Background
Methods
Study design and definition
Endpoints
Statistical analysis
Results
Patients, disease, and transplant characteristics
NTD-Haplo (n = 186) | SUCBT (n = 147) | p value | |
---|---|---|---|
Follow-up, months median (range) | 22.07 (0–96.3) | 24.42 (0–83.1) | |
HSCT year, median (range) | 2014 (2008–2015) | 2011 (2007–2015) | < 0.001 |
Age, years. median (range) | 44.3 (18.5–66.1) | 42.6 (18–67.9) | 0.046 |
Recipient sex | |||
Male | 85 (45.7%) | 65 (44.2%) | 0.787 |
Female | 101 (54.3%) | 82 (55.8%) | |
Missing | 0 | 6 | |
Karnofsky performance status | |||
< 90 | 21 (12.5%) | 15 (15.31%) | 0.519 |
≥ 90 | 147 (87.5%) | 83 (84.69%) | |
Missing | 18 | 49 | |
Interval from diagnosis to HSCT, months, median (range) | 6.6 (2.1–189.6) | 6 (3–214.2) | 0.097 |
Disease status at HSCT | |||
CR1 | 130 (69.9%) | 113 (76.9%) | 0.154 |
CR2 | 56 (30.1%) | 34 (23.1%) | |
MRC risk classification | |||
Good | 16 (8.6%) | 13 (8.8%) | 0.762 |
Intermediate | 67 (36.0%) | 60 (40.8%) | |
Poor | 19 (10.2%) | 16 (10.9%) | |
Missing | 84 (45.2%) | 58 (39.5%) | |
Female donor to male recipient | |||
No | 143 (76.9%) | 108 (76.6%) | 0.952 |
Yes | 43 (23.1%) | 33 (23.4%) | |
Recipient CMV serostatus | < 0.001 | ||
Negative | 35 (19.1%) | 29 (25.9%) | |
Positive | 148 (80.9%) | 83 (74.1%) | |
Missing | 3 | 35 | |
In-vivo T cell depletion (ATG) | |||
No | 131 (71.2%) | 13 (9.0%) | < 0.001 |
Yes | 53 (28.8%) | 131 (91.0%) | |
Missing | 2 | 3 |
Engraftment
Acute and chronic GvHD
Acute GvHD II–IV [95% CI] | Acute GvHD III–IV [95% CI] | 2-year chronic GvHD [95% CI] | 2-year relapse [95% CI] | 2-year NRM [95% CI] | 2-year LFS [95% CI] | 2-years OS [95% CI] | 2-year GRFS [95% CI] | |
---|---|---|---|---|---|---|---|---|
Donor type | ||||||||
NTD-Haplo | 25.6% [19.4–32.2] | 6.8% [3.7–11.2] | 33% [25.2–40.9] | 16.6% [11.1–23.1] | 20.6% [14.7–27.2] | 62.8% [55.1–70.6] | 69.2% [61.9–76.6] | 55.5% [47.5–63.5] |
SUCBT | 28.5% [21.3–36] | 7% [3.6–12] | 37.1% [27–47.2] | 11.6% [6.9–17.6] | 48.4% [39.4–56.8] | 40% [31.5–48.6] | 41.7% [33–50.4] | 30.3% [22.3–38.3] |
p value | 0.853 | 0.997 | 0.492 | 0.709 | < 0.001 | < 0.001 | < 0.001 | < 0.001 |
HSCT year | ||||||||
≤ 2013 | 26.5% [20.6–32.9] | 6.2% [3.4–10.2] | 37.1% [29.4–44.8] | 14.1% [9.6–19.4] | 37.4% [30.5–44.3] | 48.5% [41.4–55.7] | 52.8% [45.7–59.9] | 41.1% [34.1–48.1] |
> 2013 | 27.4% [19.8–35.4] | 8% [4.1–13.6] | 27.6% [18.4–37.6] | 14.6% [8.3–22.7] | 26.3% [17.4–36] | 59.1% [48.5–69.7] | 61.4% [50.1–72.8] | 49.5% [38.9–60.2] |
p value | 0.780 | 0.483 | 0.278 | 0.834 | 0.027 | 0.022 | 0.023 | 0.142 |
Age, years | ||||||||
< 44 | 30.7% [23.7–37.9] | 6.3% [3.2–10.8] | 32.6% [24.1–41.3] | 16.5% [10.9–23.1] | 28% [20.9–35.5] | 55.5% [47.2–63.7] | 61% [53–69] | 48.2% [39.9–56.6] |
≥ 44 | 23% [16.8–29.8] | 7.5% [4.1–12.2] | 36.3% [27.4–45.2] | 11.8% [7.2–17.8] | 38.6%[30.5–46.6] | 49.6% [41.2–57.9] | 52.2% [43.7–60.7] | 39.2% [30.9–47.4] |
p value | 0.133 | 0.683 | 0.355 | 0.576 | 0.043 | 0.137 | 0.089 | 0.090 |
Karnofsky performance status | ||||||||
< 90 | 31.6% [16.9–47.3] | 14.4% [5.1–28.2] | 33.4% [14.7–53.4] | 20.5% [8.8–35.6] | 49.2% [29.9–65.9] | 30.2% [13.5–47] | 41.1% [23.4–58.8] | 22.9% [7.1–38.7] |
≥ 90 | 26.3% [20.7–32.3] | 5% [2.6–8.4] | 32.2% [25–39.6] | 12.9% [8.6–18.1] | 29.1% [22.9–35.7] | 58% [50.9–65] | 59.8% [52.8–66.8] | 49.2% [42–56.5] |
p value | 0.634 | 0.042 | 0.880 | 0.085 | 0.017 | < 0.001 | 0.007 | 0.002 |
Interval from diagnosis to HSCT, months | ||||||||
≤ 6.3 | 25.2% [18.7–32.2] | 6.3% [3.2–10.9] | 33.9% [25.3–42.7] | 15.9% [10.1–22.8] | 33.3% [25.4–41.3] | 50.8% [42.2–59.5] | 56.4% [47.8–65] | 40% [31.4–48.5] |
> 6.3 | 28% [21.3–35.1] | 7.5% [4.1–12.3] | 34.8% [25.9–43.8] | 12.9% [8.2–18.8] | 33.4% [26–41] | 53.7% [45.7–61.7] | 56.7% [48.7–64.7] | 47.7% [39.6–55.7] |
p value | 0.502 | 0.665 | 0.955 | 0.718 | 0.713 | 0.830 | 0.676 | 0.576 |
Disease status at HSCT | ||||||||
CR1 | 26.8% [21.3–32.6] | 7.3% [4.4–11.1] | 36% [28.8–43.2] | 13.9% [9.6–19.1] | 33.2% [26.9–39.7] | 52.9% [45.9–59.8] | 57.7% [50.8–64.5] | 42.8% [35.8–49.7] |
CR2 | 26.8% [17.9–36.6] | 5.8% [2.1–12.2] | 29.8% [18.3–42.2] | 15% [8.2–23.9] | 33.3% [23.1–43.9] | 51.6% [40.4–62.9] | 54.1% [42.9–65.2] | 46.2% [35.1–57.3] |
p value | 0.965 | 0.654 | 0.367 | 0.591 | 0.906 | 0.618 | 0.376 | 0.960 |
Female donor to male recipient | ||||||||
No | 25.7% [20.4–31.4] | 5.4% [3–8.8] | 32.1% [25.1–39.2] | 14% [9.7–19.1] | 30.2% [24.2–36.5] | 55.8% [49–62.6] | 60.2% [53.6–66.9] | 46.8% [39.9–53.7] |
Yes | 31.5% [21.2–42.3] | 12.3% [6–21] | 42.4% [29–55.2] | 13.3% [6.4–22.6] | 41.9% [29.8–53.5] | 44.8% [32.7–57] | 48.5% [36.2–60.8] | 36.2% [24.6–47.8] |
p value | 0.295 | 0.041 | 0.133 | 0.485 | 0.073 | 0.035 | 0.055 | 0.063 |
Acute GvHD II–IV | Chronic GvHD | Relapse | NRM | LFS | OS | GRFS | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
HR (95% CI) |
p
| HR (95% CI) |
p
| HR (95% CI) |
p
| HR (95% CI) |
p
| HR (95% CI) |
p
| HR (95%CI) |
p
| HR (95% CI) |
p
| |
Donor type | ||||||||||||||
SUCBT vs. Haplo | 1.03 (0.56–1.89) | 0.923 | 1.86 (0.70–4.95) | 0.21 | 0.81 (0.32–2.04) | 0.65 | 2.63 (1.44–4.83) | 0.002 | 1.95 (1.20–3.16) | 0.007 | 2.19 (1.31–3.65) | 0.003 | 2.39 (1.51–3.79) | < 0.001 |
Year of HSCT | 0.97 (0.85–1.11) | 0.677 | 0.91 (0.77–1.08) | 0.30 | 0.93 (0.76–1.14) | 0.50 | 1.01 (0.88–1.15) | 0.925 | 0.98 (0.88–1.10) | 0.772 | 1.00 (0.89–1.12) | 1.000 | 1.07 (0.97–1.189) | 0.197 |
Age (per 10 years) | 0.89 (0.72–1.08) | 0.236 | 1.17 (0.93–1.47) | 0.19 | 1.07 (0.80–1.42) | 0.66 | 1.20 (0.99–1.47) | 0.071 | 1.15 (0.98–1.35) | 0.096 | 1.18 (0.99–1.40) | 0.055 | 1.11 (0.96–1.29) | 0.164 |
Karnofsky PS | ||||||||||||||
≥ 90 vs. < 90 | 0.67 (0.35–1.31) | 0.243 | 1.05 (0.44–2.55) | 0.91 | 0.35 (0.15–0.81) | 0.01 | 0.60 (0.33–1.09) | 0.094 | 0.50 (0.31–0.81) | 0.005 | 0.60 (0.36–1.00) | 0.053 | 0.58 (0.36–0.92) | 0.020 |
Disease status at HSCT | ||||||||||||||
CR2 vs. CR1 | 1.16 (0.68–1.98) | 0.582 | 0.89 (0.44–1.79) | 0.74 | 0.79 (0.34–1.84) | 0.59 | 1.19 (0.70–1.20) | 0.524 | 1.07 (0.69–1.66) | 0.760 | 1.19 (0.76–1.87) | 0.457 | 0.92 (0.61–1.39) | 0.703 |
Female donor to male recipient | ||||||||||||||
Yes vs. No | 1.63 (0.97–2.73) | 0.064 | 1.15 (0.60–2.18) | 0.67 | 1.25 (0.57–2.73) | 0.58 | 1.84 (1.12–3.02) | 0.016 | 1.67 (1.11–2.53) | 0.014 | 1.67 (1.08–2.58) | 0.020 | 1.55 (1.05–2.28) | 0.027 |
Center | 0.935 | < 0.001 | 0.94 | 0.262 | 0.924 | 0.278 | 0.206 |