Fluorouracil plus racemic leucovorin versus fluorouracil combined with the pure l-isomer of leucovorin for the treatment of advanced colorectal cancer: A randomized phase III study

W. Scheithauer, G. Kornek, A. Marczell, G. Salem, J. Karner, E. Kovats, D. Burger, R. Greiner, J. Pidlich, B. Schneeweiss, M. Raderer, H. Rosen, D. Depisch

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Abstract

Purpose: To compare the efficacy and toxicity of fluorouracil (FU) and racemic leucovorin (d, I-LV) versus FU combined with the I-isomer of leucovorin (I-LV) in the treatment of advanced colorectal cancer. Patients and Methods: A total of 248 patients with advanced measurable colorectal cancer previously unexposed to chemotherapy were randomly assigned to treatment with either FU (400 mg/m2/d by intravenous [IV] infusion for 2 hours) and racemic LV (100 mg/m2/d by IV bolus injection) given for 5 consecutive days, or the combination of FU and the pure I-isomer of LV using the same dose schedule. In both treatment arms, courses were administered every 28 days if toxicity allowed for a total of 6 months, unless evidence of tumor progression was documented earlier. Results: There were no significant differences between the FU/racemic LV and the FU/I-LV arm in the overall response rate (25% v 32%), duration of response (7.2 v 8.0 months), median time to progression or death (6.25 v 8.0 months), or median overall survival time (14.5 v 15.0 months). Except for minor myeloid toxic effects associated with FU/I-LV, there was also no significant difference in terms of adverse reactions. Gastrointestinal symptoms, specifically mucositis and diarrhea, were less frequent and less severe in both treatment arms compared with other trials with FU/racemic LV reported in the literature, which might be because of the prolonged administration of FU used in both arms. Conclusion: The combination of FU/I-LV produced response rates, response durations, and survival times similar to those with FU/d, I-LV. Biochemical modulation of FU by either pure I-LV or racemic LV thus appears to result in equivalent clinical efficacy.

Original languageEnglish
Pages (from-to)908-914
Number of pages7
JournalJournal of Clinical Oncology
Volume15
Issue number3
Publication statusPublished - Mar 1997

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Leucovorin
Fluorouracil
Colorectal Neoplasms
Therapeutics
Mucositis
Survival
Poisons
Intravenous Infusions
Intravenous Injections
Diarrhea
Appointments and Schedules

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Fluorouracil plus racemic leucovorin versus fluorouracil combined with the pure l-isomer of leucovorin for the treatment of advanced colorectal cancer : A randomized phase III study. / Scheithauer, W.; Kornek, G.; Marczell, A.; Salem, G.; Karner, J.; Kovats, E.; Burger, D.; Greiner, R.; Pidlich, J.; Schneeweiss, B.; Raderer, M.; Rosen, H.; Depisch, D.

In: Journal of Clinical Oncology, Vol. 15, No. 3, 03.1997, p. 908-914.

Research output: Contribution to journalArticle

Scheithauer, W, Kornek, G, Marczell, A, Salem, G, Karner, J, Kovats, E, Burger, D, Greiner, R, Pidlich, J, Schneeweiss, B, Raderer, M, Rosen, H & Depisch, D 1997, 'Fluorouracil plus racemic leucovorin versus fluorouracil combined with the pure l-isomer of leucovorin for the treatment of advanced colorectal cancer: A randomized phase III study', Journal of Clinical Oncology, vol. 15, no. 3, pp. 908-914.
Scheithauer, W. ; Kornek, G. ; Marczell, A. ; Salem, G. ; Karner, J. ; Kovats, E. ; Burger, D. ; Greiner, R. ; Pidlich, J. ; Schneeweiss, B. ; Raderer, M. ; Rosen, H. ; Depisch, D. / Fluorouracil plus racemic leucovorin versus fluorouracil combined with the pure l-isomer of leucovorin for the treatment of advanced colorectal cancer : A randomized phase III study. In: Journal of Clinical Oncology. 1997 ; Vol. 15, No. 3. pp. 908-914.
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abstract = "Purpose: To compare the efficacy and toxicity of fluorouracil (FU) and racemic leucovorin (d, I-LV) versus FU combined with the I-isomer of leucovorin (I-LV) in the treatment of advanced colorectal cancer. Patients and Methods: A total of 248 patients with advanced measurable colorectal cancer previously unexposed to chemotherapy were randomly assigned to treatment with either FU (400 mg/m2/d by intravenous [IV] infusion for 2 hours) and racemic LV (100 mg/m2/d by IV bolus injection) given for 5 consecutive days, or the combination of FU and the pure I-isomer of LV using the same dose schedule. In both treatment arms, courses were administered every 28 days if toxicity allowed for a total of 6 months, unless evidence of tumor progression was documented earlier. Results: There were no significant differences between the FU/racemic LV and the FU/I-LV arm in the overall response rate (25{\%} v 32{\%}), duration of response (7.2 v 8.0 months), median time to progression or death (6.25 v 8.0 months), or median overall survival time (14.5 v 15.0 months). Except for minor myeloid toxic effects associated with FU/I-LV, there was also no significant difference in terms of adverse reactions. Gastrointestinal symptoms, specifically mucositis and diarrhea, were less frequent and less severe in both treatment arms compared with other trials with FU/racemic LV reported in the literature, which might be because of the prolonged administration of FU used in both arms. Conclusion: The combination of FU/I-LV produced response rates, response durations, and survival times similar to those with FU/d, I-LV. Biochemical modulation of FU by either pure I-LV or racemic LV thus appears to result in equivalent clinical efficacy.",
author = "W. Scheithauer and G. Kornek and A. Marczell and G. Salem and J. Karner and E. Kovats and D. Burger and R. Greiner and J. Pidlich and B. Schneeweiss and M. Raderer and H. Rosen and D. Depisch",
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T1 - Fluorouracil plus racemic leucovorin versus fluorouracil combined with the pure l-isomer of leucovorin for the treatment of advanced colorectal cancer

T2 - A randomized phase III study

AU - Scheithauer, W.

AU - Kornek, G.

AU - Marczell, A.

AU - Salem, G.

AU - Karner, J.

AU - Kovats, E.

AU - Burger, D.

AU - Greiner, R.

AU - Pidlich, J.

AU - Schneeweiss, B.

AU - Raderer, M.

AU - Rosen, H.

AU - Depisch, D.

PY - 1997/3

Y1 - 1997/3

N2 - Purpose: To compare the efficacy and toxicity of fluorouracil (FU) and racemic leucovorin (d, I-LV) versus FU combined with the I-isomer of leucovorin (I-LV) in the treatment of advanced colorectal cancer. Patients and Methods: A total of 248 patients with advanced measurable colorectal cancer previously unexposed to chemotherapy were randomly assigned to treatment with either FU (400 mg/m2/d by intravenous [IV] infusion for 2 hours) and racemic LV (100 mg/m2/d by IV bolus injection) given for 5 consecutive days, or the combination of FU and the pure I-isomer of LV using the same dose schedule. In both treatment arms, courses were administered every 28 days if toxicity allowed for a total of 6 months, unless evidence of tumor progression was documented earlier. Results: There were no significant differences between the FU/racemic LV and the FU/I-LV arm in the overall response rate (25% v 32%), duration of response (7.2 v 8.0 months), median time to progression or death (6.25 v 8.0 months), or median overall survival time (14.5 v 15.0 months). Except for minor myeloid toxic effects associated with FU/I-LV, there was also no significant difference in terms of adverse reactions. Gastrointestinal symptoms, specifically mucositis and diarrhea, were less frequent and less severe in both treatment arms compared with other trials with FU/racemic LV reported in the literature, which might be because of the prolonged administration of FU used in both arms. Conclusion: The combination of FU/I-LV produced response rates, response durations, and survival times similar to those with FU/d, I-LV. Biochemical modulation of FU by either pure I-LV or racemic LV thus appears to result in equivalent clinical efficacy.

AB - Purpose: To compare the efficacy and toxicity of fluorouracil (FU) and racemic leucovorin (d, I-LV) versus FU combined with the I-isomer of leucovorin (I-LV) in the treatment of advanced colorectal cancer. Patients and Methods: A total of 248 patients with advanced measurable colorectal cancer previously unexposed to chemotherapy were randomly assigned to treatment with either FU (400 mg/m2/d by intravenous [IV] infusion for 2 hours) and racemic LV (100 mg/m2/d by IV bolus injection) given for 5 consecutive days, or the combination of FU and the pure I-isomer of LV using the same dose schedule. In both treatment arms, courses were administered every 28 days if toxicity allowed for a total of 6 months, unless evidence of tumor progression was documented earlier. Results: There were no significant differences between the FU/racemic LV and the FU/I-LV arm in the overall response rate (25% v 32%), duration of response (7.2 v 8.0 months), median time to progression or death (6.25 v 8.0 months), or median overall survival time (14.5 v 15.0 months). Except for minor myeloid toxic effects associated with FU/I-LV, there was also no significant difference in terms of adverse reactions. Gastrointestinal symptoms, specifically mucositis and diarrhea, were less frequent and less severe in both treatment arms compared with other trials with FU/racemic LV reported in the literature, which might be because of the prolonged administration of FU used in both arms. Conclusion: The combination of FU/I-LV produced response rates, response durations, and survival times similar to those with FU/d, I-LV. Biochemical modulation of FU by either pure I-LV or racemic LV thus appears to result in equivalent clinical efficacy.

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