Source:http://linkedlifedata.com/resource/pubmed/id/20212250
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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
11
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| pubmed:dateCreated |
2010-4-9
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| pubmed:abstractText |
PURPOSE This phase III, multicenter, randomized, placebo-controlled trial assessed the efficacy and safety of sorafenib, an oral multikinase inhibitor, in combination with carboplatin and paclitaxel in chemotherapy-naïve patients with unresectable stage IIIB or IV non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS Nine hundred twenty-six patients were randomly assigned to receive up to six 21-day cycles of carboplatin area under the curve 6 and paclitaxel 200 mg/m(2) (CP) on day 1, followed by either sorafenib 400 mg twice a day (n = 464, arm A) or placebo (n = 462, arm B) on days 2 to 19. The maintenance phase after CP consisted of sorafenib 400 mg or placebo twice a day. The primary end point was overall survival (OS); secondary end points included progression-free survival and tumor response. RESULTS Overall demographics were balanced between arms; 223 patients (24%) had squamous cell histology. On the basis of a planned interim analysis, median OS was 10.7 months in arm A and 10.6 months in arm B (hazard ratio [HR] = 1.15; 95% CI, 0.94 to 1.41; P = .915). The study was terminated after the interim analysis concluded that the study was highly unlikely to meet its primary end point. A prespecified exploratory analysis revealed that patients with squamous cell histology had greater mortality in arm A than in arm B (HR = 1.85; 95% CI, 1.22 to 2.81). Main grade 3 or 4 sorafenib-related toxicities included rash (8.4%), hand-foot skin reaction (7.8%), and diarrhea (3.5%). CONCLUSION No clinical benefit was observed from adding sorafenib to CP chemotherapy as first-line treatment for NSCLC.
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| pubmed:commentsCorrections | |
| pubmed:language |
eng
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| pubmed:journal | |
| pubmed:citationSubset |
IM
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| pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Benzenesulfonates,
http://linkedlifedata.com/resource/pubmed/chemical/Carboplatin,
http://linkedlifedata.com/resource/pubmed/chemical/Paclitaxel,
http://linkedlifedata.com/resource/pubmed/chemical/Placebos,
http://linkedlifedata.com/resource/pubmed/chemical/Pyridines,
http://linkedlifedata.com/resource/pubmed/chemical/sorafenib
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| pubmed:status |
MEDLINE
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| pubmed:month |
Apr
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| pubmed:issn |
1527-7755
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| pubmed:author |
pubmed-author:Abrão MiziaraJosé EliasJE,
pubmed-author:AlbertIstvanI,
pubmed-author:ArénOsvaldoO,
pubmed-author:BalintBeatrixB,
pubmed-author:BarriosCarlos HenriqueCH,
pubmed-author:CihonFrankF,
pubmed-author:CsollakMariaM,
pubmed-author:CupitLisaL,
pubmed-author:De MarinisFilippoF,
pubmed-author:DimatteoSandraS,
pubmed-author:GrossiFrancescoF,
pubmed-author:HannaNasserN,
pubmed-author:KellerAlanA,
pubmed-author:KrzakowskiMaciejM,
pubmed-author:NovelloSilviaS,
pubmed-author:PereiraJosé RodriguesJR,
pubmed-author:ReckMartinM,
pubmed-author:ScagliottiGiorgioG,
pubmed-author:ThomasMichaelM,
pubmed-author:von PawelJoachimJ
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| pubmed:issnType |
Electronic
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| pubmed:day |
10
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| pubmed:volume |
28
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| pubmed:owner |
NLM
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| pubmed:authorsComplete |
Y
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| pubmed:pagination |
1835-42
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| pubmed:meshHeading |
pubmed-meshheading:20212250-Adenocarcinoma,
pubmed-meshheading:20212250-Adult,
pubmed-meshheading:20212250-Aged,
pubmed-meshheading:20212250-Aged, 80 and over,
pubmed-meshheading:20212250-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:20212250-Benzenesulfonates,
pubmed-meshheading:20212250-Carboplatin,
pubmed-meshheading:20212250-Carcinoma, Large Cell,
pubmed-meshheading:20212250-Carcinoma, Non-Small-Cell Lung,
pubmed-meshheading:20212250-Carcinoma, Squamous Cell,
pubmed-meshheading:20212250-Female,
pubmed-meshheading:20212250-Humans,
pubmed-meshheading:20212250-Lung Neoplasms,
pubmed-meshheading:20212250-Male,
pubmed-meshheading:20212250-Middle Aged,
pubmed-meshheading:20212250-Neoplasm Staging,
pubmed-meshheading:20212250-Paclitaxel,
pubmed-meshheading:20212250-Placebos,
pubmed-meshheading:20212250-Pyridines,
pubmed-meshheading:20212250-Survival Rate,
pubmed-meshheading:20212250-Treatment Outcome
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| pubmed:year |
2010
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| pubmed:articleTitle |
Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer.
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| pubmed:affiliation |
Department of Clinical and Biological Sciences, University of Turin, San Luigi Hospital, Regione Gonzole 10, Orbassano, Torino, Italy 10043. scagliotti@ihnet.it
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| pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Multicenter Study,
Clinical Trial, Phase III
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