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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe addition of lapatinib (L) to capecitabine plus oxaliplatin (Cape\/Ox) does not improve overall survival in patients with locally advanced or metastatic gastric, esophageal, or gastroesophageal junction cancer whose tumors have amplification of the HER2 gene, although an improvement in survival was seen in patients of Asian descent and those aged \u0026lt;60 years. Results were presented from the Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer [LOGiC; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00680901\u0026amp;atom=%2Fspmdc%2F13%2F6%2F20.1.atom\u0022\u003ENCT00680901\u003C\/a\u003E; \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2013 (suppl; abstr LBA4001)], which compared Cape\/Ox alone or in combination with lapatinib (Cape\/Ox\/L) as first-line treatment for patients with advanced or metastatic HER2 -positive upper gastrointestinal tract cancers.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EGastrointestinal Cancers Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EGastrointestinal Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe addition of lapatinib (L) to capecitabine plus oxaliplatin (Cape\/Ox) does not improve overall survival (OS) in patients with locally advanced or metastatic gastric, esophageal, or gastroesophageal junction cancer whose tumors have amplification of the HER2 gene, although an improvement in survival was seen in patients of Asian descent and those aged \u0026lt;60 years.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EResults were presented from the Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer [LOGiC; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00680901\u0026amp;atom=%2Fspmdc%2F13%2F6%2F20.1.atom\u0022\u003ENCT00680901\u003C\/a\u003E; \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2013 (suppl; abstr LBA4001)] by J. Randolph Hecht, MD, University of California, Los Angeles, Los Angeles, California, USA, which compared Cape\/Ox alone or in combination with lapatinib (Cape\/Ox\/L) as first-line treatment for patients with advanced or metastatic HER2-positive upper gastrointestinal tract cancers.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe Phase 3 trial included 545 patients enrolled between June 2008 and January 2012 from 186 centers in 22 countries. Eligible patients included those with locally advanced or metastatic histologically confirmed adenocarcinoma of the stomach, esophagus, or gastroesophageal junction; measurable or evaluable disease according to RECIST; HER2-positive disease, \u226518 years of age; ECOG PS \u0026lt;2, and no prior palliative chemotherapy.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EHER2-positive disease was confirmed in a central laboratory in 487 of the 545 patients by fluorescence \u003Cem\u003Ein situ\u003C\/em\u003E hybridization. These patients were used as the primary efficacy population (PEP) to evaluate the primary outcome of OS.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EOf these 487 patients, 249 were randomized to Cape\/Ox\/L (oxaliplatin 130 mg\/m\u003Csup\u003E2\u003C\/sup\u003E Day 1, capecitabine 850 mg\/m\u003Csup\u003E2\u003C\/sup\u003E BID Days 1 to 14, and lapatinib 1250 mg QD Days 1 to 21) and 238 to Cape\/Ox plus placebo (Cape\/Ox\/P).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EBased on this PEP, the study found no difference in OS between the two treatments with a median OS of 12.2 months and 10.5 months for Cape\/Ox\/L and Cape\/Ox\/P, respectively (HR, 0.91; 95% CI, 0.73 to 1.12; p=0.3492).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EUnder prespecified subgroup analyses, however, significant improvements in OS were seen in Asian patients compared with populations in the rest of the world (ROW) and those aged \u0026lt;60 years. Asian patients had an improvement in median OS from 10.9 months with Cape\/Ox\/P to 16.5 months with Cape\/Ox\/L (HR, 0.68; 95% CI, 0.48 to 0.96). The median OS in ROW populations improved from 9.1 for Cape\/Ox\/P to 10.0 months for Cape\/Ox\/L (HR, 1.04; 95% CI, 0.79 to 1.37).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EPatients aged \u0026lt;60 years also had significantly improved OS compared with those aged \u226560 years, with an improvement in median OS from 9.0 months with Cape\/Ox\/P to 12.9 months with Cape\/Ox\/L (HR, 0.69; 95% CI, 0.51 to 0.94). In patients aged \u226560 years, the median OS was 10.9 months with Cape\/Ox\/P and 11.3 months with Cape\/Ox\/L (HR, 1.08; 95% CI, 0.81 to 1.45).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003ESecondary outcomes of the study showed a progression-free survival of 6 months and 5.4 months for Cape\/Ox\/L and Cape\/Ox\/P, respectively, as well as overall response rates of 53% and 40%, respectively, with a median duration of response of 7.3 months and 5.6 months, respectively.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EToxicity was comparable between the two treatment arms, except that Cape\/Ox\/L was associated with increased overall diarrhea (58%) compared with Cape\/Ox\/P (29%), Grade 3 diarrhea (12% vs 3%), and skin rash (21% vs 7%).\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EBased on these results, no improvement in OS was seen with the addition of lapatinib to Cape\/Ox except for in Asian patients and those aged \u0026lt;60 years; however, the addition of lapatinib did confer some improvement in progression-free survival and overall response rates.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/13\/6\/20.1.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nznw21\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}