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Title: | Resultsof a phase III, randomized, double-blind, placebocontrolledtrialofpegfilgrastim (PEG) inpatients (pts) receivingfirst-line FOLFOX or FOLFIRI andbevacizumab (B) forcolorectalcancer (CRC) |
Authors: | Tamas Pinter Esteban Abella Alvydas Cesas Adina Croitoru Jochen Decaestecker Peter Gibbs Yevhen Hotko Jacek Jassem Galina Petrova Kurteva Jan Novotny Seamus O'Reilly Tomas Salek May F. Mo L. MiRim Choiand Charles Davic Blanke |
Issue Date: | 2013 |
Publisher: | JournalofClinicalOncology, 2013 ASCO AnnualMeetingAbstracts. Vol 31, No 15_suppl (May 20 Supplement), 2013: 3575 |
Abstract: | Background: Theliteraturereportsthataddingbiologicstochemotherapy (ctx) mayincreasetheincidenceofclinicallysignificantneutropenia. histrialwasconductedtoevaluatetheefficacyof PEG inreducingtheincidenceoffebrileneutropenia (FN) inptswithlocally-advanced (LA) ormetastatic (m)CRC receivingfirst-linetreatmentwitheither FOLFOX/B or FOLFIRI/B. Methods: Keyeligibility: 18 yearsold; measurable, nonresectable CRC per RECIST 1.1. Ptswererandomlyassigned 1:1 toeitherplaceboor 6 mg PEG ~24 h afterctx/B. Thestudytreatmentperiodincludedfour Q2W cycles, butptscouldcontinuetheirassignedregimenuntilprogression. Ptswerestratifiedbyregion (NorthAmericavsrestofworld), stage (LA vsmCRC), andctx (FOLFOX vs FOLFIRI). Estimatedsamplesize (N = 800) wasbasedontheexpectedincidenceofgrade 3/4 FN (primaryendpoint) acrossthefirst 4 cyclesofctx/B, poweredfor PEG superiorityoverplacebo. Otherendpointsincludedoverallresponserate (ORR), progression-freesurvival (PFS), andoverallsurvival (OS). Results: 845 ptswererandomized (Nov 2009 toJan 2012) andreceivedstudytreatment; 783 ptscompleted 4 cyclesofctx/B. Medianagewas 61 years; 512 (61%) ptsweremale; 819 (97%) hadmCRC; 414 (49%) received FOLFOX, and 431 (51%) received FOLFIRI. Grade 3/4 FN (first 4 cycles) forplacebovs PEG was 5.7% vs 2.4%; OR 0.41; p = 0.014. A similarincidenceofother grade 3 adverseeventswasseeninbotharms (28% placebo; 27% PEG). Seetableforadditionalresults. Conclusions:PEGsignificantlyreducedtheincidenceofgrade 3/4 FN inthisptpopulationreceivingstandardctx/B for CRC. Follow-upisongoing. |
Type: | Text |
Publication type: | Стаття |
URI: | https://dspace.uzhnu.edu.ua/jspui/handle/lib/10466 |
Appears in Collections: | Наукові публікації кафедри радіології та онкології |
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Journal_of_Clinical_Oncolog2.PDF | 91.53 kB | Adobe PDF | View/Open |
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