1018 - confex

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JALSG AML201 study Hideaki Kato +81-45-787-2800 ext 5430/6248 [email protected] 1018 Background: Remission induc/on (RI) chemotherapy for acute myeloid leukemia (AML) is one of the most intensive chemotherapy available. An/bio/c prophylaxis and prompt treatment for infec/ous complica/ons during RI chemotherapy plays a major role in suppor/ve care. Methods: We retrospec/vely analyzed the infec/ous complica/ons associated with RI chemotherapy listed in the Japan Adult Leukemia Study Group AML201 protocol, a na/onwide study of de-novo AMLs, conducted between 2001 and 2005 in Japan. Of the 1057 cases ini/ally included in the AML201 study, 980 cases with data on infec/ous complica/ons during RI chemotherapy were analyzed. The incidences of infec/ous complica/ons and the causa/ve pathogens were compared with previous studies [(period A) 1987–1991, 577 cases; (B) 1992–1995, 669 cases; (C) 1995–1997, 531 cases; (D) 1997–2001, 808 cases; (E) 2001–2005, 980 cases]. Results: In study period E, the causa/ve pathogens of bacteremia/fungemia were Staphylococcus epidermidis (20.9%), S. aureus (11.6%), Streptococcus sp. (14.0%), and other Gram-posi/ve bacteria (12.6%); P. aeruginosa (12.8%) and other Gram-nega/ve bacteria (10.5%); and fungi (9.3%). Pathogens causing pulmonary infec/ons were Aspergillus sp. (15.8%), P. aeruginosa (7.9%), and other Gram-nega/ve bacteria (6.9%) and Gram-posi/ve bacteria (3.0%). Pulmonary aspergillosis was diagnosed mainly using serological test. The prevalence of bacteremia/fungemia was reported in 11.8%, 9.4%, 8.7%, 9.2% and 8.3% of cases and pulmonary infec/ons were reported in 24.6%, 16.9%, 13.9%, 12.9%, and 10.3% of cases in the study periods A, B, C, D and E, respec/vely. The incidence of Gram-nega/ve bacteremia was significantly lower in period E compared with the periods A, B, and C (2.0% vs. 4.9%, 3.7%, and 3.4%). Conclusions: The prevalence of Gram-posi/ve bacteremia and pulmonary aspergillosis was higher in period E than in the periods A–D. This trend was possibly due to the wide use of fluoroquinolone prophylaxis in neutropenic pa/ents and high performance of the serological test for aspergillosis. Sufficient monitoring for Gram-posi/ve bacterial infec/on and mold infec/on is therefore essen/al during RI chemotherapy for AML. Prevalence of Bacteremia/Fungemia and Pneumonia in Remission InducIon Chemotherapy for Adult Acute Myeloid Leukemia from 1987 to 2005: Japan Adult Leukemia Study Group (JALSG) Hideaki Kato 1 , Hiroyuki Fujita 2 , Nobu Akiyama 3 , Shun-Ichi Kimura 4 , Nobuhiro Hiramoto 5 , Naoko Hosono 6 , Tsutomu Takahashi 7 , Kazuyuki Shigeno 8 , Hitoshi Minamiguchi 9 , Junichi Miyatake 10 , Hiroshi Handa 11 , Yoshinobu Kanda 12 , Minoru Yoshida 13 , Shuichi Miyawaki 14 , Shigeki Ohtake 15 , Tomoki Naoe 16 , Hitoshi Kiyoi 17 , Itaru Matsumura 18 , Yasushi Miyazaki 19 Affilia/ons: 1 Dept. of Hematology and Clinical Immunology, Yokohama City Univ. 2 Dept. of Hematology, Saiseikai Yokohama Nanbu Hospital, Yokohama 3 Dept. of Internal Medicine, Teikyo Univ. School of Medicine, Tokyo 4 Division of Hematology, Saitama Medical Center, Jichi Medical Univ. 5 Dept. of Hematology, Kobe City Medical Center General Hosp., Kobe 6 Dept. of Hematology and Oncology, Univ. of Fukui 7 Dept. of Oncology/Hematology, Shimane Univ. Hosp., Izumo 8 Dept. of Hematology and Oncology, Hamamatsu Medical Center 9 Dept. of Gastroenterology and Hematology, Shiga Univ. Newly diagnosed adult AML cases (except M3) [n = 1057] IDA arm IDA 12mg/m 2 x 3d Ara-C 100mg/m 2 x 7d (2 courses) DNR arm DNR 50mg/m 2 x 5d Ara-C 100mg/m 2 x 7d (2 courses) randomized remission inducIon chemotherapy CR rate 78% CR rate 78% HDAC arm Ara-C 2g/m 2 x 5d (3 courses) AML201D arm ①MIT 7mg/m 2 x 3d+Ara-C 200mg/m 2 x 5d ②DNR 50mg/m 2 x 3d+Ara-C 200mg/m 2 x 5d ③ACR 20mg/m 2 x 3d+Ara-C 200mg/m 2 x 5d ④Ara-C+ETP+VCR+vindecise randomized consolidaIon chemotherapy JALSG protocols Study period (year) CR rate (5yr survival) Prevalence of bacteremie/fungemia Prevalence of pulmonary infecIon AML87/89 A (1987–1991) 79.9/78.5% (30.1/33.5%) 11.8% 24.6% AML92 B (1992–1995) 77.2% (33.5%) 9.4% 16.9% AML95 C (1995–1997) 80.7% (44.3%) 8.7% 13.9% AML97 D (1997–2001) 78.7% (40.8%) 9.2% 12.9% AML201 E (2001–2005) 77.5% (48%) 8.3% 10.3% S. aureus, 11.6 S. epidemidi s, 20.9 CNS, 7 Streptoco cccus sp., 14 Enterococcu s sp., 7 Other Gram- posi=ve bacteria, 5.8 P. aeruginos a, 12.8 E. coli, 7 Other Gram- nega=ve bacteria, 2.3 Candida sp., 5.8 Other fungi, 3.5 12.8% 10.3% 9.3% CausaKve pathogens of bacteremia/fungemia (leh) and pulmonary infecKon (right) in JALSG AML201 remission-inducKon chemotherapy (%) Uniden/fi ed, 63.4 P. aeruginos a, 7.9 Other Gram- negaKve, 6.9 PCP, 1 Aspergillu s, 15.8 Other Gram- posiKve, 3 Other, 2 10 Dept. of Hematology and Oncology, Sakai Hosp. Kinki Univ. Faculty of Medicine 11 Dept. of Hematology and Oncology, Gunma Univ. Graduate School of Medicine 12 Division of Hematology, Dept. of Medicine, Jichi Medical Univ., Tokyo 13 Fourth Dept. of Internal Medicine, Teikyo Univ. School of Medicine, Mizonokuchi Hosp. 14 Dept. of Transfusion, Tokyo Metropolitan Ohtsuka Hosp. 15 Kanazawa Univ. 16 Na/onal Hosp. Organiza/on Nagoya Medical Center 17 Dept. of Hematology and Oncology, Nagoya Univ. Graduate School of Medicine 18 Dept. of Hematology and Rheumatology, Kinki Univ. Faculty of Medicine 19 Dept. of Hematology and Molecular Medicine Unit, Nagasaki Univ., Atomic Bomb Disease Ins/tute 5.9 11.5 11.6 10.8 14.7 7.4 11.5 7.0 18.9 26.5 26.5 23.0 30.2 29.7 41.2 23.5 23.0 20.9 13.5 16.2 17.6 16.4 18.6 12.2 13.2 16.2 11.5 9.3 10.8 11.8 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Mixed infec/on Fungi Other Gram-nega/ve P. aeruginosa Other Gram-posi/ve S. epidermidis S. aureus 5.6 3.8 2.9 7.9 4.9 5.7 9.8 15.8 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% AML87/89 [A] AML92 AML97 [D] AML201 [E] IPA Other Gram-nega/ve P. aeruginosa Gram-posi/ve Uniden/fied [B] CausaKvemicroorganisms in bacteremia/fungemia during remission inducKon chemotherapy CausaKvemicroorganisms in pulmonary infecKon during remission inducKon chemotherapy * This study was published in Support Care Cancer 2018.

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Page 1: 1018 - Confex

JALSGAML201study

HideakiKato+81-45-787-2800ext5430/6248

[email protected]

1018Background:Remissioninduc/on(RI)chemotherapyforacutemyeloidleukemia(AML)isoneofthemostintensivechemotherapyavailable.An/bio/cprophylaxisandprompttreatmentforinfec/ouscomplica/onsduringRIchemotherapyplaysamajorroleinsuppor/vecare.Methods:Weretrospec/velyanalyzedtheinfec/ouscomplica/onsassociatedwithRIchemotherapylistedintheJapanAdultLeukemiaStudyGroupAML201protocol,ana/onwidestudyofde-novoAMLs,conductedbetween2001and2005inJapan.Ofthe1057casesini/allyincludedintheAML201study,980caseswithdataoninfec/ouscomplica/onsduringRIchemotherapywereanalyzed.Theincidencesofinfec/ouscomplica/onsandthecausa/vepathogenswerecomparedwithpreviousstudies[(periodA)1987–1991,577cases;(B)1992–1995,669cases;(C)1995–1997,531cases;(D)1997–2001,808cases;(E)2001–2005,980cases].Results:InstudyperiodE,thecausa/vepathogensofbacteremia/fungemiawereStaphylococcusepidermidis(20.9%),S.aureus(11.6%),Streptococcussp.(14.0%),andotherGram-posi/vebacteria(12.6%);P.aeruginosa(12.8%)andotherGram-nega/vebacteria(10.5%);andfungi(9.3%).Pathogenscausingpulmonaryinfec/onswereAspergillussp.(15.8%),P.aeruginosa(7.9%),andotherGram-nega/vebacteria(6.9%)andGram-posi/vebacteria(3.0%).Pulmonaryaspergillosiswasdiagnosedmainlyusingserologicaltest.Theprevalenceofbacteremia/fungemiawasreportedin11.8%,9.4%,8.7%,9.2%and8.3%ofcasesandpulmonaryinfec/onswerereportedin24.6%,16.9%,13.9%,12.9%,and10.3%ofcasesinthestudyperiodsA,B,C,DandE,respec/vely.TheincidenceofGram-nega/vebacteremiawassignificantlylowerinperiodEcomparedwiththeperiodsA,B,andC(2.0%vs.4.9%,3.7%,and3.4%).Conclusions:TheprevalenceofGram-posi/vebacteremiaandpulmonaryaspergillosiswashigherinperiodEthanintheperiodsA–D.Thistrendwaspossiblyduetothewideuseoffluoroquinoloneprophylaxisinneutropenicpa/entsandhighperformanceoftheserologicaltestforaspergillosis.SufficientmonitoringforGram-posi/vebacterialinfec/onandmoldinfec/onisthereforeessen/alduringRIchemotherapyforAML.

PrevalenceofBacteremia/FungemiaandPneumoniainRemissionInducIonChemotherapyforAdultAcuteMyeloidLeukemiafrom1987to2005:JapanAdultLeukemiaStudyGroup(JALSG)

HideakiKato1,HiroyukiFujita2,NobuAkiyama3,Shun-IchiKimura4,NobuhiroHiramoto5,NaokoHosono6,TsutomuTakahashi7,KazuyukiShigeno8,HitoshiMinamiguchi9,JunichiMiyatake10,HiroshiHanda11,YoshinobuKanda12,MinoruYoshida13,

ShuichiMiyawaki14,ShigekiOhtake15,TomokiNaoe16,HitoshiKiyoi17,ItaruMatsumura18,YasushiMiyazaki19

Affilia/ons:1Dept.ofHematologyandClinicalImmunology,YokohamaCityUniv.2Dept.ofHematology,SaiseikaiYokohamaNanbuHospital,Yokohama3Dept.ofInternalMedicine,TeikyoUniv.SchoolofMedicine,Tokyo4DivisionofHematology,SaitamaMedicalCenter,JichiMedicalUniv.5Dept.ofHematology,KobeCityMedicalCenterGeneralHosp.,Kobe6Dept.ofHematologyandOncology,Univ.ofFukui7Dept.ofOncology/Hematology,ShimaneUniv.Hosp.,Izumo8Dept.ofHematologyandOncology,HamamatsuMedicalCenter9Dept.ofGastroenterologyandHematology,ShigaUniv.

Newlydiagnosed

adultAMLcases(exceptM3)

[n=1057]

IDAarmIDA12mg/m2x3d

Ara-C100mg/m2x7d

(2courses) �

DNRarmDNR50mg/m2x5dAra-C100mg/m2x7d

(2courses) �

randomized

remissioninducIonchemotherapy

CRrate78%

CRrate78%

HDACarm

Ara-C2g/m2x5d

(3courses) �

AML201Darm①MIT7mg/m2x3d+Ara-C200mg/m2x5d②DNR50mg/m2x3d+Ara-C200mg/m2x5d③ACR20mg/m2x3d+Ara-C200mg/m2x5d④Ara-C+ETP+VCR+vindecise

randomized

consolidaIonchemotherapy

JALSGprotocolsStudyperiod(year)

CRrate(5yrsurvival)�

Prevalenceofbacteremie/fungemia �

PrevalenceofpulmonaryinfecIon

AML87/89A(1987–1991)�

79.9/78.5%(30.1/33.5%)� 11.8% � 24.6% �

AML92B(1992–1995)�

77.2%(33.5%)� 9.4% � 16.9% �

AML95C(1995–1997)�

80.7%(44.3%)� 8.7% � 13.9% �

AML97D(1997–2001)�

78.7%(40.8%)� 9.2% � 12.9% �

AML201E(2001–2005)�

77.5%(48%)� 8.3% � 10.3% �

S.aureus,11.6

S.epidemidis,20.9

CNS,7

Streptococccussp.,

14

Enterococcussp.,7

OtherGram-posi=ve

bacteria,5.8

P.aeruginosa,12.8

E.coli,7

OtherGram-nega=ve

bacteria,2.3

Candidasp.,5.8

Otherfungi,3.5

12.8%

10.3%

9.3%

CausaKvepathogensofbacteremia/fungemia(leh)andpulmonaryinfecKon(right)inJALSGAML201remission-inducKonchemotherapy(%)

Uniden/fied,63.4

P.aeruginosa,7.9

OtherGram-

negaKve,6.9

PCP,1Aspergillus,15.8

OtherGram-

posiKve,3

Other,2

10Dept.ofHematologyandOncology,SakaiHosp.KinkiUniv.FacultyofMedicine11Dept.ofHematologyandOncology,GunmaUniv.GraduateSchoolofMedicine12DivisionofHematology,Dept.ofMedicine,JichiMedicalUniv.,Tokyo13FourthDept.ofInternalMedicine,TeikyoUniv.SchoolofMedicine,MizonokuchiHosp.14Dept.ofTransfusion,TokyoMetropolitanOhtsukaHosp.15KanazawaUniv.16Na/onalHosp.Organiza/onNagoyaMedicalCenter17Dept.ofHematologyandOncology,NagoyaUniv.GraduateSchoolofMedicine18Dept.ofHematologyandRheumatology,KinkiUniv.FacultyofMedicine19Dept.ofHematologyandMolecularMedicineUnit,NagasakiUniv.,AtomicBombDiseaseIns/tute

5.9 11.5 11.6 10.8 14.77.411.5 7.0

18.9 26.526.523.0 30.2

29.7 41.223.523.0 20.9

13.516.217.6

16.4 18.6 12.2 13.216.2 11.5 9.3 10.8 11.8

0%10%20%30%40%50%60%70%80%90%

100%

Mixedinfec/on FungiOtherGram-nega/ve P.aeruginosaOtherGram-posi/ve S.epidermidisS.aureus

5.6 3.8 2.97.9

4.9 5.7 9.8 15.8

0%10%20%30%40%50%60%70%80%90%

100%

AML87/89[A]

AML92 AML97[D]

AML201[E]

IPAOtherGram-nega/veP.aeruginosaGram-posi/veUniden/fied

[B]

CausaKvemicroorganismsinbacteremia/fungemiaduringremissioninducKonchemotherapy

CausaKvemicroorganismsinpulmonaryinfecKonduringremissioninducKonchemotherapy

*ThisstudywaspublishedinSupportCareCancer2018.