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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\u003EChemoradiotherapy is not superior to chemotherapy and the addition of erlotinib provides no benefit in the treatment of locally advanced pancreatic cancer. This article presents data from the Randomized Multicenter Phase 3 Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas [LAP07; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00634725\u0026amp;atom=%2Fspmdc%2F13%2F6%2F21.atom\u0022\u003ENCT00634725\u003C\/a\u003E; Hammel P et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2013 (suppl; abstr LBA4003)].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EGastrointestinal Cancers\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EGastrointestinal Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EChemoradiotherapy (CRT) is not superior to chemotherapy and the addition of erlotinib provides no benefit in the treatment of locally advanced pancreatic cancer (LAPC). Pascal Hammel, MD, PhD, H\u00f4pital Beaujon, Clichy, France, presented data from the Randomized Multicenter Phase 3 Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas [LAP07; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00634725\u0026amp;atom=%2Fspmdc%2F13%2F6%2F21.atom\u0022\u003ENCT00634725\u003C\/a\u003E; Hammel P et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2013 (suppl; abstr LBA4003)].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAlthough not metastatic, LAPC is nonresectable due to the involvement of the superior mesenteric artery and the celiac trunk with tumor. Overall survival (OS) of LAPC is 9 to 12 months, which is greater than that of metastatic pancreatic cancer; however, the treatment of LAPC, including the role of CRT is controversial. The primary objective of the LAP07 study was to determine if CRT improved OS in patients whose disease was controlled following 4 months of induction chemotherapy.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the international Phase 3 LAP07 study, 442 patients with LAPC and a performance status of 0 to 2 were first randomized to receive gemcitabine (n=223) or gemcitabine plus erlotinib 100 mg\/day (n=219) for 4 months. Of the 442 patients, 269 patients (61%) with controlled disease were able to undergo a second randomization to receive 2 additional months of gemcitabine or 54 Gy of CRT plus 1600 mg\/m\u003Csup\u003E2\u003C\/sup\u003E of daily capecitabine. Erlotinib (150 mg\/day) was continued as maintenance therapy in patients that had received it during the first randomization.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe median follow-up was 36 months and included 221 deaths, which allowed the interim analysis to be adequately powered. The primary endpoint was OS following the second randomization. The effect of erlotinib on OS, tolerance of treatment, predictive markers, and presence of circulating tumor cells were secondary endpoints.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EIn the LAP07 study, CRT was demonstrated not to be superior to chemotherapy in the treatment of LAPC. In the chemotherapy arm, OS was 16.4 months, compared with 15.2 months in the CRT arm (HR, 1.03; 95% CI, 0.79 to 1.34; p=0.8295). Following the first randomization, there was a trend for decreased OS in the gemcitabine plus erlotinib arm at 11.9 months compared with the gemcitabine arm at 13.6 months (HR, 1.19; 95% CI, 0.97 to 1.45; p=0.093); however, this result was not statistically significant.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EFollowing the first randomization, a greater number of patients experienced adverse events such as decreased hemoglobin, febrile neutropenia, diarrhea, and acneiform rash in the gemcitabine plus erlotinib arm, compared with the gemcitabine arm. Following the second randomization, both treatment regimens were well tolerated with a similar frequency of adverse events except for an increase in the number of patients that experienced nausea in the CRT arm (0 vs 6 patients; p=0.009).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EDr. Hammel stated that, in his opinion, the data from the LAP07 trial suggest that the standard of care for the treatment of LAPC should be chemotherapy, with CRT reserved for use as an option if the disease is controlled by chemotherapy. Although CRT or erlotinib provided no additional advantage to patients in the present study, there may be a subset of patients that could benefit, which is currently under investigation.\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\/21.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?nznw3p\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}