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Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer

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Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer : European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. / Köhne, C-H; van Cutsem, E; Wils, J; Bokemeyer, C; El-Serafi, M; Lutz, M P; Lorenz, M; Reichardt, P; Rückle-Lanz, H; Frickhofen, N; Fuchs, R; Mergenthaler, H-G; Langenbuch, T; Vanhoefer, U; Rougier, P; Voigtmann, R; Müller, L; Genicot, B; Anak, O; Nordlinger, B; European Organisation for Research and Treatment of Cancer Gastrointestinal Group.

In: J CLIN ONCOL, Vol. 23, No. 22, 01.08.2005, p. 4856-65.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Köhne, C-H, van Cutsem, E, Wils, J, Bokemeyer, C, El-Serafi, M, Lutz, MP, Lorenz, M, Reichardt, P, Rückle-Lanz, H, Frickhofen, N, Fuchs, R, Mergenthaler, H-G, Langenbuch, T, Vanhoefer, U, Rougier, P, Voigtmann, R, Müller, L, Genicot, B, Anak, O, Nordlinger, B & European Organisation for Research and Treatment of Cancer Gastrointestinal Group 2005, 'Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986', J CLIN ONCOL, vol. 23, no. 22, pp. 4856-65. https://doi.org/10.1200/JCO.2005.05.546

APA

Köhne, C-H., van Cutsem, E., Wils, J., Bokemeyer, C., El-Serafi, M., Lutz, M. P., Lorenz, M., Reichardt, P., Rückle-Lanz, H., Frickhofen, N., Fuchs, R., Mergenthaler, H-G., Langenbuch, T., Vanhoefer, U., Rougier, P., Voigtmann, R., Müller, L., Genicot, B., Anak, O., ... European Organisation for Research and Treatment of Cancer Gastrointestinal Group (2005). Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J CLIN ONCOL, 23(22), 4856-65. https://doi.org/10.1200/JCO.2005.05.546

Vancouver

Köhne C-H, van Cutsem E, Wils J, Bokemeyer C, El-Serafi M, Lutz MP et al. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J CLIN ONCOL. 2005 Aug 1;23(22):4856-65. https://doi.org/10.1200/JCO.2005.05.546

Bibtex

@article{14acef9b36ff4beb84e37ad60b384bc3,
title = "Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986",
abstract = "PURPOSE: To demonstrate that adding irinotecan to a standard weekly schedule of high-dose, infusional fluorouracil (FU) and leucovorin (folinic acid [FA]) can prolong progression-free survival (PFS).PATIENTS AND METHODS: Four hundred thirty patients with measurable or assessable metastatic colorectal cancer were randomly assigned to receive either FA 500 mg/m(2) as a 2-hour infusion and FU 2.6 g/m(2) by intravenous 24-hour infusion, both administered weekly for 6 weeks, followed by a 2-week rest (Arbeitsgemeinschaft f{\"u}r Internistische Onkologie [AIO] arm, n = 216), or a similar schedule but with FU 2.3 or 2.0 g/m(2) preceded by irinotecan 80 mg/m(2) administered over 30 minutes (experimental group, n = 214).RESULTS: The median PFS time in the experimental group was 8.5 months (95% CI, 7.6 to 9.9 months) compared with 6.4 months (95% CI, 5.3 to 7.2 months) in the AIO arm (P < .0001). The median overall survival time was increased from 16.9 to 20.1 months (P = .2779). The objective response rate was 62.2% (95% CI, 55.0% to 69.5%) in the experimental group and 34.4% (95% CI, 27.5% to 41.3%) in the AIO arm (P < .0001).CONCLUSION: The addition of irinotecan to the standard AIO FU/FA regimen was associated with a highly significant improvement in PFS and response rate and was well tolerated. The results of this study confirm that irinotecan in combination with high-dose infusional FU/FA is a reference first-line treatment.",
keywords = "Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Colorectal Neoplasms, Disease Progression, Drug Administration Schedule, Female, Fluorouracil, Humans, Infusions, Intravenous, Leucovorin, Male, Middle Aged, Survival Analysis, Treatment Outcome",
author = "C-H K{\"o}hne and {van Cutsem}, E and J Wils and C Bokemeyer and M El-Serafi and Lutz, {M P} and M Lorenz and P Reichardt and H R{\"u}ckle-Lanz and N Frickhofen and R Fuchs and H-G Mergenthaler and T Langenbuch and U Vanhoefer and P Rougier and R Voigtmann and L M{\"u}ller and B Genicot and O Anak and B Nordlinger and {European Organisation for Research and Treatment of Cancer Gastrointestinal Group}",
year = "2005",
month = aug,
day = "1",
doi = "10.1200/JCO.2005.05.546",
language = "English",
volume = "23",
pages = "4856--65",
journal = "J CLIN ONCOL",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "22",

}

RIS

TY - JOUR

T1 - Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer

T2 - European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986

AU - Köhne, C-H

AU - van Cutsem, E

AU - Wils, J

AU - Bokemeyer, C

AU - El-Serafi, M

AU - Lutz, M P

AU - Lorenz, M

AU - Reichardt, P

AU - Rückle-Lanz, H

AU - Frickhofen, N

AU - Fuchs, R

AU - Mergenthaler, H-G

AU - Langenbuch, T

AU - Vanhoefer, U

AU - Rougier, P

AU - Voigtmann, R

AU - Müller, L

AU - Genicot, B

AU - Anak, O

AU - Nordlinger, B

AU - European Organisation for Research and Treatment of Cancer Gastrointestinal Group

PY - 2005/8/1

Y1 - 2005/8/1

N2 - PURPOSE: To demonstrate that adding irinotecan to a standard weekly schedule of high-dose, infusional fluorouracil (FU) and leucovorin (folinic acid [FA]) can prolong progression-free survival (PFS).PATIENTS AND METHODS: Four hundred thirty patients with measurable or assessable metastatic colorectal cancer were randomly assigned to receive either FA 500 mg/m(2) as a 2-hour infusion and FU 2.6 g/m(2) by intravenous 24-hour infusion, both administered weekly for 6 weeks, followed by a 2-week rest (Arbeitsgemeinschaft für Internistische Onkologie [AIO] arm, n = 216), or a similar schedule but with FU 2.3 or 2.0 g/m(2) preceded by irinotecan 80 mg/m(2) administered over 30 minutes (experimental group, n = 214).RESULTS: The median PFS time in the experimental group was 8.5 months (95% CI, 7.6 to 9.9 months) compared with 6.4 months (95% CI, 5.3 to 7.2 months) in the AIO arm (P < .0001). The median overall survival time was increased from 16.9 to 20.1 months (P = .2779). The objective response rate was 62.2% (95% CI, 55.0% to 69.5%) in the experimental group and 34.4% (95% CI, 27.5% to 41.3%) in the AIO arm (P < .0001).CONCLUSION: The addition of irinotecan to the standard AIO FU/FA regimen was associated with a highly significant improvement in PFS and response rate and was well tolerated. The results of this study confirm that irinotecan in combination with high-dose infusional FU/FA is a reference first-line treatment.

AB - PURPOSE: To demonstrate that adding irinotecan to a standard weekly schedule of high-dose, infusional fluorouracil (FU) and leucovorin (folinic acid [FA]) can prolong progression-free survival (PFS).PATIENTS AND METHODS: Four hundred thirty patients with measurable or assessable metastatic colorectal cancer were randomly assigned to receive either FA 500 mg/m(2) as a 2-hour infusion and FU 2.6 g/m(2) by intravenous 24-hour infusion, both administered weekly for 6 weeks, followed by a 2-week rest (Arbeitsgemeinschaft für Internistische Onkologie [AIO] arm, n = 216), or a similar schedule but with FU 2.3 or 2.0 g/m(2) preceded by irinotecan 80 mg/m(2) administered over 30 minutes (experimental group, n = 214).RESULTS: The median PFS time in the experimental group was 8.5 months (95% CI, 7.6 to 9.9 months) compared with 6.4 months (95% CI, 5.3 to 7.2 months) in the AIO arm (P < .0001). The median overall survival time was increased from 16.9 to 20.1 months (P = .2779). The objective response rate was 62.2% (95% CI, 55.0% to 69.5%) in the experimental group and 34.4% (95% CI, 27.5% to 41.3%) in the AIO arm (P < .0001).CONCLUSION: The addition of irinotecan to the standard AIO FU/FA regimen was associated with a highly significant improvement in PFS and response rate and was well tolerated. The results of this study confirm that irinotecan in combination with high-dose infusional FU/FA is a reference first-line treatment.

KW - Adult

KW - Aged

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Camptothecin

KW - Colorectal Neoplasms

KW - Disease Progression

KW - Drug Administration Schedule

KW - Female

KW - Fluorouracil

KW - Humans

KW - Infusions, Intravenous

KW - Leucovorin

KW - Male

KW - Middle Aged

KW - Survival Analysis

KW - Treatment Outcome

U2 - 10.1200/JCO.2005.05.546

DO - 10.1200/JCO.2005.05.546

M3 - SCORING: Journal article

C2 - 15939923

VL - 23

SP - 4856

EP - 4865

JO - J CLIN ONCOL

JF - J CLIN ONCOL

SN - 0732-183X

IS - 22

ER -