SRPSKA MIJELOMSKA GRUPA (SMG) SERBIAN MYELOMA GROUP (SMG) MULTIPLI MIJELOM PREDLOG DIJAGNOSTIČKIH I TERAPIJSKIH VODIČA

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1 SRPSKA MIJELOMSKA GRUPA (SMG) SERBIAN MYELOMA GROUP (SMG) MULTIPLI MIJELOM PREDLOG DIJAGNOSTIČKIH I TERAPIJSKIH VODIČA

2 Incidenca multiplog mijeloma Savremena istraživanja ukazuju na porast godišnje incidence mijeloma u Evropi sa 3-4/ na 6/ Prosečna starost bolesnika sa mijelomom je 69 godina, i samo 5% bolesnika je mlađe od 40 godina.(1,2,3) Savremena dijagnostika multiplog mijeloma Dijagnostiĉki kriterijumi Dijagnoza multiplog mijeloma (MM) postavlja se na osnovu postojanja najmanje 1 major i jednog minor ili najmanje 3 minor kriterijuma (4, Kyle/Greipp kriterijumi): 1 major + 1 minor ; ili 3 minor kriterijuma Major Minor Plazmocitna infiltracija 30% u aspiratu i/ili bioptatu kostne srži i/ili PH dokazan plazmocitom u biopsiji Tu tkiva Plazmocitna infiltracija 10-29% u aspiratu i/ili bioptatu kostne srži Monoklonski paraprotein IgG > 35gr/L; IgA > 20gr/L; Bence Jones 1gr/24h Monoklonski paraprotein u nižoj koncentraciji od navedenih Osteolitične promene skeleta Hipogamaglobulinemija IgM < 0,5gr/L; IgA < 1gr/L; IgG < 6gr/L 2

3 Dijagnoza se može postaviti i na osnovu sledećih kriterijuma (4,5): Simptomatski multipli mijelom*: Sva 3 kriterijuma 1. 10% i veća infiltracija srži u aspiratu i/ili bioptatu kostne srži 2. Monoklonski protein u serumu i/ili urinu¹ 3. Organska disfunkcija uzrokovana aktivnošću mijeloma ( 1 kriterijum)²: (C) Povišena vrednost kalcijuma u serumu (>10,5mg/l ili >gornje granice normalnog) (R) Bubrežna insuficijencija (kreatinin >177mmol/l) (A) Anemija (hemoglobin niži <10gr/dl ili 2gr niži od normalnih vrednosti) (B) Osteolitične lezije ili osteoporoza³ *Ovim kriterijumima se definišu IB, II i III A i IIIB klinički stadijum (Durie&Salmon kriterijumi). Time se IA klinički stadijum (Durie&Salmon kriterijum) poistovećuje sa tzv. «smouldering» ili indolentnim mijelomom. ¹Ukoliko se ne detektuje monoklonski protein (nesekretorna bolest), kriterijumi neophodni za postavljanje dijagnoze su infiltracija srži 30% ili plazmocitom dokazan biopsijom tumorskog tkiva. ²Osim navedenih, dijagnostički kriterijumi mogu biti organske disfunkcije vezane za aktivnost MM-a kao što su: simptomatski hiperviskozitet, amiloidoza, rekurentne bakterijske infekcije (>2 epizode u toku 12 meseci); koje zahtevaju započinjanje terapije. ³U slučaju plazmocitoma dokazanog biopsijom tumorskog tkiva ili izolovane osteoporoze bez patoloških fraktura, kriterijum neophodan za postavljanje dijagnize MM-a je infiltracija 30% kostne srži plazmocitima. 3

4 Posebni entieti kao što su monoklonske gamapatije, indolentni mijelom i solitarni plazmocitom definišu se na osnovu u sledećih kriterijuma: MGUS: Neophodno postojanje sva 4 kriterijuma 1. Monoklonski protein u serumu i/ili urinu u niskoj koncentranciji* 2. Infiltracija srži monoklonskim plazmocitima <10% 3. Normalne koncentrancije kalcijuma, hemoglobina i kreatinina 4. Odsustvo: a) osteolitičnih lezija dokazanih radiografijom skeleta i/ili drugim radiografskim metodama; b) kliničkih i laboratorijskih znaka amiloidoze/bolesti taloženja lakih lanaca i drugih B ćelijskih limfoproliferativnih bolesti. *Definicija niske koncentrancije paraproteina: U serumu IgG<3,0gr/dl; IgA<2,0gr/dl; u urinu kappa/lambda<1,0gr/24h. Smouldering ili indolentni mijelom*: Neophodno postojanje sva 3 kriterijuma 1. Monoklonski protein u serumu i/ili urinu 2. Infiltracija srži monoklonskim plazmocitima i/ili biopsijom dokazan plazmocitom 3. Odsustvo kriterijuma za MGUS, multipli mijelom ili solitarni plazmocitom kostiju ili mekih tkiva *Ovim se definiše IA klinički stadijum mijeloma (Durie&Salmon kriterijumi) 4

5 Solitarni plazmocitom kostiju*: Neophodno postojanje sva 3 kriterijuma 1. Biopsijom dokazan izolovan plazmocitom kosti. Odsustvo drugih koštanih lezija dokazano nalazima Rtg-a skeleta, MR-om i/ili PET scan-om. Moguća je udruženost sa niskim koncentracijama monoklonske belančevine u serumu i/ili urinu. 2. Infiltracija srži monoklonskim plazmocitima <10%. 3. Odsustvo drugih znakova organske disfunkcije vezane za aktivnost multiplog mijeloma. *Definicija niske koncentracije paraproteina: U serumu IgG<3,0gr/dl; IgA<2,0gr/dl; u urinu kappa/lambda<1,0gr/24h. (5, B.Durie et al. Myeloma management guidelines: a consensus report from the Scientific Advisors of the International Myeloma Foundation. The Hematology Journal, 2003, 4, ). 5

6 Dijagnostiĉke metode U cilju dijagnostikovanja multiplog mijeloma prema navedenim kliničkim i laboratorijskim kriterijumima, neophodno je sprovođenje širokog panela dijagnostičkih testova koga čine: Osnovna (bazična) dijagnostika; Prognostički značajna dijagnostika; i Dopunska dijagnostika. (5,6) Panel osnovnih dijagnostiĉkih testova (5,6) Istorija bolesti (porodična anamneza!) i fizikalni nalaz Kompletna krvna slika sa leukocitarnom formulom Kompletna analiza biohumoralnog statusa uključujući određivanje ukupnih proteina, albumina, nivoa kalcijuma u serumu i laktat dehidrogenaze (LDH) Elektroforeza proteina u serumu sa imunofiksacijom* Nefelometrijsko određivanje koncentracije imunoglobulina* Rutinska analiza urina, i elektroforeza sa imunofiksacijom uzorka 24h urina uz kvantifikaciju monoklonske belančevine i albuminurije* Analiza i procena infiltracije patološkim plazmocitima iz aspirata i/ili bioptata kostne srži* Radiografija lobanje, cele kičme, grudnog koša, karlice i dugih kostiju¹ Određivanje koncentracije Beta2 mikroglobulina i C reaktivnog proteina (CRP). 6

7 * U dijagnostički nerazjašnjenim slučajevima neophodno je uraditi: a) Imunohistohemijsku analizu bioptata i/ili imunofenotipizaciju uzorka aspirata kostne srži u cilju dokazivanja klonalnosti plazmocitne infiltracije b) Kvantitativno određivanje slobodnih lakih lanaca u serumu u slučaju sumnje na nesekretorni mijelom Prognostiĉki znaĉajna dijagnostika: Analiza konvencionalne (metafazne) i interfazne citogenetike (FISH) na prisustvo specifičnih citogenetskih abnoramalnosti: a) de1 13q14 [metafazna citogenetika] b) del 17p; t(4;14); t(11;14); t(14;16) i t(6;14) [FISH] MR aksijalnog skeleta u slučaju sumnje na solitarni plazmocitom ili oligosekretorni oblik bolesti Dopunska dijagnostika: PET scan čitavog tela u cilju isključenja MGUS, ili ekstramedularnog mijeloma Biopsija potkožnog masnog tkiva ili rektuma u slučaju sumnje na postojanje amiloidoze Biopsija solitarne osteolizne lezije Imunofiksacija na IgD ili IgE paraprotein u slučaju negativnosti imunofiksacije na druge tipove paraproteina (5,6) ¹ Scintigrafija skeleta se NE preporuĉuje u proceni skeletnih lezija kod bolesnika sa multiplim mijelomom. U slučaju nereprezentativnog ili 7

8 negativnog radiografskog nalaza, uz postojeću sumnju na koštane lezije i/ili ektramedularnu bolest i/ili kompresiju medule spinalis, neophodno sprovesti pregled kompjuterizovanom tomografijom (CT), PET/CT ili magnetnom rezonancom (NMR). (7) Indikacije za odreċivanje odnosa slobodnih lakih lanaca u serumu Određivanje odnosa slobodnih lakih lanaca u serumu, kao parametar tumorske mase, ima 3 osnovne primene: 1. Dijagnostički kriterijum u slučaju mijeloma lakih lanaca, amiloidoze, oligosekretornog MM-a ili sumnje na nesekretorni mijelom. 2. Procena i praćenje terapijskog odgovora tokom lečenja bolesnika sa nemerljivom M komponentom ili oligosekretornim MM-om. 3. Tokom praćenja bolesnika u remisiji u slučaju sumnje na progresiju/relaps bolesti. 4. Prognostički značaj u praćenju i detekciji progresije MGUS-a, asimptomatskog mijeloma, indolentnog ili solitarnog plazmocitoma. NAPOMENA: Merljiva M komponenta se definiše kao: 10gr/l u serumu ili 200mg/24h u urinu. U slučaju dijagnostikovanog oboljenja plazmocitne loze, određivanje odnosa slobodnih lakih lanaca u serumu se NE može koristiti kao zamena za analizu uzorka 24h urina. (6,8) 8

9 Kliniĉki stadijumi i prognostiĉki faktori Najčešće primenjivani kriterijumi za određivanje kliničkog stadijuma bolesti su Durie-Salmon kriterijumi kao parametar tumorske mase (9): Durie&Salmon kriterijumi I stadijum Sve od navedenog II stadijum 1 kriterijum III stadijum 1 kriterijum Hemoglobin > 100gr/l gr/l < 85gr/l Kalcijum < 3mmol/l < 3mmol/l > 3mmol/l M komponenta IgA IgG Laki lanci u urinu < 30gr/l < 50gr/l < 4gr/24h 30-50gr/l 50-70gr/l 4-12gr/24h > 50gr/l > 70gr/l > 12gr/24h Rtg skeleta Normalan - 3 osteolizne promene Podklasifikacija A. kreatinin < 177µmol/l B. kreatinin > 177µmol/l U slučaju negativnog Rtg nalaza a sumnje na zahvaćenost skeleta potrebno je uraditi MR ili PET scan. Značaj ovih pregleda definisan je Durie-Salmon plus klasifikacijom u koju su uključeni dodadtni parametri nepovoljnog prognostičkog značaja. (10,11,12) 9

10 Durie-Salmon PLUS klasifikacija Stadijum PLUS MGUS MRI i/ili FDG PET nalaz Negativan nalaz MM IA (smouldering) MM IB MM IIA/B MM IIIA/B Solitarni plazmocitom ili ograničena bolest <5 fokalnih lezija, blaga propagacija bolesti 5-20 fokalnih lezija, umerena propagacija bolesti >20 fokalnih lezija, teška difuzna bolest A) Kreatinin <2,0mg/dl¹; Odsustvo ekstramedularne bolesti B) Kreatinin >2,0mg/dl¹; Ekstramedularna bolest ¹Dodatni parametri negativnog prognostičkog značaja: Trombociti niži od 130x10e9/l, i/ili povišena vrednost LDH Brojne multivarijantne analize mogućih prognostičkih faktora u multiplom mijelomu rezultovale su formiranjem internacionalnog prognostičkog indeksa International Staging System (ISS) kao parametra aktivnosti bolesti, kojim su definisane tri prognostički različite grupe bolesnika sa mijelomom: niskog; umerenog i visokog stepena rizika. (12) International Staging System 1 (niskog rizika) 2 (umerenog rizika) 3 (visokog rizika) β2 mikroglobulin < 3,5mg/l < 3,5mg/l > 5,5gr/l Albumin > 35gr/l < 35gr/l ili β2 3,5-5,5mg/l 10

11 Primenom ISS skora definišu se bolesnici sa veoma lošom prognozom i očekivanim preživljavanjem meseca, kao i bolesnici sa veoma dobrim preživljavanjem dužim od 5 godina. Faktori rizika koji dodatno ukazuju na agresivni tok bolesti su starost bolesnika iznad 60 godina, snižen broj trombocita (ispod 130 x 10e9/l), i povišena vrednost LDH. Sa druge strane, preživljavanje duže od 5 godina se očekuje kod bolesnika kod kojih nisu prisutni navedeni faktori rizika, delecija hromozoma 13 dokazana konvencionalnom citogenetikom i/ili kompleksne citogenetske abnormalnosti.(12) Prognostiĉki profil bolesnika sa multiplim mijelomom Primenom konvencionalne citogenetike, citogenetske abnormalnosti se registruju kod trećine bolesnika. Ovako dokazani hipodiploidni kariotip i del13 su značajni parametri nepovoljnog prognostičkog značaja. Primenom FISH-a, citogenetske abnormalnost se registruju kod više od 90% bolesnika sa mijelomom. (6,8) Analizom prognostičkog značaja nalaza konvencionalne citogenetike i 5 najčešćih citogenetskih abnormalnosti dokazanih FISH-om, definisani su visoko- i niskorizični bolesnici sa multiplim mijelomom (13,14) 11

12 1. Visokoriziĉni bolesnici (25%) Jedan od sledećih nalaza: t(4;14) FISH t(14;16) ili t(14;20) FISH del17p13 FISH Del13 ili aneuploidija metafazna citogenetika 2. Niskoriziĉni bolesnici (75%) Odsustvo visokoriziĉnih faktora i prisustvo jednog od sledećih nalaza: Hiperdiploidija t(11;14) FISH t(6;14) FISH Imajući u vidu prognostički značaj i pojedinačnu zastupljenost specifičnih citogenetskih abnormalnosti, predlog panela lokus-specifičnih FISH metodom za optimalnu dijagnostiku MM-a je: (ref. 13,14) 1. de1 13q14 2. del 17p 3. t(4;14) 4. t(11;14) 5. t(14;16) 6. t(6;14) 12

13 Procena terapijskog odgovora Visokodozna hemioterapija praćena autologom transplantacijom matične ćelije hematopoeze (MĆH), i uvođenje novih terapijskih modaliteta rezultovali su definisanjem kompletne i «čvrste» kompletne remisije kao najviših stepena postignutog terapijskog odgovora. (15) Kriterijumi terapijskog odgovora (International Myeloma Working Group uniform response criteria for multiple myeloma, 15): 1. Ĉvrsta kompletna remisija (scr) = CR PLUS Normalan kvantitativni odnos slobodnih lakih lanaca u serumu Odsustvo monoklonskih plazmocita u kostnoj srži, dokazano imunohistohemijom ili imunofenotipizacijom 2. Kompletna remisija (CR) Odsustvo paraproteina u serumu i/ili 24h urinu tokom 6 nedelja Manje od 5% plazmocita u aspiratu i bioptatu kostne srži Normalna vrednost kalcijuma Odsustvo Rtg znaka progresije na skeletu Odsustvo znaka tzv. ekstramedularne bolesti 3. Vrlo dobra parcijalna remisija (VGPR) Isključivo imunofiksacijom dokazan paraprotein, uz odsustvo istog primenom elektroforeze seruma, ili Redukcija paraproteina 90%, plus paraprotein u 24h urinu ispod 100mg/24h 13

14 4. Parcijalna remisija (PR) Održavanje tokom 6 nedelja paraproteina ili slobodnih lakih lanaca u serumu redukovanih za 50% Održavanje tokom 6 nedelja paraproteina u 24h urinu redukovanog za 90% (ispod 200mg/24h) 50% redukcija plazmocitne infiltracije srži kod bolesnika sa nesekretornim mijelomom Normalna vrednost kalcijuma Odsustvo Rtg znaka progresije na skeletu Redukcija ekstramedularne bolesti za 50% 5. Stabilna bolest (SD) Oscilacija paraproteina u serumu ±25% tokom 3 meseca Oscilacija paraproteina u 24h urinu ±25% tokom 3 meseca Odsustvo Rtg znaka progresije promena na skeletu tokom 3 meseca 6. Progresija bolesti - recidiv (PD) Prisustvo jednog od sledećih kriterijuma potvrđen u 2 uzastopna nalaza u roku od 4 nedelje: Porast paraproteina ili slobodnih lakih lanaca u serumu za više od 25% Porast paraproteina u urinu za više od 25% Infiltracija srži patološkim plazmocitima 10% Hiperkalcemija (iznad 2,65mmol/l) Pojava novih promena na skeletu ili povećanje veličine inicijalnih 50% poprečnog preseka Kod bolesnika sa nesekretornim mijelomom: Povećanje broja i veličine koštanih promena; Povišen nivo kalcijuma; povećanje plazmocitne infiltracije srži i/ili porast β2 mikroglobulina 50% u odnosu na inicijalnu vrednost NAPOMENA: Normalan odnos slobodnih kappa (3,3-19,4mg/l) i lambda (5,7-26,3mg/l) lakih lanaca u serumu se kreće u opsegu 0,26-1,65. Bolesnici sa κ/λ <0,26 se odlikuju monoklonskim λ paraproteinom, dok je κ paraproteinemija definisana sa κ/λ >1,65. 14

15 Dopunski kriterijumi terapijskog odgovora (16): Relapsirajući mijelom: Bolesnici prethodno lečeni sa najmanje jednom terapijskom linijom Relapsirajući i refraktarni mijelom: Progresija bolesti u toku «salvage» terapije ili u toku prvih 60 dana nakon poslednje terapijske linije Minimalni odgovor (MR) kod bolesnika sa relapsirajućim/refraktarnim mijelomom: a) Redukcija M komponente u serumu za 25% -49% b) Redukcija paraproteina u 24 urinu za 50-89% uz perzistiranje 24h proteinurije iznad 200mg/24h c) Redukcija veličine ekstramedularnog infiltrata 25-49% d) Otsustvo Rtg znaka progresije na skeletu Progresija indolentnog u aktivni multipli mijelom: Progresija bolesti prema IMWG kriterijumima i najmanje jedan od sledećih kriterijuma: a) Pojava novih mekotkivnih infiltrata ili koštanih lezija b) Hiperkalcemija (>2,65mmol/l) c) Pad hemoglobina najmanje 2gr/100ml d) Porast kreatinina iznad 177μmol/l 15

16 Prognostiĉki znaĉaj terapijskog odgovora Terapijske smernice savremenog lečenja multiplog mijeloma zasnovane su na analizi prognostičkog profila bolesnika, njemu prilagođenog terapijskog pristupa i proceni stepena i dužine terapijskog odgovora (17): 1. Cilj savremenog leĉenja: Postizanje CR od esencijalnog znaĉaja na tok bolesti i dužinu preživljavanja! 2. Prognostiĉki znaĉaj dužine povoljnog terapijskog odgovora: Rani recidiv (remisija kraća od 1 godine) VISOKORIZIĈNI BOLESNICI = INTENZIFIKACIJA LEĈENJA Intermedijarni proseĉni recidiv (trajanje remisije 1-3 godine) = Sekvencijalna primena NOVIH terapijskih modaliteta Kasni recidiv (remisija duža od 3 godine) = REINDUKCIJA INICIJALNOM terapijom ILI kombinacije bazirane na primeni NOVIH terapijskih modaliteta, UZ NASTAVAK LEĈENJA visokodoznom hemioterapijom i autologom transplantacijom MĆH. 16

17 Lečenje bolesnika sa multiplim mijelomom Odluka o inicijalnom terapijskom pristupu bolesniku zavisi od: Stadijuma bolesti Kliničke prezentacije (indolentni, sistemski, ili ekstramedularni mijelom) Starosti bolesnika tj. podobnosti za lečenje visokodoznom hemioterapijom Prisustva bubrežnog oštećenja Opšteg stanja Pridruženih komorbiditeta (kardiovaskularna oboljenja, dijabetes, prisustvo trombofilije i drugih trombogenih stanja) Prognostičkog profila. U zavisnosti od ovih kriterijuma, za svakog pojedinačnog bolesnika potrebno je definisati se cilj lečenja i konkretan terapijski pristup. 1. Novodijagnostikovani bolesnici u IA kliniĉkom stadijumu (Durie&Salmon) Bolesnici u IA kliničkom stadijumu bez simptoma ne zahtevaju primenu specifičnog hematološkog lečenja. Kod ovih bolesnika je indikovano praćenje hematološkog statusa u tromesečnim intervalima.(3) 17

18 2. Novodijagnostikovani bolesnici mlaċi od 65 godina Krajnji cilj lečenja ovih bolesnika je postizanje dugotrajne remisije (>10 godina) i potencijalno izlečenje (17): II i III kliniĉki stadijum (< 65 godina) 1) Hemioterapijske kombinacije sa talidomidom (CTD ili TAD) 2) Hemioterapijske kombinacije sa bortezomibom (Vel-Dex, PAD ili VTD) NAPOMENA: Terapijski izbor zavisi će od individualnog profila bolesnika: Prisustva bubrežnog oštećenja, opšteg stanja, prisustva kardiovaskularnih oboljenja, dijabetesa, trombofilije i drugih trombogenih stanja, specifičnih citogenetskih abnormalnosti, ekstramedularnog vida bolesti. 3) Kod bolesnika mlađih od 65 godina, bez bubrežnog oštećenja, nakon 4. ciklusa indukcione terapije i postignute parcijalne remisije (PR), lečenje se nastavlja primenom visokodozne hemioterapije i autologe transplantacije MĆH. 4) Kod bolesnika sa oštećenjem bubrežne funkcije koje ne zahteva hemodijalizu, koji su mlađi od 50 godina i u dobrom opštem stanju, nakon 4. ciklusa indukcione terapije i postignute PR, lečenje se može nastaviti primenom visokodozne hemioterapije redukovane za 50%. 5) Bolesnici sa bubrežnom insuficijencijom koja zahteva hemodijalizu mogu biti lečeni visokim dozama Dexamethason-a, 2 ciklusa + lečenje prema vodičima 1, 2, 3, i 4. zavisno od oporavka bubrežne funkcije.(3,17,18,19,20,21,22,23). 18

19 6) Mobilizacija sa aferezom i krioprezervacijom 5x10e6/kgTT CD34+/MĆH iz periferne krvi treba da bude sprovedena 3-5 nedelja nakon 3-4. ciklusa indukcionog lečenja, primenom mobilizacionog protokola CAD uz G-CSF. (20,21,22) 7) Visokodozna hemioterapija po protokolu Melphalan 200mg/m² praćena autologom transplantacijom MĆH iz periferne krvi treba da bude sprovedena 3-5 nedelja nakon mobilizacije i afereze MĆH. Procena terapijskog odgovora se sprovodi +100.dana od autologe transplantacije. (20,21,22) 8) «Tandem» autologa transplantacija se sprovodi u slučaju postizanja PR kao maksimalnog odgovora i to +100.dana od prve autologe transplantacije. Optimalno, «tandem» autologa transplantacija MĆH se sprovodi u prvih 3-12 meseci nakon prve transplantacije.(17,18,19,20,23) 19

20 3. Novodijagnostkovani bolesnici stariji od 65 godina Cilj lečenja ovih bolesnika je produžiti ukupno preživljavanje, uz održavanje dobrog opšteg stanja i smanjenje neophodnosti hospitalnog lečenja u najvećoj mogućoj meri. (17) II i III kliniĉki stadijum (> 65 godina) 1) Hemioterapijske kombinacije sa talidomidom (MPT ili CTD) 2) Hemioterapijske kombinacije sa bortezomibom (MPV, Vel-Dex ili VTD) NAPOMENA: Terapijski izbor zavisi će od individualnog profila bolesnika: Prisustva bubrežnog oštećenja, opšteg stanja, prisustva kardiovaskularnih oboljenja, dijabetesa, trombofilije i drugih trombogenih stanja, specifičnih citogenetskih abnormalnosti, ekstramedularnog vida bolesti. 3) Bolesnici stariji od 65 godina sa bubrežnom insuficijencijom koja zahteva hemodijalizu mogu biti lečeni visokim dozama Dexamethason-a, 2 ciklusa + lečenje prema stavovima 1 i 2. zavisno od oporavka bubrežne funkcije.(17,18,19,20) Praćenje terapijskog odgovora U slučaju otsustva povoljnog terapijskog odgovora i/ili progresije bolesti nakon 2. kompletno sprovedenog ciklusa hemioterapije, indikovan je nastavak lečenja primenom druge terapijske linije. 20

21 Specifiĉnosti leĉenja talidomidom i bortezomibom: A. Hemioterapijske kombinacije sa talidomidom i deksametazonom: Antikoagulantna profilaksa (niskomolekularni heparin i/ili peroralna antikoagulantna terapija) tokom prvih 4-6 meseci lečenja. B. MPT kombinacija ili monoterapija talidomidom: Antiagregaciona profilaksa aspirinom (100mg/dan p.o.) uz otsustvo drugih faktora rizika za tromboze. C. Pozitivna liĉna anamneza o prethodnim trombozama: Hemostatsko i genetsko ispitivanje na trombofiliju. Kod bolesnika sa trombofilijom preporučuje se lečenje bez talidomida. (7,18) D. Oštećenje bubrežne funkcije (kreatinin > 300mmol/l): Potrebno praćenje nivoa kalijuma. U slučaju perzistirajuće hiperkaliemije, obustaviti talidomid.(17,18,19,20,24,25) E. Pojava polineuropatije u toku leĉenja: Polineuropatija NCI CTC gradus 1+bol ili 2, redukcija doze talidomida (100mg/dan p.o.) ili bortezomiba (1,0mg/m²). Polineuropatija gradus 2+bol ili 3: Obustavljanje talidomida; Odlaganje primene bortezomiba do povlačenja simptoma, a nakon toga primena redukovane doze 0,7mg/m² 1x nedeljno. Polineuropatija gradus 4: Obustavljanje bortezomiba. (25) F. Hemioterapijske kombinacije sa bortezomibom Neophodna antivirusna profilaksa HZV infekcije. (25,26,27) 21

22 Terapija održavanja Postignuta parcijalna remisija: Talidomid mg/dan p.o. (3,17) Leĉenje bolesnika u relapsu multiplog mijeloma Bolesnici u relapsu multiplog mijeloma se mogu podeliti u tri grupe: Rani relaps (trajanje remisije kraće od 1 godine) Intermedijarni relaps (trajanje remisije 1-3 godine) Kasni relaps (remisija duža od 3 godine) 1. Rani relaps (remisija < 1godine), i bolesnici < 65godina: Intenzivni hemioterapijski protokoli sa bortezomibom (PAD, VDT-PACE) ili TCED kod bolesnika koji inicijalno nisu bili lečeni talidomidom. 2. Intermedijarni relaps (remisija 1-3 godine) i bolesnici 65 godina: Hemioterapijske kombinacije umerenog intenziteta sa bortezomibom (MPV, Bortezomib-Dexamethason) ili CTD kod bolesnika koji inicijalno nisu bili lečeni talidomidom. 3. Kasni relaps (remisija > 3 godine): Ponoviti inicijalno indukciono lečenje Hemioterapijske kombinacije sa bortezomibom ili talidomidom kod bolesnika kod kojih nije bio primenjen inicijalno. 22

23 NAPOMENA: Kod bolesnika u I i II relapsu primeniti lečenje prema stavovima 1, 2 i 3. Po postizanju kompletne/parcijalne remisije, primeniti talidomid kao terapiju održavanja. Kod bolesnika < 65 godina, razmotriti mogućnost autologe i/ili alogene transplantacije MĆH sa kondicionim protokolima redukovanog intenziteta. (3,17,26,27) 8. Leĉenje primarno refraktarnih bolesnika Primarno rezistentni neprogresivni bolesnici nakon indukcione terapije mogu biti lečeni primenom tandem visokodozne hemioterapije praćene autologom transplantacijom MĆH. Primarno rezistentni progresivni bolesnici mogu biti lečeni novim modalitetim u okviru kliničkih studija.(17) 9. Palijativna terapija Nakon drugog i/ili sledećih recidiva može se primeniti palijativna terapija: Cyclophosphamide 50mg/II dan p.o. ili prednisone 30mg/II dan p.o, ukoliko bolesnik nije podoban za dalje intenzivno hematološko lečenje.(3,17,26,27) 23

24 Hiperkalcemija i koštana bolest Hiperkalcemija Hiperkalcemija se javlja kod 30% bolesnika sa multiplim mijelomom, i znak je aktivne/progresije bolesti: a) Blaga hiperkalcemija (2,6-2,9mmol/l): Rehidratacija. b) Umerena-teška hiperkalcemija (kalcijum > 2,9mmol/l): 1) Rehidratacija; 2) Osmotski diuretici i/ili furosemid (80-100mg/dan); 3) Neodložna primena bisfosfonata (zolendronat 4mg i.v. u 15 min infuziji; pamidronat 90mg i.v. u 4h infuziji); 4) kalcitonin. c) Pri oštećenju bubrežne funkcije: 1) Ne preporučuje se primena zolendronata u slučaju kreatinina > 300mmol/l; 2) produžava se trajanje infuzije pamidronata preko 4h; 3) izbegavati simultanu primenu nefrotoksičnih lekova (nesteroidni antireumatici, aminoglikozidi, kontrastna sredstva). (3,7,28,29) Multiple skeletne lezije Skeletne lezije se javljaju u 90% bolesnika sa multiplim mijelomom. a) Terapijski pristup bolesnicima sa koštanim lezijama podrazumeva uz lokalnu zračnu terapiju (8-30Gy), ortopedske intervencije (kifoplastika i vertebroplastika) i dugotrajnu primenu bisfosfonata: zolendronate (4mg i.v. u 5-15min infuziji, u četvoronedeljnim ciklusima)*; ili pamidronate (90mg i.v. u 2-4h infuziji, u četvoronedeljnim ciklusima); ili clodronate (1600mg/dan p.o.). b) Indikacije za primenu bisfosfonata: Bolesnici u III kliničkom stadijumu sa izraženim koštanim lezijama, i/ili progresija bolesti u vidu novih patoloških fraktura. 24

25 c) Terapijski izbor između navedenih bisfosfonata zavisi od opredeljenja ordinirajućeg lekara i bolesnika. d) Dužina primene: 1) Optimalno tokom godinu dana lečenja; 2) Maksimalno tokom dve godine lečenja. * Primena zolendronata zahteva: a) Praćenje nivoa kreatinina. U slučaju kreatinina >265micromol/l, ne preporučuje se primena kreatinina. b) Suplementaciju preparatima kalcijuma (500mg/dan p.o.) i vitamina D (400IU/dan p.o).(3,7,28,29) 25

26 Appendix HT kombinacije sa talidomidom i visoke doze Dexamethason-a CTD Cyclophosphamide 500mg i.v. 1; 8; 15.dan. Thalidomide mg/dan p.o. Dexamethasone 40mg/dan i.v. 1-4; dana. * 4-6 tronedeljnih ciklusa. TAD Thalidomide mg/dan p.o. Doxorubicin 9mg/m² i.v. u 30min infuziji 1-4. dan Dexamethasone 40mg/dan i.v. 1-4; 9-12; dan. * 4-6 četvoronedeljnih ciklusa. Thal-Dex Thalidomide mg/dan p.o. Dexamethasone 40mg i.v. 1; 8; 15; 22. dan. * 12 četvoronedeljnih ciklusa. MPT Melphalan 4mg/m²/dan p.o. u toku 7 dana Prednisone 40mg/m²/dan p.o. u toku 7 dana Thalidomide 100mg/dan p.o. * 6 četvoronedeljnih ciklusa. TCED Thalidomide mg/dan p.o. Cyclophosphamide 400mg/m²/dan i.v. cont dana. Etoposide 40mg/m²/dan i.v. cont. 1-4.dana. Dexamethasone 40mg/dan i.v dana. * 6 četvoronedeljnih ciklusa. Visoke doze Dexamethasone-a Dexamethasone 40mg/dan i.v. 1-4; 9-12; dan. * 2-6 četvoronedeljnih ciklusa. HT kombinacije sa bortezomibom MPV Melphalan 9mg/m²/dan p.o dan. Prednisone 60mg/m²/dan p.o dan. Bortezomib 1,3mg/m² i.v. 1; 4; 8; 11; 22; 25; 29; i 32. dan. * 4 šestonedeljna ciklusa. Vel-Dex Bortezomib 1,3mg/m² 1; 4; 8; 11. dan. Dexamethasone 20mg i.v. 1; 2; 4; 5; 8; 9; 11; i 12. dan. * 8 tronedeljnih ciklusa. PAD Bortezomib 1,3mg/m² i.v. 1; 4; 8; 11. dan. Doxorubicin 9mg/m² i.v. u 30min infuziji 1-4. dana. Dexamethasone 40mg/dan i.v. 1-4; 9-12; i dana. * 4-8 četvoronedeljnih ciklusa. VTD Bortezomib 1,3mg/m² i.v. 1; 4; 8; 11. dan. Thalidomid 200mg/dan p.o. Dexamethasone 40mg/dan i.v. 1; 2; 4; 5; 8; 9; 11; 12. dan. * 3 tronedeljna ciklusa pre autosct. VDT-PACE Bortezomib 1,0mg/m² i.v. 1; 4; 8; i 11. dan Dexamethasone 40mg/dan i.v dana. Thalidomide 200mg/dan p.o dana. Cisplatinum 10mg/m²/dan i.v. cont dana. Doxorubicin 9mg/m²/dan i.v. cont dana. Cyclophosphamide 400mg/m²/dan i.v. cont dana. Etoposide 40mg/m²/dan i.v. cont dana. G-CSF 5µgr/kg TT/dan s.c. počevši od 7. dana do oporavka. * 2 šestonedeljna ciklusa. 26

27 LITERATURA 1. Tricot G. Multiple Myeloma and Other Plasma Cell Disorders. In Hoffman R. (ed): Hematology-Basic Principles and Practice, 4 th ed. Churchill Livingstone, New York, , Dispenzieri A.et al. Multiple myeloma. In Gertz A.M, Greipp R.P. (ed): Multiple Myeloma and Related Plasma Cell Disorders, Hematologic malignancies, Springer, , J.L.Harousseau & M.Dreyling on behalf of the ESMO Guidelines Working Group. Multiple myeloma: ESMO clinicam recommendations fod diagnosis, treatment and follow-up. Annals of Oncology 19, Suppl 2, , Kyle R. Diagnostic criteria of multiple myeloma. Hematol Oncol Clin North Am 6, , Durie B. et al. Myeloma management guidelines: a consensus report from the Scientific Advisors of the International Myeloma Foundation. The Hematology Journal 4, , Munshi C.N. Investigative tools for diagnosis and management. Hematology, , Roodman G.D. Skeletal Imaging anf management of bone disease. Hematology, , Kyle R.A.&Rajkumar S.V. Criteria for diagnosis, staging, risk stratification and response assesment of multiple myeloma. Leukemia, 1-7, Durie B, Salmon S. A clinical staging system for multiple myeloma. Cancer 36, ,

28 10. Bauer et al. Magnetic resonance imaging as a supplement for the clinical staging system of Durie and Salmon? Cancer, 95, , Durie et al. Whole-body F-FDG PET identifies high-risk myeloma. J Nucl Med, 43, , Greipp at al. Development of an International Prognostic Index (IPI) for myeloma: Report of the International Myeloma Working Group. Haematol J, 4 (Suppl 1), P7.1, , Stewart A.K. et al. A practical guide to defining high-risk myeloma for clinical trials, patient counseling, and choice of therapy. Leukemia 21, , Dispenzieri A. et al. Treatment of newly diagnosed multiple myeloma based on Mayo Stratification and Risk-Adapted Therapz (msmart): Consensus Statement. Mayo Clin Proc, 82(3), , Durie M.B. et al. International uniform response criteria for multiple myeloma (leading article). Leukemia 20, , Anderson C.K, Kyle A.R, Rajkumar V.S, Stewart A.K, Weber D, Richardson P. Clinically relevant end points and new drug approvals for myeloma. Leukemia 22, , San Miguel J. et al. Individualizing treatment of patients with myeloma in the era of novel agents. J Clin Oncol, 26(16), Palumbo A. & Rajkumar S.V. Treatment of newly diagnosed myeloma Spotlight review. Leukemia 1-8, Harousseau J.L. Induction treatment in multiple myeloma. Hematology, , Dispenzieri A, Rajkumar S.V. et al. Treatment of newly diagnosed multiple myeloma based on Mayo stratification of myeloma and risk- 28

29 adapted therapy (msmart): Consensus statement. Mayo Clin Proc, 82(3)m , Ljungman P.et al. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: definitions and current practice in Europe. Bone marrow transplant 37, , German Speaking Myeloma Multicenter Group. Tandem- Hochdosistherapie und autologe Transplantation gefolgt von einer Interferon-Alpha-Enhaltungstherapie vs. Thalidomid plus Tandem- Hochdosistherapie und autologe Transplantation gefolgt von einer Thalidomid-Enhaltungstherapie.Multizentrische, offene, randomisierte Sudie zur Therapieoptimierung beim Multiplem Myelom, GMMG-HD3, 1-94, Blade J. Transplantation for multiple myeloma: who, when, how often? Blood, 102, 10, , Izzedine et al. Thalidomide for nephrologist. Nephrol Dial Transplant, 20, , Palumbo et al. Thalidomide for treatment of multiple myeloma: 10 years later. Blood 111, , Rajkumar S.V. & Kyle R. Multiple myeloma: Diagnosis and treatment. In: Neoplastic Hematology-Diagnosis and treatment.ed: Tefferi A, Rajkumar S.V, Kantarjian M.H , Durie G.B, Kyle R. Et al. Myeloma management guidelines: a consensus nreport from the Scientific Advisors of the International Myeloma Foundation. The Hematology Journal, 4, ,

30 28. Smith A, Wisloff F & Simpson D. Guidelines on the diagnosis and management of multiple myeloma Br J of Haematology 132, , Ludwig H. & Zojer N. Supportive care in multiple myeloma. Best practice and research Clinical haematology 20, 4, ,

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