Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015.

C-H Köhne; J De Greve; J T Hartmann; I Lang; P Vergauwe; K Becker; D Braumann; E Joosens; L Müller; J Janssens; Carsten Bokemeyer; P Reimer; H Link; E Späth-Schwalbe; H-J Wilke; H Bleiberg; J Van Den Brande; M Debois; U Bethe; E Van Cutsem

Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015.

Standard

Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015. / Köhne, C-H; De Greve, J; Hartmann, J T; Lang, I; Vergauwe, P; Becker, K; Braumann, D; Joosens, E; Müller, L; Janssens, J; Bokemeyer, Carsten; Reimer, P; Link, H; Späth-Schwalbe, E; Wilke, H-J; Bleiberg, H; Van Den Brande, J; Debois, M; Bethe, U; Van Cutsem, E.

In: ANN ONCOL, Vol. 19, No. 5, 5, 2008, p. 920-926.

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

Harvard

Köhne, C-H, De Greve, J, Hartmann, JT, Lang, I, Vergauwe, P, Becker, K, Braumann, D, Joosens, E, Müller, L, Janssens, J, Bokemeyer, C, Reimer, P, Link, H, Späth-Schwalbe, E, Wilke, H-J, Bleiberg, H, Van Den Brande, J, Debois, M, Bethe, U & Van Cutsem, E 2008, 'Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015.', ANN ONCOL, vol. 19, no. 5, 5, pp. 920-926. <http://www.ncbi.nlm.nih.gov/pubmed/18065406?dopt=Citation>

APA

Köhne, C-H., De Greve, J., Hartmann, J. T., Lang, I., Vergauwe, P., Becker, K., Braumann, D., Joosens, E., Müller, L., Janssens, J., Bokemeyer, C., Reimer, P., Link, H., Späth-Schwalbe, E., Wilke, H-J., Bleiberg, H., Van Den Brande, J., Debois, M., Bethe, U., & Van Cutsem, E. (2008). Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015. ANN ONCOL, 19(5), 920-926. [5]. http://www.ncbi.nlm.nih.gov/pubmed/18065406?dopt=Citation

Vancouver

Köhne C-H, De Greve J, Hartmann JT, Lang I, Vergauwe P, Becker K et al. Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015. ANN ONCOL. 2008;19(5):920-926. 5.

Bibtex

@article{89445f55a9f24662b7eab01b442cbc29,

title = "Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015.",

abstract = "BACKGROUND: The study aimed to demonstrate the noninferiority of capecitabine to 5-fluorouracil (5-FU)/folinic acid (FA), in relation to progression-free survival (PFS) after first-line treatment of metastatic colorectal cancer and the benefit of adding celecoxib (C) to irinotecan/fluoropyrimidine regimens compared with placebo (P). PATIENTS AND METHODS: Patients were randomly assigned to receive FOLFIRI: irinotecan (180 mg/m(2) i.v. on days 1, 15 and 22); FA (200 mg/m(2) i.v. on days 1, 2, 15, 16, 29 and 30); 5-FU (400 mg/m(2) i.v. bolus, then 22-h, 600 mg/m(2) infusion) or CAPIRI: irinotecan (250 mg/m(2) i.v. infusion on days 1 and 22); capecitabine p.o. (1000 mg/m(2) b.i.d. on days 1-15 and 22-36). Patients were additionally randomly assigned to receive either placebo or celecoxib (800 mg: 2 x 200 mg b.i.d.). RESULTS: The trial was closed following eight deaths unrelated to disease progression in the 85 enrolled (629 planned) patients. Response rates were 22% for CAPIRI + C, 48% for CAPIRI + P, 32% for FOLFIRI + C and 46% for FOLFIRI + P. Median PFS and overall survival (OS) times were shorter for CAPIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months) and celecoxib versus placebo (PFS 6.9 versus 7.8 months and OS 18.3 versus 19.9 months). CONCLUSION: Due to the small sample size following early termination, no definitive conclusions can be drawn in relation to the noninferiority of CAPIRI compared with FOLFIRI.",

author = "C-H K{\"o}hne and {De Greve}, J and Hartmann, {J T} and I Lang and P Vergauwe and K Becker and D Braumann and E Joosens and L M{\"u}ller and J Janssens and Carsten Bokemeyer and P Reimer and H Link and E Sp{\"a}th-Schwalbe and H-J Wilke and H Bleiberg and {Van Den Brande}, J and M Debois and U Bethe and {Van Cutsem}, E",

year = "2008",

language = "Deutsch",

volume = "19",

pages = "920--926",

journal = "ANN ONCOL",

issn = "0923-7534",

publisher = "Oxford University Press",

number = "5",

}

RIS

TY - JOUR

T1 - Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015.

AU - Köhne, C-H

AU - De Greve, J

AU - Hartmann, J T

AU - Lang, I

AU - Vergauwe, P

AU - Becker, K

AU - Braumann, D

AU - Joosens, E

AU - Müller, L

AU - Janssens, J

AU - Bokemeyer, Carsten

AU - Reimer, P

AU - Link, H

AU - Späth-Schwalbe, E

AU - Wilke, H-J

AU - Bleiberg, H

AU - Van Den Brande, J

AU - Debois, M

AU - Bethe, U

AU - Van Cutsem, E

PY - 2008

Y1 - 2008

N2 - BACKGROUND: The study aimed to demonstrate the noninferiority of capecitabine to 5-fluorouracil (5-FU)/folinic acid (FA), in relation to progression-free survival (PFS) after first-line treatment of metastatic colorectal cancer and the benefit of adding celecoxib (C) to irinotecan/fluoropyrimidine regimens compared with placebo (P). PATIENTS AND METHODS: Patients were randomly assigned to receive FOLFIRI: irinotecan (180 mg/m(2) i.v. on days 1, 15 and 22); FA (200 mg/m(2) i.v. on days 1, 2, 15, 16, 29 and 30); 5-FU (400 mg/m(2) i.v. bolus, then 22-h, 600 mg/m(2) infusion) or CAPIRI: irinotecan (250 mg/m(2) i.v. infusion on days 1 and 22); capecitabine p.o. (1000 mg/m(2) b.i.d. on days 1-15 and 22-36). Patients were additionally randomly assigned to receive either placebo or celecoxib (800 mg: 2 x 200 mg b.i.d.). RESULTS: The trial was closed following eight deaths unrelated to disease progression in the 85 enrolled (629 planned) patients. Response rates were 22% for CAPIRI + C, 48% for CAPIRI + P, 32% for FOLFIRI + C and 46% for FOLFIRI + P. Median PFS and overall survival (OS) times were shorter for CAPIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months) and celecoxib versus placebo (PFS 6.9 versus 7.8 months and OS 18.3 versus 19.9 months). CONCLUSION: Due to the small sample size following early termination, no definitive conclusions can be drawn in relation to the noninferiority of CAPIRI compared with FOLFIRI.

AB - BACKGROUND: The study aimed to demonstrate the noninferiority of capecitabine to 5-fluorouracil (5-FU)/folinic acid (FA), in relation to progression-free survival (PFS) after first-line treatment of metastatic colorectal cancer and the benefit of adding celecoxib (C) to irinotecan/fluoropyrimidine regimens compared with placebo (P). PATIENTS AND METHODS: Patients were randomly assigned to receive FOLFIRI: irinotecan (180 mg/m(2) i.v. on days 1, 15 and 22); FA (200 mg/m(2) i.v. on days 1, 2, 15, 16, 29 and 30); 5-FU (400 mg/m(2) i.v. bolus, then 22-h, 600 mg/m(2) infusion) or CAPIRI: irinotecan (250 mg/m(2) i.v. infusion on days 1 and 22); capecitabine p.o. (1000 mg/m(2) b.i.d. on days 1-15 and 22-36). Patients were additionally randomly assigned to receive either placebo or celecoxib (800 mg: 2 x 200 mg b.i.d.). RESULTS: The trial was closed following eight deaths unrelated to disease progression in the 85 enrolled (629 planned) patients. Response rates were 22% for CAPIRI + C, 48% for CAPIRI + P, 32% for FOLFIRI + C and 46% for FOLFIRI + P. Median PFS and overall survival (OS) times were shorter for CAPIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months) and celecoxib versus placebo (PFS 6.9 versus 7.8 months and OS 18.3 versus 19.9 months). CONCLUSION: Due to the small sample size following early termination, no definitive conclusions can be drawn in relation to the noninferiority of CAPIRI compared with FOLFIRI.

M3 - SCORING: Zeitschriftenaufsatz

VL - 19

SP - 920

EP - 926

JO - ANN ONCOL

JF - ANN ONCOL

SN - 0923-7534

IS - 5

M1 - 5

ER -