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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\u003EA randomized, open-label Phase 2 trial with patients who had small cell lung cancer (SCLC) that had progressed during or after first-line platinum-based chemotherapy found no significant difference in progression-free survival with cabazitaxel against topotecan, the current standard for comparison [Riemsma R et al. \u003Cem\u003EBMC Cancer\u003C\/em\u003E 2010]. The median overall survival was shorter for patients taking cabazitaxel versus those taking topotecan [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01500720\u0026amp;atom=%2Fspmdc%2F14%2F3%2F13.atom\u0022\u003ENCT01500720\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERespiratory Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECancer Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERespiratory Cancers\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECancer\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\u003EA randomized, open-label Phase 2 trial with patients who had small cell lung cancer (SCLC) that had progressed during or after first-line platinum-based chemotherapy found no significant difference in progression-free survival (PFS) with cabazitaxel against topotecan, the current standard for comparison [Riemsma R et al. \u003Cem\u003EBMC Cancer\u003C\/em\u003E 2010]. The median overall survival (OS) was shorter for patients taking cabazitaxel versus those taking topotecan [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01500720\u0026amp;atom=%2Fspmdc%2F14%2F3%2F13.atom\u0022\u003ENCT01500720\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe authors of the study sought to determine the efficacy of cabazitaxel, a next-generation taxane shown to be safe and effective as second-line treatment of metastatic castrate-resistant prostate cancer (mCRPC) and other advanced solid tumors [de Bono JS et al. \u003Cem\u003ELancet\u003C\/em\u003E 2010; Dieras V et al. \u003Cem\u003EEur J Cancer\u003C\/em\u003E 2013; Fumoleau P et al. \u003Cem\u003EBMC Cancer\u003C\/em\u003E 2013; Pivot X et al. \u003Cem\u003EAnn Oncol\u003C\/em\u003E 2008] versus topotecan as second-line treatment of SCLC. Two randomized studies demonstrated the efficacy of topotecan in relapsed SCLC [Ardizzoni A et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 1997; von Pawel I et al. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 1999]. No other agent has shown superior clinical activity.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EOne hundred seventy-nine patients with locally advanced or metastatic SCLC were randomly assigned to intravenous (IV) cabazitaxel 25 mg\/m\u003Csup\u003E2\u003C\/sup\u003E (Day 1 every 3 weeks; n=91) or IV topotecan 1.5 mg\/m\u003Csup\u003E2\u003C\/sup\u003E (Days 1 to 5, every 3 weeks; n=88). The patients were divided into 2 subgroups: chemosensitive (progression \u226590 days; n=91) or chemorefractory (progression during or within 90 days; n=88). They were also separated by the presence or the absence of brain metastasis and by plasma concentration of lactate dehydrogenase (LDH; less than or equal to vs greater than the upper limit of normal).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EKey eligibility criteria included Eastern Cooperative Oncology Group Performance Status (ECOG-PS) \u22641, 1 round of prior chemotherapy, and no prior treatment with a taxane or with topotecan.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ETracey L. Evans, MD, Abramson Cancer Center, Philadelphia, PA, USA, presented results for the primary endpoint of improvement in PFS and the secondary endpoints of OS, tumor response rate, and adverse events from this multinational trial. Other secondary endpoints are disease progression-free rate at 12 weeks, duration of response, and health-related quality of life (HRQoL).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe median age of the patients was 61 years. Baseline characteristics were balanced between treatment arms; approximately 50% of patients in each arm were chemorefractory. Patients received a median number of 2 cycles of cabazitaxel and 4 cycles of topotecan.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EMedian PFS was 1.4 months with cabazitaxel and 3.0 months with topotecan in the intention-to-treat (ITT) analysis. The study failed to meet the primary endpoint of improvement in PFS with cabazitaxel versus topotecan (log-rank test 2-sided, p\u0026lt;0.0001); hazard ratio (HR), 2.169; 95% CI, 1.563 to 3.010). The median PFS was similar to the overall results in the chemosensitive (1.5 vs 3.8 months) and chemoresistant (1.4 vs 2.7 months) subgroups. The tumor response rates by ITT analysis for the overall study population and for the 2 subgroups are detailed in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/15800\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/15800\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15800\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003EThe Objective Tumor Response Rate in the Intention-to-Treat Analysis\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003EThe OS was 5.2 months with cabazitaxel and 6.8 months with topotecan in the ITT population (log-rank test 2-sided, p=0.0125; HR, 1.57; 95% CI, 1.10 to 2.25). Similar results were seen for OS with the subgroups (6.3 vs 7.2 months chemosensitive; 3.4 vs 5.7 months chemorefractory).\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003ETreatment-emergent adverse events (TEAEs) were more frequent with topotecan. Any TEAE of any grade occurred in 94.3% of the topotecan and 88.8% of the cabazitaxel groups, and \u2265grade 3 TEAE occurred in 71.6% and 58.4%, respectively. Overall, 29 deaths resulted from TEAEs. TEAEs that led to death and were considered possibly related to treatment were neutropenic infection in 3 patients, febrile neutropenia in 2 patients, neutropenic sepsis in 1 patient, and cardiopulmonary failure in 1 patient.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 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\/14\/3\/13.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?nzpasp\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzpasp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}