Nehodgkinovi limfomi Poročilo EHA 2011 MARIJA ČEH SB NOVO MESTO
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1 Nehodgkinovi limfomi Poročilo EHA 2011 MARIJA ČEH SB NOVO MESTO
2 Folikularni limfom Najpogostejši izmed indolentnih malignih limfomov 70 % Limfom celic folikla (centrociti, centroblasti) Klinična slika: povečane periferne, hilarne in mediastinalne bezgavke, jetra, vranica, kostni mozeg Na začetku večinoma asimptomatski, 20 % B simptomi < 20 % bolnikov LDH Imunofenotip: CD19+, CD20+, CD79a+; CD21+, CD10+, CD5 -, CD43 -, CD11c -; CD23+- t (14;18)
3 Overall survival (%) Zdravljenje folikularnega limfoma (FL) N Deaths 4-year OS % % % CHOP + protitelo* ProMACE CHOP p < Čas(leta) *SWOG 9911: CHOP I-tositumomab; SWOG 9800: CHOP + MabThera 1. Fisher RI, et al. J Clin Oncol 2005; 23: Schulz H, et al. J Natl Cancer Inst 2007; 99: Pulte D, et al. Arch Intern Med 2008; 168:
4 Survival probability Bolniki v vseh prognostičnih skupinah kljub dobremu izhodu po R-KT dožive relaps Event-free survival po R-CHVP-IFN FLIPI 0 1 FLIPI 2 FLIPI FLIPI 0.0 p < Leta > 60 Čas (leta) 2. Ann Arbor stadij III or IV 3. Hemoglobin < Povišan LDH Salles G, et al. Blood 2008; 112: Bezgavke > 4 področja
5 Tumour burden Tumour burden Redefining our treatment goals: Increase the length and depth of remission Current treatment approach MabThera Chemo Disease progression Diagnosis Clinically controlled disease Molecular remission MabThera Chemo Induction Induction and maintenance Diagnosis Induction Maintenance Disease progression Clinically controlled disease Molecular remission Note: Conceptual illustration
6 Event-free rate Vzdrževalno zdravljenje z Mabtero pomembno izboljša PFS po 36 mes. sledenja (PRIMA) % Mabtera vzdrževanje Patients at risk Stratified HR = % CI: p < Čas (meseci) opazovanje % Salles G, et al. Lancet 2011; 377:42 51.
7 bolniki (%) Vzdrževalno zdravljenje z Mabtero bolniki dobro prenašajo opazovanje (n = 508) Mabtera vzdrževanje (n = 501) Kakršenkoli neželen dogodek stopnja 2 infekcije <1 Stopnja 3/4 neželeni dogodki stopnja 3/4 nevtropenija 1 4 stopnja 3/4 infekcije Salles G, et al. Lancet 2011; 377:42 51.
8 Vzdrževalno zdravljenje z Mabtero Učinkovito: pomembno izboljša PFS pri novo zdravljenih, ki so odgovorili na indukcijsko zdravljenje z Mabtero in KT Zaradi dolge razpolovne dobe je optimalen režim dajanja na 2 meseca Optimalna dolžina vzdrževalnega zdravljenja - sprejemljivo razmerje rizika/korist znotraj 2 let Dolgotrajna varnost vzdrževalnega zdravljenja: - meta-analiza - riziko infekcij se podvoji Karakteristika relapsa med vzdrževalnim zdravljenjem - preliminarni rezultati: nižja incidenca histološke transformacije (12 vs 20) Kako izboljšati kvaliteto življenja: sc. aplikacije Mabtere
9 EORTC 20981: vzdrževalno zdravljenje z Mabtero podaljša PFS v relapsu FL Mediana sledenja: 6 let PFS porast > 2.4 leti PFS (%) R-vzdrževanje mediana: 44 mes p < Čas (leta) opazovanje mediana: 16 mese. van Oers MHJ, et al. J Clin Oncol 2010; 28:
10 PFS (%) EORTC 20981: vzdrževalno zdravljenje z Mabtero podaljša PFS neodvisno od kvalitete odgovora po indukciji 100 po CR 100 po PR R-vzdrževanje mediana: 52.8 mes R-vzdrževanje mediana: 40.8 mes HR = 0.48 p = Čas (leta) opazovanje mediana: 14.4 mes HR = 0.58 p < opazovanje mediana: 15.6 mes Čas (leta van Oers MHJ, et al. J Clin Oncol 2010; 28:
11 EORTC 20981: Trend izboljšanja overall survival z vzdrževalnim zdravljenjem z Mabtero Overall survival (%) HR = 0.70 p = let Mabtera vzdrževanje: 74% opazovanje: 65% Čas (leta) van Oers MHJ, et al. J Clin Oncol 2010; 28:
12 SAKK 35/03 študija: Mabtera vzdrževanje 5 let Mabtera 375 mg/m² tedensko x 4 R PR, CR MabThera q2mo x 4 Kratko vzdrževanje Mabtera /2mes. Do relapsa (največ 5 let, 34 doz) PD SD off study 83 bolnikov, 63 bolnikov > 2 leti 48 bolnikov > 3 leta Podaljšano vzdrževanje Taverna CJ, et al. J Clin Oncol 2009; 27:Abstract 8534.
13 Zdravljenje relapsa FL 2 študiji: 1. bolniki FL (relapsed/refractory) (n = 24): 4 ciklusi R-bendamustine (ORR: 96%; CR: 71%) 2. inhl (61% FL) 4 6 ciklusi R-bendamustine, ORR: 93%; CR/CRu: 54%) Indukcija z R-bendamustinom pomembno podaljša PFS in izboljša hitrost odgovora napram R-fludarabine Varnostni profil R-bendamustin in R-fludarabin se ne razlikuje Vsi bolniki so prejemali vzdrževalno terapijo z Mabtero 1. Rummel MJ, et al. J Clin Oncol 2005; 23: Robinson KS, et al. J Clin Oncol 2008; 26:
14 Probability R-bendamustine : R-fludarabine: PFS R-bendamustine: mediana 30.4 mes p < HR = 0.50 (95% CI: ) Čas (meseci) R-fludarabine: mediana 11.2 mes. Mediana opazovanja 33 mesecev Rummel MJ, et al. Blood 2010; 116:Abstract 856.
15 Zdravljenje relapsa FL (GALLIUM (BO21223) Phase III) nezdravljeni advanced inhl (n = 1,400) GA mg + kemoterapija* (n = 700) Mabtera 375 mg/m 2 + kemoterapija* (n = 700) CR,PR GA101 vzdrževanje na 2 mes. 2 leti Mabtera vzdrževanje na 2 mes. 2 leti NCT
16 Presaditev V dobi rituximaba: v 2. relapsu, - vzdrževalno zdravljenje podaljša PFS neodvisno od vrste indukcije za več let - lahko avtopkmc, če podaljšaš za > 4-5 let pri relapsu FL: opredeliti tiste bolnike, ki bi imeli korist od presaditve: tisti z visokim rizikom: - FLIPI na začetku ali v remisiji - hiter progres po prvem zdravljenju (1-2 leti) - refrakterni na rituksimab - PET/CT+ po indukciji Mladi bolniki z visokim rizikom (relapsed/refractory) v drugi remisiji
17 Limfom plaščnih celic (MCL) Eden izmed indolentnih malignih limfomov, B-celični, 7 % NHL 90 % odkritih v razširjeni fazi, B simptomi v 1/3 primerih uvrščamo ga v nizko maligne limfome, vendar pa je potek pogosto agresiven in s tem slabše preživetje bolnikov Klinična slika: povečane bezgavke (75%), ekstranodalna prizadetost (25%): prebavila; jetra, vranica, kostni mozeg imunofenotip: pan B (CD19+, CD20+), CD5+, FMC7, redko CD5- ali CD23-, ciklin D1+ (> 90% primerov) t(11,14)
18 Preživetje (OS) glede na MIPI Overall survival according to the new prognostic index (MIPI). Hoster E et al. Hoster E, et al. Blood. 2008;111:
19 MCL MIPI (PALL) Low INT 4-5 High
20 Patogeneza MCL 1. Večina MCL izraža cyclin D1 na 11q13 - pospeši prehod celic iz G1 v S fazo in njihovo proliferacijo 2. moten odgovor na okvaro DNA, čemur sledi kromosomska nestabilnost- zaradi defekta v p53 in ATM 3. podaljšano preživetje: aktivna PI-3 kinaza/akt pot, aktivacijo nuclear faktor-kb in mutaciji p53
21 Razlogi za uporabo inhibitorjev mtor pri zdravljenju MCL 1. PI3K/Akt pot aktivna pri nekaterih MCL 2. povečana aktivnost mtor poti pri MCL 3. povečana aktivnost Akt zaradi prisotnosti inaktivne oblike PTEN -- rapamycin signifikantno zniža nivo ciklina in vitro, ob zdravljenju pa nivo ni bistveno spremenjen -- temsirolimus se z veliko afiniteto veže na FKBP12, zmanjša fosforilacijo, zavre sintezo RNA, za 15 % zmanjša sintezo proteinov
22 Terapija MCL Majhen riziko toksičnosti Grupa 3 fit kompromitirani bolniki frail bolniki Funkcija organov Funkcija organov Funkcija organov Funkcionalni status Funkcionalni status Funkcionalni status Pričakovano preživetje Pričakovano preživetje Pričakovano preživetje komorbidnost komorbidnosti komorbidnosti riziko toksičnosti riziko toksičnosti riziko toksičnosti go-go Slow go no-go Intenzivna terapija Manj intenzivna Podporna terapija Cilj: dolgo trajajoča remisija Redukcija limfoma Kontrola simptomov
23 Standardna terapija MCL indukcijska terapija: - R-CHOP/R-DAHP- sprejeto za mlajše bolnike - R-bendamustin lahko pri starejših visokodozna terapija - konsolidacija v 1. zdravljenju - v 1. relapsu second-line terapija - fludarabin vsebujoče terapije, bendamustin - alogenična presaditev pri izbranih bolnikih > kot second-line terapija - ni sprejetega standarda
24 Mlajši bolniki (<65) starejši bolniki(>65) kompromitirani dose-intensified immuno-chemotherapy (either sequential: R-DHAP/R-CHOP =>PBSCT or R-Hyper-CVAD) high tumor load: immuno-chemotherapy (e.g. R-FC) allo-transplant? radioimmunotherapy? Rituximab maintenance? First line treatment conventional immuno-chemotherapy (e.g. R-CHOP) Rituximab maintenance! radioimmunotherapy? 1. relapse immuno-chemotherapy (e.g. R-FC, R-Bendamustin) molecular approaches? autologous PBSCT radioimmunotherapy? Rituximab maintenance? higher relapse watch & wait? Rituximab monotherapy Chlorambucil Bendamustin immunochemotherapy (e.g. R-Bendamustin) molecular approaches molecular approaches: temsorolimus, Bortezomib, Lenalidomide (preferable in combination) repeat previous therapy (long remissions)
25 Učinkovitost everolimusa v relapsu/refraktorni obliki MCL everolimus in temsirolimus - obetavna aktivnost pri MCL Uporaba: * v monoterapiji - če odgovori, prejemanje dokler je toksičnost sprejemljiva * v kombinaciji: Bendamustin 90mg/m² 1-2 dan, ponovitev dan (BERT) Rituximab 375mg/m² dan 0 ali 1, ponovitev dan 28 ali 29 Temsirolimus 75mg dan 2, 8, 15, ponovitev dan 30 sinergistično delovanje novih učinkovin in protiteles Cilj: z novimi preiskavami predvsem odkriti bolnike, ki bi imeli korist od uporabe specifičnih zdravil
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