Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK
Open accessAbstract
Background To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC).Patients and methods In a multicenter two-arm phase II trial, patients were randomized to receive oxaliplatin 130 mg/m(2) on day 1 and capecitabine 1000 mg/m(2) twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab. Treatment was limited to a maximum of six cycles.Results Seventy-four patients with good performance status entered the trial. Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively. Stable disease has been observed in 62% and 35% of the patients, with 76% disease control in both arms. Cetuximab led to skin rash in 65% of the patients. The median overall survival was 16.5 months for arm A and 20.5 months for arm B. The median time to progression was 5.8 months for arm A and 7.2 months for arm B.Conclusion Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX. The correct place of the cetuximab, oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials.
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The clinical benefit in responders treated with anti-EGFR monoclonal antibodies lasts only 8-10 months.
“The clinical benefit in responders treated with anti-EGFR mAbs has been shown to only last 8–10 months [6, 7].”
From Resistance to anti-EGFR therapies in metastatic colorectal cancer: underlying mechanisms and reversal strategies (2021) · cites this paper as [7]
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References 27 · Cited by 124
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- original article Annals of Oncology 1292 | Borner et al. Volume 19 | No. 7 | July 2008
- Authors
- Borner, M., Koeberle, D., Von Moos, R., Saletti, P., Rauch, D., Hess, V., Trojan, A., Helbling, D., Pestalozzi, B., Caspar, C., Ruhstaller, T., Roth, A., Kappeler, A., Dietrich, D., Lanz, D., & Mingrone, W.
- Affiliations
- University Hospital of Bern (CH)
- Corresponding author
- Borner, M.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2008-07
- Volume
- 19
- Issue
- 7
- Pages
- 1288-1292
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2110097275
- Cited by
- 124
- References
- 27
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 7 · 2023: 2 · 2022: 2 · 2021: 2 · 2020: 2 · 2019: 1 · 2018: 4 · 2017: 7 · 2016: 6 · 2015: 6 · 2014: 7 · 2013: 14 · 2012: 6
- FWCI
- 8.97
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- Archive ouverte UNIGE (University of Geneva) (acceptedVersion)
- reroDoc Digital Library (submittedVersion)
- BORIS (University Library Bern) (submittedVersion, other-oa)
- HighWire Press Open Archive (submittedVersion)
- Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
- Health Sciences › Medicine › Surgery › Intraperitoneal and Appendiceal Malignancies
- Keywords
- cetuximab, capecitabine, oxaliplatin, XELOX, metastatic colorectal cancer, first-line therapy, EGFR inhibitors, fluoropyrimidine, rash, overall survival, time to progression, disease control
- MeSH terms
- Cetuximab, Oxaliplatin, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Drug Administration Schedule, Exanthema, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Metastasis, Organoplatinum Compounds, Radiography, Switzerland, Time Factors, Colorectal Neoplasms, Treatment Outcome, Antibodies, Monoclonal, Humanized
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