The DOI matches its Crossref record; 34 of the 34 references it cites were found in a registry or an index.
Phase III Trial of Cetuximab With Continuous or Intermittent Fluorouracil, Leucovorin, and Oxaliplatin (Nordic FLOX) Versus FLOX Alone in First-Line Treatment of Metastatic Colorectal Cancer: The NORDIC-VII Study
Abstract
Purpose: The NORDIC-VII multicenter phase III trial investigated the efficacy of cetuximab when added to bolus fluorouracil/folinic acid and oxaliplatin (Nordic FLOX), administered continuously or intermittently, in previously untreated metastatic colorectal cancer (mCRC). The influence of KRAS mutation status on treatment outcome was also investigated. Patients and Methods: Patients were randomly assigned to receive either standard Nordic FLOX (arm A), cetuximab and FLOX (arm B), or cetuximab combined with intermittent FLOX (arm C). Primary end point was progression-free survival (PFS). Overall survival (OS), response rate, R0 resection rate, and safety were secondary end points. Results: Of the 571 patients randomly assigned, 566 were evaluable in intention-to-treat (ITT) analyses. KRAS and BRAF mutation analyses were obtained in 498 (88%) and 457 patients (81%), respectively. KRAS mutations were present in 39% of the tumors; 12% of tumors had BRAF mutations. The presence of BRAF mutations was a strong negative prognostic factor. In the ITT population, median PFS was 7.9, 8.3, and 7.3 months for the three arms, respectively (not significantly different). OS was almost identical for the three groups (20.4, 19.7, 20.3 months, respectively), and confirmed response rates were 41%, 49%, and 47%, respectively. In patients with KRAS wild-type tumors, cetuximab did not provide any additional benefit compared with FLOX alone. In patients with KRAS mutations, no significant difference was detected, although a trend toward improved PFS was observed in arm B. The regimens were well tolerated. Conclusion: Cetuximab did not add significant benefit to the Nordic FLOX regimen in first-line treatment of mCRC.
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New Guidelines to Evaluate the Response to Treatment in Solid Tumors
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K-ras Mutations and Benefit from Cetuximab in Advanced Colorectal Cancer
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Wild-Type KRAS Is Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer
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Self-citationEGFR Antagonists in Cancer Treatment
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Epidermal growth factor receptor (EGFR) signaling in cancer
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ESMO consensus guidelines for the management of patients with metastatic colorectal cancer
Van Cutsem, E., Cervantes, A., Adam, R., Sobrero, A., Van Krieken, J. H., Aderka, D., Aranda Aguilar, E., Bardelli, A., Benson, A., Bodoky, G., et al. (2016) · Annals of Oncology · doi:10.1093/annonc/mdw235 · Cited by 3,421
Self-citationComprehensive review of targeted therapy for colorectal cancer
Xie, Y.-H., Chen, Y.-X., & Fang, J.-Y. (2020) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-020-0116-z · Cited by 1,687
Van Cutsem, E., Cervantes, A., Nordlinger, B., & Arnold, D. (2014) · Annals of Oncology · doi:10.1093/annonc/mdu260 · Cited by 1,167
Pietrantonio, F., Petrelli, F., Coinu, A., Di Bartolomeo, M., Borgonovo, K., Maggi, C., Cabiddu, M., Iacovelli, R., Bossi, I., Lonati, V., et al. (2015) · European Journal of Cancer · doi:10.1016/j.ejca.2015.01.054 · Cited by 486
A Review of the Evolution of Systemic Chemotherapy in the Management of Colorectal Cancer
Gustavsson, B., Carlsson, G., Machover, D., Petrelli, N., Roth, A., Schmoll, H.-J., Tveit, K.-M., & Gibson, F. (2015) · Clinical Colorectal Cancer · doi:10.1016/j.clcc.2014.11.002 · Cited by 381
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Metadata
- Authors
- Tveit, K. M., Guren, T., Glimelius, B., Pfeiffer, P., Sorbye, H., Pyrhonen, S., Sigurdsson, F., Kure, E., Ikdahl, T., Skovlund, E., Fokstuen, T., Hansen, F., Hofsli, E., Birkemeyer, E., Johnsson, A., Starkhammar, H., Yilmaz, M. K., Keldsen, N., Erdal, A. B., Dajani, O., Dahl, O., & Christoffersen, T.
- Venue
- Journal of Clinical Oncology
- Published
- 2012-05-20
- Volume
- 30
- Issue
- 15
- Pages
- 1755-1762
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2129255527
- Cited by
- 533
- References
- 34
- FWCI
- 35.22
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Phase III Trial of Cetuximab With Continuous or Intermittent Fluorouracil, Leucovorin, and Oxaliplatin (Nordic FLOX) Versus FLOX Alone in First-Line Treatment of Metastatic Colorectal Cancer: The NORDIC-VII Study. https://app.cochat.ai/papers/10.1200/jco.2011.38.0915
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- Tveit, K. M., Guren, T., Glimelius, B., Pfeiffer, P., Sorbye, H., Pyrhonen, S., Sigurdsson, F., Kure, E., Ikdahl, T., Skovlund, E., Fokstuen, T., Hansen, F., Hofsli, E., Birkemeyer, E., Johnsson, A., Starkhammar, H., Yilmaz, M. K., Keldsen, N., Erdal, A. B., . . . Christoffersen, T. (2012). Phase III Trial of Cetuximab With Continuous or Intermittent Fluorouracil, Leucovorin, and Oxaliplatin (Nordic FLOX) Versus FLOX Alone in First-Line Treatment of Metastatic Colorectal Cancer: The NORDIC-VII Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2011.38.0915
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