fluorouracil plus leucovorin was active and comparatively safe and should be considered as a standard therapy for patients with advanced colorectal cancer. Expand
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