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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\u003Cp id=\u0022p-1\u0022\u003EThe XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer [TROPIC; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00417079\u0026amp;atom=%2Fspmdc%2F12%2F7%2FNP.5.atom\u0022\u003ENCT00417079\u003C\/a\u003E] trial showed that treatment with cabazitaxel (CbzP) produced statistically significant improvement in overall survival versus mitoxantrone plus prednisone in patients with metastatic, castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen (HR, 0.70; p\u0026lt;0.0001). This article discusses interim results from a cohort compassionate-use program with CbzP plus prednisone for patients with mCRPC [EAP; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01254279\u0026amp;atom=%2Fspmdc%2F12%2F7%2FNP.5.atom\u0022\u003ENCT01254279\u003C\/a\u003E; Bavbek SE et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E (suppl; asbtr e15112) 2012].\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ereproductive cancers clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epain management\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EThe XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer [TROPIC; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00417079\u0026amp;atom=%2Fspmdc%2F12%2F7%2FNP.5.atom\u0022\u003ENCT00417079\u003C\/a\u003E] trial showed that treatment with cabazitaxel (CbzP) produced statistically significant improvement in overall survival versus mitoxantrone plus prednisone in patients with metastatic, castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen (HR, 0.70; p\u0026lt;0.0001). Sevil E. Bavbek, MD, Istanbul University Oncology Institute, Istanbul, Turkey, presented interim results from a cohort compassionate-use program (CUP) with CbzP plus prednisone for patients with mCRPC [EAP; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01254279\u0026amp;atom=%2Fspmdc%2F12%2F7%2FNP.5.atom\u0022\u003ENCT01254279\u003C\/a\u003E; Bavbek SE et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E (suppl; asbtr e15112) 2012].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EResults from the TROPIC trial supported the establishment of a CUP and an early access program (EAP). The aims of this Phase 3, single-arm, open-label trial are to provide access to CbzP prior to commercial availability to mCRPC patients who may benefit from it, and to further assess the agent\u0027s safety profile. Estimated enrollment is 1600 patients from 250 centers globally. Eligible patients received CbzP in combination with oral prednisone until disease progression, death, unacceptable toxicity, or physician\/patient decision.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EBaseline characteristics and safety data are available for the first 399 patients. The median age is 68 years (range, 43 to 89); 90.2% of patients had ECOG Performance Status scale 0 to 1. The median cumulative dose of prior docetaxel was 675 mg\/m\u003Csup\u003E2\u003C\/sup\u003E; previous therapy with mitoxantrone plus prednisone was allowed.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe median time from the last dose of docetaxel to progression was 4 months; 53.3% of patients experienced disease progression either during or \u0026lt;3 months after docetaxel therapy; 61% had =2 metastatic sites, most commonly bone (93.2%) and regional lymph nodes (34.4%). At the time of analysis, a median of four cycles of CbzP had been administered; four patients received =10 cycles.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EMedian relative dose intensity was 99.2% (range, 80.1 to 104.9). Granulocyte colony-stimulating factor was administered to 34.3% of patients in Cycle 1 (6.3% therapeutic, 26.6% prophylactic). Overall, 71.4% of patients had adverse events (AEs). The most common grade 3 to 4 AEs were neutropenia (11.3%), febrile neutropenia (6.3%), anemia (2.8%), fatigue (2%), neutropenic sepsis (1.8%), vomiting (1.3%), and diarrhea (1%). Eight (2%) treatment-related deaths were reported.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe investigators concluded that CUP\/EAP provides additional safety data for CbzP in a routine clinical practice patient population with heavily pretreated mCRPC. Treatment was tolerable, with a predictable and manageable toxicity profile consistent with data reported for TROPIC and product labeling.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\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\/7\/NP.5.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?nzngtq\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}