| A randomized, phase II trial of standard triweekly compared with dose-dense biweekly capecitabine plus oxaliplatin plus bevacizumab as first-line treatment for metastatic colorectal cancer: XELOX-A-DVS (dense versus standard). | |
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MedLine Citation:
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PMID: 22622147 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Capecitabine administered for 7 days biweekly with oxaliplatin (XELOX) biweekly has been reported to have activity and safety profiles similar to those of standard capecitabine given for 14 days triweekly. Multiple studies have shown that the addition of bevacizumab to 5-fluorouracil-based chemotherapy is active and well tolerated. METHODS: Patients with metastatic colorectal cancer (mCRC) were randomized to XELOX plus bevacizumab using a standard triweekly cycle (Q3W) or a dose-dense biweekly cycle (Q2W) schedule. The primary endpoint was the progression-free survival (PFS) interval. This trial is registered on ClinicalTrials.gov (identifier, NCT00159432). RESULTS: In total, 435 U.S. patients were randomized. The median PFS intervals were 9.6 months in the Q3W group and 9.1 months in the Q2W group. The median overall survival times were 28.4 months and 22.1 months and the median times to treatment failure were 5.5 months and 3.4 months, respectively. Overall, gastrointestinal disorders were the most common (93%) adverse event (AE). Grade 3 or 4 AEs occurred in 75% and 81% of patients in the Q3W and Q2W groups, respectively. Treatment discontinuation as a result of diarrhea (5% versus 10%) and hand-foot syndrome (2% versus 9%) was less common in the Q3W group than in the Q2W group, respectively. CONCLUSIONS: Based on these results, the first-line treatment of U.S. patients with mCRC using a biweekly combination of XELOX and bevacizumab at the doses studied cannot be recommended. XELOX Q3W remains the preferred schedule for the management of mCRC. |
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Authors:
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Herbert Hurwitz; Edith P Mitchell; Thomas Cartwright; Ambrose Kwok; Sylvia Hu; Edward McKenna; Yehuda Z Patt |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2012-05-23 |
Journal Detail:
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Title: The oncologist Volume: 17 ISSN: 1549-490X ISO Abbreviation: Oncologist Publication Date: 2012 |
Date Detail:
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Created Date: 2012-07-19 Completed Date: 2013-02-07 Revised Date: 2013-04-16 |
Medline Journal Info:
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Nlm Unique ID: 9607837 Medline TA: Oncologist Country: United States |
Other Details:
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Languages: eng Pagination: 937-46 Citation Subset: IM |
Affiliation:
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Comprehensive Cancer Center, Duke University Medical Center, Durham, NC 27710, USA. Hurwi004@mc.duke.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00159432 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized / administration & dosage, adverse effects Antineoplastic Combined Chemotherapy Protocols / administration & dosage*, adverse effects Colorectal Neoplasms / drug therapy*, pathology Deoxycytidine / administration & dosage, adverse effects, analogs & derivatives Drug Administration Schedule Female Fluorouracil / administration & dosage, adverse effects, analogs & derivatives Humans Male Middle Aged Neoplasm Metastasis Organoplatinum Compounds / administration & dosage, adverse effects Prospective Studies |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Monoclonal, Humanized; 0/Organoplatinum Compounds; 0/bevacizumab; 154361-50-9/capecitabine; 51-21-8/Fluorouracil; 63121-00-6/oxaliplatin; 951-77-9/Deoxycytidine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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