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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
Appears in Collections:Наукові публікації кафедри радіології та онкології

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