SEIFEM-2010 study: PRE-HOSPITAL risk factors for IFDs in acute myeloid leukemia
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1 SEIFEM-2010 study: PRE-HOSPITAL risk factors for IFDs in acute myeloid leukemia
2 1. ANCONA 2. BARI 3. BOLOGNA 4. BRESCIA 5. CAGLIARI 6. CAMPOBASSO 7. FIRENZE 8. LA SPEZIA 9. LECCE 10. MILANO-Niguarda 11. MODENA e REGGIO 12. MONZA 13. NAPOLI-Federico II 14. NOVARA 15. PALERMO 16. PARMA 17. PAVIA-Ematologia 18. PAVIA-Medicina 19. PERUGIA 20. PESCARA 21. REGGIO CALABRIA 22. REGGIO EMILIA 23. ROMA-IFO 24. ROMA-S.Andrea 25. ROMA-S.Camillo ROMA-S.Giovanni 27. ROMA-Tor Vergata 28. ROMA-UCSC 29. S.GIOVANNI ROTONDO 30. TORINO- Le Molinette 31. TRICASE 32. UDINE 33. VERONA....
3 To investigate the relationship between PRE-HOSPITAL risk factors and IFDs FROM JAN 1 ST 2010 ALL NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIAS CONSECUTIVELY TARGET: 2 YEARS or 1000 patients in 40 ACTIVE CENTRES
4 AT ADMISSION Demographic information AML Comorbidities (diabetes, liver disease, COPD ) Antileukemic treatment choices (intensive, supportive ) Job & hobbies Living and working sites Personal habits (smoking, drug/alcohol assumption, frequency of cleaning... ) Animals and plants Construction and reconstruction works
5 Colonization Mucosal damages Catheters Antifungal prophylaxis Neutropenia AT 30 th DAY FROM: - End of chemotherapy - Diagnosis* * For those who do not receive any intensive chemotherapy IFI occurrence Etiological agent Antifungal therapy (type and drug) Patient s outcome
6 Jan 1 st, 2010 Apr 30 th, months
7 Enrolled patients Completed at April 30 th ,192 adult patients Median age: 60 (18-96) 100% 90% 11.7% 48.9% 51.1% 80% 70% 18.2% 60% 818 (70%) de novo AML 213 (18.2%) post-mds 137 (11.7%) therapy-related 24 missing Maschi Femmine Secondarie post-mds 50% 40% 30% 20% 10% 70% De Novo 0%
8 PS in the study population PS 3 7% PS 4 2% Missing 4% Cases % PS % PS % PS % PS % PS % Missing % PS 2 18% PS 1 35% PS 0 34%
9 PS according to age PS at 1 st diagnosis in 1,192 AML patients from the PS 0-1: 89% SEIFEM-2010 Registry 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% PS 0-1: 31% ALL AGES PS 0-1: 69% MISSING WHO IV WHO III WHO II WHO I WHO 0 Missing 43!!
10 Treatment for AML 1,192 AML* Intensive CTX 997 (84%) Contenitive 156 (13%) No therapy 33 (3%) 13% AZA 66 Ld ARA-C 50 HU/other 40 84% 42% * 6 missing
11 Treatment according to AGE 100% 90% 80% 70% 96% 89% 84% 60% 50% 40% 30% 55% missing none/support contenitive conventional 20% 10% 0% 26% all ages
12 Treatment according to PS 100% 90% 80% 70% 60% 50% 40% 30% 20% WHO % WHO % none/support contenitive intensive 10% 0% WHO 0 WHO 1 WHO 2 WHO 3 WHO 4
13 Treatment decisions over time Patients 55+ reported FIT for intensive chemotherapy * % ** % p-value <0.001 *** 76% % 20% 40% 60% 80% 100% FIT UNFIT * Tailor et al, Leukemia 1995, 9(2); ** Juliusson et al, Blood 2009,113(18); *** SEIFEM-2010
14 Invasive Fungal Diseases 249 IFDs cases in 1,192 newly diagnosed AML 65% 12% 23% 23 YEASTS 26% 64 MOLDS 74% proven probable possible 87 proven/probable cases Molds/yeasts ratio 2.8/1
15 Incidence of IFDs esordio 63% ALL PHASES!! 12,0 10,0 8,0 12% , ,192 4,0 2,0 0,0 AML ALL CML CLL NHL HL MM Incidence 21% Incidence 7.3% ONSET + POSA AML IFIs prov/prob
16 Characteristics Median age (range) 59 (18-84) Maschi 142 (58%) Deep neutropenia 236 (95%) Previous treatment for AML intensive chemotherapy supportive/low dose 225 (90%) 24 (10%) Previous systemic AF prophylaxis 207 (83%) Previous AF prophylaxis Posaconazole Itraconazole Fluconazole other 3% fluco 21% 109 (53%) 48 (23%) 43 (21%) Other * itra 23% posa 53% 5 (3%) * 4 AmB, 1 vorico
17 Rare fungal agents Only 5 cases (of 87 proven/probable) 6% 94% 1 Fusarium 1 Pneumocystis 1 Trichosporon 1 Geotrichum, 1 Blastoschizomyces NO Zygomycetes
18 Subgroup analysis for PRE-HOSPITAL risk factors All ALL 1, INTENSIVE CTX missing M3 EXCLUDED 887 Final study population: Patients: 887 Mean age: 55 y (18-86) M/F: 1
19 IFDs in the study population intensive chemotherapy, M3 excluded: 887 pts IFDs cases: 214 (incidence 24%) PROVEN/PROBABLE IFDs: 73 (incidence 8.2%) 12% 26 cases Proven Probable 22% 47 cases Possible yeasts 27% 65% 141 cases molds 73%
20 Demographic data intensive chemotherapy, M3 excluded: 887 pts Incidence % % % % p = 0.06 Age N IFDs Incid 0 Male Female % % % P VALUE?? % % %
21 Role of neutropenia intensive chemotherapy, M3 excluded: 887 pts N Deep Neutropenia > 7d - No - Yes 51 (6%) 836 (94%) Deep Neutropenia > 7d - No - Yes N pts IFDs p Molds Yeasts
22 IFDs incidence according to PS PS 0: 333 pts 20 IFDs (incid. 6.1%) PS 1: 321 pts 23 IFDs (incid. 7.2%) PS 2: 144 pts 17 IFDs (incid. 11.8%) PS 3: 43 pts 6 IFDs (incid. 14%) PS 4: 13 pts 5 IFDs (incid. 38.5%) p < % Missing 33 40,0 35,0 30,0 25,0 20,0 15,0 10,0 5,0 0,0 6.1% PS 0 PS 1 PS 2 PS 3 PS 4
23 Personal habits: Smoking intensive chemotherapy, M3 excluded: 887 pts Smoking N pts IFDs MOLDS YEASTS NO (7%) (5%) (2%) YES (11%) 24 (9%) 7 (3%) 0.67 Illicit drugs N pts IFDs MOLDS YEASTS NO (8%) (6%) (2%) YES 36 2 (6%) 1 (3%) 1 (3%) 0.83
24 Alcohol intensive chemotherapy, M3 excluded: 887 pts Alcohol N pts IFDs Incidence NO % YES % p = % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 8% NO 10% YES IFDs NO IFDs
25 Working & living sites - I intensive chemotherapy, M3 excluded: 887 pts N pts IFDs p Moulds Yeasts AREA OF RESIDENCE - rural - urban (8%) 54 (8%) 0.69 p (5%) 40 (6%) p (2%) 14 (2%) HOUSE TYPE - flat - with garden (8%) 36 (9%) 0.38 p (5%) 28 (7%) p (2%) 8 (2%) CONSTRUCTION WORKS CLOSE TO HOME - no - yes INCINERATOR - no - yes (8%) 23 (8%) 62 (8%) 11 (10%) p (6%) 17 (6%) p (6%) 8 (8%) p (2%) 6 (2%) p (2%) 3 (3%)
26 Working & living sites - II PLANTS - NO - YES HUMIDITY - NO - YES N pts IFDs p Moulds Yeasts (9%) 42 (8%) 60 (8%) 13 (9%) p (6%) 32 (6%) P (6%) 8 (6%) p (3%) 10 (2%) p (2%) 5 (4%) HOUSE RENOVATION - no - yes (8%) 12 (12%) 0.15 p (5%) 11 (11%) p (2%) 1 (1%) FIREPLACE - no - yes (9%) 22 (8%) 0.58 p (6%) 17 (6%) p (3%) 5 (2%) FIREPLACE frequnt use - no - yes (8%) 13 (8%) (6%) 10 (6%) (2%) 3 (2%)
27 PETS intensive chemotherapy, M3 excluded: 887 pts N pts IFDs p Moulds Yeasts POULTRY - No - Yes (8%) 6 (7%) 0.65 p (6%) 5 (6%) p (2%) 1 (1%) PETS - No - Yes (10%) 20 (6%) 0.06 p (7%) 15 (5%) p (2%) 5 (3%)
28 HIGH JOB and IFDs incidence - I Agricoltori Braccianti Falegnami N pts IFDs (Incidence) MOLDS YEASTS 0.44 HIGH 24 3 (13%) 3(13%) 0 OTHER (8%) 50 (6%) 20 (2%) N.S. TEST RIPETUTO PER IL SOLO GRUPPO NON POSA HIGH Muratori Piastrellisti Asfaltisti N pts IFDs (Incid) MOLDS YEASTS HIGH 18 4 (22%) 3 (17%) 1 (6%) NO (8%) 50 (6%) 19 (2%) 0.34
29 JOB and IFDs incidence - II HIGH Agricoltori, braccianti, falegnami Muratori, piastrellisti, asfaltisti Allenatori, operatori ecologici OUTDOOR WORKERS OUTDOOR WORKERS N pts IFDs (Incidence) MOLDS YEASTS (17%) 9 (16%) 1 (2%) NO (8%) 44 (5%) 19 (2%) 0.78
30 HOBBIES and IFDs incidence DATA FOR 477 PATIENTS ONLY 1 N pts IFDs (Incidence) PLANTS/GRASS (10%) NO (8%) N pts IFDs (Incidence) DUST 19 1 (5%) NO (8%) N pts IFDs (Incidence) MOLDS YEASTS OUTDOOR (8%) (6%) (2%) NO (8%) 37 (6%) 16 (3%) 0.39 TEST RIPETUTO PER IL SOLO GRUPPO NON POSA
31 Body weight intensive chemotherapy, M3 excluded: 887 pts Cases IFDs Incidence p-value Normal weight % Overweight % 0.09 Underweight % Missing 11 under/normal Over 5% 11% 9.5% p % 20% 40% 60% 80% 100% 6% Over under/normal IFD no IFD
32 Frequency of cleaning intensive chemotherapy, M3 excluded: 887 pts 16.7% 6.9% 9.5% 7.1% 8.9% 100% 90% 80% % 60% 50% 40% IFD NO IFD 30% 20% 10% 0% <1/week 1/week 2-3/week 4-5/week 6-7/week
33 Mucosal damages intensive chemotherapy, M3 excluded: 887 pts MUCOSITIS - No - Yes ESOPHAGITIS - No - Yes VOMITING - No - Yes DIARRHEA - No - Yes N pts IFDs p value Moulds Yeasts (7%) 38 (10%) 60 (7%) 13 (16%) 52 (8%) 21 (10%) 431 (7%) 30 (12%) (5%) 27 (7%) (6%) 8 (10%) (6%) 14 (7%) (6%) 18 (7%) p (2%) 11 (3%) (2%) 5 (6%) p (2%) 7 (3%) (1%) 12 (5%)
34 Medical devices intensive chemotherapy, M3 excluded: 887 pts CVC - No - Yes URINARY CATHETER - No - Yes N pts IFDs p value Moulds Yeasts (7%) 60 (8%) 42 (6%) 31 (22%) 0.66 < (7%) 41 (6%) (5%) 17 (12%) p (1%) 19 (3%) < (1%) 14(10%) Strictly related to performance status 3-4 p <0.0001
35 Comorbidities - I intensive chemotherapy, M3 excluded: 887 pts Cases IFDs Incidence P-value MOULDS YEASTS Diabetes - yes - no % 8% p (13%) 44 (5%) p (3%) 18 (2%) COPD* - yes - no % 8% p p (15%) 1 (2%) 47 (6%) 19 (2%) Chronic renal failure - yes - no % 8% 0.03 p (12%) 50 (6%) p (8%) 18 (2%) Liver disease - yes - no % 8% 0.60 p (3%) 52 (1%) p (8%) 17 (2%) * Chronic Obstructive Pulmonary Disease
36 Any additive effect?? Comorbidities - II intensive chemotherapy, M3 excluded: 887 pts Performance status as confounding variable?? Odds ratio P value 95% CI N comorbidities 1, ,032 1, Performance status 1, ,002 1,
37 Summary AGE AT ADMISSION IFDs Moulds Yeasts 1. AGE 2. PERFORMANCE STATUS 3. DIABETES 4. COPD 5. CHRONIC RENAL FAILURE 6. LIVER DISEASE 7. N COMORBIDITIES 8. JOB 9. SMOKING 10. BODY WEIGHT 11. HOME RECONSTRUCTURING < DURING APLASIA 12. NEUTROPENIA 13. URINARY CATHETER 14. DIARRHEA 15. ESOPHAGITIS 0.04 < <
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