Autologous Stem Cell Transplanation as First line Treatment? (Against) Joan Bladé Berlin, September 9 th, 2011
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1 Autologous Stem Cell Transplanation as First line Treatment? (Against) Joan Bladé Berlin, September 9 th, 2011
2 Significant impact of ASCT before the availability of novel agents?
3 Randomized trials: Single auto-sct vs. conventional chemotherapy Author CR (%) PFS (meses) OS (meses) Attal et al (IFM), vs 5 28 vs vs 42 Auto-SCT Gold-standard for initial treatment in patients younger than 65 yrs.? Morgan et al (MRC), vs 9 32 vs vs 42 Only chemosensitive patients Bladé et al (PETHEMA), vs vs vs 65 Higher chemotherapy intensity Fermand et al (GMA), vs 6 25 vs vs 48 Barlogie et al (US Intergroup), vs vs vs 53
4 Who benefit from ASCT?
5 TTP according response to transplant (CR vs. PR) 1,0 0,9 0,8 Cumulative Proportion Surviving 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0,0-0,1 PR Median: 1.3 yrs CR Median: 6.1 yrs Years P= Rovira et al., EBMT 2009
6 Overall survival according response to transplant (CR vs. PR) 1,0 0,9 Cumulative Proportion Surviving 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0,0 PR Median: 4 yrs CR Median: 9.6 yrs Years p= Rovira et al., EBMT 2009
7 Which are the factors associated with CR postransplant?
8 CR after HDT According to Tumor Burden Pretransplant M-protein size CR (%) P-value Serum* - < 10 g/l g/l 15 Serum and urine** - < 10 g/l and < 0.5 g/24h g/l and / or 0.5 to 1 g/24h > 20 g/l and / or > 1 g/24h 7 *Alexanian et al, BMT 2001; 27: ** Nadal et al, BMT 2004; 33: 61-64
9 Do patients who achieve CR with primary therapy benefit from HDT/ASCT intensification?
10 Patients achieving CR with standard-dose therapy Similar PFS and OS to those in CR after HDT/ASCT* Need for controlled trials *Alexanian et al, BMT 2001; Wang et al, BMT 2010
11 Is ASCT a useful salvage therapy for patients with primary refractory myeloma?
12 HDT/SCT in Primary Refractory Myeloma Author, yr No. Pts Age (yrs.) B2M (mg/l) CR (%) EFS (yrs) OS (yrs) Alexanian et al, Blood, 1994 Vesole et al, Blood 1994 Singhal et al, BMT, 2002 Kumar et al, BMT, 2004 Alexanian et al, BMT * 7* * In patients achiving CR after HDT/SCT
13 SPANISH TRIAL PETHEMA / GEM-2000 Primary Refractory patients VBMCP/VBAD Bu/MEL-140 or MEL-200 / ASCT 81 refractory 50 stable disease (62%) 31 progressive disease (38%) CVB/ASCT or Allo-RIC* *Fludarabine/Melphalan-140
14 Overall Survival: Progressive vs Chemosensitive Disease vs No-change 1,0 0,9 Cumulative Proportion Surviving 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 Non-responsive, non-progressive Progressive disease Chemosensitive 0, Years
15 Will induction with novel agents improve the postransplant outcome?
16 Autologous transplantation Up-front therapy Pre and Post-ASCT CR Rate with old Regimens* Regimen Pre-ASCT Post-ASCT Dexa/VAD 5% 35% Cyclophosphamide/Dexa 7% 32% VBMCP/VBAD 10% 35% *Bladé et al. Blood 2010;115: ; Bladé et al. Haematologica 2010;95:702-4; Harousseau et al. ASH 2009 (abstract 353); Mellqvist et al. Cancer 2008;112:129-35; Rosiñol et al, ASH 2009 (abstract 130)
17 Autologous transplantation Up-front therapy Pre and Post-ASCT CR Rate with Novel Regimens* Regimen Pre-ASCT Post-ASCT Thal/Dex 6% 23-34% Vel/Dex 12% 33% PAD-1 24% 43% VTD 21-30% 43-52% Total Therapy III** - 56% at 2 yrs **VTD-PACE + Tandem ASCT + VTD/TD *Cavo et al, ASH 2009 (abstract 351); Rosiñol et al, ASH 2009 (abstract 130); Harousseau et al, Haematologica 2006; 91: ; Rosiñol et al, JCO 2007; 25: ; Popat et al, BJH 2008; 141: 512-6; Barlogie et al, BJH 2007; 138:
18 Best Pre-transplant Induction Old drugs vs. gentle new drug approach (VEL/DEX) vs. multidrug (VTD, VRD, PAD, VTD-PACE)? Longer EFS? Longer OS? Superior long-term outcome (cure rate)?
19 ASCT in MM Refractory disease Suboptimal response to primary therapy CR with primary therapy Highly sensitive disease (not CR) No indication No indication? Need for controlled trials Likely of benefit
20 Tandem autograft?
21 Autologous transplantation Up-front therapy Single versus double (tandem) ASCT Author No. Pts RR (%) EFS mos. OS mos. Attal et al, NEJM vs 50* (p=ns) 25 vs 30 (p=0.03) 48 vs 58 (p=0.01) Cavo et al, JCO vs 47** (p=0.008) 23 vs 35 (p=0.001) 65 vs 71 (p=ns) Sonneveld et al, Haematol vs 32*** (p<0.001) 24 vs 27 (p=0.006) 50 vs 55 (p=ns) Fermand et al, IMW vs 39*** (p=ns) 31 vs 34 (p=0.75) 57 vs 73 (p=0.09) * CR/VGPR, ** CR/nCR, *** CR
22 Autologous transplantation Up-front therapy Single versus double (tandem) ASCT Author No. Pts RR (%) EFS mos. OS mos. Attal et al, NEJM vs 50* (p=ns) 25 vs 30 (p=0.03) 48 vs 58 (p=0.01) Cavo et al, JCO vs 47** (p=0.008) 23 vs 35 (p=0.001) 65 vs 71 (p=ns) Sonneveld et al, Haematol vs 32*** (p<0.001) 24 vs 27 (p=0.006) 50 vs 55 (p=ns) Fermand et al, IMW vs 39*** (p=ns) 31 vs 34 (p=0.75) 57 vs 73 (p=0.09) * CR/VGPR, ** CR/nCR, *** CR
23 Autologous transplantation Up-front therapy Single versus double (tandem) ASCT: Systematic Review and Meta-analysis on 1608 Patients* Significantly longer EFS Kumar A et al. J Natl Cancer Inst 2009; 101:
24 AnyhelptoDr. Harousseau?
25 ASCT in MM with Induction with Long-term outcome Old Drugs Total Therapy I: 16/231 patients in continued CR after a median follow-up of 12 yrs* Single ASCT: 11/95 patients in continued CR from 8 to 15 yrs** * Barlogie et al, BJH 2007 ** Rovira et al, EBMT 2009
26 GEM05MENOS65 De novo symptomatic MM <65 yrs 1st randomization VBMCP/VBAD X 4 BORTEZOMIB** X 2 THALIDOMIDE/ DEXAMETHASONE* (TD) X 6 THAL/DEX*/ BORTEZOMIB** (VTD) X 6 ASCT (MEL200) 2nd randomization INTERFERON- 2b THALIDOMIDE THALIDOMIDE/BORTEZOMIB *Thalidomide: 200 mg/day; Dexamethasone: 40 mg on days 1-4, 9-12 **Bortezomib: 1.3 mg/m 2 on days 1,4,8, and 11 TD and VTD at 4 week-interval
27 Current PHETEMA Trial: Pre- and post-asct CR rate according to the induction regimen* Pre-ASCT Post-ASCT VBMCP/VBAD+ Bortezomib 21% 38% TD 14% 24% VTD 35% 46% *Rosiñol et al, ASH 2010
28
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