Page 166 - Haematologica3

J. Koreth et al.
Subjectshadamedianageof64years(range:24-75),vary- ing diagnoses (53 acute myeloid leukemia [AML], 33 myelodysplastic syndrome [MDS], 20 non-Hodgkin lym- phoma [NHL], 11 chronic lymphocytic leukemia [CLL],
etc.) and disease-risk indices (low 14, intermediate 96, high/very high 28). They received T-replete 8/8 MUD (n=98) or 7/8 MMD (n=40) PBSC grafts. Median follow up in survivors was 30 months (range: 14-46).
Table 3. Summary of the secondary endpoints A (Tac/MTX)
Arm
B (Bort/Tac/MTX)
31%(18, 45) 8.9% (2.8, 19)
29%(16, 43) 8.9% (2.8, 19)
60% (43, 73) 49% (33, 64) 16% (7, 29) 32% (19, 47) 52% (35, 65)
62% (45, 74)
C (Bort/Sir/Tac)
21% (11, 34) 15% (6.5, 27)
15% (6.5, 27) 11% (3.8, 21)
55% (39, 68) 48% (33, 62) 6.4% (1.6, 16) 38% (24, 52) 55% (40, 68)
62% (46, 74)
A vs. B 0.71
0.64
0.54 0.64
0.9
0.37
0.92
0.64
0.76
0.96
P
A vs. C
0.33 0.07
0.11 0.2
0.43
0.57
0.42
0.75
0.87
0.9
A vs. B vs. C 0.36
0.1
0.15 0.6
0.66
0.64
0.62
0.74
0.95
0.98
Day 180 aGvHD* (a) grade II-IV (95% CI) grade III-IV (95% CI) Day 180 aGvHD* (b) grade II-IV (95% CI) grade III-IV (95% CI)
2y cGvHD*
All cGvHD (95% CI) Ext cGvHD (95% CI)
2y NRM* (95% CI)
2y Relapse* (95% CI) 2y PFS (95% CI)
2y OS (95% CI)
33%(20, 47) 2.2% (0.2, 10)
33%(20, 47) 2.2% (0.2, 10)
59% (43, 72) 39% (24, 53) 14% (5, 26) 32% (18, 46) 54% (38, 68)
61% (45, 74)
*cumulative incidence. P-values for cumulative incidence, PFS and OS are from Gray’s test and log-rank test measuring the difference of entire distributions between two groups. All P-values are two-sided. (a): aGvHD after relapse with IS taper included; (b): aGvHD after relapse with IS taper excluded; aGvHD: acute graft-versus-host disease; cGvHD: chronic graft-versus-host disease; Ext: extensive; IS: immunosuppression; NRM: non-relapse mortality; PFS: progression-free survival; OS: overall survival; CI: confidence interval; Tac: tacrolimus; Mtx: methotrexate; Bort: bortezomib; Sir: sirolimus.
Figure 2. aGvHD: non-relapse mortality and relapse outcomes. Cumulative incidence of (A) grade II-IV aGvHD*, (B) grade III-IV aGvHD*, (C) non-relapse mortality (NRM), and (D) relapse per treatment arm. Black indicates arm A (tac/mtx), red indicates arm B (bort/tac/mtx), and blue indicates arm C (bort/sir/tac). Gray’s test for comparing the entire distributions was used. *: Acute graft-versus-host disease (GvHD) after relapse with IS taper included. Tac: tacrolimus; Mtx: methotrexate; Bort: bortezomib; Sir: sirolimus.
A Grade II-IV Acute GvHD B
P=0.36
CD
P=0.62
Grade III-IV Acute GvHD
P=0.1
P=0.74
526
haematologica | 2018; 103(3)