Source:http://linkedlifedata.com/resource/pubmed/id/20473862
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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
3
|
| pubmed:dateCreated |
2010-11-29
|
| pubmed:abstractText |
A regimen consisting of 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOX-6) is widely used in France in the first-line treatment of metastatic colorectal cancer (MCRC). The aim of our study was to demonstrate the non-inferiority of capecitabine plus oxaliplatin (XELOX) versus FOLFOX-6 for this indication. Patients were randomly assigned to receive XELOX or FOLFOX-6 for 6 months. The primary endpoint was overall response rate (ORR) in the per-protocol (PP) population; however, progression-free and overall survival (OS), time to response and response duration were also assessed. A total of 306 patients were enrolled (XELOX n = 156; FOLFOX-6 n = 150). ORR was 42 and 46% with XELOX and FOLFOX-6, respectively, in the PP population. The difference between groups was 4.7%; the upper limit of the unilateral 95% confidence interval (14.4%) was below the non-inferiority margin of 15%. In the intent-to-treat population, median progression-free survival was 8.8 months with XELOX and 9.3 months with FOLFOX-6, and median OS was 19.9 and 20.5 months, respectively. XELOX patients had significantly more grade 3/4 thrombocytopenia (12% vs. 5%) and diarrhoea (14% vs. 7%), but significantly less grade 3/4 neutropenia (5% vs. 47%), febrile neutropenia (0% vs. 6%) and neuropathy (11% vs. 26%) than FOLFOX-6 patients. We conclude that XELOX is non-inferior in terms of efficacy to FOLFOX-6 in the first-line treatment of MCRC, but has a different toxicity profile.
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| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
|
| pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Deoxycytidine,
http://linkedlifedata.com/resource/pubmed/chemical/Fluorouracil,
http://linkedlifedata.com/resource/pubmed/chemical/Leucovorin,
http://linkedlifedata.com/resource/pubmed/chemical/Organoplatinum Compounds,
http://linkedlifedata.com/resource/pubmed/chemical/capecitabine,
http://linkedlifedata.com/resource/pubmed/chemical/oxaliplatin
|
| pubmed:status |
MEDLINE
|
| pubmed:month |
Feb
|
| pubmed:issn |
1097-0215
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| pubmed:author |
pubmed-author:AdenisAntoineA,
pubmed-author:BennounaJaafarJ,
pubmed-author:BergougnouxLoicL,
pubmed-author:ConroyThierryT,
pubmed-author:DouillardJean-YvesJY,
pubmed-author:DucreuxMichelM,
pubmed-author:FarouxRogerR,
pubmed-author:GI Group of the French Anti-Cancer Centers,
pubmed-author:HebbarMohamedM,
pubmed-author:KocklerLeilaL,
pubmed-author:LledoGérardG,
pubmed-author:RebischungChristineC,
pubmed-author:YchouMarcM
|
| pubmed:issnType |
Electronic
|
| pubmed:day |
1
|
| pubmed:volume |
128
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
682-90
|
| pubmed:meshHeading |
pubmed-meshheading:20473862-Adult,
pubmed-meshheading:20473862-Aged,
pubmed-meshheading:20473862-Aged, 80 and over,
pubmed-meshheading:20473862-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:20473862-Colonic Neoplasms,
pubmed-meshheading:20473862-Colorectal Neoplasms,
pubmed-meshheading:20473862-Deoxycytidine,
pubmed-meshheading:20473862-Disease-Free Survival,
pubmed-meshheading:20473862-Female,
pubmed-meshheading:20473862-Fluorouracil,
pubmed-meshheading:20473862-Humans,
pubmed-meshheading:20473862-Leucovorin,
pubmed-meshheading:20473862-Male,
pubmed-meshheading:20473862-Middle Aged,
pubmed-meshheading:20473862-Neoplasm Metastasis,
pubmed-meshheading:20473862-Neoplasm Staging,
pubmed-meshheading:20473862-Organoplatinum Compounds,
pubmed-meshheading:20473862-Rectal Neoplasms,
pubmed-meshheading:20473862-Treatment Outcome,
pubmed-meshheading:20473862-Young Adult
|
| pubmed:year |
2011
|
| pubmed:articleTitle |
Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOX-6) as first-line treatment for metastatic colorectal cancer.
|
| pubmed:affiliation |
Department of Medicine, Gustave Roussy Institute, Villejuif, France. ducreux@igr.fr
|
| pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Multicenter Study
|