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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003ELenalidomide, has been used to treat myeloma and myelodysplastic syndrome. This article reports on results from the Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination with Docetaxel and Prednisone for Patients with Castrate-Resistant Prostate Cancer [MAINSAIL; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00988208\u0026amp;atom=%2Fspmdc%2F12%2F15%2F10.atom\u0022\u003ENCT00988208\u003C\/a\u003E] trial, which showed that the addition of lenalidomide to docetaxel and prednisone did not improve overall survival in castrate-resistant prostate cancer patients and its use was associated with greater toxicity.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EReproductive Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOncology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ELenalidomide, has been used to treat myeloma and myelodysplastic syndrome. When used in combination with docetaxel and prednisone, or as a single agent, it has been shown to demonstrate activity and tolerability in patients with castrate-resistant prostate cancer (CRPC) [Petrylak DP et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2009]. Daniel P. Petrylak, MD, Yale Cancer Center, New Haven, Connecticut, USA, reported results from the Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination with Docetaxel and Prednisone for Patients with Castrate-Resistant Prostate Cancer [MAINSAIL; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00988208\u0026amp;atom=%2Fspmdc%2F12%2F15%2F10.atom\u0022\u003ENCT00988208\u003C\/a\u003E] trial, which showed that the addition of lenalidomide to docetaxel and prednisone did not improve overall survival (OS) in CRPC patients and its use was associated with greater toxicity.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThis Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of docetaxel plus prednisone as first-line treatment for CRPC. Chemotherapy-na\u00efve patients with progressive metastatic CRPC (effective castration defined as serum testosterone levels \u0026lt;50 ng\/dL) and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score \u22652 were randomized to either lenalidomide (25 mg on Days 1 to 14) plus docetaxel (75 mg\/m\u003Csup\u003E2\u003C\/sup\u003E on Day 1 of each cycle) plus prednisone (5 mg BID on Days 1 to 21) or placebo plus docetaxel plus prednisone at similar doses and scheduling. Treatment phase was 21-day cycles until disease progression. Follow-up for survival occurred every 90 days for up to 5 years following study treatment discontinuation. The primary study endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response, and safety. Patient enrollment was completed in November 2011, with a total of 1059 patients. The data analysis results were based on the cutoff date of January 13, 2012.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe lenalidomide (n=533) and placebo (n=526) arms were well balanced; mean age was 69 years, and ECOG PS scores were 0 in 48.1% and \u22651 in 51.8% of patients. About 71% of patients had radiographic disease progression. Metastatic sites included bone, soft tissue, and both bone and soft tissue. Median OS and PFS were 77 and 45 weeks in the lenalidomide arm, compared with median not reached (HR, 1.53; 95% CI, 1.17 to 2.00; p=0.0017) and 46 weeks (HR, 1.32; 95% CI, 1.05 to 1.66; p=0.0187; in the placebo arm, respectively. Objective response rate was 22.1 % for lenalidomide versus 24.3% for the placebo arm (p=0.3975). The median number of cycles administered were 6 and 8 in the lenalidomide and placebo arms, respectively. All dose reductions were due to adverse events, except for 2 dose reductions of docetaxel that were due to other reasons.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe most common grade \u22653 adverse events that occurred significantly more often in the lenalidomide group included neutropenia (22%), febrile neutropenia (12%), diarrhea (7%), and pulmonary embolism (6.5%). Significantly more deaths (\u0026gt;28 days from last lenalidomide dose) occurred in the lenalidomide arm (20.8%) compared with the placebo arm (15.0%; p=0.016).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe addition of lenalidomide to docetaxel plus prednisone did not improve OS in patients with CRPC and was associated with greater toxicity. Shorter treatment duration, earlier treatment discontinuation, and lower dose intensity of docetaxel might have contributed to this lack of benefit. Studies to explain the poorer outcome of the lenalidomide arm are under way.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 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\/12\/15\/10.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?nzn7sq\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}