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Mieloma Multiplo
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MM: Sopravvivenza più lunga utilizzando i nuovi farmaci
Sopravvivenza mediana a 5 anni
≤ 65 aa > 65 aa
2006-2010 73 % 56 %
2001-2005 63 % 31 %
Mediana: 7.3 aa1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
Pe
rce
ntu
ale
de
i s
op
ravvis
su
ti
100 1 2 3 4 5 6 7 8 9
Follow-up dalla diagnosi (anni)
2006-2010
2001-2005
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Mieloma Multiplo
eleggibile al trapianto recidive/refrattari
non eleggibile al trapianto
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2008
• MPT
• MPV
2009
2010
• Bortezomib settimanale• MPR
2011
• Seconda neoplasia
• Pazienti fragili
2013
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
2014
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
pazienti non eleggibili per il trapianto
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2008
• MPT
• MPV
2009
2010
• Bortezomib settimanale• MPR
2011
• Seconda neoplasia
• Pazienti fragili
2013
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
2014
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
pazienti non eleggibili per il trapianto Nuovi Standard
MPT
(Melfalan, Prednisone,Talidomide)
approvato per pazienti
di nuova diagnosi non
elegibili per le alte dosi
di chemioterapia
età ≥ 65 anni
Italia: Luglio 2009Italia: Marzo 2009
MPV
(Melfalan, Prednisone, Velcade)
approvato per pazienti
di nuova diagnosi non
elegibili per le alte dosi
di chemioterapia
età ≥ 65 anni
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2008
• MPT
• MPV
2009• Bortezomib settimanale
2010
• Bortezomib settimanale• MPR
2011
• Seconda neoplasia
• Pazienti fragili
2013
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
2014
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
pazienti non eleggibili per il trapianto
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follow-up mediano 60.1 m
Da VMP bi-settimanale a mono-settimanale
Follow-up mediano 54 m
5aa OS VISTA VMP BW 5aaOS GIMEMA VMP OW
31% riduzione del rischio di morte
VMP VISTA VMP OW
5-anni OS (%) 46 51
mOS (m) 56,4 60,6
Dose totale pianificata, mg/m2 67.6 46.8
Dose mediana cumulata, mg/m2 38.5 40.3
% della dose pianificata 57 86.1
30% riduzione del rischio di morte
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Studi di Fase 3 pazienti
anziani con MM alla diagnosi
Studio CR (IF-) TTP, OS PN Interruzione
VISTA: VMP vs MP
San Miguel et al. N Engl J Med 2008
VMP: 33%
TTP: 24 months
OS: median not reached at 25.9 months
3-year OS: 72%
14%14 VMP
+ 19% V only
VMPT vs VMP
Palumbo et al. JCO 2010VMP: 20%
Median TTP and OSnot yet available
VMPT: 3-year PFS 75%
VMP: 3-year PFS 70%
2% 10%
VMP vs VTP
Mateos et al. Lancet Oncol2010
VMP: 22%Median TTP and OSnot yet available
2-year TTP: 72%
2-year OS: ~90%
5% 8%
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2008
• MPT
• MPV
2009• Bortezomib settimanale
2010• MPR
2011
• Seconda neoplasia
• Pazienti fragili
2013
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
2014
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
pazienti non eleggibili per il trapianto
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2008
• MPT
• MPV
2009• Bortezomib settimanale
2010• MPR
2011
• Seconda neoplasia
• Pazienti fragili
2013
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
2014
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
pazienti non eleggibili per il trapianto
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Incidence of Second Primary Malignancies in Normal Population
PY, person-year. Piedmont Cancer Registry, Italy, City of Turin, 2005-2007.
Incid
ence R
ate
(per
100 P
Y)
Years of Age
INCIDENCE – Age Specific Rates (per 100 PY)
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Retrospective Study Design
ASCT-R, autologous stem cell transplantation followed by lenalidomide
maintenance; CRD, cyclophosphamide, lenalidomide, dexamethasone; CPR,
cyclophosphamide, prednisone, lenalidomide; EMN, European Myeloma Network;
MP, melphalan, prednisone; MPR, melphalan, prednisone, lenalidomide; MPT,
melphalan, prednisone, thalidomide; NDMM, newly diagnosed multiple myeloma;
SPM, second primary malignancy; VMP, bortezomib, melphalan prednisone; VMPT,
bortezomib, melphalan, prednisone, thalidomide.
1. Palumbo A, et al. Blood. 2008;112:3107-3114.
2. Palumbo A, et al. J Clin Oncol. 2010;28:5101-5109.
Gay F, et al. Eur J Haematol. 2010;85:200-208.
www.clinicaltrials.gov.
• Times of observation were censored on Mar 15, 2011
9 EMN experimental trials
2459 NDMM Patients
CRD/CPR: n = 287
MPR: n = 685
ASCT-R maint: n = 484
VMPT: n = 2543
MP: n = 164
MPT: n = 3281
VMP: n = 2572
1798 analyzed patients(with at least 1 year of follow-up)
661 excluded patients(diagnosed in the last year; after Mar 15, 2010)
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Second Primary Malignancies and MM Progression Risk
MM, multiple myeloma; SPM, second primary malignancy.
No Lenalidomide
Pro
po
rtio
no
f p
atie
nts
All patients
Second primary malignanciesand MM progression risk
Lenalidomide
Progression or death Solid SPMs Hematologic SPMs
SPM, secondary primary malignancy.
0 20 40 60 80 100
0.00
0.25
0.50
0.75
1.00
0 20 40 60 80 1000 20 40 60 80 100
0.00
0.25
0.50
0.75
1.00
0.00
0.25
0.50
0.75
1.00
0 10 20 30 40 50 60 70 80
0.00
0.25
0.50
0.75
1.00
0 10 20 30 40 50 60 70 800 10 20 30 40 50 60 70 80
0.00
0.25
0.50
0.75
1.00
0.00
0.25
0.50
0.75
1.00
0 10 20 30 40 50 60 70
0.00
0.25
0.50
0.75
1.00
0 10 20 30 40 50 60 700 10 20 30 40 50 60 70
0.00
0.25
0.50
0.75
1.00
0.00
0.25
0.50
0.75
1.00
months months months
Palumbo et al, IMW 2011
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Rationale 1
AGE NEGATIVELY AFFECTS SURVIVAL OF ELDERLY
NEWLY DIAGNOSED MYELOMA PATIENTS
Results are shown, on a log10 scale, for analysis adjusted for gender, International Staging
System stage and creatinine. Interaction test (heterogeneity) P=0.0041.
Bringhen S, et al. Haematologica 2013; 98 (6): 980-988
L’età è un fattore negativo sulla sopravvivenza dei pazienti
di nuova diagnosi affetti da MM
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PATIENT STATUS ASSESSMENT
- Age
- ADL
- IADL
- Charlson co-morbidity score
FIT UNFIT FRAIL
Age <80 yr
ADL 6
IADL 8
Charlson 0
Fit >80 yr
ADL 5
IADL 6-7
Charlson 1
Unfit >80 yr
ADL ≤4
IADL ≤5
Charlson ≥2
Full-dose regimens
Dose level 0
Reduced-dose regimens
Dose level -1
Reduced-dose
Palliative approach
Dose level -2
New treatment algorithm for elderly MM
Go-go moderate-go slow-go
ADL, Activity of Daily Living; IADL, Instrumental Activity of Daily Living; ASCT, autologous stem cell transplantation
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2008
• MPT
• MPV
2009• Bortezomib settimanale
2010• MPR
2011
• Seconda neoplasia
• Pazienti fragili
2013
• KCyD
• VP vs VCP vs VMP pazienti ‘’frail’’
2014
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
pazienti non eleggibili per il trapianto
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2008
• MPT
• MPV
2009• Bortezomib settimanale
2010• MPR
2011
• Seconda neoplasia
• Pazienti fragili
2013
• KCyD
• VP vs VCP vs VMP pazienti ‘’frail’’
2014
• Rd vs Rd 18 cicli vs MPT 12 cicli
• Terapia continuativa vs intermittente
pazienti non eleggibili per il trapianto
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FIRST: Progression-free Survival
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Trattamenti di Induzione
MPT
(Melfalan, Prednisone,Talidomide)
approvato per pazienti di nuova diagnosi
non elegibili per le alte dosi di
chemioterapia
età ≥ 65 anni
Terapia durata definita
MPV
(Melfalan, Prednisone, Velcade)
approvato per pazienti di nuova
diagnosi non elegibili per le alte dosi
di chemioterapia
età ≥ 65 anniLuglio 2009Marzo 2009
Terapia continuativa
Rd
Lenalidomide, Desametasone
approvato per pazienti di nuova diagnosi
non elegibili per le alte dosi di
chemioterapia
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Esempio: VMP
Possibile strategia terapeutica
Terapia A
Progressione
Fixed duration treatment
Terapia B
Terapia A
Progressione
Continuous treatment
Terapia B Esempio: RD
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Terapia di induzione
consolidamento
mantenimento
Trapianto in induzione vs in recidiva
pazienti eleggibili al trapianto
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Terapia di induzione
consolidamento
mantenimento
Trapianto in induzione vs in recidiva
pazienti eleggibili al trapianto
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2016’s
VTD
PAD
TD
Rd
CRd
VRD
VDCR
ASCT
VD
Increasing of PFS, DFS and OS
…ultimo approccio: la terapia continuativa
VCD(CyBorD)
VTD/VRd
consolidamento
Btz o Len
mantenimento
2008’s
CTDTAD
KRD
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Approccio terapeutico nei pazienti elegibili al trapianto
“The Italian Real Life”
VTD x 4/6
VTD x 2
± 2nd ASCT
± thalidomide maintenance
ASCT
2017: EMA approva Lenalidomide in mantenimento
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Terapia di induzione
consolidamento
mantenimento
Trapianto in induzione vs in recidiva
pazienti eleggibili al trapianto
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Autologous transplant vs oral chemotherapy and lenalidomide in
newly diagnosed young myeloma patients: a pooled analysis
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Autologous transplant vs oral chemotherapy and lenalidomide in
newly diagnosed young myeloma patients: a pooled analysis
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PFS: protocollo EMN02/HO95
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PFS: alto rischio citogenetico
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Risultati dell’autotrapianto nel MM induzione con i nuovi farmaci
• Risposte complessive 70 - 100 %
• Risposte complete 31 - 57 %
• Sopravvivenza mediana 3 anni >85%
• PFS 3 anni >65%
• Mortalità correlata a trapianto < 2 %
• Buona qualità di vita post auto
Indicazione assoluta nei pazienti < 65/70 aa
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2012
• Poma
• CFZ
• EloRd
• DARA
2013
• Poma
• DARA
2014
• Panobinostat
• DRd
2015
• DARA
• EloRd
• KRd
2016
• DVd
• DRd
• Venetoclax
pazienti in recidiva/refrattari
Pomalidomide approvata nel 2016
Dara in monoterapia approvato nel 2017
EloRd approvato nel 2017
KRd approvato nel 2016
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2017
• Federico Silvestri Udine
• Tolomeo Anna Vercelli
• Ursoleo Paola Milano
• Garvey Kimberly Ancona
• Tomassetti Simona Rimini
• Ferrara Maria Giovanna Napoli
• Fani Arianna Firenze
• Veltroni Marinella Firenze
• Camera Andrea Caserta
• Califano Catello Pagani
• Attingenti Enrico Caserta
• Maesano Silvana Sondrio
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Domande
• Citogenetica/citofluorometria
– Eseguita in alcuni centri ma non per indirizzo
terapeutico
– Terapia Anziano
• MPT 1 centro
• VMP o Rd decisione sulla base delle caratteristiche
del paziente, malattia e logistica
– Terapia Giovane
• VTD 4icli + Auto + e VDT no Tal 2 centri Lena
• NON SEMPRE DOPPIO TRAPIANTO
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Recidiva
Difficoltà di eseguire KRd o EloRd (centri
prescrittori)
Seconodo autotrapianto considerato se almeno
24 mesi
Daratumumab difficoltà organizzative
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Algoritmo terapeutico
Diagnosi
Velcade +Thalidomide
Dexamethasone
MEL200 + SCT
(Stell Cell Transplant)
Melphalan +Prednisone+ Thalidomide
Melphalan +Prednisone +Velcade
Lenalidomide+Desametasone
< 65 y > 65 y
recidiva
Lenalidomide
Desametasone
Velcade
or
Velcade-Caelyx
Bendamustina
(+/- Velcade)
Pomalidomide+Dex
o
Daratumumab
Kyprolis
Daratumumab
Lenalidomide
Desametasone
Ixazomib
Panobinostat
Velcade
Desametasone
Daratumumab
Velcade
Desametasone
og
gi
do
man
i
Carfilzomib
Lenalidomide
Desametasone
Elotuzumab
Lenalidomide
Desametasone
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