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ByAngela Townsend, The Plain Dealer

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RecommendBrianKachaylo,PollyannaAngel-Fletcherand27others recommendthis.

Page 1of 3Oncology group's report calls for smaller, more-tailored clinical trials | clev...4/22/2012http://www.cleveland.com/medical/index.ssf/2011/11/oncology_groups_rep...

"Whentheyexplainedtometheirteamapproach,Iknewthatnothingwouldbeoverlooked,"hesaid."ItgavemeasenseofhopeIhadn'tfeltsinceIhadbeendiagnosed.Thatmadeallofthedifferenceintheworld."TheclinicaltrialthatKachayloand223otherpatientsathospitalsacrossthecountryhaveenrolledinisexactlywhattheAmericanSocietyofClinicalOncologyiscallingfor:asmallstudythatlooksatthespecificmolecularcharacteristicsofaperson'scancertumortotailorhisorhertreatment.OnThursdaythesocietyissueda29-pagereportintendedtobeaguidelinefortransformingclinicalcareresearchandspeedinguptheprocessofcreatingdrugtherapies.It'san"ambitiousvision,"saidMeropol,thenationalstudychairmanoftheclinicaltrialthatKachayloisin,duringamediaconferencecall.MeropolisoneofthreeexecutiveeditorsoftheAmericanSocietyofClinicalOncologyreport."Webelievethatcancercareandpatientcarecanbemoretargeted,moreefficientandmoreeffective,"Meropolsaid.""Theexistingdrugdevelopmentandclinicalresearchstructurecan'tkeepupwiththemajoradvancesincancerresearchandtreatmentthathavebeenmadeoverthelastfewdecades,thereport'sauthorsstate.Theoldwayofapproachingtreatmentisdeterminedbyatumor'slocationinthebody.Thenewer,morefavoredwayhastreatmentdeterminedbymolecularcharacteristicsofthepatientorthetumor.Underthe"oldmodel,"clinicaltrialshavelargepatientenrollment.The"newmodel"wouldhavefewerpatientsandwhoarecarefullychosenbasedonhavingrelevantmutationsorgeneticmoleculardefects.Becausealiverbiopsyrevealedhighlevelsofaparticularproteinthatwouldhavecausedhimnottorespondwelltothestandardtherapy,Kachayloendedupgettingtheexperimentaltherapy.Barriersmustberemoved,includingthosethatstymiecollaborationamongcompaniesandresearchers;alossoffederalfunding;lackofflexibilityforclinicaltrials;andinconsistentuseofelectronicmedicalrecords.Inthenextthreeyears,theAmericanSocietyofClinicalOncologyisproposing:•Researchersapproachdrugdevelopmentdifferently,withabetterunderstandingofcancerbiology."Youreallyaretalkingaboutdoingsmallerstudieswithsmallernumbersofpatientsinthem,"Meropolsaid.•Hospitalsuseelectronicmedicalrecordsmorewidelyandmoreeffectivelysothatanindustrystandardisreached.•Researchersdesignsmarterclinicaltrialsthatcanidentifymorequicklywhichpatientsaremostlikelytoreapthelargestbenefitfromaparticulartherapy.Afterfourroundsofchemotherapywiththedrugirinotecan,thesixtumorsonKachaylo'sliverandtheoneinhiscolonallhadshrunkbymorethan50percent.Aftertwomoreroundsofchemotherapy,KachaylohadsurgeryOct.21.HecamehomeOct.30andwillrecoverforafewweeksbeforereceivingmorechemotherapy."Byallrights,Ishouldbeamonthawayfrommydeath,"hesaid,referringtotheinitialdirenews.Instead,he'sconfidentenoughabouthisfuturethathewentoutandboughtanewtoolset."Theydidnotcomeoutandsay,'You'recured,'"hesaid."Buttheysaidthegoalwastoshrinkthetumorsandgetthemcutout.Providedthattheydon'tcomeback,I'dbecured.They'reveryconfidentthattheygotallofthecancer."

To read the full ASCO report go to

http:/ / tinyurl.com / ASCO-blueprint

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Page 2of 3Oncology group's report calls for smaller, more-tailored clinical trials | clev...4/22/2012http://www.cleveland.com/medical/index.ssf/2011/11/oncology_groups_rep...

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