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Multicenter Randomi...
Multicenter Randomized Phase II Clinical Trial Comparing Neoadjuvant Oxaliplatin, Capecitabine, and Preoperative Radiotherapy With or Without Cetuximab Followed by Total Mesorectal Excision in Patients With High-Risk Rectal Cancer (EXPERT-C)
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Dewdney, Alice (author)
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Cunningham, David (author)
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Tabernero, Josep (author)
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Capdevila, Jaume (author)
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- Glimelius, Bengt (author)
- Uppsala universitet,Enheten för onkologi
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Cervantes, Andres (author)
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Tait, Diana (author)
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Brown, Gina (author)
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Wotherspoon, Andrew (author)
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de Castro, David Gonzalez (author)
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Chua, Yu Jo (author)
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Wong, Rachel (author)
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Barbachano, Yolanda (author)
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Oates, Jacqueline (author)
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Chau, Ian (author)
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(creator_code:org_t)
- 2012
- 2012
- English.
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In: Journal of Clinical Oncology. - 0732-183X .- 1527-7755. ; 30:14, s. 1620-1627
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Purpose To evaluate the addition of cetuximab to neoadjuvant chemotherapy before chemoradiotherapy in high-risk rectal cancer. Patients and Methods Patients with operable magnetic resonance imaging-defined high-risk rectal cancer received four cycles of capecitabine/oxaliplatin (CAPOX) followed by capecitabine chemoradiotherapy, surgery, and adjuvant CAPOX (four cycles) or the same regimen plus weekly cetuximab (CAPOX + C). The primary end point was complete response (CR; pathologic CR or, in patients not undergoing surgery, radiologic CR) in patients with KRAS/BRAF wild-type tumors. Secondary end points were radiologic response (RR), progression-free survival (PFS), overall survival (OS), and safety in the wild-type and overall populations and a molecular biomarker analysis. Results One hundred sixty-five eligible patients were randomly assigned. Ninety (60%) of 149 assessable tumors were KRAS or BRAF wild type (CAPOX, n = 44; CAPOX + C, n = 46), and in these patients, the addition of cetuximab did not improve the primary end point of CR (9% v 11%, respectively; P = 1.0; odds ratio, 1.22) or PFS (hazard ratio [ HR], 0.65; P = .363). Cetuximab significantly improved RR (CAPOX v CAPOX + C: after chemotherapy, 51% v 71%, respectively; P = .038; after chemoradiation, 75% v 93%, respectively; P = .028) and OS (HR, 0.27; P = .034). Skin toxicity and diarrhea were more frequent in the CAPOX + C arm. Conclusion Cetuximab led to a significant increase in RR and OS in patients with KRAS/BRAF wild-type rectal cancer, but the primary end point of improved CR was not met.
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- By the author/editor
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Dewdney, Alice
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Cunningham, Davi ...
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Tabernero, Josep
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Capdevila, Jaume
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Glimelius, Bengt
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Cervantes, Andre ...
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show more...
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Tait, Diana
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Brown, Gina
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Wotherspoon, And ...
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de Castro, David ...
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Chua, Yu Jo
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Wong, Rachel
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Barbachano, Yola ...
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Oates, Jacquelin ...
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Chau, Ian
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show less...
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Journal of Clini ...
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Uppsala University