Community oncology
`v 6 no 3 Mar 2009
`General Collection
`VV1 C0429IN
`20090418 122846
`
`ONCOLOGY
`
`THE ISSUES THAT MATTER TO YOU YOUR PRACTICE
`
`AND YOUR PATIENTS
`
`REVIEW ARTICLE
`
`Identifying and treating
`fiAh re iin CPALz
`a review of treatment guidelines and
`available agents
`Stuart L Goldberg anal Aisha Masood
`
`PHARMACOGENET1CS
`
`A new era for cancer
`Jeffrey Allen and Clinton F Stewart
`
`treatment
`
`BRIEF COMMUNICATIONS
`
`Elevated alphafetoprotein levels and
`liver lesions in the absence of
`
`WASHINGTON
`UPDATE
`Can we fix the economy and
`EP n t
`A report from the 4ti Annual
`Communiiy Oncology Conference
`Caroline Helwick
`
`ADVERSE EVENTS ALERT
`
`Anaphylaxis caused by
`Crerr
`
`preventing and treating
`a hypersensitivity reaction
`Lauren D Irizarry et al
`
`hepa
`
`Nazik
`
`Volum
`
`March
`
`I
`
`it hiril
`
`11
`
`If
`
`littli
`
`MB XHLRZO
`PD SUB
`WET
`IRFORMATIoU
`SERVICES IBC
`160 If INTH AVE
`STE A
`
`11111111111iiitlidi
`
`LOT C 006
`
`P0026
`13162
`32066
`V9002
`
`RUNUEMEDE
`
`a
`
`08078 1181
`
`le table of content
`jes 94 and 96
`
`Abraxis EX2019
`Actavis LLC v Abraxis Bioscience LLC
`1PR201701101 1PR201701103 1PR201701104
`
`

`

`Community Oncology is
`published by
`
`11 DAt
`
`toot
`
`Editor in Chief
`Lee S Schwartzberg MD FACP
`
`The West Clinic
`
`Editors
`
`Linda D Bosserman MD FACP
`
`Wilshire Oncology Medical Group
`
`David H Henry MD FACP
`
`Pennsylvania Hospital
`
`Elsevier Oncology
`46 Green Street 2nd Floor
`Huntington NY 11743
`tel 6314248905 fax
`6314248900
`
`Editoriai Board
`Carolyn R Aldige
`Cancer Research and Prevention Foundation
`Paul N Anderson MD
`
`Randi Londer Gould Managing Editor
`Gail M van Koot Editorial Manager
`Susan Redding MA Copy Editor
`
`Rocky Mountain Cancer Center
`Francis P Arena MD
`Arena Oncology Associates
`Ralph V Boccia MD
`Georgetown University
`Susan Carter PhD
`Claremont CA
`Bank R Cassileth PhD
`
`Caroline Helwick Contributing Writer
`
`Memorial
`
`Edwin S Geffner Design
`
`Director
`
`Wendy McGullam Production Manager
`
`Devin Gregorie National Accounts Manager
`
`Kelly McNulty National Sales Manager
`Dan H Kim President and Publisher
`
`Community Ontology ISSN 15485315 is
`Inc Elsevier
`published monthly by Elsevier
`Oncology 46 Green Street 2nd Floor
`Huntington NY 11743 Periodicals postage
`paid at Huntington NY and additional mailing
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`offices
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`Recipient
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`Oncology Circulation Elsevier Inc 6013
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`
`On The cover Colored scanning electron
`micrograph of blood cells in a patient
`suffering from leukemia Four white blood
`cells leukocytes browngreen and two red
`blood cells erythrocytes red are seen
`
`Photo Steve GschrneissnerPhoto
`
`Researchers Inc
`
`SloanKettering Cancer Center
`
`Lawrence R Cola MD
`Community Kimball Regional Cancer Center
`Steven M Coplon MHA
`
`The West Clinic
`
`Barry Fortner PhD
`P4 Healthcare
`John A Fracchia MD
`Lenox Hill Hospital
`James N George MD
`
`University of Oklahoma Health
`Sciences Center
`
`Michael S Gordon MD
`Premiere Oncology of Arizona
`Richard J Grab MD
`Multinational Association for Supportive
`Cancer Care
`
`Patrick Gruscnmeyer SeD
`Helen E Graham Cancer Center
`Hackney MD
`Mary Helen
`Massey Cancer Center
`I Craig Henderson MD
`University of California San Francisco
`David MI Hoffman MD
`Tower Hematology Oncology Medical Group
`Dawn G Holcombe FACMPE
`DGH Consulting and
`Connecticut Oncology Association
`Jimmie Holland MD
`
`Memorial
`
`SloanKettering Cancer Center
`
`Rankle Ann Holmes MD
`US Oncology Houston
`L Wayne Keiser MD
`Redwood Regional Medical Group
`Mary Kniczynski
`CommunityOncology Alliance
`
`Section Editors
`
`COMMUNITY TRANSLATIONS
`
`Jame Abraham MD
`
`West Virginia University
`
`ADVERSE EVENTS ALERT
`
`Charles L Bennett MD PhD MPP
`Feinberg School of Medicine
`Northwestern University
`CASES IN COMMUNITY ONCOLOGY
`Michael A Danso MD
`US Oncology Cancer Centers of Florida
`
`Leslie Rodgers Laufman MD
`Hematology Oncology Consultants
`Stuart M Lichtman MD
`Memorial SloanKettering Cancer Center
`at Suffolk
`
`Cancer Center
`
`Cancer Center
`
`Advanced Medical Specialties
`
`LLC
`
`Centec
`
`University
`
`of Tidewater
`
`John S Macdonald MD
`St Vincents Comprehensive
`John L Marshall MD
`Lombardi Comprehensive
`Cathy Maxwell RN OCN CCRC
`Bradley J Monk MD FACOG
`Chao FamilyComprehensive Cancer
`Anne Moore MD
`WciIl Medical College of Cornell
`Timothy D Moore MD
`Mid Ohio OncologyHematology
`Deborah A Nagle MD
`Beth Israel Deaconess Medical Center
`Ricky Newton CPA
`Cancer Specialists
`
`Theodore A Okon MBA
`Supportive Oncology Services
`
`Edith A Perez MD
`Philip A Philip MD PhD
`Barbara Ann Karmanos Cancer Institute
`Nicholas 3 Robert MD
`US Oncology Fairfax
`Peter J Rosen MD
`Myrna R Rosenfeld MD PhD
`
`Mayo Clinic Jacksonville
`
`Tower Cancer Research Foundation
`
`of Medictn
`
`School
`
`University of Pennsylvania
`Mark Santos RPh
`International Oncology Network
`Philip Schulman MD
`Memorial SloanKettering Cancer
`
`Center
`
`at Suffolk
`
`Jeffrey A Scott MD
`N Simon Tchekmedyian MD
`
`P4 Healthcare
`
`Pacific Shores Medical Group
`Steven Tucker MD
`West Clinic Excellence Cancer Center
`James L Wade III MD
`
`Decatur Memorial Hospital
`Cancer Care Institute
`
`92 COMMUNITY ONCOLOGY
`
`March 2009
`
`This material was copied
`at the NLM and may be
`Su b act US Gauvright Laws
`
`wwwCommunityOncologyflet
`
`ma
`
`

`

`COMMUNITY ONCOLOGY
`
`March 2009
`VOLUME 6 NUMBER 3
`
`Guide for Authors
`
`resource
`
`Community Oncology sows as a forum and
`for more than 31000
`practice
`based oncologists hematologists oncology
`nurses pharmadsts and administrators
`
`TYPES OF ARTICLES
`Br4Communications Short case reports
`Challenging CasesRare Cancers Expert
`opinion and resources
`
`Community Translations
`places
`pivotal
`new research
`findings into the context of
`
`Controversies
`
`community practice
`in Patient Management
`the difficult
`questions that arise
`looks at
`when delivering quality care
`EconomicsPractice Management How to
`make your practice more efficient
`Having Year Say Guest editorials
`Clinical articles on
`Managing Side
`Ejects
`dealing with comorbidities
`Nurse Management Nursing perspective
`on patient care and managing side effects
`Peer reviewed ar
`
`reviews
`
`to
`
`Original Contributions
`ticles ranging from retrospective
`and results of clinical
`
`original observations
`
`trials conducted
`
`in the community setting
`
`Pract ice Survival Personal essays
`Psychosocial Oncology details the spiri
`tual psychological social and emo
`tional side of cancer care
`
`Issues
`
`from pay
`Quality Care
`ranging
`for performance to implementing treat
`ment guidelines in your practice
`
`LETTER FROM THE EDITOR
`
`99 Cancer treatment its getting personal
`in MCP The West Clinic Memphis TN
`1ee S Schwartzberg
`This issue of Community Oncology focuses on it number of
`of personaliml
`medicine At this moment the grand vision of tailoring therapy to a tumor
`specific target while calibrating dosages according to underlying subtle metabolic
`there has
`remains more a theory than a reality Yet
`in each patient
`differences
`been remarkable progress already with practical
`for clinicians
`
`implications
`
`aspects
`
`LETTER TO THE EDITOR
`
`105 5Fluorouracilinduced cardiotoxicity hints for
`predicting patients at risk
`Jan Cerny hiD and BiIal Piperdi
`io Depadinent 9filgerfirine Division
`Hematology and Oncology University ofMassachusetts Medical School Worcster A41
`Dr Teivearsi reiponds
`SheelaTejwani NIU MCP Senior Stag Physician Division of HematologyOncology
`Ford Cancer Center Henry Ford Hospital Detroit MI
`
`Josephine
`
`BRIEF COMMUNICATIONS
`
`108 Two patients with elevated alphafetoprotein
`levels and liver
`lesions in the absence of
`hepatocellular carcinoma
`Nazik Hammad hID NiSc Philip A Philip ii MD and Busse F ElRayes
`Hind Nassar Nii and KalefOrd IIong MD Division yllemaiology and Oncology
`Karmanos Cancer Center Wayne State University Detroit MI Department of
`Pathology johns Hopkins University Baltimore MD Department of Radiology
`Wayne State University Detroit MI
`Two cases demonstrate the limitations of using alphafetoprorein
`levels to
`in patients with hepatitis virus C infection
`diagnose heparocellular carcinoma
`
`MANUSCRIPT SUBMISSION
`Manuscripts should be sent to the jour
`nal as an email attachment addressed
`
`113
`
`to Gail van Koot Editorial Manager
`Original contri
`
`gvankwtelsevieecom
`butions are subject
`to peer
`usual manner Generally articles will be
`published within 8 weeks of acceptance
`The Editors require that authors disclose
`all potential conflicts of interest
`
`review in the
`
`CommunityOncology conforms in genend to
`the Unifotm Requ i rer wilts for ManuseripN
`Submitted to Biomedical Journals IV Eng
`1 Med 1997336309315
`For additional
`information please visit our Web site
`at wwwcommunityoncoIogynet
`
`REVIEW ARTICLE
`
`Identifying and treating imatinib failure in chronic
`myelogenous leukemia a practical
`review of
`treatment guidelines and available agents
`Stuart L Goldberg Nin and Aisha Masood mp Division olLeakemia The John
`Theurer Cancer Center at Hackensack University Medical Collo Hackensack NJ
`
`Although most patients respond to imati nib and achieve prolonged remission
`the development of imatinib resistance has emerged as a major clinical
`issue
`Two recently approved tyrosine kinase inhibitors the dual BCRABL and SRC
`inhibitor dasatinib and the imatinib analogue nilotinib have shown substantial
`activity among patients with resistance or intolerance to imatinib Given these
`new options identification of non responders has become increasingly important
`to ensure the earliest administration of appropriate therapy The authors review
`recommendations fir
`identifying and treating patients with chronic phase
`chronic myelogenous leukemia who have experienced
`failure of first
`line iniati
`
`94 COMMUNITY ONCOLOGY N March 2009
`
`wwwCommunityOncaIogynet
`
`This rrEteriai WRS copied
`
`

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`PHARMACOGENETICS
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`126 Personalized therapy for cancer
`has pharmacogenetics delivered
`Jeffrey Allen Ntp and Clinton F Stewart Pharinn UniVerthy opinmessee Cancer
`Institute Memphis IN Pharmaceutical
`Sciences St Jude Childrens Resennh
`Haspital Memphis TN
`The prescribing information tin several drugs has already been changed on the
`data In addition two drugsirinotccan a eamptothecin
`basis of pharmacogenetie
`analog with activity in a number of solid tumors and tamoxifen a selective
`modulator with activity in breast and uterine cancershave
`estrogen receptor
`past decade For
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`the
`patients and oncologists alike pharmacogenetic studies on these drulrs and others
`arc opening the door to a new era of personalized anticancer
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`UP
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`
`Cremophor ELcontaining paclitaxelinduced
`anaphylaxis a call
`to action
`Lauren D Irizarry LiA Th1111 h Fitt Luu itA June M NIcKoy Nu ju Nirl
`Athena T Samaras BA Matthew J Fisher iiA Edson E Callas BA Dennis W
`Raisch PhD Rlh Elizabeth A Calhoun PhD and Charles L Bennett Nip PhD
`mvP Division of HematologyOncology Northwestern University Feinberg School
`of Medicine Chicago IL VA Midwest CenterOr Management olComplex Chronic
`Care jaw Brown WI Medical Collo Chicago
`Division of Geriatric Medicine
`Northwestern University Feinberg School of Medicine The Robert
`IL Lurie
`Comprehensive Cancer Center Northwestern University Chicago IL University of
`New Mexico COlege oPharmacy and VA COOperailVe
`Provmn Aliniquergne
`NM University ofIllinois Chicago IL
`Published literature indicates that hypersensitivity
`reactions to cremophor
`containing paclitaxel occur quite often and arc of varied severity The authors
`review the problem and make a number of reecnnmendations for prevention
`and treatment
`
`WASHINGTON UPDATE
`
`135
`
`The tallest order fixing the economy
`and healthcare
`
`Caroline Helwick
`
`part
`
`The current
`fiscal crisis is taking center stage and although healthcare is a key
`of our financial woes fixing the economy will have to come firstat
`least
`Fm now A report on the legislative roundtable at
`the 41 Annual Community
`Oncology Conference
`
`by
`lloard fin any injury analor damage to inrcons or properly at
`ifgatcr maim liability
`ileghgeneet or Ilthenvise hr Into
`else or operation of any methods
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`Because or rod
`ideas contained in the material herein
`verification of
`in the medic ill sciences independent
`Iii
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`recognige tuept dud 1111Ine hanky lior
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`Community Oncology is indexed by EMBASE and the Cumulative Index to Nursing and Allied Health Literature CINAHL
`
`96 COMMUNITY ONCOLOGY e March 2009
`
`Thri materiai wo5 copied
`
`wwwCommunityOncolagynet
`
`

`

`Adverse Events Alert
`
`Crernophor EL containing paclitaxel
`induced anaphylaxis a call to action
`I tiLren D Irizarry BA2 Thanh Ha Luu BA2 June M McKay MD JD MPH34 Athena
`T Samaras BA12 Matthew J Fisher BA12 Edson E Carias BAP Dennis W Raisch PhD
`RPh5 Elizabeth A Calhoun PhD 6 and Charles L Bennett MD PhDpm pi21
`Division of I lematologyOncology Northwestern University Feinberg School of Medicine Chicago IL
`VA Midwest Center for Management of Complex Chronic Care Jesse Brown VA Medical Center Chicago IL
`Division of Geriatric Medicine Northwestern University Feinberg School of Medicine The Robert H Lurie
`Comprehensive Cancer Center Northwestern University Chicago IL University of New Mexico College of
`Pharmacy and VA Cooperative Studies Program Albuquerque NM 6
`University of Illinois Chicago IL
`
`reac
`
`to Cremophor
`tions
`EL containing
`Hypersensitivity
`pacli
`taxel range from mild
`pruritus to systemic anaphylaxis and
`can result in potentially severe clini
`cal outcomes
`including respiratory
`arrest cardiac collapse and death
`
`Fast Facts
`
`severe hypersensitivity
`
`reactions
`
`to occur
`
`in patients
`
`and
`ANAPHYLAXiS
`are known
`infusion In early phase I
`during paclitaxel
`there were a number
`studies of paclitaxel
`of anaphylactic reactions and deaths which
`raised great concern about the potential de
`this drug7 Although the exact
`velopment of
`mechanism of these reactions to Cremophor
`is not known these re
`containing paclitaxel
`sponses are clinically consistent with a type
`an immediate
`1 hypersensitivity reaction
`Emediated
`The
`reaction
`immunoglobulin
`hypersensitivity reactions may result from di
`rect mast cell degranulation induced by ei
`agent itself or by
`ther the chemotherapeutic
`Crennophor EL
`is generally believed that such reactions
`are due to the surfactant Cremophor EL be
`cause these effects have also been observed
`in other drugs utilizing it The amount of Cre
`mophor EL used in paclitaxel
`is considerably
`than the amount used in other mar
`larger
`and anaphylaxis can occur
`keted products
`despite the use of premedication74
`
`It
`
`r0 2009 Elsevier
`
`int All
`
`rights reserved
`
`132 COMMUNITY ONCOLOGY
`
`March 2009
`
`clitaxel clinical
`
`In Cremophor EL containing pa
`trials up to 41 of
`tivity reaction From 24 of pa
`patients experienced a hypersensi
`
`or
`
`tients experienced anaphylaxis
`a severe hypersensitivity
`reaction
`characterized by dyspnea hypoten
`sion angioederna and generalized
`reac
`urticaria
`Hypersensitivity
`tions occurred even in patients who
`received prophylaxis
`Up to 95 of hypersensitivity re
`actions to taxanes occurred during
`administration of the first or sec
`ond dose and almost 80 of symp
`10
`toms developed during the first
`minutes of infusion with many re
`after only 1 mg
`actions occurring
`was infused A black box warning
`on the drugs package insert alerts
`patients and healthcare profession
`als to the potential occurrence of
`fatal hypersensitivity reactions Al
`reaction
`though
`hypersensitivity
`recommended nei
`prophylaxis is
`ther the frequency of use nor
`the
`efficacy of premedication
`prophy
`lactic measures is known
`
`ly
`
`Pharmacovigilance
`As with all serious and potential
`fatal adverse drug reactions the
`US Food and Drug Administration
`FDA MedWatch
`database
`repre
`sents an important source of safety
`
`information This is particularly rele
`vant for Cremophor EL containing
`paclitaxelassociated
`hypersensitivity
`where the potential
`for severe anaphy
`laxis or death exists No prior study
`has investigated FDA Med Watch
`re
`ports for Cremophor EL containing
`paclitaxelassociated
`hypersensitivity
`affiliated with the
`Investigators
`Research on Adverse Drug Events
`and Reports RADAR an estab
`lished pllarmaemigilance
`program
`reviewed case reports of paclitaxelin
`duced hypersensitivity reactions
`from
`the FDAs Adverse Event Report Sys
`tem Our objectives were to 1 assess
`the quality and timing of individual
`ease reports of serious or
`fatal pacli
`reactions sub
`taxel hypersensitivity
`mitted to regulatory agencies
`in the
`United States Europe
`and Japan
`and 2 evaluate whether any of these
`events occurred despite the use of pre
`medication prophylaxis Table 1
`What we reported
`In a review of adverse event reports
`submitted to regulatory agencies be
`tween 1997 and 2007 in the United
`States Europe and Japan 171 unique
`cases of Cremophor EL containing
`t aXela ssoci ate d
`pac I
`
`hypersensitiv
`
`Dr Raise bllsui mnreslricled gran jiom
`4braxis
`
`This material was copied
`at the KM and may ba
`Subject US Copyright Laws
`
`wwwComrnunityOncologynet
`
`

`

`ity were identified of which 58 34
`
`TABLE 1
`
`event
`
`fatalities
`
`For
`adverse
`represented
`reports submitted to regulato
`ry agencies in the United States Eu
`rope and Japan the median age was
`59 58 and 64 years the proportion
`of female patients was 51 67 and
`78 and the most common diag
`noses were lung breast and ovarian
`cancers for each region respectively
`the most common cancer di
`Overall
`agnosis was lung cancer The median
`duration of time between the date of
`
`the event
`to regulatory notification
`to the FDA varied between regions
`with Japan being the fastest followed
`by the United States and then Eu
`rope 18 27 and 55 days respective
`ly In some cases reports were not
`filed until after the FDA required the
`additional black box warning
`In all three regions completeness
`of reporting of anaphylactic reactions
`to Cremophor EL containing pacli
`taxcl was poor Reporting was fairly
`complete >65 for the date of the
`anaphylactic event demographic in
`formation on age and gender
`type
`of cancer and vital status following
`the adverse event
`flowever
`
`report
`information
`
`ing of important clinical
`describing the anaphylactic event
`duration of
`
`including anaphylaxis
`symptoms dosage information pa
`tient history of Cremophor EL con
`Inergy prophylax
`taining paclitaxel
`is other concomitant
`chemotherapy
`sta
`regimens and hospitalization
`tuswas lacking 5 65 complete
`ness in the reports Most important
`and surprising only 96 reports in
`cluded information on prophylaxis
`of which 2 22 cases were Fatali
`ties that occurred despite the use of
`premedication prophylaxis with car
`ticosteroids antihistamines andor
`histamine 2 H2blockers
`
`Conclusion
`
`The published literature indicates
`that
`reactions
`to
`hypersensitivity
`Cremophor EL containing paclitaxel
`occur quite often and are of varied se
`
`Comparison of quality of case reports of Cremophor ELcontaining
`paclitaxelassociated anaphylaxis from the United States Europe
`and Japan n = 171
`
`United States
`
`Dead
`n = 36
`31
`
`Survived
`In = 59
`75
`
`Europe
`
`Japan
`
`Demi
`n
`17
`41
`
`Survived
`n
`
`211
`
`67
`
`Dead
`Survived
`n = 5 n = 31
`60
`86
`
`22
`
`33
`
`43
`
`61
`
`9
`
`20
`
`Percent of patients who
`received prophylaxis
`
`Median duration
`between date of event
`and regulatory
`notification days
`
`Percentage of reports containing
`86
`
`Date of anaphylactic
`event
`
`i
`
`motion re
`75
`
`arding individual data elements
`82
`86
`100
`
`Anaphylaxis
`
`Dyspnea shortness of
`breath bronchospasms
`
`25
`19
`
`93
`49
`
`29
`59
`
`Hypotension
`
`32
`12
`Duration of symptoms 3
`12
`15
`41
`Prophylaxis information 31
`73
`lo On for be individual data element
`
`Petcomagas are less than or equot
`
`76
`43°
`
`40
`20
`
`29
`20
`24 03
`60
`
`520
`
`90
`
`77
`26°
`
`23
`42
`58
`
`talities
`
`occurred
`
`and H2 recep
`verity The use of
`tor antagonists and corticosteroids
`has significantly decreased the risk of
`developing a hypersensitivity reaction
`in this treatment setting However
`RADAR investigators found that fa
`in 22 of reported
`cases despite the use of premedica
`tion prophylaxis Another important
`finding from this work is that poor
`quality adverse event
`reporting is not
`unique to the United States Equally
`reports were sub
`poor adverse event
`mitted to regulatory agencies in Eu
`rope and Japan
`Our findings also have policy im
`plications As Cremophor EL con
`ana
`
`taining paclitaxelassociated
`phylaxis is an acknowledged
`reaction
`healthcare professionals may not feel
`a compelling need to report new cas
`es to regulatory authorities However
`and underreporting
`poor
`reporting
`of this drug are indicative of a wid
`flaw in global pharmacovigilance
`efforts and are not
`the exception
`The voluntary nature of the report
`ing system coupled with the FDAs
`
`er
`
`passive approach makes analysis for
`signals extremely hap
`drug safety
`hazard especially when relying solely
`on these volunteered reports In fact
`half of serious adverse drug reactions
`after drug ap
`are identified 7 years
`proval by the FDA9 As recently as
`2006 the Institute of Medicine has
`that drug safety sig
`raised concerns
`nals go largely unnoticed for
`periods
`
`large
`
`Recommendations
`
`All patients receiving Cremophor
`EL containing
`therapy
`paclitaxel
`should be pretreated with eortico
`and H2
`steroids diphenhydramine
`
`receptor antagonists
`Because prophylaxis is not al
`additional precau
`ways effective
`tions should be taken when admin
`istering Cremophor EL containing
`paclitaxel such as immediate avail
`drugs and
`ability of
`resuscitative
`equipment
`Physicians should be informed of
`the potential alternative of a recently
`FDA approved Cremophor Elfree
`
`Volume 6Number 3
`
`This material was copied
`atthe NUVI and may be
`
`March 2009
`
`COMMUNITY ONCOLOGY
`
`133
`
`

`

`Adverse Events Alert
`
`paclitaxel
`
`formulation
`
`events
`
`a
`
`nanoparticle
`Abraxane
`With respect
`to pharmacovigi
`lance as with other serious adverse
`the FDA should consider
`the development of
`mandating
`risk management program to ad
`dress this serious toxicity12 Such an
`program would alert all
`awareness
`physicians and patients of these po
`tentially fatal reactions despite the
`use of premedication
`Oncologists are strongly urged to
`report all cases of potentially serious
`adverse drug reactions such as pacii
`taxelinduced
`reac
`hypersensitivity
`tions to the FDAs MedWatch Pro
`gram wwwfdagovmedwatch We
`can and should do better to protect
`the safety of our patients
`
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`Ill
`
`Dr Bonsai
`
`is Associate Director of the P21 Center
`for Managemeni of Complex Chronic Care Jesse
`Brown VA ofMe Chicago Healthcare Sysiem Chi
`cago IL II in also affiliate with the Division y
`Northwestern ljniversitY
`lennaokyOncology
`and the Robert
`Ninheig School oplfledieine
`Cancer Center Northwes
`LI fie Comprehensive
`IL He ran be reached a
`ern Univenky Chicago
`chennee4northwesternetht
`
`r
`
`I
`
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`lost
`
`ABOUT THE AUTHORS
`
`Affiliations Or Allen is A5saciate Director of
`Clinical Research University of Tennessee Cam
`cer Institute Memphis TN Dr Stewart
`is a
`Member
`in the Deportment of Pharmaceutical
`Sciences St Jude Childrens Research Hospital
`and Professor Department of Clinical Pharmacy
`Department of Pharmacy University of Tennes
`see Memphis TN
`Conflicts of interest None to disclose
`
`134 COMMUNITY ONCOLOGY
`
`March 2009
`
`This material was copied
`at the NLM and may be
`Subiert US Convrieht Laws
`
`wwwCommunityOncologynet
`
`