Table 2. Results of univariate analysis of factors affecting outcome.
| RI % at 2 years (95% CI) | NRM % at 2 years (95% CI) | LFS % at 2 years (95% CI) | OS % at 2 years (95% CI) | aGVHD II-IV % at 100 days (95% CI) | aGVHD III-IV % at 100 days (95% CI) | cGVHD % at 2 years (95% CI) | ||
|---|---|---|---|---|---|---|---|---|
| CD34(+) dose – quartiles (cells per kg x 10^6) | 1 (1.34-5.0) | 21 (10-36) | 19 (8-32) | 60 (45-76) | 64 (49-79) | 30 (18-42) | 6 (2-15) | 48 (32-62) |
| 2 (5.0-6.53) | 22 (11-35) | 16 (6-29) | 62 (48-77) | 68 (54-82) | 36 (23-50) | 9 (3-19) | 42 (27-56) | |
| 3 (6.53-8.25) | 27 (14-42) | 11 (4-22) | 62 (47-78) | 68 (53-83) | 29 (17-42) | 6 (2-15) | 38 (22-53) | |
| 4 (8.25-41.3) | 26 (14-39) | 19 (9-33) | 54 (40-69) | 55 (40-70) | 30 (18-43) | 18 (9-30) | 46 (31-60) | |
| P-value | 0.87 | 0.45 | 0.67 | 0.49 | 0.79 | 0.12 | 0.68 | |
| CD34(+) dose < >3 quartile cut-off point value (cells per kg x 10^6) | <8.25 | 23 (16-31) | 15 (9-22) | 62 (53-71) | 67 (58-75) | 31 (24-39) | 7 (4-12) | 43 (34-51) |
| >8.25 | 26 (14-39) | 19 (13-27) | 54 (40-69) | 55 (40-70) | 30 (18-43) | 18 (9-30) | 46 (31-60) | |
| P-value | 0.69 | 0.44 | 0.24 | 0.16 | 0.84 | 0.02 | 0.79 | |
| CD3(+) dose – quartiles (cells per kg x 10^6) | 1 (50-175.4) | 20 (10-33) | 16 (7-29) | 64 (49-78) | 70 (56-84) | 25 (14-38) | 6 (2-15) | 40 (25-55) |
| 2 (175.4-250) | 28 (15-43) | 16 (7-29) | 56 (41-71) | 65 (50-79) | 31 (18-44) | 6 (2-15) | 52 (36-66) | |
| 3 (250-347) | 32 (18-46) | 12 (5-24) | 55 (40-71) | 57 (41-72) | 23 (12-36) | 6 (2-16) | 41 (26-55) | |
| 4 (347-885) | 15 (6-26) | 21 (10-35) | 65 (50-79) | 64 (49-79) | 45 (31-59) | 20 (10-32) | 43 (28-58) | |
| P-value | 0.27 | 0.67 | 0.73 | 0.60 | 0.04 | 0.03 | 0.57 | |
| CD3(+) dose < >3 quartile cut-off point value (cells per kg x 10^6) | <347 | 27 (19-35) | 15 (9-21) | 59 (50-67) | 64 (55-72) | 26 (20-34) | 6 (3-11) | 44 (35-53) |
| >347 | 15 (7-26) | 21 (14-28) | 65 (50-79) | 64 (49-79) | 45 (31-59) | 20 (10-32) | 43 (28-58) | |
| P-value | 0.13 | 0.39 | 0.53 | 0.73 | 0.007 | 0.003 | 0.88 | |
| Interval from diagnosis to achieve CR1 | <median | 22 (14-32) | 10 (5-18) | 67 (57-77) | 68 (58-78) | 29 (21-39) | 8 (4-15) | 46 (34-56) |
| >median | 23 (15-33) | 23 (15-33) | 53 (42-64) | 60 (49-71) | 33 (24-43) | 11 (6-18) | 45 (34-55) | |
| P-value | 0.93 | 0.03 | 0.13 | 0.23 | 0.59 | 0.49 | 0.86 | |
| Interval from CR1 to transplantation | <median | 27 (18-37) | 23 (14-33) | 50 (39-62) | 52 (41-63) | 32 (23-41) | 8 (4-15) | 42 (30-52) |
| >median | 19 (11-28) | 11 (6-19) | 70 (60-80) | 75 (66-85) | 30 (21-40) | 11 (6-18) | 49 (38-59) | |
| P-value | 0.12 | 0.08 | 0.007 | 0.001 | 0.86 | 0.54 | 0.12 | |
| Female donor to male recipient | No | 23 (17-31) | 15 (10-22) | 61 (53-69) | 65 (57-73) | 30 (23-37) | 8 (4-13) | 44 (36-52) |
| Yes | 25 (10-43) | 19 (13-26) | 56 (37-75) | 61 (43-78) | 39 (22-55) | 19 (8-35) | 44 (26-60) | |
| P-value | 0.91 | 0.35 | 0.51 | 0.39 | 0.21 | 0.04 | 0.81 | |
| Cytogenetic risk | Intermediate | 18 (12-25) | 16 (11-23) | 65 (57-73) | 69 (61-77) | 30 (23-37) | 11 (8-17) | 45 (36-53) |
| Adverse | 44 (27-60) | 15 (10-21) | 41 (24-58) | 43 (27-60) | 37 (22-51) | 2 (1-11) | 40 (24-56) | |
| P-value | 0.003 | 0.64 | 0.02 | 0.004 | 0.27 | 0.09 | 0.77 | |
| In-vivo T-cell depletion | No | 24 (11-40) | 25 (10-44) | 51 (32-71) | 49 (30-69) | 38 (22-54) | 6 (1-17) | 64 (40-80) |
| Yes | 23 (17-30) | 15 (4-32) | 62 (54-70) | 67 (59-75) | 30 (23-37) | 10 (6-16) | 40 (32-48) | |
| P-value | 0.53 | 0.27 | 0.16 | 0.04 | 0.38 | 0.39 | 0.01 | |
| Donor CMV serostatus | Negative | 22 (15-30) | 13 (7-20) | 65 (56-74) | 70 (61-79) | 24 (17-32) | 8 (4-13) | 44 (35-53) |
| Positive | 27 (16-40) | 22 (15-30) | 50 (37-64) | 51 (37-65) | 44 (31-56) | 12 (6-22) | 44 (30-57) | |
| P-value | 0.46 | 0.31 | 0.16 | 0.06 | 0.005 | 0.29 | 0.87 | |
| TBI-based conditioning | No | 21 (14-28) | 16 (10-23) | 63 (54-71) | 67 (59-76) | 31 (24-39) | 11 (6-17) | 41 (32-49) |
| Yes | 30 (18-43) | 16 (10-23) | 54 (39-68) | 55 (40-70) | 30 (19-42) | 7 (2-15) | 53 (37-67) | |
| P-value | 0.08 | 0.63 | 0.04 | 0.04 | 0.65 | 0.40 | 0.31 |
Abbreviations: RI – relapse incidence; NRM – non-relapse mortality; LFS - leukemia-free survival; OS-overall survival; aGVHD – acute graft-versus-host disease; cGVHD – chronic graft-versus-host disease; CI – confidence interval; CR1 – first complete remission; CMV – cytomegalovirus; TBI – total body irradiation