The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.
Fluorouracil, Leucovorin, and Oxaliplatin With and Without Cetuximab in the First-Line Treatment of Metastatic Colorectal Cancer
Open accessAbstract
Purpose: This randomized study assessed whether the best overall response rate (ORR) of cetuximab combined with oxaliplatin, leucovorin, and fluorouracil (FOLFOX-4) was superior to that of FOLFOX-4 alone as first-line treatment for metastatic colorectal cancer. The influence of KRAS mutation status was investigated. Patients and Methods: Patients received cetuximab (400 mg/m 2 initial dose followed by 250 mg/m 2/wk thereafter) plus FOLFOX-4 (oxaliplatin 85 mg/m 2 on day 1, plus leucovorin 200 mg/m 2 and fluorouracil as a 400 mg/m 2 bolus followed by a 600 mg/m 2 infusion during 22 hours on days 1 and 2; n = 169) or FOLFOX-4 alone (n = 168). Treatment was continued until disease progression or unacceptable toxicity. KRAS mutation status was assessed in the subset of patients with assessable tumor samples (n = 233). Results: The confirmed ORR for cetuximab plus FOLFOX-4 was higher than with FOLFOX-4 alone (46% v 36%). A statistically significant increase in the odds for a response with the addition of cetuximab to FOLFOX-4 could not be established (odds ratio = 1.52; P = .064). In patients with KRAS wild-type tumors, the addition of cetuximab to FOLFOX-4 was associated with a clinically significant increased chance of response (ORR = 61% v 37%; odds ratio = 2.54; P = .011) and a lower risk of disease progression (hazard ratio = 0.57; P = .0163) compared with FOLFOX-4 alone. Cetuximab plus FOLFOX-4 was generally well tolerated. Conclusion: KRAS mutational status was shown to be a highly predictive selection criterion in relation to the treatment decision regarding the addition of cetuximab to FOLFOX-4 for previously untreated patients with metastatic colorectal cancer.
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Cites
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Cited by
Dekker, E., Tanis, P. J., Vleugels, J. L. A., Kasi, P. M., & Wallace, M. B. (2019) · The Lancet · doi:10.1016/s0140-6736(19)32319-0 · Cited by 4,974
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Self-citationESMO consensus guidelines for the management of patients with metastatic colorectal cancer
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“(1) Patients appropriate for intensive therapy (a) When the patient has become refractory or intolerant to the first-line therapy, including OX • FOLFIRI [62] + Bmab [85] ▪ FOLFIRI + Rmab [86] • IRIS (note 6) [87] + Bmab • IRI [88] + Bmab • FOLFIRI (or IRI) + Cmab/Pmab [88, 89] (b) When the patient has become refracto…”
InfluentialHashiguchi, Y., Muro, K., Saito, Y., Ito, Y., Ajioka, Y., Hamaguchi, T., Hasegawa, K., Hotta, K., Ishida, H., Ishiguro, M., et al. (2020) · International Journal of Clinical Oncology · doi:10.1007/s10147-019-01485-z · Cited by 1,922
Metadata
- Authors
- Bokemeyer, C., Bondarenko, I., Makhson, A., Hartmann, J. T., Aparicio, J., de Braud, F., Donea, S., Ludwig, H., Schuch, G., Stroh, C., Loos, A. H., Zubel, A., & Koralewski, P.
- Venue
- Journal of Clinical Oncology
- Published
- 2009-02-10
- Volume
- 27
- Issue
- 5
- Pages
- 663-671
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2144425748
- Cited by
- 1,636
- References
- 28
- FWCI
- 72.99
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Bokemeyer, C., Bondarenko, I., Makhson, A., Hartmann, J. T., Aparicio, J., de Braud, F., Donea, S., Ludwig, H., Schuch, G., Stroh, C., Loos, A. H., Zubel, A., & Koralewski, P. (2009). Fluorouracil, Leucovorin, and Oxaliplatin With and Without Cetuximab in the First-Line Treatment of Metastatic Colorectal Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2008.20.8397
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